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From BioWorld Today, the most respected news source to the biotech industry's executive suite for more than 20 years, comes the most in-depth industry analysis! BioWorld's Biotechnology State of the ...

From BioWorld Today, the most respected news source to the biotech industry's executive suite for more than 20 years, comes the most in-depth industry analysis! BioWorld's Biotechnology State of the Industry Report 2011 - a $299 value!

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BioWorld's Biotechnology State of the Industry Report 2011 Document Transcript

  • 1. 2011
  • 2. BioWorld®BIOTECHNOLOGY S TAT E O F T H E INDUSTRY REPORT 2 0 1 1
  • 3. The BioWorld® Biotechnology State of the Industry Report 2011Copyright © 2011BioWorld®AHC Media3525 Piedmont RoadBuilding Six, Suite 400Atlanta, GA 30305 U.S.A.All rights reserved. Printed in the United States of America. Except as permitted under the United States Copyright Act of1976, no part of this publication may be reproduced or distributed in any form or by any means, or stored in a database orretrieval system, without the prior written permission of the publisher.ISBN 978-1-931107-79-2 The BioWorld® Biotechnology State of the Industry Report 2011 is published by AHC Media, a division of Thompson Media Group LLC, 3525 Piedmont Road, Building Six, Suite 400, Atlanta GA 30305 U.S.A. Opinions expressed are not necessarily those of the publication. Mention of products or services does not constitute endorsement. BioWorld is a trademark of AHC Media. (GST Registration Number R128870672) Executive Editor: Michael Harris. Managing Editor: Amanda Lanier. Managing Editor: Lynn Yoffee. Assistant Managing Editor: Jennifer Boggs. Senior Staff Writer: Karen Pihl-Carey. Staff Writers: Trista Morrison, Tom Wall. Washington Editor: Mari Serebrov. Science Editor: Anette Breindl. European Editor: Nuala Moran. Senior Vice President/Group Publisher: Donald R. Johnston. Director of Product Management: Jane Cazzorla. Marketing Manager: Sarah Cross. Account Representatives: Matt Hartzog, Chris Wiley, Scott Robinson. Customer Service: (800) 888-3912 or (404) 262-5476 Please visit our website: www.bioworld.com Follow us on Twitter: www.twitter.com/bioworld Please note: BioWorld has made every effort to ensure that the information in this report is accurate and up-to-date, but cannot be responsible for errors, inaccuracies or changes in the data. If the reader identifies any information that is incorrect or has changed, please notify BioWorld so that it can be corrected for future editions. Send an email to Managing Editor Amanda Lanier at amanda.lanier@ahcmedia.com. Notice: This report is an information tool, and the user should make business decisions based on an independent investigation, verification and evaluation of this as well as other information relevant to the user’s business interest. BioWorld has gathered information for this work from many different sources and quotes information which has been gathered by other sources. Although BioWorld has taken reasonable steps to ensure the accuracy of this report, due to the tremendous amount of information, and the third-party control of some information, BioWorld cannot verify the accuracy of all infor- mation that it gathers and reports and thus does not warrant that the information is error-free. AS A RESULT, BIOWORLD DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE.ii BioWorld® State of the Industry Report 2011
  • 4. About BioWorld®BioWorld Today, biotechnology’s most respected news source, is read by industry professionals worldwide forits hard-hitting, objective news reporting. BioWorld Today is delivered by email every business morning, and alsois found exclusively online at www.bioworld.com. The BioWorld Online website has been internationally recog-nized as the most comprehensive resource for strategic biotechnology news and information available today.In addition to original daily news reporting, BioWorld offers an extensive searchable database with more than20 years of biotechnology archives. This site is not only a great source for insightful, up-to-the-minute newscoverage, but a veritable library of information on the developments of the industry as well. With a quick search,BioWorld subscribers have instant access to a wealth of biotechnology market intelligence from every biotechhotspot around the globe.BioWorld does not post press releases, but rather uses information that is researched and written by the topbusiness and science reporters in the industry. With nearly 20 contributors across the globe, BioWorld coversnews on public companies and hard-to-find information on private companies. Our seasoned reporters get theinside scoop on what’s happening within the corporate walls, on regulatory issues in Washington and else-where, and on scientific breakthroughs worldwide. This news coverage of the biotechnology industry is 100percent original and available only at BioWorld.All of the BioWorld resources are available for easy online searching, including: • BioWorld Today – The daily biotechnology newspaper. • BioWorld International – The weekly monitor of global biotechnology developments. • BioWorld Insight – The weekly report on all market data and business trends in biotechnology. • BioScan: The Worldwide Biotech Industry Reporting Service – The most comprehensive directory of biotechnol- ogy companies available. • The BioWorld Executive Compensation Report – An annual report revealing executive compensation data at biotechnology companies in the U.S. • The BioWorld Private Company Directory: 1,200 Biotech Companies – And Opportunities – To Watch – An essen- tial business intelligence data resource that provides in-depth profiles of privately held firms and also includes a fully-maneuverable Excel file that can be manipulated for personal business uses. • BioWorld’s Innovations in Biotechnology 2010: Visionary Start-Ups and Revolutionary Science – A landmark compilation of start-up companies and scientific advances paving the way in emerging biotech markets. • The BioWorld Obesity Report: Tipping The Market Scales With Biotech & Med-Tech Regimens – An innovative report that will help tip the market scales in your favor with the business acumen on this market that can optimize your R&D and medical efforts in fighting the Battle of the Bulge. • BioWorld Today’s Advancing Vaccines: New Science, New Opportunities – A report that synthesizes the emerg- ing science behind vaccines, and how companies are using that science against our deadliest foes: pandem- ics, cancer and HIV. • BioWorld Industry Snapshots – An exclusive online product updated daily with market data, such as col- laborations, mergers, acquisitions, financings, market cap rankings and more. • BioWorld Perspectives – A free weekly e-zine that brings you unique perspectives on the trends and issues that are shaping the biotech industry. Sign up for free at www.bioworld.com.BioWorld® State of the Industry Report 2011 iii
  • 5. • Medical Device Daily – The daily medical technology newspaper. Available every business morning via email, fax or online at www.medicaldevicedaily.com. • Medical Device Daily Perspectives – A free weekly e-zine offering unique viewpoints on developments within the medical technology industry. Sign up for free at www.medicaldevicedaily.com.For more information on BioWorld, please contact:Donald R. Johnston, Sr. VP/Group PublisherBioWorld® TodayAHC Media3525 Piedmont RoadBuilding Six, Suite 400Atlanta, GA 30305 USAPhone: 404-262-5439E-mail: don.johnston@ahcmedia.comWebsite: www.bioworld.comFollow us on Twitter: www.twitter.com/bioworldiv BioWorld® State of the Industry Report 2011
  • 6. Table of ContentsAnalysis 11Biotech ‘Just Deals With It’ in 2010 13Biotech’s IPO Rally Counters Tough Markets, R&D Setbacks 18Uncertainty Clouds Health Care Reform, FDA Approval Process 20Investments Rebounded, But European Biotechs Still Underfunded 23The Light Bulb Burns Bright in the Discovery Phase 26Financial Data 29Corporate Deals 1152010 Biotech M&As and Collaborations: ‘No Big Deal’ 117Biotech Product Development 241Report Card For Wall Street 299Stock Performance 311Restructurings 317Lawsuits 325BioWorld® State of the Industry Report 2011 v
  • 7. vi BioWorld® State of the Industry Report 2011
  • 8. List of TablesAnalysis 11Revenue of the Market-Leading Biotech Drugs in 2010 14Revenue of the Top Biotech Drugs, 2003-2010 17Financial Data 29Biotech Money Raised By Month In 2010: Jan. - Dec. 31Initial Public Offerings Of Biotechnology In 2010 32Biotechnology Follow-On Offerings In 2010 352010 Initial Public Offerings 442010 Follow-on Offerings 44Gross Proceeds of Biotech Public Stock Offerings 45Biotech Money Raised: 1997-2010 46Nasdaq Stock Index 47BioWorld Stock Index 2010 47Other Financings Of Public Biotech Companies In 2010 49 Venture Capital And Other Investments In Private 76Biotechnology Companies In 2010 76Milestone Payments From Corporate Partners in 2010 94Grants and Awards Given to Biotech Companies in 2010 101Corporate Deals 1152010-2009 M&As 1172009-2010 Biotech-Pharma Collaborations 1172009-2010 Biotech-Biotech Collaborations 1172010 Top 10 M&As 1182010 Top 10 Biotech-Pharma Collaborations 1192010 Top 10 Biotech-Biotech Collaborations 121Biotech Mergers And Acquisitions In 2010 123Biotechnology Company Deals With Pharmaceutical Companies In 2010 131Modified Deals Between Biotechs and Pharmas in 2010 159Terminated Deals Between Biotechs and Pharmas in 2010 167Manufacturing/Supply/Distribution Deals Between Biotechs and Pharmas in 2010 170Biotechnology Company Deals With Other Biotechnology Companies In 2010 179Biotech–Biotech Collaborations: Modified Agreements for 2010 205Biotech–Biotech Collaborations: Terminated Agreements in 2010 209Manufacturing, Marketing And Distribution Agreements Between Biotech Companies 211 in 2010 Collaborations Between Biotechnology Companies And Government/Nonprofit 216 Institutions In 2010Biotech Product Development 241Biotechnology Products Approved by the FDA in 2010 243Biotech Products: 1982-2010, A-Z 249FDA Actions on Pending Applications in 2010 273Licensing Applications Filed and Pending at FDA in 2010 277Recommendations by FDA Advisory Panels in 2010 282Overseas Approvals and Other Regulatory Actions in 2010 285Orphan Designations Granted in 2010 292BioWorld® State of the Industry Report 2011 vii
  • 9. Report Card For Wall Street 299U.S. Public Offering Performance By Underwriter: Jan. 1 - Dec. 31, 2010 301U.S. Public Offering Performance By Underwriter: Jan. 1 - Dec. 31, 2010 303Lead Underwriter Performance on All U.S. Offerings: Jan. 1 - Dec. 31, 2010 305Lead Underwriter Performance on All U.S. Offerings: Jan. 1 - Dec. 31, 2010 306Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 307Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 308Underwriters’ Performance on IPOs: Jan. 1 - Dec. 31, 2010 309Stock Performance 3112010 U.S. Biotechnology Stock Report 3132010 British Biotechnology Stock Report 3152010 Canadian Biotechnology Stock Report 316Restructurings 317Biotech Restructurings, Scale-Backs, Bankruptcies 319Lawsuits 325Biotech Lawsuits: Jan. 1 - Dec. 31, 2010 327viii BioWorld® State of the Industry Report 2011
  • 10. BioWorld® BIOTECHNOLOGY S TAT E O F T H E INDUSTRY REPORT 2 0 1 1BioWorld® State of the Industry Report 2011 9
  • 11. 10 BioWorld® State of the Industry Report 2011
  • 12. BioWorld® A N A LY S I SBioWorld® State of the Industry Report 2011 11
  • 13. 12 BioWorld® State of the Industry Report 2011
  • 14. State of the Industry: AnalysisBiotech ‘Just Deals With It’ in 2010By Michael J. HarrisExecutive Editor, Market Reports Recession begets lost revenue, begets exit-less strategy, Just as breaking up with a friend is almost painlessbegets displeased investors, begets downsizing, begets compared to the consequences of ending a marriage; it’s amore bad news down the line, until . . . catastrophe! Well, at lot easier to get out of a bad partnership than it is to negateleast in the automobile, housing and financial industries. the adverse cost of an incompatible acquisition. Some primary metrics in the biotechnology industry, This pharma trend-in-the-making will undoubtedlyparticularly number of deals and financing investments, take some steam out of the biotech exit strategy model, butwere officially down – but far from taking the market out of would not appear to have enough sway to critically dampenbalance or significance. down the prospects for biotechnology market growth, nor Biotechnology, with significant participation from big will it likely diminish biotech’s capacity to attract pharmapharma, embarked upon a unique biopartnering strategy suitors to contribute money and resources for its innovationlong ago that has endured through everything from biotech’s engine. The less-is-better attitude regarding M&A deals willindustry startup through the 21st century recession. And change the way things are done in the biopharma transactioneven though it may be undergoing a slight retooling in 2011 , milieu, but ultimately, the most practicable scenario thatas pharma vows to rely less on M&A as a coping strategy, that unfolds will that the M&A reticence will kindle and ignite abusiness relationship dynamic is still the keystone of both swell of activity in the less risky alternative of engaging inmarkets’ stability in the present economic environment. biopartnering transactions. Biopartnering is less an “I don’t need anyone else” An ongoing trend is observably unfolding in the market,strategy that is broadly employed in most other major as we have seen the acquisition, on average, of one large capmarkets, and more of a “let’s exploit the sum of our parts” biotech per year over the past few years and that theme hastactic. Deal-making in biotech remains almost exclusively legs, based on general industry buzz and projections thatuncopied in other markets, based not on competition of infer the futures of just about every biotech frontrunner totriumph over rivals, but on an undertaking to use the core be under big pharma M&A consideration. Market-leadingstrengths of all involved. biotechs such as Biogen Idec Inc., Human Genome Sciences Have you ever heard of Ford Motor Co. and General Inc., Amgen Inc. and Gilead Sciences Inc. seem to be onMotors Co. putting their too-big-to-fail heads together and someone’s list of most likely candidates to be acquired inproducing a product to wring market share in a competitive the current market environment. Those companies thatenvironment? Unlikely, as almost every market outside of are undergoing restructuring measures to identify anddrug development is a go-it-alone universe, rather than the cut back money-leaking aspects of their operations areelementary sum-of-our-parts model employed by biotech particularly attractive to the big pharmas that are still in theand pharma. biotechnology shopping mall. Wal-Mart and Target collaborating to market a better Biotechnology still has that sheen of innovation thatanything? Only in biotech! pharma is, at least, years away from mirroring. Although That’s how hundreds of the top-selling drugs were biopartnering is down, as shown by the data in the Dealsbrought to market, to millions of patients and by the billions chapter, in 2010 and market growth is not breaking recordsto investors. It is difficult to find a drug that has no deal in thus far in 2011 , the observable panic verifiably resides inits history. Looking at the BioWorld Top 25 Biotechnology pharma, not biotech. If biotech feels the need to worry aboutDrugs list for 2010, those 25 drugs split $84.292 billion in something, its speculative apprehension should focus on theprofit among partners, up from 2009 total of $76. 168 billion, potential of pharma to overreach in its endeavor to correct itsa 10.7 percent increase. And it is practical to consider that M&A appetite. In an effort to recover from its overindulgencenone of these therapeutics would be approved without the in biotech prix fixes, big pharma could refuse to pull theintervention of that business expedient. trigger on sound deals that might be advantageous, but would be considered “too soon” after the fallout from its M&A binge.As M&A is Out; Partnering Is in . . . Even More Even that scenario, which absolutely will not The new attitude of pharma that is guiding the senior marginalize the stride of biopartnering, is also not likelymarket to stop trying to be biotech and, instead, just try to to enduringly capsize the biopharma M&A model. Thatbe like biotech, is news that will reverberate throughout 2011 outlook is attributable to the broad industry professionaland influence industry behavior, activity and performance.BioWorld® State of the Industry Report 2011 13
  • 15. acknowledgement and projections citing biotechnology as prognostications are, VCs still prefer biotech above all otherthe drug market of the immediate future. markets on a par with the all-the-rage high technology In gradual-to-overdrive progress since the turn of the market. Biotech’s cup may not be running over and it’scentury, biotech’s rise is slowly wresting revenue market not exactly a glass-half-full/half-empty parable, so let’sshare from pharma’s 100-year grip in the drug development just agree to acknowledge that biotechnology seems tomarket, but is taking over the pace of drug development at have weathered the economic storm and is navigating itsa breakneck pace. BioWorld data reveal that biopartnering aftermath competently.deals are averaging more than one deal per day over most Usually, market leaders of the pack receiveof this 11-year-old century and that by mid-decade, more than acknowledgment, but biotech was founded to go againsthalf of the top 100 revenue-generating drugs will be biotech the grain of convention and has since been a risky market.products. That news implicates pharma’s current interest, But if you think about it, there has been nothing in its historyreliance and participation in the biotechnology market, to date – decisions, circumstances, misfortune, competition,as well as implying the practicality and probability of its etc. – that has appreciably affected the progress of biotech’sbiopartnering involvement going forward. maturation and value. Since 2010 was a flat-to-moderate Deals may be down, M&As may be in for a respite and growth market year in many essential biotech metrics andVC financing may be idling at a yellow-light intersection; was far from being the worst year, despite some cause-for-however, biotechnology drug revenue is on a decade-long concern issues that linger into 2011 , it’s practical to presumestreak of increasing value, the valve on its innovation spigot measured success in 2011 and assume market growthis stripped open, and no matter how dire the financing dominance beyond that, on schedule. Revenue of the Market-Leading Biotech Drugs in 2010 Rank Drug name (maker) Indication 2010 Revenue 1 Avastin (Roche) Colorectal cancer, non-small-cell lung cancer $7,212M 2 Rituxan (Roche) Non-Hodgkin’s lymphoma, rheumatoid arthritis $7,077M 3 Humira (Abbott) Rheumatoid arthritis, psoriatic arthritis $6,548M 4 Herceptin (Roche) Breast cancer $6,045M 5 Lantus (Sanofi-Aventis) Types I and II diabetes $4,883M 6 Remicade (J&J) Crohn’s disease, ankylosing spondylitis, arthritis, ulcerative $4,610M colitis, rheumatoid arthritis, plaque psoriasis 7 Gleevec (Novartis) Chronic myelogenous leukemia, gastrointestinal stromal tumors $4,265M 8 Neulasta (Amgen) Infection associated with chemotherapy-induced neutropenia $3,558M 9 Enbrel (Amgen) Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, $3,534M plaque psoriasis 10 Copaxone (Teva) Multiple sclerosis $3,316M 11 Taxotere (Sanofi-Aventis) Breast cancer, non-small-cell lung cancer, prostate cancer, gastric $2,953M cancer, squamous cell carcinoma of the head and neck 12 Atripla (Gilead Sci) HIV $2,927M 13 Truvada (Gilead Sci) HIV $2,650M 14 Epogen (Amgen) Anemia $2,524M 15 Avonex (Biogen Idec) Multiple sclerosis $2,518M 16 Aranesp (Amgen) Anemia $2,486M 17 Rebif (Merck Serono) Multiple sclerosis $2,323M 18 Alimta (Lilly) Lung cancer $2,209M 19 Erbitux (Lilly) Colorectal cancer, head and neck cancer $2,192M 20 Humalog (Lilly) Diabetes $2,054M 21 Procrit/Eprex (J&J) Anemia $1,934M 22 Cialis (Lilly) Erectile dysfunction $1,699M 23 Betaseron (Bayer Sch) Multiple sclerosis $1,681M 24 Lucentis (Roche) Wet age-related macular degeneration, macular edema $1,621M following retinal vein occlusion 25 Tarceva (Roche) Pancreatic cancer, non-small-cell lung cancer $1,473M Source: BioWorld research.14 BioWorld® State of the Industry Report 2011
  • 16. Biopartnering’s Impact and Value is Evident in The FDA has finally been given the authority to regulateDrug Revenues biosimilar versions of biotech brand drugs, but cannot Innovation may be where the drug development perform its legislated duties until the agency acquires thecycle begins, but commercialization is where it pays off. know-how to confidently determine just what constitutesNo matter how you look at it, big pharma’s imprint is all a biosimilar. The agency has the green light, but cannotover the final round of the process, with 18 of the top 25 find the pathway. In drug development, it seems to bedrugs bearing the names of pharma companies as the drug increasingly possible that it could take as long to enactdeveloper. relative legislation as it takes to develop a drug to market The drug is still the prize in biotech and the top- stage. Is it practical to think that the approval process forselling list of drugs in 2010 features 23 of the top revenue- each biosimilar submission will be addressed differently . . .generating drugs from the 2009 list, with only Roche’s sort of a personalized medicine approach to drug approval?Tamiflu and Amgen’s Neupogen dropping off and being But this may be rightfully so since biosimilars are slightlyreplaced by two other Roche products: Lucentis and modified versions of the drugs they aim to copy, unlikeTarceva. generics, which are exact duplicates. This difference will Each of the top four drugs, (Avastin, Rituxan, Humira likely be played out in patent wars as well as regulatoryand Herceptin) increased its revenue by more than $1 billion paths yet to be defined.over 2009 totals. All but three drugs (Enbrel, Aranesp andProcrit/Eprex) showed revenue increases compared to From the Bench: The ‘I’ Word Seeks to Offsettheir 2009 totals. the ‘P’ Word Considering its status as a pharmaceutical company, it An examination of the bench stage of R&D indicatesmay seem strange that Roche is poised to rule the biotech that the science of discovery is as vigorous as usual.drug list for the most of the present decade. The owner of Likewise, as usual, is that the bench is miles and years awayGenentech Inc. has five drugs on the top 25 list, including from the market.the top two, and three of the top four spots, and its Avastin The bench phase in the drug development cycleis projected to lead the pack through mid-decade on the is fueled by ideas, proof-of-concept and the dreadedway to becoming biotech’s first-ever $10 billion drug. designation of “potential.” In other words, it is as far from the market as an investor or R&D program can be . . . andWashington: Incredibly Busy, but no Finishing typically, much too far from commercialization to even thinkTouch about proffering the slightest guarantee of success. No one Some long-standing, critical things finally got done, is going to be persuaded into buying into a scientific paperbut did not get finalized. Do patent reform, biosimilars with the hope of overnight riches.and health care reform ring a bell? If not, there’ll be time in The potential of genomics research provided “first-time-2011(and perhaps beyond) to catch up on the relative, and ever” news of disease marker identification gene function inenduring, goings-on in those imperative market-bearing vital indication markets such as cancer on a consistent basis,issues. and even had revolutionary synthetic genomics success in Government flexed its muscle, flashed its badge and kick-starting the cellular cytoplasm process form man-madepounded its gavel on some of the industry’s most powerful genomes.companies on many occasions throughout the past year, The stage of biotechnology science discovery is muchdoling out verdicts, rejections, warnings and penalties more than concepts, but it is, even more than that, alsofor a host of proceedings, applications, shortcomings a lot less than a product. Although it may represent theand deceptions in matters involving manufacturing plant hardest sell in the drug development world, innovation atviolations, denial of obesity drug approval applications, the concept stage is, nonetheless, a powerful drug itself tounscrupulous marketing practices, patent infringement agencies, nonprofits and financiers with a vested interest inand more. particular disease indications and it even have occasional It was better to be a brand maker than a biogenerics appeal to patient investors with more altruistic or long-drugmaker, as 2010 proved to afford another year of market range pecuniary motives. The discovery phase continuedexclusivity, due to the omission of a successful conversion in 2010 to churn out bright ideas, present ground-breakingof biosimilars law into regulatory implementation. papers and display positive clinical results, not the leastThe law was passed, but the formula for biosimilar of which was the big news in CAPRISA 004 that produceddetermination remains muddled by matters of bureaucracy the historic evidence of a microbicide that showed efficacyand uncertainty, while patent-holding drug companies in helping to prevent sexual disease transmission. And notindefinitely reap market-share-as-usual profits, even just any sexual disease, rather HIV, a disease that has largelybeyond patent expirations in some cases. defied clinical therapeutic containment endeavors.BioWorld® State of the Industry Report 2011 15
  • 17. Innovation has never been one of biotech’s character many of the previous years, that the biotech market mightflaws. Its Achilles’ heel is strictly on the clout-cash-and- be apt to regain some of its vim. At the least, there wereresources back end of the drug development process. But as enough indicators to show that the market definitely hadlong as biotech continues to produce a glut of innovation, as not lost its will to the protracted slump that has suffocatedit did in 2010, something will stick to the wall and attract the many of its constituent companies, damaged its fundingpartner with the corresponding interest, the philanthropist capacities and deflated a substantial amount of thewith the apposite passion, the investor with the considered European biotechnology market’s R&D energy.instinct – and if all else fails – the government agency As more evidence that deals have emerged to be thecharged with funding the most gifted undeveloped distinguishing dynamic that anchors the global market andresearch and the most talented researchers with nascent may be even be an intervening factor in the re-emergenceprograms. of the European market, the pharma industry is candidly And a couple of the year’s most prominent story lines – acknowledging the value of biopartnering and adoptingone involving unreliable data from longevity predictor gene the new model of less upfront “signing bonus” risk, withstudies and the other culminating with the implosion of a more deference to the milestone, or back-end-laden, pay-well-known autism study – reminded that biotechnology for-results deal model. This is a model that would make theresearch is also in the invalidation business, in which it European market less of a risk to edgy pharmas that haveidentifies and challenges dubious theories and refutable become very judicious in that market. An anticipation ofscience, ideally before extensive time and resources are more brisk collaboration activity comes with the optimismcommitted to problematic research agendas. that more clinical successes will be the payoff. Europe has been under-productive in the clinic andBudget Cuts for Science’s Key Funding underfunded in the market for so long that risk hasAgencies Could’ve Been Worse become the four-letter word no one is willing to chance. The science R&D/funding arm of the U.S. government As the funding opportunities retract, it stands to reasondid not completely escape the budget-cutting swath of that in-house talent will be downsized and the ability tofederal legislation, walking away with some funding intact. compete for the best available external talent will severely The past-the-11th-hour budget deal agreement reached compromised. That is one principal consequence workingin April 2011 on Capitol Hill to keep the government from against that market now and looms to be a corollary effectshutting down included millions of dollars in funding cuts whenever that market would eventually begin to make afor several major science-funding agencies. However, that profoundly perceptible comeback move.chagrin is mitigated by the fact that the cuts affecting However, the public acknowledgement of a commitmenthealth science R&D were not as deep as initially proposed. by pharma to risk-averse biopartnering as the latest go-to The National Institutes of Health now faces a reduction dynamic that will be pursued to turn things around on theof $260 million, but that is markedly less than the $1 .6 continent, is at least a tactic that has a chance to provide anbillion figure that was earmarked for slashing in an earlier upside in a stalled market.bill that was passed by the House of Representatives. The Perhaps the biggest bad news from Europe was theDepartment of Energy’s Office of Science will undergo a spate of devastating late-stage clinical failures and new$20 million budget cut under the latest bill, compared to drug application rejections that hit that market. If that trendan $866 million reduction in the earlier House version (H.R. continues in 2011 in this already-precarious market, it would1), while the Centers for Disease Control and Prevention, be a crippling blow to any chance for a timely market-widenow faces a $730 million cut in funding, instead of the recovery in Europe.H.R. 1 amount of $1 .4 billion. None of the key agencies Baby steps are usually the first phase in any recovery,received their traditional budget increases, but the cuts so positive indicators such as Europe’s head start on theto their budgets that endow research grants and advance U.S. market in stem cell technology, clinical trial potentialinnovation started out as a threat of much more austerity. shown in under-addressed disease indications and a focus on orphan drug R&D opportunities, might not be primedIs the Sky Still Falling in Europe? to deliver the blockbuster success that the European Queue the soundbite: “This could be the year that biotechnology market most needs, but they may beEurope turns the corner, depending on a few factors such sufficient to attract enough funding, pharma deals andas . . .” clinical trial advances to persuade the chorus of Chicken For quite a few years, variations on that outlook have Little analysts and expert observers to once again don thebeen the most optimistic viewpoint to which most industry rose-colored glasses.analysts have been guardedly willing to commit. But wait! If You Innovate, They Will ComeIn 2010, there were actually indications, as there were in As far the whole market is evaluated, the menacing16 BioWorld® State of the Industry Report 2011
  • 18. force of recession and its lingering repercussions and market can still lay claim to: having a prolific sciencelooming ramifications may have sank a number of engine that delivers more innovation than the investmentcompanies and careers and been a substantial part of or R&D markets can manage; being one of the top twobiotech’s story; however growth, profitability, innovation, or three most attractive destinations for venture capitalnew product successes and investor partiality buoyed investment throughout this century; riding a long-termquite a few more companies through the year than were market growth rate that surpassed pharma’s averagelost to the roughness of the pitching market. growth and achieved overall profitability in 2010; and is Despite some declining market indicators in 2010 that poised to incrementally dominate the top-selling drugby and large reflect the economic environment, rather list on its way to becoming the predominant face of drugthan the biotech industry itself, the global biotechnology development in the 21st century. Revenue of the Top Biotech Drugs, 2003-2010 Rank Drug name (maker) 2010 2009 2008 2007 2006 2005 2004 2003 1 Avastin (Roche) $7,212M $5,832M $4,479M $4,070M $2,380M $1,133M $545M (US) 2 Rituxan (Roche) $7,077M $5,705M $5,082M $5,467M $3,881M $1,831M $1,574M $1,489M 3 Humira (Abbott) $6,548M $5,488M $4,521M $3,064M $2,044M $1,400M $852M $246M 4 Herceptin (Roche) $6,045M $4,936M $4,394M $4,809M $3,150M $2,416M $1,591M $2,064M 5 Lantus (Sanofi-Aventis) $4,883M $3,080M $3,159M $3,160M $2,172M $1,476M $1,025M $400M (US) 6 Remicade (J&J) $4,610M $4,304M $3,748M $3,327M $3,014M $2,535M $2,145M $1,729M 7 Gleevec (Novartis) $4,265M $3,900M $3,700M $3,050M $2,554M $2,170M $1,634M $1,128M 8 Neulasta (Amgen) $3,558M $3,318M $3,000M $2,710M $2,288M $1,700M $1,300M 9 Enbrel (Amgen) $3,534M $3,871M $5,982M $5,275M $4,379M $3,673M $1,900M $1,300M 10 Copaxone (Teva) $3,316M $2,800M $2,262M $1,713M $1,414M $1,176M $936M $720M 11 Taxotere (Sanofi-Aventis) $2,953M $2,177M $2,622M $2,941M $2,284M $1,956M $1,747M $1,577M 12 Atripla (Gilead Sci) $2,927M $2,382M $1,570M $903M $206M 13 Truvada (Gilead Sci) $2,650M $2,490M $2,110M $1,589M $1,190M $568M $68M 14 Epogen (Amgen) $2,524M $2,569M $2,456M $2,489M $2,511M $2,455M $2,600M $2,400M 15 Avonex (Biogen Idec) $2,518M $2,323M $2,203M $1,870M $1,710M $1,540M $1,417M $1,168M 16 Aranesp (Amgen) $2,486M $2,652M $3,137M $3,614M $4,121M $3,273M $2,500M $1,600M 17 Rebif (Merck Serono) $2,323M $2,062M $1,668M $1,912M $1,452M $1,270M $1,091M $819M 18 Alimta (Lilly) $2,209M $1,706M $1,155M $854M $612M $463M 19 Erbitux (Lilly) $2,192M $1,594M $1,457M $1,430M $1,100M $413M $261M 20 Humalog (Lilly) $2,054M $1,959M $1,736M $1,475M $1,300M $1,198M $1,102M $1,021M 21 Procrit/Eprex (J&J) $1,934M $2,245M $2,460M $2,885M $3,180M $3,324M $3,589M $3,984M 22 Cialis (Lilly) $1,699M $1,559M $1,445M $1,144M $971M $747M $552M $203M 23 Betaseron (Bayer Sch) $1,681M $1,647M $1,439M $1,586M $1,311M $1,046M $941M $926M 24 Lucentis (Roche) $1,621M $1,342M $1,076M $1,110M $535M 25 Tarceva (Roche) $1,473M $1,461M $1,361M $1,189M $911M $434M NOTE: Some figures not originally reported in U.S. dollars. Exchange rates used for conversion were for that year. SOURCE: BioWorld research from company press releases and SEC filings. Companies and/or drugs not reporting drug sales in SEC documents may be excluded.BioWorld® State of the Industry Report 2011 17
  • 19. Financings: A ‘Year in Transition’Biotech’s IPO Rally Counters Tough Markets, R&D SetbacksBy Jennifer BoggsAssistant Managing Editor With the realization that a rapid and painless economic so few buyers, it’s not really a market at all; it’s more of a club.”recovery was a mere pipe dream, 2010 brought biotech a In the year ahead, it will come down to whether themixed bag. While fundraising was up from 2009 – and the venture community can gain access to new money. Flemingindustry celebrated the creaking open of the initial public isn’t optimistic, but a few funds did manage to scrapeoffering (IPO) window – the year also was defined by a together some new cash last year. In fact, 2010 ended withnumber of surprising regulatory setbacks. reports that new firm Longwood Founders Management LLC But first, the good news. managed to raise $85 million in an inaugural fund, with the Overall, the industry managed to raise a healthy chunk aim of backing early stage innovation.of capital. BioWorld Insight reported public and privatefinancings totaling $19.3 billion for the year, up from the A Small [IPO] Window of Opportunity$17.6 billion in 2009, though that figure is still a far cry from Probably the best news of 2010 was the opening of the IPOthe $24.8 billion raised back in the pre-economic-meltdown window, following nearly two years of no IPO exits for biotech.year of 2007. BioWorld Insight reported that 19 biotechs priced on global “2010 wasn’t a horrible year, in terms of aggregate markets last year and, altogether, those offerings brought indollars,” said Glen Giovannetti, global biotechnology leader about $1 2 billion and averaged about $64 million per offering. .and Ernst & Young LLP. “But the trend continues of investors The downside was that nearly every company priced belowbeing very selective.” its anticipated range and most traded down after hitting the Private company financings were up slightly in 2010 – $4.5 market. A handful also ended up having to return to public orbillion vs. $4.3 billion in 2009. The largest venture rounds in private investors later in the year for additional capital, such as2010 included Reata Pharmaceuticals Inc., which added $78 AVEO Pharmaceuticals Inc., of Cambridge, Mass., which raised amillion in a Series G round aimed at giving the Irving, Texas- $61 million PIPE less than seven months after pricing an IPO atbased company enough runway to get its chronic kidney about a 35 percent discount to its target price.disease drug bardoxolone to the FDA. Redwood City, Calif.- And the IPO market became more uncertain as the yearbased Pearl Therapeutics Inc. also had success reaching out wore on. Fourth quarter IPOs seemed particularly harsh. Paloto new investor Vatera Healthcare Partners, which led a $69 Alto, Calif.-based Anacor Pharmaceuticals Inc. slashed itsmillion Series C round in October. offering price to $5 (from the hoped-for $16 to $18 range) and Breaking it down by round showed that 55 firms closed raised the number of shares from 4.7 million to 12 million. Anddesignated Series A financings in 2010. Total Series A funding San Diego-based specialty pharma firm Zogenix Inc. had hopedreached $774.7 million for the year. (Two companies did to sell 6 million shares priced between $12 and $14 each, butnot disclose amounts.) BioWorld Snapshots showed that 52 had to settle for pricing 14 million shares at a mere $4 each.firms raised a total of $1 . 1 billion in Series B rounds, while 30 But the rash of steeply discounted IPOs that ended 2010companies pulled in about $727.9 million in Series C funding left Forward Venture’s Fleming to believe that the windowfor the year. Eighteen firms closed Series D or later-stage is closing. “And as the window closes, strong companiesrounds, raising a total of $447. 1 million. step back. They can afford to wait,” he said. “It’s the weaker Yet, going forward, industry experts continue to expect companies that have no choice and end up being veryventure capital to contract, especially as many funds start to vulnerable to the monopolistic pricing.”reach – even exceed – their decade marks. So far in 2011 , similar stories are playing out. Four Stan Fleming, managing member at Forward Ventures, biotechs went public on Nasdaq in the first quarter – AcelRxsaid he thinks the venture community is in for a tough Pharmaceuticals Inc., Pacira Pharmaceuticals Inc., Endocyte2011 . “The overall macroenvironment is showing signs of Inc. and BG Medicine Inc. – and all slashed their offeringimprovement, but biotech is still locked in the depths of the prices by considerable margins. And Clarus Therapeuticsgreat recession. And, for the bio venture community, it’s more Inc. opted to postpone its IPO in February, citing unfavorablelike the great depression,” he said. market conditions. There’s less new money in the private market these days, As of March 31 , 13 firms have pending IPOs, and someleaving many syndicates to rely on inside rounds. And most of remain optimistic that the window will remain, thoughthe venture money remains in the hands of a few. “It’s a pretty perhaps not widely, open for additional firms to squeakinefficient market in the first place,” Fleming added. “But with through.18 BioWorld® State of the Industry Report 2011
  • 20. “I think we’ll see a similar number of companies [price a positive recommendation by the European Committee forIPOs in 2011], but stronger companies,” said Jack Florio, an Medicinal Products for Human Use. InterMune’s stock priceinvestment banker at Brinson Patrick Securities. increased 179 percent over 2009. E&Y’s Giovannetti agreed. “It’s not going to be a bull rush,” Others weren’t so lucky. Another FDA surprise, thehe noted, but for companies in Phase II- or Phase III-stage rejection of once-weekly GLP-1 drug Bydureon (exenatide),development, with validating partnerships and a solid R&D sent shares of partners Amylin Pharmaceuticals Inc. andplan, the IPO will remain a possible exit. Alkermes Inc. falling. And the long-awaited obesity drugs For companies already established on the public markets, failed to get past the agency. Arena Pharmaceuticals Inc.,most were able to go to investors when they needed in 2010, which boasted only an early stage pipeline beyond obesitywith 72 follow-on offerings last year vs. 54 offerings in 2009. candidate lorcaserin, was one of the biggest decliners of theBut the amounts were more conservative. In 2010, follow-ons year, sinking about 52 percent.raised $5.6 billion and averaged $78. 1 million each, while Other decliners included Affymax Inc., which fell 73fewer offering in 2009 brought in $6.5 billion and averaged percent for the year, primarily due to disappointing safety$120.5 million each. data in its top-line results for anemia candidate Hematide, But in 2010, biotech also began embracing some of the the drug it was hoping to position against Thousand Oaks,financing vehicles that have been used for years in other Calif.-based Amgen’s Aranesp (darbepoetin alfa). RNAi firmindustries, Florio said. Brinson Patrick recorded 25 at-the- Alnylam Pharmaceuticals Inc. also declined last year – by 44market financings in 2010 compared to only nine the year percent – after Novartis AG declined a $100 million option tobefore. And equity credit lines continued to be a popular all of Alnylam’s targets under the firms’ collaboration, andflexible financing tool, with about a dozen of those in 2010. partner Roche AG announced in November that it planned to discontinue efforts in RNAi. Cambridge, Mass.-based AlnylamBiotech and Wall Street in 2010 also cut its staff by 25 percent in September. Stock activity in the always-volatile biotech industry hadits ups and downs in 2010. As a whole, the industry held its Industry Remains in Cost-Cutting Modeown. The AMEX Biotech Index jumped 37.7 percent over 2009, As in 2009, last year saw more than its share of dramaticwhile the Nasdaq Biotech Index gained 15 percent. Biotech restructurings, and those cuts left firms leaner and forcedheavyweights Celgene Corp. and Amgen Inc. remained fairly many to cut programs that either weren’t producing or weresteady, up 6 percent and down 3 percent, respectively. too long term. Gilead Sciences Inc. dropped 16 percent in 2010, while Basel, Switzerland-based Roche’s RNAi exit, whichBiogen Idec Inc.’s stock gained 25 percent over 2009. Genzyme resulted in a 6 percent workforce reduction – about 4,800Corp., coming off a disastrous 2009 on manufacturing employees – represented more than half of the roughlytroubles related to its leading enzyme replacement therapies, 7,600 jobs lost in 2010, according to BioWorld Snapshots. Thatrebounded in 2010, jumping 45 percent for the year due to figure compares to about 5, 100 jobs cut in 2009. While fewerSanofi-Aventis SA’s buyout bid. Cambridge, Mass.-based companies reported cutbacks in 2010 – 33 vs. 85 – biotechGenzyme and Paris-based Sanofi finally reached a $20. 1 executives still faced realizations that they would need tobillion deal, plus contingent value rights largely connected to concentrate resources on only the most advanced promisingthe success of multiple sclerosis candidate alemtuzumab, in candidates.February. South San Francisco-based Exelixis Inc., for instance, Unlike 2009, the big stock winners of 2010 weren’t easy dropped work on all of its internal programs except for XL184,to spot. In 2009, the industry had Human Genome Sciences a dual MET/VEGFR inhibitor that yielded stellar Phase II data.Inc., which saw its stock surge more than 1 ,000 percent on And Biogen Idec Inc., of Cambridge, Mass. said in Novemberpositive late-stage data for now-approved lupus drug Benlysta that it was moving out of the cardiovascular and oncology(belimumab), and Dendreon Corp., which soared following arenas to focus more efforts on its more lucrative franchises,approval of the first cancer vaccine Provenge (sipuleucel-T). including multiple sclerosis. Regulatory triumphs were harder to come by in 2010. Companies could continue to make cutbacks in 2011 ,In fact, drug approvals were down – 21 biologics license but it’s unlikely the wave of restructurings that plagued theapplication and new molecular entity approvals last year vs. industry over the past two years will continue. If 2010 taught26 in 2009 – though part of that was due to fewer companies the sector anything, it’s that capital efficiency should be afiling for approval in 2010. long-term strategy rather than a short-term solution. But the FDA stunned Wall Street in May by rejecting “It was a year in transition,” said Brinson Patrick’s Florio.InterMune Inc.’s idiopathic pulmonary fibrosis drug “In 2009, folks were scrambling to survive and just waitingpirfenidone, though the Brisbane, Calif.-based firm ended up for everything to get back to normal, but this is the newas one of the sector’s biggest gainers for the year, thanks to normal.”BioWorld® State of the Industry Report 2011 19
  • 21. The View from WashingtonUncertainty Clouds Health Care Reform, FDA Approval ProcessBy Mari SerebrovWashington Editor From beginning to end, 2010 was riddled with uncertainty, and restrict substitution, which would set up a systemespecially in Washington, D.C. encouraging multiple competing brand biologics with no Take the Affordable Care Act (ACA), the health care reform competition from biogenerics.legislation passed last spring amid much fanfare among the Because of the iffyness of this regulatory latitude, someDemocrats in the 111th Congress. The law promised biotechs companies have continued following the old route, pursuinga biosimilar pathway with 12 years of exclusivity, a share of biologic license applications (BLAs) for their biosimilars,$1 billion in R&D tax credits and grants, and a bigger market rather than chasing down the new 351(k) pathway. Tevadue to expanded health insurance coverage. Pharmaceuticals, for instance, filed traditional BLAs for In exchange, biotechs would have to be more upfront two biosimilars, its granulocyte-colony stimulating factorabout conflicts of interest and cough up some of the $90 product and its Neupoval version of Amgen Inc.’s Neupogen.billion in taxes that would be levied against pharmaceutical Merck scrapped plans for MK-2578, a biosimilar tocompanies over a 10-year period. Amgen’s Aranesp, after the FDA said it would require trials From the outset, the voluminous law was punctuated evaluating the cardiovascular effects of the drug. But Merck,with question marks. Namely, could it survive a court battle? hoping the agency would be less rigorous in what it requiresToday, several states are challenging the constitutionality of from other biosimilar candidates, said it expected the newmandating health care coverage, the linchpin of the act, all abbreviated pathway to help it get its remaining portfolio ofthe way to the Supreme Court. If that part falls, the entire law biosimilars to market.could be rendered void because Congress didn’t include a The fact that Sandoz had to sue to get the agency to act onseverability clause. (Such a clause permits a part of a law, if its biosimilar growth hormone Omnitrope and consideringdeemed unconstitutional, to be removed while keeping all that the Office of Generic Drugs sat on abbreviated new drugother provisions intact.) applications (NDAs) for three generic versions of Sanofi- Regardless of what happens in the courts, the 112th Aventis SA’s blood thinner Lovenox (enoxaparin) for moreCongress, which has more of a Republican complexion, than five years, had industry experts predicting it would beis trying to undo various parts of the bill. Even President a long time before the FDA establishes a reliable, predictableBarack Obama has some changes he wants to make. In 351(k) pathway that applicants can use with some confidence.his 2012 budget request in February, the president called Last year, the FDA finally approved Momentafor cutting the exclusivity period for biosimilars to seven Pharmaceuticals Inc.’s generic Lovenox, which it developedyears and prohibiting “evergreening,” a process that would in partnership with Sandoz, the generic unit of Novartisallow brandmakers to tweak their products and receive AG. The agency said the approval process took so longan additional 12 years of exclusivity. Rep. Henry Waxman because it had to determine whether it had the authority to(D-Calif.) also has renewed his fight for shorter exclusivity. review a complex generic drug like Lovenox. It also had to develop criteria to demonstrate the generic’s “sameness” to the brand product, and it had to address potential heparinBiosimilars put into law, but not into practice contamination issues, after tainted products from China While the future of the 12-year exclusivity may be caused several deaths.in doubt, the entire approval pathway for biosimilars isshrouded in uncertainty as industry waits to see how the FDAwill implement it. The problem is that the ACA doesn’t clearly ACA Raised More Issues than it Resolved in 2010map out a pathway; rather, it gives the FDA a destination and Meanwhile, other provisions of the ACA, should it survivesays, “Go find it.” the court challenges, could remain up in the air because of Thus, the agency is theoretically left with the discretion pressure to curb spiraling federal deficits. In the midtermto approve a biosimilar without any sort of clinical testing elections in November, Republicans swept the House andoutside of basic pharmacokinetic/pharmacodynamic gained seats in the Senate on a pledge to cut governmentstudies and declare it interchangeable with the reference spending.drug – even if it has undefined “minor differences” from the That pledge clouds the chances for getting programsoriginal. such as the Cures Acceleration Network (CAN) funded. However, it also could require strenuous clinical trials The ACA included $500 million in funding for the network,20 BioWorld® State of the Industry Report 2011
  • 22. designed to speed development of therapies that might in a way that is efficient, predictable and well-coordinatednot otherwise be funded by the marketplace. The big within FDA,” PhRMA said.question now is whether the network will be funded by the Regulatory uncertainty also was reflected in the druggovernment. candidates the FDA rejected. Three widely anticipated Unable to pass a budget for fiscal 2011 , which started new weight loss therapies – Vivus Inc.’s Qnexa, Arenalast October, Congress has kept the government afloat for Pharmaceuticals Inc.’s Lorcaserin and Orexigen Therapeuticsmore than half a year on continuing resolutions (CRs) tied Inc.’s Contrave – were not approved. Instead, the agencyto 2010 spending levels. The CRs don’t include funding for issued complete response letters for Qnexa and Lorcaserin,new programs such as CAN. If the network eventually gets neither of which got the support of the Endocrinologic andbudgeted this year, the National Institutes of Health plans Metabolic Drugs Advisory Committee.to roll it into its National Center for Advancing Translational More questions were raised when some notable drugsSciences that’s set to open Oct. 1 . were pulled from the market or had their availability severely Another ACA provision that could be undermined restricted: the weight loss drug Meridia, the diabetes drugbecause of funding is the Patient-Centered Outcomes Avandia and the painkillers Darvon and Darvocet.Research Institute, a nonprofit corporation tasked with The future of accelerated approvals also becameidentifying priorities for comparative-effectiveness research dubious as the FDA hardened its stance on the approvals(CER).The health care act mandated that $10 million be set in an effort to avoid potential future problems. The agencyaside in fiscal 2010 to fund the institute, $50 million in fiscal revisited several past accelerated approvals– Roche AG’s2011 and $150 million next year. Avastin for breast cancer, Pfizer Inc.’s Mylotarg for acute The institute became a reality in September when 19 myeloid leukemia and Shire plc’s ProAmatine for orthostaticboard members were named to serve staggered terms. But hypotension.continued funding remains an issue for the corporation In addition, it refused to consider Roche and Immunogencharged with carrying out CER – one of the most contentious Inc.’s trastuzumab-DM1 for accelerated approval, despitemeasures for industry in the health care reform law. the fact that it has shown activity in HER-2 positive breast Fearing that “comparative effectiveness” would cancer patients who have failed multiple courses of priortranslate to “cost effectiveness,” the Biotechnology Industry therapy.Organization fought hard to ensure the act specifically One of the issues the FDA cited with acceleratedprohibited the government from denying coverage solely on approvals was getting companies to come up with thethe basis of CER data. However, the trade group remained follow-up data to support the approval in a timely manner.concerned about how CER would be implemented over time. For instance, Mylotarg was approved in 2000, but Pfizer Some experts worried that CER would create a barrier (then Wyeth) didn’t start the confirmatory studies until 2004.that makes existing products in the marketplace far more In the case of Avastin, the FDA yanked the HER2-competitive while holding newer, more innovative products negative metastatic breast cancer indication becauseto tougher approval standards. four follow-up studies failed to demonstrate that the drug prolonged overall survival in breast cancer. They also didn’tFDA’s Half-Empty/Half-Full Performance confirm the magnitude of benefit originally observed in the Even without CER fully in force, the FDA’s approval randomized, multicenter, open-labeled E2100trial, whichprocess was unpredictable in 2010. Citing a drop in the showed a 52 percent increase in progression-free survivalnumber of applications, the agency approved 21 new in patients treated with Avastin.molecular entities last year, down from 25 in 2009 and 24 The FDA’s Risk Evaluation and Mitigation Strategyin 2008. Although the agency hit or surpassed its 90 percent (REMS) authority is one way the agency could forcePDUFA goal for timely reviews of standard NDAs/BLAs last companies to go to market with plans already in handyear, only 78 percent of priority NDAs/BLAs with 2010 PDUFA for following up on accelerated approvals. But with nodates were reviewed within six months. final REMS guidance from the FDA, and what appear to be That’s worrisome for the pharmaceutical industry, inconsistencies between the 2009 draft guidance and thewhich started negotiating the reauthorization of PDUFA law establishing REMS, drugmakers have been left withoutwith the FDA last year. Before the negotiations began on much clarity.new user fees and performance requirements for the FDA, The ambiguities increased as the FDA moved towardthe Pharmaceutical Research and Manufacturers of America requiring REMS for classes of drugs last year. In addition to(PhRMA) identified timely review of new applications as a the growing number of REMS, numerous public commentscritical issue. on the draft guidance raised concerns about the costs and “It is essential that new drug reviews be accomplished time-consuming burdens for drugmakers, prescribers and pharmacies involved in implementing the programs.BioWorld® State of the Industry Report 2011 21
  • 23. Law & Order: Washington - Government Gets An Impending Court Ruling and a Looming Pat-Tough on Drugs ent Reform Bill Have Blockbuster Implications REMS implementation also raised another question: How As if fears of criminal prosecutions, hefty fines andwould monetary fines be imposed for noncompliance?For debarment from federal programs and increased FDAinstance, if a pharmacy or prescriber failed to give a patient authority weren’t enough to worry about, industry alsothe required medication guide, could the drugmaker be fined saw the underlying foundation for several key biotech$250,000 for “every single” medication dispensed without patents seriously threatened in 2010.the guide? In a sweeping summary judgment against Myriad Aside from possible REMS penalties, biopharmaceuticals Genetics Inc., Judge Robert Sweet of the U.S. District Courtfaced a growing danger of criminal prosecution in 2010 as the for the Southern District of New York in Manhattan ruled thatDepartment of Justice (DOJ) stepped up investigations into off- the U.S. Patent and Trademark Office (PTO) had improperlylabel violations and fraud allegations. Drugmakers, including granted seven BRCA gene patents to Myriad because theyAllergan Inc., Novartis AG and AstraZeneca plc, were involved involved a law of nature. If allowed to stand, the decisionin eight of 10 of DOJ’s fraud-related settlements last year. could eliminate the validity of all gene patents. In addition, the government collected about $3. 1 billion Myriad appealed the case, brought in May 2009 by theunder the False Claims Act in fiscal 2010, with about 80 American Civil Liberties Union and a coalition of patients,percent of that coming from health care companies. Many of pathologists, genetic researchers and other scientists thatthe cases resulted from whistle-blower suits. argued gene patents stifle research and competition and To curb off-label promotion and kickbacks, government limit options for medical care.officials proposed using a statute that permits prosecutors The U.S. Court of Appeals for the Federal Circuit isto charge executives with a misdemeanor offense of not expected to rule on the appeal by early fall. But ultimately,acting as a responsible corporate officer if a company fails the issue appears to be destined for the U.S. Supremeto comply with misbranding rules. Court. To strengthen that club, the Department of Health and The ruling came as industry faced a steep patent cliffHuman Services’ Office of Inspector General proposed as patents on several blockbuster drugs began to expire.excluding culpable individuals from future participation Amid pipeline worries, drugmakers had to continue toin Medicare and Medicaid if their company violates off- contend with a long wait to get new patents through thelabel promotion rules. Such exclusion could effectively ban PTO, which struggled with a historic logjam created, incompany officials or staff from the health care industry. part, by Congress raiding patent fees for other purposes. Assigning responsibilities to corporate board members As it had in the past, Congress failed to deliver on itsin corporate integrity agreements could be another remedy. promise of patent reform. However, 2011 could be the year Along with the stepped-up investigations, a rash of the job gets done. The Senate overwhelmingly passed adrug safety issues and manufacturing problems, which led bill that would provide the first substantial reform to theto major recalls, especially at Johnson & Johnson subsidiary patent system in 60 years. Not only does it safeguard theMcNeil Consumer Healthcare, had some members of PTO’s funding, it also would switch the U.S. to a first-to-fileCongress calling for increased authority for the FDA. system, putting it in step with the rest of the world. As chairman of the House Oversight and Government A similar bill, with a few key differences, was introducedReform Committee last year, Rep. Edolphus Towns (D-N.Y.) in the House, but it remains to be seen whether the twoinsisted the FDA should have the authority to automatically chambers will work out their differences. In other words,recall suspect products, rather than having to persuade a the uncertainty continues.drugmaker to do a recall.22 BioWorld® State of the Industry Report 2011
  • 24. The View from EuropeInvestments Rebounded, But European BiotechsStill UnderfundedBy Nuala MoranBioWorld International Correspondent After the capital-starved privations of the financial biotech (and the only one in the global top 10) into a distractingcrisis, the only way was up for the European biotechnology and very public conflict with the activist investor Elliottsector in 2010. Investment did rebound – venture capital Advisors. The bad news on almorexant followed the failureinvestment in France rose by 56 percent to �148 million four months earlier of clazosentan in a Phase III pivotal trial(US$208.5 million), for example, and there were seven initial in stroke, and the missing of the primary endpoint in a trialpublic offerings (IPO), compared to a mere one in 2009. designed to widen the label of Tracleer (bosentan) beyond But venture capital funding remains lower than before pulmonary arterial hypertension to idiopathic pulmonarythe credit crunch, and with the exception of Zealand Pharma fibrosis in March 2010.A/S, which raised $67.9 million, IPOs were for small amounts It’s clear at this point that the company will be likelyand did not represent exits for the investors. In other words, restructure and rethink its portfolio.the numbers flatter to deceive, with the sector as a whole Similarly, in Denmark the Phase III failure of zalutumumabremaining dramatically underfunded. forced the resignation of one of Europe’s most high profile Yet rising public investment in R&D – in many cases as biotech CEOs, Lisa Drakeman, with the inevitable corporatepart of government economic stimulus packages – means remodeling following in her wake. Santhera AS too, wasEurope’s science base is as strong and superior as ever. hit with a 43 percent fall in its share price when idebenone The most significant advance in 2010 was that the flopped in a Phase III study in Friedrich’s ataxia. And therepharma industry openly acknowledged that flexible, was a first set back for the Austrian vaccines companynimble and innovative biotech companies provide it with Intercell AG, when its Traveler’s diarrhea vaccine failed tothe best route to tapping this resource. The result was yet show significant effect in Phase III. That led to a reductionanother redrawing of biotech business models, to structure in headcount and a 40 percent cut in R&D funding at thecompanies for long-term collaborations with pharma, with Vienna-based company.the aim of an eventual trade sale. These examples highlight the all-or-nothing, binary nature of the whole biotech enterprise and underline that to date few European biotechs have built broad enoughTrial Failures Rock the Sector pipelines, or have deep enough pockets, to withstand a Overhanging this shift is the sector’s endless tango with product flop.risk. The CEO of Zealand Pharma, David Solomon, admittedthe IPO in November 2010 was “tricky” even though thecompany was presenting a relatively low-risk portfolio, with Success in the Clinic Builds Valuelixisenatide, its GLP-1 agonist, having reported success in With very few marketed products, success in the clinicthree Phase III trials in Type II diabetes and partnered with is by far the most important source of value, as evidencedSanofi-Aventis Group. by Zealand’s Pharma’s success in going public on the back The toll that risk takes was underlined by a number of of positive results in the lixisenatide Phase III studies.late-stage failures. In the UK these eviscerated the sector, Thrombogenics NV too, was boosted by two successfulwith three of the best-funded public companies putting up Phase III trials of microplasmin in treating vitreomacularfor sale signs as a result. adhesion, allowing it to raise �56 million in a placing to fund The gene therapy specialist Ark Therapeutics plc has the US and European launch of the product.regrouped and downsized following the European Medicines There were also earlier-stage advances in the clinic forAgency’s rejection of its glioma treatment Cerepro. But companies that are staking ground in new types of therapy,when Antisoma plc’s lead product AS1413 for treating acute such as stem cells. So, for example, after managing to staymyeloid leukemia and Renovo plc’s anti-scarring treatment afloat over five long years of negotiations with regulators onJuvista, failed in Phase III, both companies decided to call it a both sides of the Atlantic and dealing with repeated requestsday in March 2011 . for more preclinical data, ReNeuron plc finally got approval Another high-profile Phase III failure, of the insomnia for the first regulated trial of a fetal stem cell product. ReN001 ,treatment almorexant, has drawn Actelion, Europe’s largest a neuronal cell line, is currently being tested in a Phase I/IIBioWorld® State of the Industry Report 2011 23
  • 25. trial in stroke at Glasgow University Hospital in the UK. – reminiscent perhaps of waiting for VCs to hand out the Another example of European biotechs applying next tranche of cash in the old days.advances in molecular biology to get a handle on previously In the absence of other funding sources, Europeanuntreatable diseases include Prosensa Therapeutics BV, biotechs have no alternative but to go along with this.which advanced its exon skipping treatment for Duchenne’s As a result, they remain exposed to those convulsions ofmuscular dystrophy (DMD) into Phase III. Also, Trophos SA partnering – the big pharma pipeline review, or one pharmamoved a novel construct it has christened a ‘mitochondrial company being taken over by another – that are impossiblepore modulator’ into a pivotal trial in spinal muscular to plan for, and which make it more difficult for biotechs toatrophy. become self sustaining. So for example, when Roche gave back rights to theOrphan Drugs Increase in Strategic Importance cervical cancer vaccine TG4001 to Transgene in February European biotechs are increasingly looking to orphan 2011 , its share price fell from �15 to �12 – even though thedrugs as a lower-risk route through development. The Strasbourg-based company was getting the product backsignificance of this was underlined in a review of the state with full rights and a Phase IIb trial, paid for by Roche, fullyof play 10 years after the enactment of the European Union’s recruited and yet to report.orphan drugs legislation, which showed R&D relating to There was greater calamity in store for Italian biotechrare diseases increasing as a proportion of total research Philogen SpA in March 2011 , when a sudden change of heartfunding. Orphan drugs also are proving an important route by Bayer Schering Pharma over two antibody programs,for biotechs to tap into a new, non-dilutive source of funding forced the Milan-based biotech to pull a proposed IPO.from medical charities that exist to promote research intothe diseases they represent. Some Inspiration and Cheer for Investors But more potently, the move into rare diseases has Whatever the vagaries of pharma partners and theput European biotechs in a prime position to benefit from reverses of clinical development, a number of companiespharma’s newly kindled interest in the field, which has raised follow-on funding, either as a result of validationseen companies including Pfizer Inc., Novartis AG and of a technology elsewhere, or on the back of their ownGlaxoSmithKline plc form dedicated rare diseases units. progress. The most notable example of reflected glory wasAs a result, orphan drugs have formed the basis of more Transgene’s $181 million June 2010 fundraising, which wasout-licensing and collaboration deals, with Prosensa NV’s inspired by the FDA’s approval of Dendreon Corp’s Provenge$678 million agreement with GlaxoSmithKline for its exon- prostate cancer vaccine.skipping DMD treatment being a prime example. On the back of strong Phase IIb data Karo Bio AB was able to raise $80 million for the Phase III development ofA New Partnering Model eprotirome in familial hypercholesterolemia, while Ablynx While pharma has long recognized the contribution NV raised $68.3 million as it advanced its nanobodybiotech can make to its pipelines, in 2010 pharmaceutical antibody constructs further into the clinic. And Agennix AGexecutives finally came up with a partnering model with took in $105 million for an all-or-nothing bet on its immunewhich they are comfortable. These new model deals modulator talactoferrin, a recombinant version of lactoferrin,typically come with small up-front payments or an equity in treating non-small cell lung cancer.investment, R&D funding for the biotech to carry on doing There were two remarkable financing rounds for privatethe work, milestones, and an option for the pharma partner biotechs, with Symphogen AS raising $131 million in Januaryto in-license products at a later date. 2011 , while in March 2010 Archimedes Pharma Ltd. raised Underlying these deals is the fact that pharma is finally $96.9 million to pay for the commercialization of PecFent, aconfronting and dealing with the diseconomies of scale in its nasally-administered version of fentanyl for treating cancerresearch and development. It no longer wants to go out and breakthrough pain.buy another company or product and bring it in house. The biggest source of inspiration for investors was This led to high value deals – Galapagos NV’s $374 Johnson & Johnson’s $2.4 billion purchase of Dutch vaccinesmillion osteoarthritis pact with Servier, or its chronic company Crucell NV. Another big ticket acquisition wasobstructive pulmonary disease deal with Roche at $400 Shire’s purchase of gastrointestinal diseases specialistmillion; Orexo AB and Johnson & Johnson’s $585 million Movetis NV for $565 million.collaboration on preclinical modulators; the Cellzome/GSK There was little hard cash changing hands for biotech/$655 million agreement in inflammatory diseases; or NicOx biotech M&A. BTG plc acquired Biocompatibles plc in an all-SA and Bausch and Lomb’s $179.5 million deal in glaucoma. share deal valued at $284.5 million. Biotie Therapies Corp.’s But despite the numbers, such deals can still leave all-share merger with Synosia Therapeutics Holding AG wasbiotech partners hanging on for the next milestone payment tagged at $120 million and Wilex AG picked up Heidelberg24 BioWorld® State of the Industry Report 2011
  • 26. Pharma AG for $27 million in stock. The European Commission also is very sympathetic There was a rare – old fashioned cash exit for VC to biotechs, offering R&D funding through its Frameworkinvestors in RespiVert Ltd., which was acquired by Centocor Research program. However, the commission has struggledOrtho Biotech Inc. The terms were not disclosed, but to bring about promised regulatory reforms that areImperial Innovations plc, the technology transfer arm of important to the industry, such as improving the currentImperial College London realized $13.8 million from the sale costly and bureaucratic system for getting approvals forof its 13.4 percent stake in the company, for an investment clinical trials, and creating a single European patent.of $3.2 million. The other venture capital investors to cash Critically though, public investment in the science base,in were SV Life Sciences, Fidelity Biosciences and the largest and a desire to see this spawn companies, means that Europeshareholder, Advent Venture. continues to have good flow of start-ups. In 2010 some of these were able to put together impressive first rounds.Governments Maintain Support Syntaxin Ltd, for example, raised $28.6 million, and antibody Europe’s governments remain keen to nurture their start-up Crescendo Ltd. raised $7. 1 million.biotech sectors, and while supportive policies cannot The desired end of all this activity is of course, newmake up for a dearth of private investment for clinical therapies, and 2010 saw approval for three products. Thesedevelopment, they continue to be important in promoting are Archimedes Pharma’s PecFent , Pharming Group NV’sthe formation and development of new companies. Rhucin, a version of human C1 inhibitor produced in the milk This is best exemplified by France, where the government of transgenic rabbits for treating hereditary angioedemasold off shares in the state owned electricity company and and GW Pharma plc’s cannabis-based Sativex, for treatingis investing the money in science-based start-ups. Amongst spasticity caused by multiple sclerosis.other measures, it has set up a combined grant and loan These are all important products serving unmet medicalscheme that allows companies to raise significant sums needs. But they also serve as an important reminder thatagainst predetermined milestones. One beneficiary is NeoVacs at the end of the development pipeline one thing will giveSA, which has a $11 .2 million award for the development of an European biotech solidity and assurance, and that is havingantibody for treating rheumatoid arthritis in patients who marketed products.have become resistant to TNF-alpha products.BioWorld® State of the Industry Report 2011 25
  • 27. The View from the BenchThe Light Bulb Burns Bright in the Discovery PhaseBy Anette BreindlScience Editor With the number of scientific papers continuing to rise proteins, and that those proteins could substitute forat dizzying rates, a stab at a comprehensive update of the naturally occurring ones and carry out metabolic functionsyear’s most important biomedical discoveries would fill in bacteria. The work received less press attention thanits own annual report. Selecting from the bounty, we have the synthetic genome. But in its attempt to create proteinsincluded some of the most important advances. not found in nature may ultimately have farther-reaching The most notable of these is the successful CAPRISA implications.trial of a microbicide that can, finally, protect against HIVinfection. Stem Cells: Everybody’s Different Most of our highlights, however, are in areas where Stem cell research continued to enable insight into moreprogress was made on a broad front. The simultaneous diseases than we can list. But among the most importantprogress of large-scale genome-wide association studies research of the year were several studies about stem cells(GWAS) and personalized genomics, and the many resistance themselves, and how different types of stem cells differtricks of cancer cells that researchers are bringing to light, from each other.are examples of such fields that had general momentum in The iPS cells of different species can differ in important2010. ways: scientists discovered that female human iPS cells do not reactivate their silenced X chromosome duringGenome Research reprogramming, while mouse iPS cells do. The authors were Genomics continues to forge ahead, with researchers sanguine about their discovery, noting that it enables theidentifying ever-new disease risk factors. The exact number generation of cells that are genetically identical except forof human genomes that has been sequenced is difficult to the inactivated X chromosome – an ability that could be apin down at any given time. But in October 2010, Nature boon for studying X-linked diseases.estimated that 180 complete genomes had been sequenced Less encouraging was a report last February that iPS cells– and that that number would rise tenfold by the end of are prone to premature aging, and were far less able then2011 . Larger-scale genome projects, such as the Thousand embryonic stem cells to go through repeated cell divisionGenomes Project (which, in a fabulous example of inflation, cycles while keeping their stem-like properties.is sequencing the genomes of about 2,500 individuals) and A report last May showed that iPS cells and embryonicThe Cancer Genome Project both reported advances in 2010. stem cells differed in their expression of FMR protein, whichThe larger the number of genomes, the better the chances of is the critical protein in Fragile X syndrome. By March of 2011 ,finding rare variants; in a October, 2010 update on the 1000 a trifecta of studies had shown that induced pluripotent cellsGenomes Project, scientists reported they had seen about 15 differ from embryonic stem cells, and from the skin cells thatmillion SNPs, 1 million short insertion/deletion changes and are used to make them, in three predictable ways. Inducedmore than 20,000 structural variations in their pilot data, pluripotent stem cells had a mutation rate ten times higherand that fully half of those variations were new. than that of their parent cells. They also have differences in At the other end of the scale, scientists are also plugging copy number variations, and epigenetic abnormalities, thataway at the Personal Genome Project, which combines set them apart.genetic and environmental information about (anonymous) Another study also showed that embryonic cells and iPSindividuals to learn how genetics and environmental factors cells differ in their metabolic pathways, which may reflectinteract to produce traits. their different environments; in fact, many of the observed And in May, researchers reported long sought-after differences may be due to the conditions under which cellssuccess in yet another aspect of genomics: they succeeded are cultured.in “booting up” one cell’s cytoplasm with the artificiallyreconstructed genome of another cell. The work marked the Cancer Resistanceculmination of 15 years of effort by genomics pioneer J. Craig Like stem cell research, the field of cancer research isVenter and his team. too broad to list every advance that is worthy of attention In another attempt at artificial life, a separate team over the course of a year. What stood out over the past year,reported in January 2011 that it had managed to create amino however, was the critical mass of papers that reported onacid sequences from scratch that folded into functional mechanisms of tumor resistance to a wide variety of drugs26 BioWorld® State of the Industry Report 2011
  • 28. ranging from off-patent stalwarts to new, still-in-clinical-trial Obesity Reaches a (Mountain) Plateaustars. In an example of the former, two studies described 2010 began with a classic example of good news/that resistance to microtubule-targeting agents such as bad news on the obesity front: in January, the Centers fortaxol (first approved in 1992) arises through mutations Disease Control and Prevention reported that the numbersin a tumor suppressor. Studies also described resistance for the percentage of the population that is obese had beenmechanisms for newer targeted drugs such as erlotinib, stable for five (men) to ten (women and children) years,and even for those still in clinical trials: in November, two long enough to consider the rate stable. The bad news, ofstudies reported independent resistance mechanisms for course, was the large number of large people: obesity ratesthe experimental melanoma drug PLX4032. More than half for adults are at 1/3 of the population, and those of childrenof all patients develop resistance to PLX4032 within a year, at almost 20 percent.apparently via a multitude of mechanisms, though this didnot prevent the drug from giving patients both an overall The Secret to a Long Lifesurvival and a progression-free survival advantage in a Disproving theories is an integral part of the scientificphase III trial whose results were reported in January. process, and from that perspective, 2010 may turn out While mutations are certainly a tumor’s standard way to be a fruitful year for longevity research. A July studyaround a chemotherapy roadblock, surprisingly, they are purported to show a longevity gene signature consisting ofnot an absolute prerequisite to developing resistance. 150 SNPs that, together, could predict with about 75 percentA study published last April showed that cancer cells accuracy whether a person would live beyond the age ofcould acquire resistance to erlotinib (Tarceva) through 90. Those longevity genes appeared to work by somehowepigenetic mechanisms. The resistance was reversible, and counteracting the effects of disease genes: 100-year-oldso such epigenetic alterations might be behind the clinical individuals with the longevity signature appeared to haveobservation that “drug holidays” – taking a patient off of a many disease risk genes at the same rate as their peers.medication for a period of time -- can sometimes restore the But the longevity signature may turn out to besensitivity to a drug after resistance has developed. short-lived: in November, Science published an editorial The ideal way to deal with mutation-based resistance, expression of concern about the paper after it became clearin the meantime, is not by taking on one mutation at a time, that the study had produced several false positives, partlybut by finding points where resistance pathways converge. due to the use of at least one genotyping chip that producedIn March, 2011 , one study identified the SRC kinase as one artifacts and partly due to skipping certain quality controlsuch point of convergence for resistance to trastuzumab procedures. The authors planned to reanalyze their data, and(herceptin.) And the developers of PLX4032 are working on in November, Science said that it would make a final decisionsecond-generation agents that “will hopefully not have this after the results from the reanalysis were in. As of late Marchresistance issue,” company executives told BioWorld when 2011 , the editorial department was still evaluating the paper.topline results of the BRIM trial were published. And On and On and OnMicrobicides: Successful on the 12th Attempt In the meantime, a widely noted study published in Another successful trial in 2010 was, in many ways, the February, 2011 , showed that at least one “longevity gene”polar opposite of the BRIM trial. While PLX4032 barreled extends health, but not lifespan, in humans. When thethrough the clinical trials process at record speed, when the gene in question, for insulin-like growth factor 1 or IGF-1 , isCAPRISA 004 trial finally reported success, it was the 12th mutated, it prevents individuals from responding properlytrial to test the abilities of a vaginal microbicide to prevent to growth hormone signaling. In affected individuals, theHIV infection. result is Laron syndrome or dwarfism – but also an almost Because they can be controlled by women, and be used complete protection against cancer and diabetes. The studywithout a partner’s consent or even knowledge, microbicides showed that basic mechanisms of aging are conservedhave long been considered a path to protection that could from roundworms all the way through to humans.withstand some of the practical realities of the lives of To the scientific community, the retraction was oldwomen who are at high risk for HICV infection. But getting news. But 2010 was the year when it officially happened:a grip on those medical risks proved to be a challenge, with The Lancet formally retracted the 1998 paper purportingsome earlier experimental microbicides actually increasing to show a link between autism and MMR vaccination. Thethe risk of infection. In the CAPRISA trial, that risk was retraction, of course, did little to convince believers in thereduced by 40 percent with regular use. Those women who theory, who continue to see lead author Andrew Wakefieldused it most consistently reduced their risk by more than as an anti-establishment fighter for the truth. Somewhathalf. The risk of contracting herpes was also reduced by more surprisingly, it also did not convince those who rejectabout 50 percent. the idea of a link to move on to more productive debates.BioWorld® State of the Industry Report 2011 27
  • 29. In January of 2011 , a new report detailed how Wakefield points in the pathway, hopefully by oral drugs with lessfalsified the medical records of his subjects, listing several abuse potential.children with preexisting developmental problems as In October, a team including some of the same scientistsdeveloping normally in their pre-vaccine medical records. identified one possible target: a phosphatase that regulates Somewhat paradoxically, the authors noted the the same pathways as ketamine and is overexpressed in theongoing damage to public health caused by Wakefield’s brains of depressed patients, and of animals subjected topaper and the vaccine skepticism it has engendered, as chronic stress.well as the resources it has taken away from research into Other studies suggested that gene therapy to parts ofother possible causes of autism. the midbrain, or blocking the interaction between two types of dopamine receptors rather than one receptor by itself,Depression: A Quicker Fix? as is more typically the case, might be novel ways to treat Research into depression made strides on different severe depression.fronts, some with potential for treatments, and others in And a large meta-analysis weighed in on the questionfinding out what causes depression in the first place. On the of whether resilience, or the ability to bounce back fromtreatment front, the most hopeful bit of news may be that stressful life events, is related to the genetic variant of athere is nothing inevitable about the slow speed with which serotonin transporter that a person possesses. Such ancurrent antidepressants work. In August, researchers from association had been reported in 2003, but not all attemptsYale University reported how the brain changes in response to replicate the finding had been successful.to ketamine – an anesthetic that can have an antidepressant The December study, a meta-analysis which is the largesteffect, within hours, in patients who are resistant to other to date, suggested there is an association for childhoodantidepressants. maltreatment and medical stressors, but not “significant Ketamine’s rapid effects are not new, but the drug life events” – quite possibly because of the widely differingneeds to be given intravenously and under direct medical definitions of stressful life events, which, depending onsupervision. The identification of the pathway ketamine the study, could range from the death of a close relative toacts on, however, opens up the possibility of targeting other having a father without a college education.28 BioWorld® State of the Industry Report 2011
  • 30. BioWorld® FINANCIAL D ATABioWorld® State of the Industry Report 2011 29
  • 31. 30 BioWorld® State of the Industry Report 2011
  • 32. Biotech Money Raised By Month In 2010: Jan. - Dec. Type of Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total financing ($M) Public 536.4 349.5 642.0 464. 1 620.6 81 .0 47.9 102.9 586.9 2,418.3 638.5 371 .6 6,859.7 offerings Public/ 236.4 147.4 450.0 272.7 278.7 1 ,692.2 2,299 820.3 149.6 481 .4 820.9 326. 1 7,975. 1 other Private 533.2 221 .5 342.6 497.6 299.7 557.5 628.8 221 .6 485. 1 314.0 257.0 124.4 4,483.0 biotechs Total ($M) 1 ,306 718.4 1 ,434.6 1 ,234.4 1  99.0 2,330.7 2,976. 1 1  44.8 1 221 6 3,213.7 ,1 ,1 , . 1 ,716.4 822. 1 19,317.8 Notes: Public offerings = Initial, follow-on. Private biotechs = Financings of private firms. Public/other = Other financings of public companies, including loans, bridge financings, exercises of warrants, debt offerings, rights offerings, standard private placements, PIPE financings and institutional offerings of registered stock. Money from exercised overallotment options are included in the month that the offering first priced. In all cases, numbers are rounded and may vary slightly from other charts in which exact totals are used.BioWorld® State of the Industry Report 2011 31
  • 33. Initial Public Offerings Of Biotechnology In 2010 Company Date Date Shares/ Price Shares Lead, Other Gross Post- (Symbol)# Filed Comm. Units Out Underwriters (US$M) Offering (M) (M)@ Market Cap (M)% FEBRUARY CBio Ltd. 11/11/09 2/8/10 N/A N/A N/A N/A A$7. 1 N/A (Australia; ($6. 1) ASX:CBZ) Ironwood 11/23/09 2/3/10 19.2S $11 .25 97.4 J.P. Morgan $216 $1 ,095.8 Pharmaceuticals Morgan Stanley (co- Inc. (IRWD) lead) Credit Suisse (co- lead) BofA Merrill Lynch Wedbush PacGrow Life Sci. MARCH Anthera 9/15/09 3/2/10 6.604S $7 22.2 Deutsche Bank Sec. $46.23 $155.4 Pharmaceuticals Piper Jaffray (ANTH) Cowen & Co. Merriman Curhan Ford AVEO 12/17/09 3/12/10 9.97S $9 30.6 J.P. Morgan $89.73 $275.4 Pharmaceuticals Morgan Stanley (co- Inc. (AVEO) lead) Leerink Swann Canaccord Adams CorMedix Inc. 3/26/10 3/26/10 1 .925U $6.50 11 .4 Maxim Group LLC $12.5 $37. 1 (AMEX: CRMD-U) APRIL AB Science- 4/27/10 4/28/10 2. 17S �12.68 N/A N/A �27.5 N/A Promesses SA ($16.84) $36.45) (France; Euronext: AB) Alimera 10/30/09 4/22/10 6.55S $11 31 .05 Credit Suisse $72.05 $341 .55 Sciences Inc. Securities (ALIM) Citigroup (co-lead) Cowen & Co. Oppenheimer & Co. Codexis Inc. 12/28/09 4/22/10 6S $13 34 Credit Suisse $78 $442 (CDXS) Piper Jaffray RBC Capital Mar. Pacific Crest Sec. Tengion Inc. 12/24/09 4/9/10 6S $5 12.4 Piper Jaffray & Co. $30 $62 (TNGN) Leerink Swann (co- lead) JUNE Aposense Ltd. 6/8/10 6/8/10 N/A N/A N/A N/A $24 $230 (Israel; TASE:APSN)32 BioWorld® State of the Industry Report 2011
  • 34. Initial Public Offerings AUGUST NuPathe Inc. 5/14/10 8/6/10 5S $10 14.5 Leerink Swann $50 $145 (PATH) Lazard Capital (co- lead) Needham & Co. Trius 11/6/10 8/4/10 10S $5 23.6 Citigroup Global $50 $118 Therapeutics Inc. Markets (TSRX) Piper Jaffray & Co. Canaccord Genuity Inc. JMP Securities OCTOBER Aegerion 8/10/10 10/25/10 5S $9.50 16.9 Leerink Swann $47.5 $160.55 Pharmaceuticals Lazard Capital (co- Inc. (AEGR) lead) Needham & Co. Canaccord Genuity Collins Stewart Pacific 8/16/10 10/27/10 12.5S $16 50. 1 J.P. Morgan $200 $801 .6 Biosciences Inc. Securities (PACB) Morgan Stanley (co- lead) Deutsche Bank Securities Piper Jaffray & Co. NOVEMBER Anacor 9/10/10 11/24/10 13.38S $5 27.98 Citigroup Global $66.9 $139.9 Pharmaceuticals Deutsche Bank (co- Inc. (ANAC) lead) Cowen and Co. LLC Wedbush PacGrow Complete 7/30/10 11/12/10 6S $9 25.8 UBS Investment $54 $232.2 Genomics Inc. Bank (GNOM) Jefferies & Co. (co- lead) Robert W. Baird & Co. Inc. Cowen and Co. Zealand Pharma 11/4/10 11/24/10 4.3S DKK86 N/A Danske Bank A/S DKK372 N/A A/S (Denmark; ($15.8) Jefferies ($67.9) CSE:ZEAL) International Bryan, Garnier & Co. SEB Enskilda (all co-leads) Zogenix Inc. 9/8/10 11/23/10 14S $4 33.6 Wells Fargo $56 $134.4 (ZGNX) Leerink Swann Oppenheimer & Co. Steifel Nicolaus WeiselBioWorld® State of the Industry Report 2011 33
  • 35. Initial Public Offerings DECEMBER Ventrus 7/20/10 12/17/10 2.9S $6 6.7 Rodman & Renshaw $17.4 $40.2 Biosciences Inc. National Securities (VTUS) (co-lead) Total: $1,220.76M Number of IPOs in 2010: 19 Average value of IPOs in 2010: $64.25M Notes: # Unless otherwise indicated, shares are traded on the Nasdaq exchange. @ This column reflects the shares outstanding following the offering, when disclosed. % Market capitalization is calculated based on the offering price. AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; TASE = Tel Aviv Stock Exchange. Currency conversions are based on exchange rates at the time of the deal.34 BioWorld® State of the Industry Report 2011
  • 36. Biotechnology Follow-On Offerings In 2010 Company Date Date Shares/ Price Shares Lead, Other Gross Post- (Symbol)# Filed Comm. Units Out Underwriters (US$M) Offering (M) (M)@ Market Cap (M)% JANUARY Aastrom 2/19/09 1/15/10 52.07U $0.26 220. 1 Oppenheimer & Co. $13.5 $57.2 Biosciences Inc. (ASTM) Achillion 10/16/09 1/22/10 11 .8S $2.08 38.5 Roth Capital Partners; $24.5 $80. 1 Pharmaceuticals Noble Financial Capital; Inc. (ACHN) National Securities AMAG 1/19/10 1/21/10 3.6S $48.25 20.99 Morgan Stanley, J.P. $173.7 $1 ,012.8 Pharmaceuticals Morgan (co-lead), Inc. (AMAG) Goldman, Sachs (co- lead), Leerink Swann Baird, Canaccord Adams InterMune Inc. 9/29/09 1/21/10 7S $14. 10 53.7 Goldman, Sachs; $98.7 $757. 17 (ITMN) Canaccord Adams; JMP Securities; Leerink Swann; Oppenheimer & Co. Pharmasset Inc. 6/26/08 1/28/10 1 .83S $18.75 30. 13 Leerink Swann $34.31 $564.9 (VRUS) Sinovac Biotech 11/30/09 1/28/10 11 .5S $5.75 54. 1 UBS Investment Bank; $66. 13 $311 . 1 Ltd. (China; SVA) Piper Jaffray (co-lead) Synta 8/28/08 1/8/10 6.43S $4.50 40.33 Lazard Capital Markets; $28.94 $181 .5 Pharmaceuticals RBC Capital Markets Inc. (SNTA) ZymoGenetics 12/11/08 1/7/10 16. 1S $6 85.2 Leerink Swann; $96.6 $511 .2 Inc. (ZGEN) Wedbush PacGrow; William Blair & Co.; Canaccord Adams; McAdams Wright Ragen FEBRUARY BioCurex Inc. 1/20/10 2/1/10 1 .3U $5 157.9 Paulson Investment Co. $6.5 $789.5 (Canada; OTC BB: BOCX) Discovery 6/18/08 2/19/10 27.5S $0.60 149.2 Lazard Capital Markets $16.5 $89.52 Laboratories Inc. (DSCO) Labopharm 12/14/10 2/12/10 13.5U $1 .70 70.96 Deutsche Bank Sec. $22.95 $120.6 (Canada; DDSS) Canaccord Adams Dundee Capital Markets Versant Partners NeoStem Inc. 2/11/10 2/11/10 5.75S $1 .35 42.95 Roth Capital Partners $7.8 $57.98 (AMEX:NBS) Maxim Group Gilford Securities Optimer 12/24/09 2/25/10 4.88S $11 38.24 Jefferies & Co. $53.68 $420.6 Pharmaceuticals Inc. (OPTR)BioWorld® State of the Industry Report 2011 35
  • 37. Follow-on Offerings Senomyx Inc. 9/2/08 2/16/10 7. 1S $2.80 38.3 Deutsche Bank Sec. $20 $107.24 (SNMX) Needham & Co. Roth Capital Partners MARCH Ablynx NV 3/10/10 3/16/10 6.7S |7.50 N/A KBC Securities |50 N/A (Belgium; BR:ABLX) UBS Invest. (co-lead) ($68.3) Piper Jaffray Ltd. KBC Bank Kempen & Co. Dyax Corp. 3/25/10 3/25/10 19.55S $3.25 97.65 Jefferies & Co. Inc. $63.55 $317.4 (DYAX) Needham & Co. LLC (co- lead) Lexicon 3/9/10 3/17/10 96.5S $1 . 15 273.9 Morgan Stanley $111 $315 Pharmaceuticals J.P. Morgan Sec. (co- Inc. (LXRX) lead) Cowen and Co. LLC Thomas Weisel Partners Micromet Inc. 3/11/10 3/12/10 11 .5S $7 80.7 Goldman, Sachs & Co. $80.5 $564.9 (MITI) Piper Jaffray RBC Capital Markets Needham & Co. LLC Roth Capital Partners Ladenburg, Thalmann & Co. Maxim Group LLC Neurocrine 12/3/07 3/5/10 10.37S $2.20 54.57 Jefferies & Co. $22.8 $120. 1 Biosciences (NBIX) Somaxon 11/10/09 3/29/10 6.9S $8.25 32.8 Jefferies and Co. $56.9 $270.6 Pharmaceuticals Oppenheimer & Co. Inc. Inc. (SOMX) Theravance Inc. 3/19/10 3/25/10 8.6S $11 .50 72.8 Morgan Stanley $98.9 $837.2 (THRX) Credit Suisse Leerink Swann APRIL ARCA 4/1/10 4/1/10 1 .075S $6.33 8.7 N/A $6.8 $55.07 Biopharma Inc. (ABIO) Ardea 4/6/10 4/9/10 4S $20 22.6 Jefferies & Co. Inc. $80 $452 Biosciences Oppenheimer & Co. (co- Inc. (RDEA) lead) Dynavax 4/2/10 4/13/10 30.3U $1 .45 86.5 Wedbush PacGrow Life $44 $125.6 Technologies Corp. (DVAX) Exact Sciences 12/3/07 4/14/10 4.2S $4.50 40.03 Robert W. Baird & Co. $18.9 $180. 14 Corp. (EXAS) Idenix 10/17/08 4/30/10 6.46S $4.35 72.8 Thomas Weisel Partners $28. 1 $316.68 Pharmaceuticals Leerink Swann Inc. (IDIX) William Blair & Co.36 BioWorld® State of the Industry Report 2011
  • 38. Follow-on Offerings Nile 4/8/10 4/23/10 7.475U $0.70 34.57 Maxim Group LLC $5.23 $24.2 Therapeutics Ladenburg Thalmann & Inc. (NLTX) Co. NPS 8/5/09 4/16/10 10.35S $5.50 58.9 Canaccord Adams $56.9 $323.95 Pharmaceuticals Needham & Co. LLC Inc. (NPSP) MAY Avanir 9/23/09 5/7/10 11 .5S $2.75 95. 1 Jefferies & Co. $31 .6 $261 .5 Pharmaceuticals Canaccord Adams Inc. (AVNR) ImmunoGen 4/22/10 5/7/10 10.35S $8 67.8 J.P. Morgan $82.8 $542.4 Inc. (IMGN) Oppenheimer & Co. RBC Capital Markets Cantor Fitzgerald & Co. Morgan Joseph Jazz 4/5/10 5/12/10 7S $8.35 38.54 Barclays Capital $58.45 $321 .8 Pharmaceuticals Inc. (JAZZ) Pharmasset Inc. 5/11/10 5/14/10 3.68S $29 33.98 Citibank $106.72 $985.42 (VRUS) J.P. Morgan Canaccord Genuity Robert W. Baird RegeneRx Bio- 4/27/10 5/19/10 13. 12U $0.41 73.52 Maxim Group LLC $5.38 $30. 14 pharmaceuticals Boenning & Inc. (AMEX:RGN) Scattergood Salix 5/27/10 5/27/10 N/A N/A N/A BofA Merrill Lynch $300 N/A Pharmaceuticals Jefferies & Co. Inc. (co- Ltd. (SLXP) lead) Ziopharm 5/10/10 5/28/10 7S $5 48.8 Jefferies & Co. $35 $244 Oncology Inc. JMP Securities LLC (ZIOP) JUNE Clinical Data 6/28/07 6/9/10 2.24S $14.30 29.7 BMO Capital Markets $32 $424.7 Inc. (CLDA) WedBush PacGrow Roth Capital Corcept 2/13/08 6/25/10 5S $3 72 Thomas Weisel Partners $15 $216 Therapeutics Inc. (CORT) Discovery 6/11/10 6/18/10 35.7U $0.28 189.7 Lazard Capital Markets $10 $53. 1 Laboratories Boenning & Inc. (DSCO) Scattergood JULY BioMimetic 7/14/10 7/15/10 5.64S $8.50 27.74 J.P. Morgan Securities $47.94 $235.79 Therapeutics Inc. Canaccord Genuity (BMTI) Wedbush PacGrow AUGUST Pharmagap Inc. 8/11/10 8/11/10 16.7U $0. 18 N/A Capital Street Group C$3 N/A (Canada; ($2.9) CDNX:GAP)BioWorld® State of the Industry Report 2011 37
  • 39. Follow-on Offerings SEPTEMBER Halozyme 1/5/10 9/8/10 8.3S $7.50 100.3 Barclays Capital $62.25 $752.25 Therapeutics Inc. (HALO) MAP 4/16/10 9/30/10 3S $14.50 29.7 Lazard Capital Markets $43.5 $430.7 Pharmaceuticals Wedbush PacGrow Life Inc. (MAPP) Sci. NPS 8/5/09 9/16/10 7.9S $6 66.9 Jefferies & Co. $47.4 $401 .4 Pharmaceuticals Canaccord Gen. Inc. (NPSP) (Co-lead) Vertex 2/19/10 9/24/10 N/A N/A N/A Bank of America Merrill $400 N/A Pharmaceuticals Lynch Inc. (VRTX) Vical Inc. (VICL) 1/29/10 9/24/10 15S $2.25 71 .2 Jefferies & Co. $33.75 $160.2 Stifel Nicolaus Weisel (Co-Lead) Canaccord Genuity OCTOBER Anadys 4/23/09 10/15/10 13.9S $1 .80 57. 1 Lazard Capital Markets $25 $102.78 Pharmaceuticals Inc. (ANDS) Ariad 1/21/10 10/25/10 16S $3.70 126.9 Jefferies & Co. Inc. $59.2 $469.53 Pharmaceuticals Oppenheimer & Co. (co- Inc. (ARIA) lead) Celgene Corp. 10/4/10 10/5/10 Notes N/A N/A Citigroup Global $1 .25B N/A (CELG) Markets J.P. Morgan Sec. (Co-Lead)Morgan Stanley (Co-Lead) Chelsea 9/30/10 10/4/10 8.21S $4.90 49.07 Deutsche Bank Sec. $40.23 $240.4 Therapeutics Needham & Co. LLC International Inc. (CHTP) Cubist 10/19/10 10/19/10 Conver- NA N/A Goldman Sachs & Co. $450 N/A Pharmaceuticals tible Morgan Stanley (co- Inc. (CBST) notes lead) Citigroup Global Markets RBC Capital Markets Cytori 2/11/09 10/8/10 4.6S $4.50 50.5 Jefferies & Co. Inc. $20.7 $227.25 Therapeutics Inc. (CYTX) Dynavax 10/6/10 10/28/10 26.45S $1 .70 114.75 Jefferies & Co. $44.97 $195. 1 Technologies Wedbush PacGrow Corp. (DVAX) Cowen and Co. GTx Inc. (GTXI) 1/17/08 10/27/10 14.3S $2.80 50.7 Lazard Capital Markets $40 $141 .9638 BioWorld® State of the Industry Report 2011
  • 40. Follow-on Offerings OncoGenex 7/17/09 10/19/10 3.2U $15.75 9.7 Stifel Nicolaus Weisel $50 $152.8 Pharmaceuticals Needham & Co. Inc. (OGXI) Rodman & Renshaw WedBush PacGrow Regeneron 10/6/10 10/8/10 6.325S $27.69 86.33 Citibank Global $175. 14 $2,390.5 Pharmaceuticals Markets Inc. (REGN) Sunesis 5/20/10 10/4/10 44. 1U $0.35 265.3 Cowen and Co. LLC $15.5 $92.9 Pharmaceuticals ThinkEquity LLC Inc. (SNSS) NOVEMBER Avanir 9/23/09 11/16/10 20S $4.40 113.9 Jefferies & Co. Inc. $88 $501 . 16 Pharmaceuticals Canaccord Genuity Inc. Inc. (AVNR) Wedbush PacGrow Life Summer Street Research Merriman Capital Cadence Phar- 9/17/09 11/8/10 12.5S $8 63. 1 Deutsche Bank $100 $504.8 maceuticals Inc. Securities (CADX) Leerink Swann LLC JMP Securities Wedbush PacGrow Life Sciences Canaccord Genuity Inc. Cerus Corp. 12/17/08 11/10/10 7.37U $2.85 47.3 Jefferies & Co. Inc. $21 $134.8 (CERS) Robert W. Baird (co- lead) Exact Sciences 9/7/10 11/4/10 10S $6 50.5 Jefferies & Co. Inc. $60 $303 Corp. (EXAS) Robert W. Baird (co- lead) Lazard Capital Markets Rodman & Renshaw Micromet Inc. 11/2/09 11/12/10 9.9S $7.30 90.9 Piper Jaffray $72.27 $663.57 (MITI) NeoStem Inc. 5/19/10 11/17/10 6.34U $1 .45 64. 1 Cowen and Co. $9.2 $92.9 (AMEX:NBS) Maxim Group LLC National Sec. Corp. PharmAthene 2/13/09 11/1/10 4.945S $3.50 41 .05 Roth Capital Partners $17.3 $143.7 Inc. (AMEX:PIP) Somaxon 11/19/10 11/19/10 8.8S $2.95 44.2 Piper Jaffray & Co. $25.96 $130.39 Pharmaceuticals Inc. (SOMX) DECEMBER Aastrom 12/10/10 12/10/10 10U $2.25 38.6 Stifel Nicolaus Weisel $22.5 $86.85 Biosciences Inc. Needham and Co. LLC (ASTM) Roth Capital partners Geron Corp. 7/22/09 12/7/10 20S $5 122.6 J.P. Morgan $100 $613 (GERN) Lazard Capital (co-lead) Rodman & Renshaw Roth Capital partners WBB SecuritiesBioWorld® State of the Industry Report 2011 39
  • 41. Follow-on Offerings Momenta 12/22/09 12/09/10 4.219S $14.35 49.62 UBS Investment Bank $60.54 $712.05 Pharmaceuticals Cowen and Co. Inc. (MNTA) Canaccord Genuity Sequenom Inc. 10/5/10 12/3/10 16. 1S $6 92.4 Jefferies & Co. Inc. $96.6 $554.4 (SQNM) Lazard Capital Markets Piper Jaffray & Co. XenoPort Inc. 7/13/10 12/9/10 4S $7. 15 34.6 Morgan Stanley $28.6 $247.39 (XNPT) RBC Capital Markets Wedbush Pacgrow Life YM BioSciences 11/30/10 12/14/10 28.75S $1 .60 109.95 Roth Capital Partners $46 $175.92 Inc. (Canada; JMP Securities AMEX:YMI) Rodman & Renshaw Total: $5,639.09M Number of follow-on offerings in 2010: 72 Average value of follow-ons in 2010: $78.32M Notes: # Unless otherwise indicated, shares are traded on the Nasdaq exchange. @ This column reflects the shares outstanding following the offering, when disclosed. % Market capitalization is calculated based on the offering price. AMEX = American Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Stock Exchange; OTC BB = Over-the-Coun- ter Bulletin Board. Currency conversions are based on exchange rates at the time of the deal.40 BioWorld® State of the Industry Report 2011
  • 42. After-Market Performance: IPO Class Of 2010 Company (Symbol)# Offering Offering 12/31/10 Close Percent Change Date Price FEBRUARY Ironwood Pharmaceuticals Inc. (IRWD) 2/3 $11 .25 $10.35 -8% MARCH Anthera Pharmaceuticals (ANTH) 3/2 $7 $4.88 -30% AVEO Pharmaceuticals Inc. (AVEO) 3/12 $9 $14.62 +62% CorMedix Inc. (AMEX:CRMD-U) 3/26 $6.50 $1 .82 -72% APRIL Alimera Sciences Inc. (ALIM) 4/22 $11 $10.38 -6% Codexis Inc. (CDXS) 4/22 $13 $10.60 -18% Tengion Inc. (TNGN) 4/9 $5 $2.54 -49% AUGUST NuPathe Inc. (PATH) 8/6 $10 $9.06 -9% Trius Therapeutics Inc. (TSRX) 8/4 $5 $3.71 -26% OCTOBER Aegerion Pharmaceuticals Inc. (AEGR) 10/25 $9.50 $14. 17 +49% Pacific Biosciences Inc. (PACB) 10/27 $16 $15.91 -1% NOVEMBER Anacor Pharmaceuticals Inc. (ANAC) 11/24 $5 $5.37 +7% Complete Genomics Inc. (GNOM) 11/12 $9 $7.47 -17% Zogenix Inc. (ZGNX) 11/23 $4 $5.67 +42% DECEMBER Ventrus Biosciences Inc. (VTUS) 12/17 $6 $6.62 +10% Notes: This chart includes IPOs of biotechnology companies conducted on U.S. markets. None occurred in the months of January, May, June, July and September. # Unless otherwise indicated, shares are traded on the Nasdaq exchange. AMEX = American Stock ExchangeBioWorld® State of the Industry Report 2011 41
  • 43. After-Market Performance: Follow-On Offerings Class Of 2010 Company (Symbol)# Offering Date Offering 12/31/10 Percent Price Close Change JANUARY Aastrom Biosciences Inc. (ASTM) 1/15 $0.26 ($2.08 $2.56 +23% adjusted) Achillion Pharmaceuticals Inc. (ACHN) 1/22 $2.08 $4. 15 +100% AMAG Pharmaceuticals Inc. (AMAG) 1/21 $48.25 $18. 10 -62% InterMune Inc. (ITMN) 1/21 $14. 10 $36.40 +158% Pharmasset Inc. (VRUS) 1/28 $18.75 $43.56 +50% Sinovac Biotech Ltd. (China; SVA) 1/28 $5.75 $4.52 -21% Synta Pharmaceuticals Inc. (SNTA) 1/8 $4.50 $6. 12 +36% ZymoGenetics Inc. (ZGEN) 1/7 $6 $9.76 +63% FEBRUARY Discovery Laboratories Inc. (DSCO) 2/19 $0.60 ($8. 10 $3.33 -59% adjusted) Labopharm (Canada; DDSS) 2/12 $1 .70 $0.97 -43% NeoStem Inc. (AMEX:NBS) 2/11 $1 .35 $1 .41 +4% Optimer Pharmaceuticals Inc. (OPTR) 2/25 $11 $11 .31 +3% Senomyx Inc. (SNMX) 2/16 $2.80 $7. 13 +155% MARCH Dyax Corp. (DYAX) 3/25 $3.25 $2. 16 -34% Lexicon Pharmaceuticals Inc. (LXRX) 3/17 $1 . 15 $1 .44 +25% Micromet Inc. (MITI) 3/12 $7 $8. 12 +16% Neurocrine Biosciences (NBIX) 3/5 $2.20 $7.64 +247% Somaxon Pharmaceuticals Inc. (SOMX) 3/29 $8.25 $3. 15 -62% Theravance Inc. (THRX) 3/25 $11 .50 $25.07 +118% APRIL ARCA Biopharma Inc. (ABIO) 4/1 $6.33 $3. 17 -50% Ardea Biosciences Inc. (RDEA) 4/9 $20 $26 +30% Dynavax Technologies Corp. (DVAX) 4/13 $1 .45 $3.20 +121% Exact Sciences Corp. (EXAS) 4/14 $4.50 $5.98 +33% Idenix Pharmaceuticals Inc. (IDIX) 4/30 $4.35 $5.04 +16% Nile Therapeutics Inc. (NLTX) 4/23 $0.70 $0.62 -11% NPS Pharmaceuticals Inc. (NPSP) 4/16 $5.50 $7.90 +44% MAY Avanir Pharmaceuticals Inc. (AVNR) 5/7 $2.75 $4.08 +48% ImmunoGen Inc. (IMGN) 5/7 $8 $9.26 +16% Jazz Pharmaceuticals Inc. (JAZZ) 5/12 $8.35 $19.68 +136% Pharmasset Inc. (VRUS) 5/14 $29 $43.56 +50% RegeneRx Bio- pharmaceuticals Inc. AMEX:RGN; 5/19 $0.41 $0.06 -85% now OTC BB:RGNXW) Ziopharm Oncology Inc. (ZIOP) 5/28 $5 $4.66 -7%42 BioWorld® State of the Industry Report 2011
  • 44. After-Market Performance: Follow-on Offerings JUNE Clinical Data Inc. (CLDA) 6/9 $14.30 $15.91 +11% Corcept Therapeutics Inc. (CORT) 6/25 $3 $3.86 +29% Discovery Laboratories Inc. (DSCO) 6/18 $0.28 ($3.60 $3.33 -8% adjusted) JULY BioMimetic Therapeutics Inc. (BMTI) 7/15 $8.50 $12.70 +49% SEPTEMBER Halozyme Therapeutics Inc. (HALO) 9/8 $7.50 $7.92 +6% MAP Pharmaceuticals Inc. (MAPP) 9/30 $14.50 $16.74 +13% NPS Pharmaceuticals Inc. (NPSP) 9/16 $6 $7.90 +32% Vical Inc. (VICL) 9/24 $2.25 $2.02 -10% OCTOBER Anadys Pharmaceuticals Inc. (ANDS) 10/15 $1 .80 $1 .42 -21% Ariad Pharmaceuticals Inc. (ARIA) 10/25 $3.70 $5. 10 +38% Chelsea Therapeutics International Inc. (CHTP) 10/4 $4.90 $7.50 +53% Cytori Therapeutics Inc. (CYTX) 10/8 $4.50 $5. 19 +15% Dynavax Technologies Corp. (DVAX) 10/28 $1 .70 $3.20 +88% GTx Inc. (GTXI) 10/27 $2.80 $2.65 -5% OncoGenex Pharmaceuticals Inc. (OGXI) 10/19 $15.75 $16.79 +7% Regeneron Pharmaceuticals Inc. (REGN) 10/8 $27.69 $32.87 +19% Sunesis Pharmaceuticals Inc. (SNSS) 10/4 $0.35 $0.52 +49% NOVEMBER Avanir Pharmaceuticals Inc. (AVNR) 11/16 $4.40 $4.08 -7% Cadence Phar-maceuticals Inc. (CADX) 11/8 $8 $7.55 -6% Cerus Corp. (CERS) 11/10 $2.85 $2.46 -14% Exact Sciences Corp. (EXAS) 11/4 $6 $5.98 -0.3% Micromet Inc. (MITI) 11/12 $7.30 $8. 12 +16% NeoStem Inc. (AMEX:NBS) 11/17 $1 .45 $1 .41 -3% PharmAthene Inc. (AMEX:PIP) 11/1 $3.50 $4.23 +21% Somaxon Pharmaceuticals Inc. (SOMX) 11/19 $2.95 $3. 15 +7% DECEMBER Aastrom Biosciences Inc. (ASTM) 12/10 $2.25 $2.56 +14% Geron Corp. (GERN) 12/7 $5 $5. 19 +4% Momenta Pharmaceuticals Inc. (MNTA) 12/09 $14.35 $14.97 +4% Sequenom Inc. (SQNM) 12/3 $6 $8.03 +34% XenoPort Inc. (XNPT) 12/9 $7. 15 $8.52 +19% YM BioSciences Inc. (Canada; AMEX:YMI) 12/14 $1 .60 $2.33 +46% Notes: This chart includes U.S. follow-on offerings of biotechnology companies. None occurred in the month of August. # Unless otherwise indicated, shares are traded on the Nasdaq exchange. AMEX = American Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.BioWorld® State of the Industry Report 2011 43
  • 45. 2010 Initial Public Offerings 19 IPOs; $1 ,220.76M Total Gross Proceeds 2171 2200 Gross Proceeds ($M) 2000 1800 1600 1400 1200 1000 800 621 587 536 494 600 394 354 400 248 127 57 48 200 2.9 0 Jan. (8) Feb. (6) March (7) April (8) May (8) June (3) July (1) Aug. (1) Sept. (5) Oct. (11) Nov. (8) Dec. (6) Month (Number of IPOs) 2010 Follow-on Offerings 72 Follow-on Offerings; $5,639M Total Gross Proceeds 2171 2200 2000Gross Proceeds ($M) 1800 1600 1400 1200 1000 800 621 587 536 494 600 394 354 400 248 127 57 48 200 2.9 0 Jan. (8) Feb. (6) March (7) April (8) May (8) June (3) July (1) Aug. (1) Sept. (5) Oct. (11) Nov. (8) Dec. (6) Month (Number of Offerings) 44 BioWorld® State of the Industry Report 2011
  • 46. Gross Proceeds of Biotech Public Stock Offerings First Through Fourth Quarter 1996-2010 Initial and Follow-on Offerings Combined 4Q:10 5,748 3Q:10 5,347 2Q:10 4,768 1Q:10 3,455 4Q:09 2,971 3Q:09 2,685 2Q:09 1,209 1Q:09 479 4Q:08 0 3Q:08 779 2Q:08 277 1Q:08 1,193 4Q:07 856 3Q:07 481 2Q:07 2,385 1Q:07 1,403 3,017 4Q:06 3Q:06 500 2Q:06 1,160 1Q:06 1,951 4Q:05 1,476 3Q:05 1,587 2Q:05 840 Quarter:Year 1Q:05 1,685 4Q:04 1,281 3Q:04 98 2Q:04 1,207 1Q:04 1,937 4Q:03 1,544 3Q:03 1,364 2Q:03 274 1Q:03 506 4Q:02 196 3Q:02 199 2Q:02 417 1Q:02 569 4Q:01 1,533 3Q:01 213 2Q:01 866 1Q:01 1,191 4Q:00 8,907 3Q:00 3,936 2Q:00 2,386 1Q:00 7,992 4Q:99 4,020 3Q:99 2,394 2Q:99 340 1Q:99 396 4Q:98 93 3Q:98 193 2Q:98 320 1Q:98 419 4Q:97 784 3Q:97 520 2Q:97 186 1Q:97 867 4Q:96 735 3Q:96 498 2Q:96 1,981 1Q:96 1,264 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 10,000 Gross Proceeds ($M)BioWorld® State of the Industry Report 2011 45
  • 47. Biotech Money Raised: 1997-2010 Biotech Money Raised: 1997 - 2010 2010 19,318 2009 17,581 2008 11,084 2007 24,774 2006 20,287 2005 20,115 2004 20,814 Year 2003 16,485 2002 10,248 2001 14,065 2000 37,658 1999 10,755 1998 5,189 1997 5,368 0 10,000 20,000 30,000 40,000 50,000 In Millions ($M)46 BioWorld® State of the Industry Report 2011
  • 48. Nasdaq Stock Index 990 Nasdaq Stock Index 2010 970 950 930 910 890 870 850 830 810 790 1/1 1/2 2/2 3/2 4/2 5 6 7 8 9 1 1 1 1 /20 9/2 6/2 6 3/2 /21/2 /18/2 /16/2 /13/2 /10/2 0/8/2 1/5/2 2/3/2 2/31 10 01 01 /201 01 01 01 01 01 01 01 01 01 /20 0 0 0 0 0 0 0 0 0 0 0 0 10 BioWorld Stock Index 2010 30 BioWorld Stock Index 2010 25 20 15 10 5 0 -5 1/1 1/2 2/2 3/2 4/2 5/2 6/1 7/1 8/1 9 10 11 12 12 /20 9/2 6/2 6/2 3/2 1/2 8/2 6/2 3/2 /10/2 /8/ 20 /5/ 20 /3/ 20 /31 /20 10 01 0 01 01 01 01 01 01 01 01 10 10 10 0 0 0 0 0 0 0 0 10BioWorld® State of the Industry Report 2011 47
  • 49. 48 BioWorld® State of the Industry Report 2011
  • 50. Other Financings Of Public Biotech Companies In 2010 TOTAL: $7,975.  M 1 Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) JANUARY Access Registered direct 2. 1S $6.3 Access raised $6.3M offering 2. 1M shares at $3 Pharmaceuticals offering each; Rodman & Renshaw LLC acted as sole Inc. (OTC BB: lead placement agent; EarlyBirdCapital Inc. ACCP) acted as a subagent (1/25) Adventrx Registered direct W for 12.5S $19 Investors received preferred stock convertible Pharmaceuticals offering of Series E into shares of common stock at a conversion Inc. (AMEX:ANX) convertible pre- price of $0.38115; investors also will receive ferred stock warrants to purchase an aggregate of 12.5M shares (1/5) BioInvent Private 5.4S SEK150 BioInvent raised $21M issuing 5.4M new International placement of ($21) shares subscribed by DnB NOR Asset AB (Sweden; common stock Management and B&E Participation AB (1/15) SSE:BINV) Cell Private placement of 24.7S and $30 Cell Therapeutics raised $30M through the Therapeutics stock and warrants W for 8.6S sale of preferred stock convertible into 24.7M Inc. (CTIC) shares and the sale of warrants to buy up to 8.6M shares priced at $1 . 18 apiece (1/15) Cortex Private placement N/A $1 .5 Cortex completed a $1 .5M private placement Pharmaceuticals of a convertible of a convertible promissory note with Inc. (OTC BB: promissory note Samyang Optics Co. Ltd., of Korea (1/19) CORX) Curis Inc. Registered 6.4U $16.25 Curis raised $16.25M offering 6.4M units at (CRIS) direct offering $2.52 per unit; RBC Capital Markets is acting as the sole lead placement agent, and Rodman & Renshaw LLC is co-agent (1/25) Cyclacel Registered N/A $7.2; Cyclacel raised $7.2M and could raise another Pharmaceuticals direct offering $5.9 $2.3M as part of the offering with select insti- Inc. (CYCC) tutional investors; Roth Capital Partners LLC served as sole placement agent, while Merriman Curhan Ford & Co. served as finan- cial advisor (1/12); company planned to raise $5.9M in gross proceeds and up to another $2M in a registered direct offering to certain existing institutional investors; it involves the sale of 2.35M units at $2.50 each (1/22) EntreMed Inc. Registered 3. 1S $2.5 EntreMed raised $2.5M offering 3. 1M shares at (ENMD) direct offering 80 cents apiece; Wharton Capital Markets LLC acted as exclusive placement agent (1/13) GenVec Inc. Registered 14U $28 GenVec raised $28M offering 14M units priced (GNVC) direct offering at $2 each; each unit consists of one common share and 0.30 five-year warrants to purchase an additional common share at an exercise price of $2.75 (1/28) Geron Corp. Private N/A $10 Geron sold shares of stock to investors for (GERN) placement of gross proceeds of $10M (1/19) common stockBioWorld® State of the Industry Report 2011 49
  • 51. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) MDRNA Inc. Registered 5.4S and $5.5 MDRNA raised $5.5M through the sale of 5.4M (MRNA) direct offering W for 3.5S shares priced at $1 .02125 per share; investors also will receive warrants to buy about 3.5M shares at $1 each (1/15) Oragenics Inc. Private 10.01S $2.5 Oragenics placed 10.01M shares at 25 cents (AMEX:ONI) placement of per share for $2.5M (1/6) common stock Osteologix Inc. Securities 1 .99S $1 Osteologix raised $1M by selling 1 .99M shares (OTC BB:OLGX) purchase (1/6) agreement Pharming Convertible N/A �7.5 Pharming Group secured a convertible debt Group NV debt ($10.8) financing structured as a one-year, nonlisted (the Netherlands; financing convertible debt instrument that is convert- Amsterdam: ible into Pharming shares at 72 cents (1/6) PHARM) Resverlogix Private 3. 19S C$8 Completed a $7.5M second tranche of a place- Corp. (Canada; placement ($7.5) ment announced in December, issuing about TSX:RVX) 3. 19M common shares at C$2.50 per unit (1/29) Rosetta Registered 2.5S and $5. 1 Rosetta raised $5. 1M selling 2.5M shares and Genomics Ltd. direct offering W for 1 .3S warrants for 1 .3M shares in units; Rodman & (ROSG) Renshaw LLC acted as exclusive placement agent (1/15) Silence Private N/A £15 Silence raised $24M via a subscription and Therapeutics placement ($24) placing with institutional investors and the plc (UK; LSE: investment vehicles of major pharmaceutical SLN) companies; this occurred following its merger with Intradigm Corp. (1/7) Vical Inc. (VICL) Equity facility N/A – Vical secured an issuer-managed equity facili- ty under which it may sell up to $25M of com- mon stock to Azimuth Opportunity Ltd. over a 24-month period (1/12) WEX Rights offering N/A C$34.51 WEX said its rights offering is fully subscribed Pharmaceuticals ($32.36) and the company is issuing 265.48M restrict- Inc. (Canada; ed voting shares at C$0. 13 per share, for gross TSX:WXI) proceeds of C$34.51M; Pharmagesic Holdings Inc. is acquiring an additional equity stake (1/28) FEBRUARY Access Private 2. 1S and W $6.3 Access raised $6.3M through the placement Pharmaceuticals placement of for 1 .05S (2/3) Inc. (OTC BB:ACCP) stock and warrants Angel Private N/A £1 .4 Angel raised $2.2M in a private placement Biotechnology placement ($2.2) (2/10**) Holdings plc (UK; LSE:ABH) BrainStorm Investment $2S $1 .5 BrainStorm raised $1 .5M from three investors Cell Thera- (2/18) peutics Inc. (OTC BB:BCLI)50 BioWorld® State of the Industry Report 2011
  • 52. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Cardiome Credit facility N/A $25 Cardiome drew down $25M from a $100M Pharma Corp. credit facility provided by Merck & Co. Inc. (Canada; CRME) (2/18) EntreMed Inc. Registered 3.8S $2.5 EntreMed raised $2.5M through the direct sale (ENMD) direct of 3.8M shares priced at 65 cents each (2/8) offering GTC Biothera- Loan N/A $7 GTC got a $7M loan from its partner LFB peutics Inc. Biotechnologies, with a term of 36 months (GTCB) and an interest rate of 4% (2/23) ICo Exercised 3.2W $0.969 ICo said about 3.2M common share purchase Therapeutics common share warrants were exercised for proceeds of Inc. (Canada; purchase $968,813 (2/11) CDNX:ICO) warrants Intellect Interim N/A ND Several shareholders agreed to provide inter- Neurosciences financing im funding (2/11) Inc. (OTC BB: ILNS) Neuralstem Inc. Private 0.647S $5.2 Neuralstem raised $1 .5M through the place- (AMEX:CUR) placement and W ment and $3.7M from warrant exercises (2/19) and warrant exercise Palatin Registered 9.6U $2.6 Palatin raised $2.6M selling 9.6M units at 27 Technologies direct offering cents each; each unit consists of one share of Inc. (AMEX:PTN) common stock, a Series A warrant to purchase 0.33 of one share at 30 cents per share, and a Series B warrant to purchase 0.33 of one share at 27 cents per share (2/26) Poniard Committed N/A – Poniard entered a committed equity financing Pharmaceuticals equity facility facility under which it may sell up to $20M of Inc. (PARD) common stock to Commerce Court Small Cap Value Fund Ltd. over an 18-month period (2/25) ProMetic Life Loan and N/A $13 ProMetic secured a $10M loan for five years, Sciences Inc. investment plus received a $3M investment for 17.85M (Canada; TSX: common shares of ProMetic to Abraxis PLI) BioScience (2/12) Pro-Pharma- Private N/A $0.325 Pro-Pharmaceuticals closed a $325,000 ceuticals Inc. placement of tranche of a private placement through the (AMEX:PRW) stock and sale of stock and warrants to 10X Fund LP warrants (2/3) Protox Private N/A C$6.5 Protox raised $6. 18M in the private placement Therapeutics placement ($6. 18) at C45 cents per unit (2/8; revised 3/1) Inc. (Canada; of units TSX:PRX) Sirona Private 2. 15U $0.215 Sirona raised $215,000 in the nonbrokered pri- Biochem Corp. placement vate placement of 2. 15M units, each compris- (Canada; CDNX: ing one common share and one transferrable SBM) share purchase warrant, priced at 10 cents per unit (2/2)BioWorld® State of the Industry Report 2011 51
  • 53. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Spectral Private N/A $4.38 Spectral raised an additional $4.38M for a Diagnostics placement total of $18.38M in the private placement; Inc. (Canada; of units $14M of the total was accounted for in TSX:SDI) December 2009 (2/4) Uluru Inc. Registered 5S $1 Uluru raised $1M through the sale of 5M (AMEX:ULU) direct offering shares at 20 cents each; Rodman & Renshaw managed the offering (2/4) Vernalis plc Private 39.4S £30 Vernalis raised $47M that it will use to buy (UK; LSE:VER) placement of ($47) back its royalty stream from Paul Capital common stock Healthcare for frovatriptan (2/16) Vyteris Inc. Private place- Notes and $1 .06 Vyteris raised $1 .06M through the placement (OTC BB:VYTR) ment of senior W for 5.3S (2/9) subordinated convertible promissory notes XOMA Ltd. Registered 42U $21 XOMA sold 42M units for 50 cents apiece, (XOMA) direct offering with each unit consisting of one common share and one five-year warrant to purchase 0.45 common shares at an exercise price of 70 cents; Lazard Capital Markets LLC served as the sole bookrunning manager for the offering (2/3) MARCH Agennix AG Private 1 .87S �9.8 Agennix raised about $13M in a private place- (Germany; FSE: placement ($13) ment (3/23) AGXA) Amicus Registered 4.9S and $18.5 Amicus is offering to sell 4.9M shares and Therapeutics direct offering W for 1 .85S warrants to buy up to about 1 .85M shares at Inc. (FOLD) $3.74 each (3/1) Biomoda Inc. Private N/A $2 Biomoda raised $2M in stock with a syndicate (OTC BB:BMOD) placement of institutional investors; LifeTech Capital acted as the exclusive placement agent (3/18) BioSante Registered 10.4S and $18 BioSante raised $18M through Great Point Pharmaceuticals direct offering W for 5.2S Partners LLC and Deerfield Management Co. Inc. (BPAX) (3/5) Bradmer Private 10.5S $1 Bradmer is raising $1M through the placement Pharmaceuticals placement of of up to 10.5M shares at 9.5 cents per share Inc. (Canada; common stock (3/5) TSX:BMR) Cardium Registered 2.3U $11 .3 Cardium raised $11 .3M offering 2.3M units at Therapeutics direct offering $5 each (3/10) Inc. (AMEX:CXM) Chelsea Registered 6.7S and $18.2 Chelsea raised $18.2M in the offering; Leerink Therapeutics direct offering W for 2.3S Swann served as lead placement agent, with International Needham & Co. LLC as co-placement agent Ltd. (CHTP) (3/9) Cleveland Private 1 .53S and $5 Cleveland BioLabs raised $5M in the place- BioLabs Inc. placement of W for 1 .01S ment (3/1) (CBLI) common stock and warrants52 BioWorld® State of the Industry Report 2011
  • 54. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) CytoCore Inc. Investment 2.7S and $1 .35 CytoCore said NeoMed Management is taking (OTC BB:CYOE) 0.217W a 6.3% investment in the company (3/12) DARA Private 3.6S and $1 .7 DARA raised $1 .7M through the sale of 3.6M BioSciences placement W for 1 .8S shares of common stock and warrants to pur- Inc. (DARA) of common chase 1 .8M shares of common stock (3/2) stock and warrants Fibrocell Private 5. 1U $3.8 Fibrocell raised $3.8M placing 5. 1M units at 75 Science Inc. placement cents each, with each unit consisting of one (OTC BB:FCSC) of units common share and one warrant to purchase an additional share at 98 cents (3/4) Genta Inc. Private N/A $25 Genta is raising $25M in the placement (3/9) (OTC BB:GNTA) placement of convertible notes Interleukin Registered 4.37S and $5.3 Interleukin raised $5.3M in the offering; Genetics Inc. direct offering W for 1 .75S Rodman & Renshaw acted as placement agent (AMEX:ILI) (3/8) Lexicon Private 88.29S $101 .5 Lexicon raised $101 . 5M through a private Pharmaceuticals placement placement with Invus LP; the placement was Inc. (LXRX) done concurrently with a public offering and included an original 59.29M-share placement, plus an additional 29M shares purchased later (3/17) MabCure Inc. Private 2U $1 MabCure secured $1M through a $500,000 (OTC BB:MBCI) placement cash investment and the conversion of a $500,000 bridge loan (3/9) Medgenics Private 14.3S £0.73 Medgenics raised $1 . 1M pricing 14.3M shares at Inc. (Israel placement ($1 . 1) 5 pence each and another 192,591 shares at LSE:MEDG) 6.5 pence each (3/8) Medivir AB Rights N/A SEK300 Medivir raised $41 . 2M through the rights (Sweden; offering ($41 .2) offering of class B shares to existing share- SSE:MVIRB) holders (3/30) MethylGene Investment N/A C$8.9 MethylGene entered an agreement to raise Inc. (Canada; ($8.7) gross proceeds of up to $8.7M in nondilutive TSX:MYG) capital from 1819400 Ontario Inc. and 1815303 Ontario Ltd. (3/29) NeoStem Inc. Warrant 1S $1 .75 NeoStem raised $1 .75M with RimAsia Capital (AMEX:NBS) exercise Partners LP exercising its warrant to purchase 1M shares at $1 .75 each (3/19) NexMed Inc. Refinance N/A $1 .4 NexMed raised $1 . 4M from refinancing the (NEXM) mortgage on its manufacturing facility in New Jersey; the mortgage secures the issuance of new convertible notes due Dec. 31 , 2012, which total $4M (3/18) NPS Sale of N/A $38.4 NPS raised $38.4M by selling royalty rights for Pharmaceuticals royalty rights hyperparathyroidism drug Regpara to a fund Inc. (NPSP) managed by DRI Capital Inc. (3/3) Orexo AB Placement of N/A SEK111 Orexo raised $15.6M by placing a convertible (Sweden; convertible ($15.6) bond with Novo (3/16) SSE:ORX) bondsBioWorld® State of the Industry Report 2011 53
  • 55. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) OxiGene Inc. Private 6.6S $7.5 OxiGene is raising about $7.5M through the (OXGN) placement of sale of about 6.6M shares of common stock common stock and warrants to certain institutional investors; and warrants Roth Capital Partners LLC acted as the sole placement agent (3/12) Poniard Private 4.2S $6.3 Poniard raised $6.3M through the sale of Pharmaceuticals placement of about 4.2M shares of common stock priced at Inc. (PARD) common stock $1 . 49 each to Commerce Court Small Cap Value Fund Ltd. under an existing committed equity financing facility (3/16) Prolor Biotech Private 10.3S $24.4 Prolor raised $24.4M for about 10.3M shares of Inc. (Israel; placement of common stock to accredited investors at BE:M3D) common stock $2.35 per share (3/19) Pro-Pharma- Private placement of N/A $0.335 Pro-Pharmaceuticals closed a $335,000 ceuticals Inc. Series B convertible tranche of a private placement of up to $6M (OTC BB:PRWP) preferred stock and with 10X Fund LP (3/12) warrants Provectus Private 7. 1S and $7.5 Provectus raised $7.5M through a placement Pharmaceuticals placement of W for 3.55S of 10M shares priced at 75 cents each plus Inc. (OTC BB: stock and warrants to buy another 5M shares with an PVCT) warrants exercise price of $1 (3/15) Response Private 3S $4 Response Genetics raised $4M in a placement Genetics Inc. placement of of 3M shares at $1 .31 each; investors were new (RGDX) common stock and existing investors and certain funds man- aged by Lansdowne Partners LP (3/9) RXi Private placement of 2.7S and $16.2 RXi is raising about $16.2M through the sale of Pharmaceuticals common stock and W for 0.54S units priced at $6 each; Rodman & Renshaw Corp. (FSE:RXK) warrants LLC is exclusive placement agent (3/24) SemBioSys Private placement of 10.2S C$1 .8 SemBioSys raised $1 .74M in a placement of Genetics Inc. shares ($1 .74) 10.2M shares priced at C17.5 cents each (3/4) (Canada; PK:SBIYF) Senesco Private 0.011S and $11 .497 Senesco is raising $11 .497M through the place- Technologies placement of W for 35.9S ment of up to 11 ,497 shares of convertible pre- Inc. (AMEX:SNT) convertible ferred stock and warrants to purchase up to preferred 35.9M shares (3/30) stock and warrants Syntopix Private 2.99S $3.8 Syntopix raised $3.8M in a placing of 2.99M Group plc (UK; placement shares (3/17**) LSE:SYN) ThromboGenics Exercise of N/A �0.6 ThromboGenics raised $797,763 through the NV (Belgium; warrants ($0.798) exercise of warrants by a number of the com- BR:THR) Unigene Three-year N/A $13.64 Unigene issued $33M in notes due 2013, in ex- Laboratories convertible change for about $19.36M of existing noncon- Inc. (OTC BB: senior secured vertible senior secured term notes, which are UGNE) term notes due in 2011 , and the payment of $13.64M in placement cash; an entity managed by Victory Park Capital Advisors LLC is the sole investor in the transaction (3/18)54 BioWorld® State of the Industry Report 2011
  • 56. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Wilex AG Standby equity N/A – Wilex can draw down up to $27. 1M through the (Germany; distribution stock deal with YA Global Master SPV Ltd. BE:WL6) agreement (3/24) YM Registered N/A $17.5 YM raised $17.5M through the placement of BioSciences direct offering units at $1 .20 each; Roth Capital partners LLC Inc. (Canada; served as lead placement agent (3/9) AMEX:YMI) APRIL Active Share N/A SEK149 Active Biotech raised $20.7M in a new share Biotech AB offering ($20.7) offering that was managed by Sectoral Asset (Sweden; Management (4/2) SSE:ACTI) Adherex Private N/A C$7.2 Adherex entered agreements with Southpoint Technologies placement ($7.2) Capital Advisors LP and certain other inves- Inc. (AMEX:ADH) tors for a $7.2M private placement (4/22) AEterna Private 11 . 1S and $15 AEterna is selling $15M worth of securities to Zentaris Inc. placement of W for 4.4S institutional investors (4/19) (Canada; common stock TSX:AEZ) Affitech A/S Investment N/A �20.9 Affitech raised $28M through the investment (Denmark; ($28) from Trans Nova Investments Ltd. (4/22) CSE:AFFI) ALDA Private 3.08U $0.616 ALDA raised $616,000 by placing 3.08M units Pharmaceuticals placement at 20 cents each; each unit consists of one Corp. (Canada; of units common share of ALDA and one nontransfer- CDNX:APH) able share purchase warrant (4/30) Alnylam Investment 0.055S $0.993 Alnylam raised $993,462 from partner Pharmaceuticals Novartis AG, which elected to exercise fully its Inc. (ALNY) right to purchase 55,223 shares (4/27) Anthera Private 2.6S $17. 1 Anthera raised $17. 1M placing 2.6M shares at Pharmaceuticals placement of $6.58 each (4/8) Inc. (ANTH) common stock Benitec Ltd. Private N/A A$6.47 Benitec raised $6M through the issuance of (Australia; placement of ($6) four two-year convertible notes (4/13) ASX:BLT) two-year convertible notes BioAlliance Equity stake N/A ND Therabel Group took an equity stake in Pharma SA BioAlliance, according to a European license (France; Paris: agreement for Loramyc and Setofilm worth BIO) $68.9M (4/28) BioDelivery Registered 2.8S and $10 BioDelivery raised $10M selling 2.8M shares Sciences direct offering W for 1 .4S priced at $3.54 each and issued warrants for International about 1 .4M additional shares (4/21) Inc. (BDSI) Cannasat Private N/A C$2.5 Cannasat raised $2.5M through a placement Therapeutics placement ($2.5) of units, each consisting of one common Inc. (Canada; of units share and one-half of a warrant, at a price of CDNX:CTH) 10 cents per unit; Wellington West Capital Inc. is acting as lead placement agent (4/8)BioWorld® State of the Industry Report 2011 55
  • 57. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Cell Private placement Preferred $20 Cell Therapeutics raised $20M in a stock sell Therapeutics of common stock stock and W to three institutional investors (4/1) Inc. (CTIC) and warrants for 20S Cerus Corp. Credit facility N/A $5 Cerus received a $5M loan through a $10M (CERS) credit facility from Oxford Finance Corp. (4/7) Corcept Warrant W for 4.3S $7.6 Corcept raised $7.6M through the exercise of Therapeutics exercise and warrants ($7. 1M) and a private placement of Inc. (CORT) private warrants to purchase 4.3M shares ($500,000) placement (4/23) CytoDyn Inc. Private N/A $3 CytoDyn raised $3M through an offering of (PK:CYDY) placements restricted common stock to a select group of investors and an offering of convertible pre- ferred shares to a broader range of investors (4/1) Diamyd Medical Private 0.292S SEK35 Diamyd raised $4.8M in the placement of AB (Sweden; placement of ($4.8) 291 ,667 new B shares (4/1) SSE:DIAMB) new B shares EntreMed Inc. Registered 5.8S $3 EntreMed raised $3M in an offering of 5.8M (ENMD) direct offering shares for 51 .8 cents apiece (4/20) Epigenomics Private N/A �33. 1 Epigenomics raised $44.8M through an AG (Germany; placement ($44.8) investment from Abingworth LLP (4/7) FSE:ECX) Generex Private 2S $0.945 Generex raised $945, 180 in the first tranche of Biotechnology placement of an agreement with Seaside 88 LP; Seaside can Corp. (GNBT) common stock purchase up to 49.5M shares of stock, and intends to purchase 2M shares every two weeks in up to 25 tranches; Midtown Partners & Co. LLC acted as placement agent (4/9) IGI Private placement of N/A $1 .55 IGI raised $1 .55M through the placement (4/1) Laboratories Series C convertible Inc. (AMEX:IG) preferred stock Incuron LLC Investment N/A $5.7 A $5.7M investment was put into Incuron by (joint venture of Bioprocess, which has committed to a total Cleveland $18M investment (4/27) BioLabs Inc., CBLI, and Bioprocess Capital Ventures) Manhattan Private 121U $3 Manhattan closed its private placement sell- Pharmaceuticals placement ing 121 units, including the conversion of Inc. (OTC BB: of units about $400,000 of existing debt into 17 units, MHAN) for an aggregate of $3M of its common stock and warrants to accredited investors (4/15) Medivir AB Rights offering N/A $3.4 Priced its rights offering at SEK62 per share; (Sweden; SSE: some of the total money raised, $44.6M, was MVIRB) was accounted for in March (4/28)56 BioWorld® State of the Industry Report 2011
  • 58. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) NovaDel Private 9S and W $1 .5 NovaDel raised $1 .5M through the sale of 9M Pharma Inc. placement of for 4.5S shares of common stock to institutional (OTC BB:NVDL) common stock investors at $0. 165 per share; the investors and warrants also will receive five-year warrants to buy about 4.5M shares at $0.25 per share; Chardan Capital Markets LLC served as the placement agent (4/1) Ondine Private 12.5U C$0.75 Ondine raised $749,868 through the issuance Biopharma placement ($0.75) of 12.5M units, each consisting of one com- Corp. (Canada; of units mon share and one share purchase warrant TSX:OBP) (4/7) Pacgen Bio- Private 10 receipts C$0.6 Pacgen raised $600,740 through the place- pharmaceuticals placement of ($0.6) ment of 10M subscription receipts priced at C6 Corp. (Canada; subscription cents each (4/21) CDNX:PGA) receipts PharmAthene Private 1 .67S and $2.5 PharmAthene raised $2.5M in the placement; Inc. (AMEX:PIP) placement of W for 0.5S Roth Capital Partners served as sole place- common stock ment agent (4/9) and warrants PolyMedix Credit facility N/A $10 PolyMedix took an advance of $10M on a $14M Inc. (OTC BB: credit facility with Hercules Technology II, LP, PYMX) an affiliate of Hercules Technology Growth Capital Inc. (4/2) Radient Convertible N/A $10.4 The second note financing was offered to 25 Pharmaceuticals promissory accredited investors with similar discount Corp. (AMEX: note and terms and lender fees to that of the first RPC) warrant financing for net proceeds of $3.225M with financing warrants to purchase 6.5M shares of common stock (4/15); the company had a third closing that raised another $3.9M; all told, the compa- ny raised $10.4M (4/19) Transdel Private debt N/A $1 Transdel issued a two-year senior convertible Pharmaceuticals financing promissory note with an annual interest rate Inc. (OTC BB: of 7.5% to an existing shareholder (4/9) TDLP) Valeant Private N/A $35 Valeant priced its private placement of $400M Pharmaceuticals placement of of 7.625% senior unsecured notes due 2020, International senior unec- with $365M going to repurchase 3% convert- Inc. (NYSE:VRX) ured notes ible subordinated notes due 2010; the rest is going toward and acquisition and general cor- porate purposes (4/8) MAY Adventrx Registered 1 .8S $19.2 Adventrx raised $19.2M in the offering, with Pharmaceuticals direct offering Rodman & Renshaw LLC acting as the exclu- Inc. (AMEX:ANX) sive placement agent (5/4)BioWorld® State of the Industry Report 2011 57
  • 59. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Alexza Loan W for 0.376S $15 Alexza secured $15M through Hercules Pharmaceuticals agreement Technology Growth Capital, issuing warrants Inc. (ALXA) to purchase 376,394 shares of common stock at $2.69 per share (5/6); company obtained a committed equity facility to sell up to $25M of registered common stock to Azimuth Opportunity Ltd. over a 24-month period (5/28) Anadys Registered 5.8S $12.5 Anadys raised $12.5M in the offering of 5.8M Pharmaceuticals direct offering shares at $2. 15 apiece (5/27) Inc. (ANDS) AspenBio Private 2.4U $10 AspenBio raised $10M by placing 2.4M units, Pharma Inc. placement each consisting of one share of common (APPY) of units stock and one warrant to purchase 0.285 shares of stock (5/3) BioTime Inc. Exercise of N/A $8 BioTime received an additional $8M from two (BTIM) stock purchase investors who elected to exercise early and in warrants full, the stock purchase warrants acquired under a May 2009 agreement; investors were Broadwood Partners LP and George Karfunkel (5/12) BSD Medical Registered 1 .64S and $2.5 BSD sold 1 .64M shares at $1 .52 per share for Corp. (BSDM) direct offering W for 1 .23S gross proceeds of about $2.5M; the company also was issuing warrants to purchase 1 .23M shares to the investors (5/4) CBio Ltd. Convertible N/A A$12.45 CBio secured $10.77M in funding through (Australia; loan agreement ($10.77) SpringTree Special Opportunities Fund LP ASX:CB2) (5/19) Cell Registered 52.5S $21 Cell Therapeutics entered a deal to sell $21M Therapeutics direct offering of Series 5 preferred shares convertible into Inc. (CTIC) 52.5M shares to three institutional investors (5/25) ConjuChem Private N/A $30 ConjuChem is recapitalizing the company Biotechnologies placement of with new investors subscribing about $35M Inc. (Canada; common stock of new common shares, with $5M of the pro- TSX:CJB) ceeds going toward debt (5/19) Critical Private 3U $1 Critical Outcome closed the first tranche of a Outcome placement placement of units, selling 3M units priced at Technologies of units 35 cents each; each unit comprises one com- Inc. (Canada; mon share and one-half a share purchase war- CDNX:COT) rant (5/3) International Private placement N/A $10 International Stem Cell received a commit- Stem Cell Corp. of nonconvertible ment for Socius CG II Ltd. to purchase up to (OTC BB:ISCO) Series F preferred $10M in stock (5/6) stock La Jolla Private 29S $6 La Jolla is raising $6M through the sale of 29M Pharmaceutical placement shares, plus the sale of convertible preferred Co. (OTC BB: stock and three-year warrants (5/26) LJPC)58 BioWorld® State of the Industry Report 2011
  • 60. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) MagForce Nano- Standby equity N/A – MagForce can sell up to $26. 1 M in shares technologies AG distribution through multiple tranches with YA Global (Germany; agreement Master SPV Ltd. (5/5) BE:MF6) MediciNova Senior secured N/A $15 MediciNova entered a $15M loan with Oxford Inc. (MNOV) term loan Finance Corp. (5/12) NeurogesX Financing N/A $40 NeurogesX signed a $40M deal with Cowen Inc. (NGSX) Healthcare Royalty Partners, creating a debt obligation to be repaid by royalties and mile- stones gained through an overseas Qutenza deal with Astellas Pharma Inc. (5/3) Oxygen Bio- Private 1 .7S and $4.93 Oxygen raised $4.93M through the sale of therapeutics placement of W for 0.732S stock and warrants (5/5) Inc. (OXBT) common stock and warrants Paion AG Equity facility N/A �15 Paion entered an $18.8M equity facility agree- (Germany; agreement ($18.8) ment with Commerce Court Small Cap Value BE:PA8) Fund Ltd. managed by Acqua Capital Management Inc. (5/14) Pro-Pharma- Private N/A $0.31 Pro-Pharmaceuticals raised $310,000 in a ceuticals Inc. placement and $0.57 tranche of a private placement of up to $6M (OTC BB:PRWP) with 10X Fund LP (5/5); it closed on another $570,000 to complete the placement (5/12) Sequenom Inc. Private 12.435S $51 .6 Sequenom raised $51 .6M through the place- (SQNM) placement ment of shares at the huge discount of $4. 15 each; Jefferies & Co. Inc. was sole lead place- ment agent, and Lazard Capital Markets LLC served as co-placement agent (5/13) Tapimmune Private placement of N/A $1 .53 Tapimmune raised $1 .53M through the place- Inc. (OTC BB: senior secured ment conducted by Olympus Securities LLC TPIV) convertible (5/20) notes JUNE Aeterna Registered 8.8S $12. 1 Aeterna raised $12. 1M through institutional Zentaris Inc. direct offering investors; Rodman & Renshaw LLC acted as (Canada; TSX:AEZ) the exclusive placement agent (6/17) Ambrilia Nondilutive N/A $2 Ambrilia raised $2M in a nondilutive financing Biopharma Inc. financing (6/3) (Canada; TSX:AMB) Aoxing Bank loan N/A $8.05 Aoxing completed a bank loan financing with Pharmaceutical financing China Citic Bank and Bank of Communications Co. Inc. of China (6/9) (AMEX:AXN) Aradigm Corp. Private 34.7S and $5 Aradigm raised $5M through a private place- (OTC BB:ARDM) placement of 7.5W ment of 34.7M shares for 11 .8 cents each as stock and well as 7.5M warrants exercisable at the same warrants price; Ladenburg Thalmann & Co. Inc. acted as the sole placement agent (6/22) Arena Private 11S $35.5 Arena agreed to sell 11M shares to Deerfield Pharmaceuticals placement Management for $35.5M (6/4) Inc. (ARNA)BioWorld® State of the Industry Report 2011 59
  • 61. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) BioSante Registered 7. 1U $15 BioSante raised $15M offering 7. 1M units at Pharmaceuticals direct offering $2. 1025 each, with each unit consisting of one Inc. (BPAX) common share and one five-year warrant exercisable at $2.45 to purchase half of an additional common share; Rodman & Renshaw LLC acted as the placement agent, with JMP Securities LLC, Oppenheimer & Co. Inc. and Trout Capital LLC acting as financial advisors (6/22) Cadence Loan facility N/A $20 Cadence secured a $30M loan facility, receiv- Pharmaceuticals ing $20M now and $10M on FDA approval of Inc. (CADX) Ofirmev (6/23) Celsion Corp. Committed N/A – Celsion may sell up to $15M of common stock (CLSN) equity finan- to Small Cap Biotech Value Ltd. over a cing facility 24-month period; Reedland Capital Partners will act as placement agent (6/18) Columbia Subordinated N/A $15 Columbia signed a $15M term loan with Laboratories term loan Watson Pharmaceuticals Inc. (6/2) Inc. (CBRX) Critical Private 3.2U C$1 . 1 Critical Outcome priced 3.2M units at C35 Outcome placement ($1 .05) cents each; each unit comprises one common Technologies share and one-half of one common share pur- Inc. (UK; chase warrant (6/2) CDNX:COT) Cytori Loan facility N/A $50 Cytori entered a $20M secured loan facility Therapeutics from GE Capital, Healthcare Financial Services, (CYTX) Oxford Finance Corp. and Silicon Valley Bank; it also raised a total of $30M from a Seaside 88 LP financing (6/15) Discovery Committed N/A – Discovery Laboratories secured a facility with Laboratories equity finan- Kingsbridge Capital Ltd., which has commit- Inc. (DSCO) cing facility ted to providing up to $35M over three years through the purchase of up to about 31 .6M shares (6/15) EpiCept Corp. Private 6. 1S $6.2 EpiCept raised $6.2M through an offering; (EPCT) placement of Rodman & Renshaw LLC acted as the exclu- common stock sive placement agent (6/29) Exelixis Inc. Financings N/A $160 Exelixis entered agreements providing for (EXEL) two separate financing transactions with Silicon Valley Bank and Deerfield Management (6/4) Genzyme Private N/A $1 ,000 Genzyme is offering $500M worth of 3.625% Corp. (GENZ) placement of senior notes due 2015 and $500M worth of 5% senior notes senior notes due 2020 (6/16); company is using the money to repurchase its common stock (6/21) GTC Biothera- Convertible N/A $7 GTC Biotherapeutics closed a new $7M financ- peutics Inc. debt financing ing by LFB Biotechnologies SAS (6/17) (OTC BB:GTCB)60 BioWorld® State of the Industry Report 2011
  • 62. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Hana Private 0.4S $40 Hana entered an agreement with Warburg Biosciences placement Pincus and Deerfield Management for the sale Inc. (OTC BB: of stock of up to $100M in preferred stock; the sale of HNAB) $40M closed June 7 (6/8) Harbor Private placement 5.9S and $2.06 Harbor raised $2.06M; Chardan Capital BioSciences of common stock W for 3.5S Markets LLC served as the placement agent Inc. (HRBR) and warrants (6/8) Lorus Private N/A $17.5 Lorus offered $17.5M in units, with each unit Therapeutics placement consisting of one common share and one-half Inc. (Canada; of units of a warrant to purchase common shares; TSX:LOR) Global Hunter Securities LLC has agreed to act as placement agent in the U.S. and D&D Securities Inc. is the placement agent in Canada (6/7) NeoStem Inc. Option and warrant N/A; $2.5; NeoStem raised $2.5M, including $700,000 (AMEX:NBS) exercises and an 2.3U $5 from the exercise of a warrant (6/9); it also equity financing raised $5M in a registered direct offering of drawdown; regis- 2.3M units for $2. 15 each (6/28) tered direct offering Neuralstem Registered 3.57U $10 Neuralstem agreed to sell $10M of units at Inc. (AMEX:CUR) direct offering $2.80 apiece; each unit consists of one share of common stock and three-fourths of a com- mon stock purchase warrant; Noble Financial Capital Markets acted as the sole placement agent (6/28) Palatin Registered 10U $2 Palatin is raising $2M in an offering of 10M Technologies direct offering units, each comprising one share of common Inc. (AMEX:PTN) stock and a warrant to purchase 0. 14 of one share of common stock priced at 20 cents each (6/28) PCI Biotech Oversubscribed N/A NOK90 PCI Biotech raised $13.8M through the rights Holding ASA rights issue ($13.8) issue (6/11) (Norway; LSE: OTGL) Pharmacyclics Registered 8S $52 Pharmacyclics is offering 8M shares at $6.51 Inc. (PCYC) direct offering to raise $52M (6/18) Proteome Private 0.24S £4.8 Proteome raised $6.9M through the place- Sciences plc placement ($6.9) ment (6/9**) (UK; LSE:PRM) Rexahn Registered 6.67S and $10 Rexahn raised $10M through the offering; Pharmaceuticals direct offering W for 2S Rodman and Renshaw acted as the exclusive Inc. (AMEX:RNN) placement agent (6/29) Soligenix Inc. Common stock 25.2S and $5. 16 Soligenix raised $5. 16M through existing and (OTC BB:SNGX) purchase agree- W for 15. 1S new investors; National Securities Corp. and ments Griffin Securities Inc. served as co-placement agents on the financing (6/17) Transgene SA Rights offering 7.7S �152 Transgene raised $185.2M from a rights offer- (France; Paris::TNG) ($185.2) ing (6/4) YM BioSciences Private placement of 2.5S $3.2 YM BioSciences raised about $3.2M through a Inc. (Canada; common stock private placement of 2.5M shares to be issued AMEX:YMI) at $1 .27 each (6/4)BioWorld® State of the Industry Report 2011 61
  • 63. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) JULY Adeona Equity financing 1 .2S $1 Adeona raised $1M placing 1 .2M shares with Pharmaceuticals Seaside 88 LP; Enclave Capital served as Inc. (AMEX:AEN) placement agent (7/7) Advanced Life Private placement of 0.714U $3 Advanced Life Sciences offered up to 714,286 Sciences units units at $4.20 each to raise $3M; Dawson Holdings Inc. James Securities acted as the exclusive place- (OTC BB:ADLS) ment agent (7/2) Advaxis Inc. (OTC Private placement of 0.00075S $7.5 Advaxis raised $7.5M through the sale of 750 BB:ADXS) Series B preferred shares of Series B preferred stock priced at stock $10,000 per share; Optimus Capital Partners agreed to buy the shares over three years; Advaxis also issued an affiliate of Optimus a warrant to purchase up to 40.5M shares of common stock (7/21) Affymax Inc. Sale of auction rate N/A $5 Affymax generated $10.4M through the sale of (AFFY) securities auction rate securities held by UBS AG; $5.4M of the total was used to repay a loan from UBS, so remaining proceeds were $5M (7/21) ALDA Private placement of 3.25U -$0.291 ALDA did not proceed on the terms disclosed Pharmaceuticals units April 15 for a private placement due to prevail- Corp. (Canada; ing market conditions; it was expected to CDNX:APH) raise $616,000, which was accounted for in the April chart; instead, it raised $325,000; the excess amount of $291 ,000 is being removed from the total (7/29) Bionovo Inc. Private placement of N/A $15 Bionovo is receiving $15M through Aspire (BNVI) common stock Capital Fund LLC, which will buy Bionovos common stock over two years (7/8) Cell Private placement of 0.004S $4.06 Cell Therapeutics entered into an agreement Therapeutics Inc. preferred stock and to sell 4,060 shares of Series 6 preferred (CTIC) warrants stock and warrants to buy an aggregate of 5.8M shares of common stock to an accredit- ed investor (7/27) Gilead Sciences Private placement of N/A $2,200 Gilead priced an offering of convertible senior Inc. (GILD) convertible senior notes to qualified institutional buyers and notes due 2014 and expects net proceeds of $2. 166B (7/27) 2016 International Investment N/A $10 International Stem Cell secured $10M from Stem Cell Corp. German investment fund ARG Vermo- (OTC BB:ISCO) gensver waltung AG and independent European sources (7/23) MediciNova Inc. Sale of auction rate N/A $9.5 MediciNova netted $9.5M after repaying the (MNOV) securities ARS loan from UBS AG (7/8) Northwest Private placement of N/A $2.65 Northwest raised $2.65M from private inves- Biotherapeutics restricted common tors and SDS Capital (7/8) Inc. (OTC BB:NWBO) stock Novelos Private placement of 21 .4S and W for $1 .5 Novelos entered an agreement with institu- Therapeutics Inc. common stock and 16.07S tional investors to sell 21 .4M shares of com- (OTC BB:NVLT) warrants mon stock and five-year warrants to purchase up to 16.07M shares at 7 cents per share (7/23)62 BioWorld® State of the Industry Report 2011
  • 64. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Omeros Corp. Committed equity N/A (up to Omeros may sell up to $40M of its shares of (OMER) financing facility $40M) common stock to investor Azimuth Opportunity Ltd. over 24 months (7/30) Oncothyreon Inc. Committed equity N/A (up to Oncothyreon secured a facility to sell up to (ONTY) financing facility $20M) $20M of its shares to Small Cap Biotech Value Ltd. over a 24-month period (7/8) Oragenics Inc. Private placement of 5S $2 Oragenics raised $2M through the placement (AMEX:ONI) common stock of 5M shares with the Koski Family Limited Partnership at a price of 40 cents per share (7/8) PharmAthene Registered direct 2.79S and 1 .32W $3.9 PharmAthene is raising $3.9M by selling Inc. (AMEX:PIP) offering 2.79M shares at $1 .40 each along with 1 .32M six-year warrants with an exercise price of $1 .63 each; Roth Capital Partners served as the sole placement agent (7/21) StemCells Inc. Private placement of 7S $6. 1 StemCells raised $6. 1M by selling the shares (STEM) common stock to Seaside 88 LP at $0.865 per share, a 12.6% discount; Seaside has agreed to purchase an additional 5M shares 12 weeks after the initial closing (7/1) Sunesis Private placement of 103.6S $28.5 Sunesis raised $28.5M pricing 103.6M shares Pharmaceuticals stock at $0.275 cents each; investors were Bay City Inc. (SNSS) Capital, New Enterprise Associates, Alta Partners, Caxton Advantage Life Sciences Fund, Merlin Nexus, Nextech Venture, OpusPoint Partners, Venrock Associates and Vision Capital Advisors and members of Sunesis management (7/2) XOMA Ltd. Committed equity N/A (up to XOMA can sell up to $30M of its registered (XOMA) financing facility $30M) common shares to Azimuth Opportunity Ltd. over a 12-month period (7/27) AUGUST Achillion Private placement of 19.8S $50 Achillion is raising $50M offering 19.8M Pharmaceuticals stock and warrants shares and warrants; investors are Domain Inc. (ACHN) A s s o c i a t e s , C l a r u s Ve n t u r e s , Q u a k e r BioVentures and Pappas Ventures (8/20) Aeolus Private placement of 2.5S and W $1 Aeolus raised $1M from Xmark Opportunity Pharmaceuticals common stock and a Partners LLC via two of its institutional share- Inc. (OTC BB:AOLS) seven-year warrant holders, exchanging 2.5M shares of common stock and a seven-year warrant to purchase 0.75 units of additional shares at $0.50 per share (8/16) Alexza Registered direct 6.7U $18 Alexza raised $18M in an offering of 6.7M Pharmaceuticals offering units, each consisting of one share and a war- Inc. (ALXA) rant to purchase half a share, priced at $2.70 (8/6) Arena Direct public 8.95S $30 Arena raised $60M through the sale of 8.95M Pharmaceuticals offering shares at $6.70 each, but $30M of the total Inc. (ARNA) will pay a portion of a loan; the shares were sold to entities affiliated with Deerfield Management (8/9)BioWorld® State of the Industry Report 2011 63
  • 65. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) ARYx Bridge financing N/A $4 ARYx secured bridge financing of up to $6.3M Therapeutics Inc. in two related loan transactions, the first pro- (ARYX) viding up to $4M from existing investors including entities affiliated with MPM Capital, and the second involving the amendment of an existing loan agreement with Lighthouse Capital Partners V LP to allow about $2.3M of required payments to Lighthouse to be deferred and extended as a new loan commit- ment to ARYx (8/17) Biodel Inc. (BIOD) Private placement of 2.4S and W for $9.4 Biodel raised about $9.4M through the sale of common stock and 2.4S shares and warrants in units priced at $3.93 warrants apiece; Wedbush PacGrow Life Sciences, Leerink Swann LLC and William Blair & Co. LLC acted as co-lead placement agents (8/30) BioTime Inc. Exercise of warrants W for 5. 1S $9.2 BioTime completed its warrant discount offer, (AMEX:BTIM) raising $9.2M, pricing warrants for 5. 1 M shares at $1 .818 per share (8/23) Dyadic Private placement of N/A $3 Dyadic completed a private placement of $3M International Inc. convertible subordi- in notes with two investors (8/25) (PK:DYAI) nated secured promissory notes Elan Corp. plc Private placement of N/A $200 Elan priced its offering of $200M in 8.75% (Ireland; NYSE:ELN) senior notes due senior notes by its subsidiaries, Elan Finance 2016 plc and Elan Finance Corp. (8/13) Emisphere Private placement of 3.5S and W for $7 Emisphere raised $3.5M through the place- Technologies common stock and 2.6S ment of units sold at $1 . 01 apiece; it also Inc. (OTC BB:EMIS) warrants entered a purchase agreement with MHR Fund Management LLC to sell 3.5M shares and warrants for 2.6M shares (8/30) Helix BioPharma Private placement of 4.53U $11 Helix closed a private placement of 4.53M Corp. (Canada; units units at $2.43 each; each unit consists of one TSX:HBP) common share and one common share pur- chase warrant (8/10) Idera Registered direct 4U $15 Idera raised $15M in the offering of 4M units Pharmaceuticals offering of stocks and warrants, priced at $3.71 , to cer- Inc. (IDRA) tain institutional investors (8/4) IntelGenx Private placement of 6.5U C$2.6 IntelGenx raised $2.5M in a private placement Technologies units ($2.5) offering of 6.5M units priced at C40 cents Corp. (Canada; apiece; each unit consists of one common CDNX:IGX) share and one common share purchase war- rant (8/30) Lorus Shareholder N/A -$12 Due to market conditions, Lorus did not com- Therapeutics Inc. rights offering plete its $17.5M public equity offering report- (Canada; TSX:LOR) and investment ed in June; instead, it is doing a shareholder rights offering and is receiving a $4M invest- ment from director Herbert Abramson, plus $1 .5M in loans from Abramson; the difference is being removed from the total (8/31)64 BioWorld® State of the Industry Report 2011
  • 66. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) MannKind Corp. Private placement of 18.2S Not MannKind entered an agreement with Seaside (MNKD) common stock disclosed 88 LP for the sale of 700,000 shares of com- mon stock every two weeks over the course of a year for a total of up to 18.2M shares (8/13) MannKind Corp. Private placement of N/A $100 MannKind is placing the notes, which will (MNKD) senior convertible have an approximate conversion price of notes due 2015 $6.80 per share; an additional $10M in notes could be purchased to cover overallotments (8/20) Mondobiotech Private placement N/A CHF 7.3M Mondobiotech raised $7M in its second Holding AG ($7M) financing transaction (8/4**) (Switzerland; SWX:RARE) Mylan Inc. (MYL) Private placement of N/A $300 Mylan placed $300M in notes due 2020 with senior notes proceeds to be used to acquire Bioniche Pharma Holdings Ltd., of Galway, Ireland (8/16) Neurokine Debt conversion 8S and W for 5S $0.04 Neurokine raised $40,000 through conver- Pharmaceuticals and private place- sion of debt and the issuance of 8M shares Inc. (Canada; OTC ment of shares and and warrants to purchase 5M shares (8/13) BB:NEUKF) warrants Raptor Private placement of 4.9U $15 Raptor raised $15M under the placement of Pharmaceutical units 4.9M units at $3.075 per unit (8/11) Corp. (RPTP) Regenicin Inc. Convertible loans N/A $3.25 Regenicin raised $3.25M in the financing, with (OTC BB:WDSTD) and a private place- NewOak Capital Inc. and Smith Point Ltd. as ment of common co-placement agents (8/19) stock Repros Private placement N/A $6.8 Repros raised $6.8M through sales agent Therapeutics Inc. Thalmann & Co. Inc. (8/4) (RPRX) Vivalis SA (France; Discounted rights N/A E30.3 Vivalis raised $40. 1M in a discounted rights Paris:VLS) issue ($40. 1) issue directed at existing shareholders (8/4**) SEPTEMBER Addex Private placement of 0.59S CHF20 Addex raised CHF6M ($5.98M) through the Pharmaceuticals shares and convert- ($19.88) issuance of 593,567 new registered shares Ltd. (Switzerland; ible notes and CHF14M ($13.9M) through the issuance of SWX:ADXN) zero coupon six-month mandatory convert- ible notes to Biotechnology Value Fund (9/16) Advanced Life Exercise of unit war- N/A $1 .5 Advanced Life received $1 . 5M in proceeds Sciences rants from the exercise of warrants issued in its July Holdings Inc. offering that raised $3M; the company also (OTC BB:ADLS) entered into an agreement with YA Global Master SPV Ltd. for the sale of up to $10M of common stock over a two-year period (9/30) Anthera Private placement of 10.5U $31 .5 Anthera raised $31 .5M in an offering of 10.5M Pharmaceuticals units units at $3 per share; each unit is one share Inc. (ANTH) and one warrant to purchase 0.40 shares at an exercise price of $3.30 per share (9/22)BioWorld® State of the Industry Report 2011 65
  • 67. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Apricus Private placement of 1 .7U $9.3 Apricus entered agreements with selected Biosciences Inc. units investors to sell up to 1 . 7M units at $5.40 (APRI) each; Dawson James Scurities acted as the exclusive placement agent (9/30) Aradigm Corp. Exercise of warrants W for 7.5S $0.891 Aradigm received proceeds of $891 ,000 from (OTC BB:ARDM) the exercise of warrants (9/24) Arno Private placement of N/A $15 Arno raised $15M in a financing led by UTA Therapeutics Inc. securities Capital LLC and Pontifax Funds; Riverbank (PK:ARNI) Capital Inc. acted as placement agent (9/14) Dyadic Private placement of N/A $1 Dyadic added $1M to its private placement of International Inc. convertible notes $3M, resulting in gross proceeds of $4M (9/8) (PK:DYAI) Dynavax At-the-market stock 1S $2 Dynavax received $2M initially, with Aspire Technologies offering Capital paying $2 per share; Dynavax will Corp. (DVAX) receive another $28M over the next 25 months as part of the deal (9/22) EntreMed Inc. Securities purchase N/A $5. 1 EntreMed raised $5. 1 M through a group of (ENMD) agreement investors (9/9) Genesis Private placement of 0.93S and W for $0.7 Genesis Biopharma raised $700,000 through Biopharma Inc. common stock and 0.47S the private offering (9/24) (OTC BB:GNBP) warrants Lorus Rights offering 5S $5.5 Lorus raised $5.5M by offering 5M shares Therapeutics Inc. (9/30) (Canada; TSX:LOR) NanoViricides Investment of Series 0.25S $2.5 Nanoviricides raised $25M with Seaside 88 Inc. (OTC BB:NNVC) B convertible pre- purchasing the stock for $10 per share (9/23) ferred stock Oncothyreon Inc. Private placement of 4.24U $14.9 Oncothyreon raised $14.9M by selling 4.24M (ONTY) stock and warrants units at $3.50 each, with each unit consisting of one common share and one five-year war- rant to purchase 0.75 of an additional share with an exercise price of $4.20 (9/27) Protox Investment N/A C$35 Private equity firm Warburg Pincus has com- Therapeutics Inc. ($33.8) mitted to invest up to $33.8M in Protox, com- (Canada; TSX:PRX) prised of an initial tranche of $10M, and an additional tranche of $25M (9/30) Stellar Private placement of 3U C$1 .05 Stellar raised $1 .01M in a private placement of Biotechnologies stocks and warrants ($1 .01) 3M units priced at C35 cents per unit (9/30) Inc. (CDNX:KLH) Titan Loan and security N/A $5 Titan entered an amended loan agreement Pharmaceuticals agreement with Oxford Finance Corp. for the $5M term Inc. (OTC BB:TTNP) loan (9/29) OCTOBER Agennix AG Combined rights N/A E78.4 Agennix priced the offering at E3.81 per share; (Germany; offering and private ($107.8) Piper Jaffray Ltd. and WestLB AG acted as joint PK:GAGXF) placement global coordinators on the transaction (10/4) Alimera Sciences Revolving line of W for 0.08S $12.5 Alimera secured a $20M credit facility provid- Inc. (ALIM) credit and a term ed by Silicon Valley Bank, and a $12.5M term loan loan provided by MidCap Financial LLC and Silicon Valley Bank (10/18)66 BioWorld® State of the Industry Report 2011
  • 68. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Apricus Private placement N/A $9.3 Apricus raised $9.3M in a securities offering; Biosciences Inc. Dawson James Securities acted as the exclu- (APRI) sive placement agent (10/6) Bionovo Inc. Registered direct 2.7S and 2W $3 Bionovo raised $3M by selling about 2.7M (BNVID) offering shares priced at $1 . 10 apiece and will issue about 2M warrants; William Blair & Co. LLC is acting as exclusive placement agent (10/4) ChemGenex Investment N/A $14.7 Cephalon Inc. provided up to $14.7M to Pharmaceuticals ChemGenex for a note convertible at 49 cents Ltd. (Australia; per share (10/25) ASX:CXS) Cyclacel Private placement of 8.3U $22. 1 Cyclacel raised $22. 1M in a sale of stock and Pharmaceuticals stock and warrants warrants; Lazard Capital Markets LLC served Inc. (CYCC) as the lead placement agent, and Roth Capital Partners LLC served as the co-placement agent for the offering (10/6) Cytomedix Inc. Registered direct 3.7S and W for $13 Cytomedix secured a $13M financing through (AMEX:GTF) offering 1 .8S a registered direct offering of shares and war- rants, plus $10M and $1 .5M equity purchase agreements (10/11) DARA Registered direct 0.613U $1 .4 DARA raised $1 .4M in an offering of 612,667 BioSciences Inc. offering units, with each unit consisting of one share (DARA) and 0.5 warrants to purchase one share, to institutional investors (10/27) DiaGenic ASA Private placement of 140S NOK70 DiaGenic raised $12M through the private (Norway; shares ($12) placement of 140M shares priced at NOK0.50 OSLO:DIAG) each (10/8) Discovery Private placement of 2.4S and W for $0.5 Discovery Laboratories raised $500,000 Laboratories Inc. common stock and 1 .2S through PharmaBio Development Inc.’s pur- (DSCO) warrants chase of 2.4M shares at 21 cents per share and warrants of 1 . 2M shares for 27.3 cents per share (10/14) Galapagos NV Share offering 2.4S E28.7 Galapagos raised $39.6M, placing 2.4M (Belgium; BR:GLPG) ($39.6) shares with institutional and other qualified investors (10/20**) Hybrigenics SA Equity line N/A E1 .43 Hybrigenics amended an agreement with YA (France; ($1 .99) Global Master SPV Ltd. for a total equity line of Paris:ALHYG) E 12M ($16.7M); it has drawn down E 1 . 43M (10/12) iBio Inc. (OTC Private placement of 3S and W for 3S $6 iBio raised $6M by placing 3M shares at $2 BB:IBPM) common stock and each; each investor was issued a warrant to warrants purchase the same number of shares at a cash exercise price of $2.20 per share for a period of five years (10/28) IS Pharma plc Private placement of 4.6S £3.6 IS Pharma raised $5.7M through the issue of (UK; LSE:ISPH) common stock ($5.7) about 4.6M shares at 77 pence per share with Abingworth LLP (10/7) Karo Bio AB Rights issue and N/A SEK530 Karo Bio secured SEK530M by raising (Sweden; SSE:KARO) equity-based credit ($79.7) SEK300M in a rights issue that is fully guaran- facility teed and another SEK230M in an equity-based credit facility (10/27)BioWorld® State of the Industry Report 2011 67
  • 69. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Omeros Corp. Financing involving 3W for 0. 133S $25 Omeros raised $25M exchanging a share of (OMER) future net proceeds each future net proceeds of its GPCR antibody ther- apeutic to Vulcan Capital and Life Sciences Discovery Fund; the deal includes warrants for Vulcan to purchase common stock at exer- cise prices of $20, $30 and $40; the three five-year warrants are good for 133,333 shares each (10/26) Ore Debt and equity 3. 1S and a five- $5.3 Ore raised $5. 1M through the sale of $1 . 1M in Pharmaceuticals investment year note shares at 35 cents each and a five-year note Holdings Inc. for $4.2M to Steel Partners Ltd. (10/26) (PK:ORXE) Oxygen Placement of senior N/A $5 Oxygen entered a note purchase agreement Biotherapeutics unsecured promis- with JP SPC 1 Vatea Segregated Portfolio to sell Inc. (OXBT) sory notes $5M of senior unsecured promissory notes in a series of closings between Oct. 31 and Dec. 31 (10/14) PDL BioPharma Private placement of Notes $88 PDL raised $88M through the placement of Inc. (PDLI) notes 2015 notes for cash (10/28) Pluristem Private placement of 4.375S and W $5.25 Pluristem raised $5.25M in the placement Therapeutics Inc. common stock and for 2.625S with selected institutional and private inves- (Israel; PSTI) warrants tors; Rodman & Renshaw LLC acted as the U.S. placement agent (10/13) QRxPharma Ltd. Private placement 16.47S $14 QRxPharma raised $14M by issuing shares at (Australia; 85 cents each (10/4) ASX:QRX) SciClone Debt financing N/A (up to SciClone said that Silicon Valley Bank Pharmaceuticals facility $15M) increased the existing debt financing facility Inc. (SCLN) from $6M to $15M (10/6) Sirona Biochem Nonbrokered pri- 10.5U C$1 .05 Sirona raised $1 .03M by selling 10.5M units for Corp. (Canada; vate placement of ($1 .03) C10 cents each, with each unit consisting of CDNX:SBM) units one share and one two-year warrant exercis- able at C20 cents (10/29) Stellar Private placement of 6U $3.6 Stellar offered 6M units at 60 cents each to Biotechnologies units raise $3.6M; each unit consists of one share Inc. (CDNX:KLH) and one transferable share purchase warrant (10/27) Stellar Private placement of 1U $1 Stellar is arranging a nonbrokered private Pharmaceuticals units placement of up to 1M units for $1 per unit Inc. (Canada; OTC (10/6) BB:SLXCF) ThromboGenics Exercise of warrants W for 0.289S E2.8 ThromboGenics raised $3.9M as the result of NV (Belgium; ($3.9) the exercise of warrants by a number of BR:THR) employees (10/28) NOVEMBER Adamis Private placement of 40S $10 Adamis signed a $10M deal with Estes Pharmaceuticals common stock Holdings Ltd., selling 40M shares at 25 cents Corp. (OTC each (11/12) BB:ADMP)68 BioWorld® State of the Industry Report 2011
  • 70. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Allon Private financing N/A $10 Allon closed a $10M financing with Isar Therapeutics Inc. Pharma KS (11/3) (Canada; TSX:NPC) Anacor Private placement 2S $10 Anacor raised $10M with a private placement Pharmaceuticals of 2M shares at $5 a share to funds affiliated Inc. (ANAC) with existing investor Venrock Associates (11/29) Anavex Life Private placement of 0.397U $1 .09 Anavex raised $1 .09M through a private place- Sciences Corp. units ment of 397,482 units for $2.75 each, with (OTC BB:AVXL) each unit representing one common share and one-half of an 18-month warrant with an exercise price of $4.50 (11/23) AVEO Private investment 4.5S $61 AVEO raised $61M selling 4.5M shares at Pharmaceuticals $13.50 each to a group of investors; J.P. Inc. (AVEO) Morgan Securities LLC and Canaccord Genuity Inc. are joint lead placement agents, and RBC Capital Markets Corp. served as co-placement agent (11/1) BiondVax Standby equity 1 .45S $1 .25 BiondVax sold 1 .45M shares at NIS3. 105 each Pharmaceuticals distribution to YA Global Investments LP (11/11) Ltd. (Israel; TASE:BNDX) BioTime Inc. Exercise of warrants N/A $6.97 BioTime raised a total of $24. 17M over the (AMEX:BTX) past 18 months from exercises of warrants; it raised $8M in May, $9.2M in August and $6.97M in November (11/5) Clavis Pharma Private placement of 4.4S $25.7 Clavis raised $25.7M in the placement of 4.4M ASA (Norway; common stock shares at NOK35 ($5.84) per share; ABG OSLO:CLAVIS) Sundial Collier ASA and Carnegie ASA led the placement, and existing and new investors participated (11/19) DiaGenic ASA Private placement 60S NOK30 DiaGenic received proceeds of $4.9M through (Norway; ($4.9) the allocation of 60M new shares at NOK0.50 OSLO:DIAG) per share (11/24) Endo Private offering of N/A $400 Endo disclosed a private offering of $400M in Pharmaceuticals senior unsecured notes due 2020 (11/16) Holdings Inc. notes due 2020 (ENDP) EpiCept Corp. Private placement of 3.3S and W for $1 .9 EpiCept raised $1 .9M in the placement; (EPCT) common stock and 1 .3S Rodman & Renshaw LLC acted as exclusive warrants placement agent (11/9) GeneNews Ltd. Private placement N/A C$2. 1 GeneNews raised $2.09M through a unit offer- (Canada; TSX:GEN) ($2.09) ing and an offering of five-year senior 15% redeemable convertible secured debentures (11/12) iBio Inc. (OTC Private placement N/A $1 .4 iBio completed a placement begun in October, BB:IBPM) bringing the total raised to $7.4M; Financial Capital Markets acted as placement agent (11/19) Lorus Rights offering 4.2U C$4.6 Lorus sold 4.2M units for C$1 . 1 1 apiece; each Therapeutics Inc. ($4.58) unit consists of one share and one warrant to (Canada; TSX:LOR) purchase a share (11/11)BioWorld® State of the Industry Report 2011 69
  • 71. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Lpath Inc. (OTC Private placement of 6.9S and W $4.9 Lpath closed a private placement of 6.9M BB:LPTN) common stock and shares of Class A stock at 70 cents per share warrants and warrants to purchase the number of shares of Class A stock equal to 50% of the number of common shares they purchased; Griffin Securities Inc., Musket Research Associates Inc. and Andrew Garrett Inc. served as placement agents for the financing (11/18) Marina Biotech Securities purchase 1 .8S $8.7 Marina sold 1 .8M shares at $1 .84 per share to Inc. (MRNA) agreement raise $8.7M; LifeTech Capital acted as place- ment agent (11/8) Neoprobe Corp. Registered direct 3.2S $6 Neoprobe added about $6M in an offering of (OTC BB:NEOP) offering 3.2M shares priced at $1 .90 each (11/9) NeoStem Inc. Registered direct 10.6U $9.8 NeoStem raised $9.8M by offering 10.6M units, (AMEX:NBS) offering each containing one share of Series E, 7%, senior, preferred stock, convertible at $2.0004, to mature on May 20, 2013, and a warrant to purchase 0.25 shares of stock with an exercise price of $2.0874 and 0.0155 shares of common stock; the company raised $9.2M in a concurrent public offering, bring- ing total proceeds to $19M (11/17) Oncolytics Bought deal financing 5.4U C$25 Oncolytics raised $24.5M through the sale of Biotech Inc. ($24.5) 5.4M units – each consisting of one common (Canada; ONCY) share and one-half of one common share pur- chase warrant – priced at C$4.60 apiece (11/1) PDL BioPharma Private placement of N/A $88 PDL raised $88M by placing convertible Inc. (PDLI) convertible senior senior notes due 2015; it also exchanged notes $92M in notes due 2012 with $92M in notes due 2015 (11/8) PharmaGap Inc. Private placement of 4. 1U $0.572 PharmaGap raised $572,000 issuing 4. 1 M (Canada; equity units units, each consisting of one common share CDNX:GAP) and one warrant to purchase a common share, priced at 14 cents per unit (11/22) Regenicin Inc. Private placement N/A $0.468 Regenicin raised $467,550 through a private (OTC BB:RGIN) placement and converted $500,000 of debt into equity (11/12) Sernova Corp. Private placement of 6.67U $0.999 Sernova raised $998,861 in a private place- (Canada; units ment (11/8) CDNX:SVA) Stem Cell Execution of 12.2W C$1 .82 Stem Cell received proceeds of $1 .81M for the Therapeutics warrants ($1 .81) execution of 12.2M warrants (11/4) Corp. (Canada; CDNX:SSS) Synta Private placement 1 .4S $5 Synta raised $5M through the sale of 1 . 4M Pharmaceuticals shares at $3.47 each (11/12) Corp. (SNTA) Theravance Inc. Investment 5.75S $129.3 GlaxoSmithKline plc purchased 5.75M shares (THRX) of Theravance for $22.50 per share (11/30)70 BioWorld® State of the Industry Report 2011
  • 72. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) DECEMBER Access Registered direct 2.3S $6 Access raised $6M selling 2.3M shares at Pharmaceuticals offering $2.55 each; Access also will issue 700,000 Inc. (OTC BB:ACCP) shares in the form of warrants to purchase common stock at $3.06; Hudson Securities was the placement agent (12/13) Anavex Life Private placement of 0.03U $0. 1 Anavex raised $100,000 pricing 29,851 units at Sciences Corp. units $3.35 each; each unit consists of one common (OTC BB:AVXL) share and one-half of a two-year warrant to purchase an additional share with an exercise price of $4.50 (12/3) Bavarian Nordic Private placement of 1 .05S DKK205 Bavarin Nordic raised $36.2M in a placement A/S (Denmark; shares ($36.2) of 1 .05M shares at DKK195 apiece (12/3) CSE:BAVA) BioSante Registered direct 10.6U $18 BioSante raised $18M through an offering of Pharmaceuticals offering stock and warrants priced at $1 .70 each, with Inc. (BPAX) each unit consisting of one common share and one five-year warrant to purchase half of an additional share with an exercise price of $2; Rodman & Renshaw LLC acted as the exclusive placement agent (12/29); the com- pany also extended its $25M committed equi- ty financing facility with Kingsbridge Capital Ltd. (12/28) Ceapro Inc. Private placement 1 .6S $0. 129 Ceapro raised $129,668 by offering 1 . 6M (Canada; shares at 8 cents each to its directors (12/14) CDNX:CZO) Cleveland Registered direct 1 .4S $8.39 Cleveland BioLabs is raising $8.39M through BioLabs Inc. sale the registered direct sale of 1 . 4M shares (CBLI) priced at $5.99 each; HFP Capital Markets LLC and Rodman & Renshaw LLC served as co- placement agents (12/28) Crucible Private placement ND ND Crucible received start-up capital in an undis- International closed amount; the funding gives Crucible a Biotechnologies post-money valuation of $14M (12/3) Corp. (subsidiary of Microbix Biosystems Inc.; Canada; TSX:MBX) Curaxis Equity purchase 14.5S $10.7 Curaxis agreed to a $25M equity purchase Pharmaceutical agreement and line of credit agreement with Southridge Corp. (OTC Partners II; the initial amount sold is 14.5M BB:CURX) shares at 74 cents each for $10.7M in proceeds (12/9) DARA Registered direct 0.0048U $4.8 DARA raised $4.8M by offering 4,800 units BioSciences Inc. offering priced at $1 ,000 each, with each unit consist- (DARA) ing of one Series A share convertible into 400 common shares, one Class A warrant to pur- chase 200 common shares, and one Class B warrant to purchase 200 shares; Ladenburg Thalmann & Co. Inc. served as the placement agent (12/30)BioWorld® State of the Industry Report 2011 71
  • 73. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Genta Inc. (GNTA) Investment N/A $5 Genta received $5M from a control account related to its $25M private placement of con- vertible notes issued in March 2010 (12/16) International Investment and 0.333S $0.5 International Stem Cell raised about $500,000 Stem Cell Corp. equity facility by selling 333,333 shares at $1 .50 each to (ISCO) Aspire Capital Fund LLC, which also agreed to provide a $25M facility that can be accessed over the next three years (12/14) Lorus Private Placement 1 .6S C$1 .7 Lorus closed a private placemnt of 1 .6M com- Therapeutics Inc. (US$1 .69) mon shares priced at C$1 . 05 per share for (Canada; TSX:LOR) gross proceeds of about C$1 .7M. About 1 .4M shares were subscribed by Herbert Abramson, a director of the company, and his aggregate holding increased to about 41% of the issued and outstanding common shares (12/2) Medivir AB Private placement of 2.25S $40.6 Medivir raised $40.6M in a private placement (Sweden; B-series shares (12/6) SSE:MVIRB) Molecular Private placement 100S $45 Molecular Insight entered into a financing Insight commitment from Savitr Capital, which is pay- Pharmaceuticals ing 45 cents per share; the financing is tied to Inc. (MIPI) the company’s filing for Chapter 11 bankruptcy (12/13) Neurologix Inc. Investments N/A $7 Neurologix received $7M from Corriente (OTC BB:NRGX) Advisors, GE Pension Trust and Palisade Capital Management LLC (12/7) OctoPlus NV (the Private placement 3.3S E4 ($5.2) OctoPlus raised $5.2M by placing 3.3M shares Netherlands; with new and existing investors, including Amsterdam:OCTO) CEO-elect Jan Egberts (12/21) Oxford Private placement of 400S £20 Oxford offered 400M new shares at 5 pence BioMedica plc common stock ($31 .7) each to raised $31 .7M (12/14) (UK; LSE:OXB) Pharming Group Placement of non- N/A $25.5 Pharming agreed to receive $25.5M from NV (the convertible debt Socius CG II Ltd. in return for the notes and Netherlands; notes and equities equities (12/6) Euronext:PHARM) Plethora Private placement 8.2S $1 . 1 Plethora raised $1 . 1M by issuing 8.2M shares Solutions (12/6) Holdings plc (UK; LSE:PLE) Provectus Equity financing 1U $1 Provectus received a $1M investment from Pharmaceuticals facility and invest- Lincoln Park Capital Fund LLC, which also set Inc. (OTC BB:PVCT) ment up a $30M committed equity financing facili- ty (12/29) Rosetta Private placement of 2.5S $2.5 Rosetta raised $2.5M by selling 2.5M shares Genomics Ltd. stock and warrants at $1 each, plus 1 .25M five-year warrants with (Israel; ROSG) an exercise price of $1 .30 and 625,000 war- rants with an exercise price of 1 cent; Rodman & Renshaw LLC acted as the placement agent (12/1)72 BioWorld® State of the Industry Report 2011
  • 74. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Thrombogenics Private placement of 2.9S $75 Thrombogenics raised $75M through the Inc. (Belgium; shares placement of 2.9M shares at $25.42 each BR:THR) (12/6) Access Registered direct 2.3S $6 Access raised $6M selling 2.3M shares at Pharmaceuticals offering $2.55 each; Access also will issue 700,000 Inc. (OTC BB:ACCP) shares in the form of warrants to purchase common stock at $3.06; Hudson Securities was the placement agent (12/13) Anavex Life Private placement of 0.03U $0. 1 Anavex raised $100,000 pricing 29,851 units at Sciences Corp. units $3.35 each; each unit consists of one common (OTC BB:AVXL) share and one-half of a two-year warrant to purchase an additional share with an exercise price of $4.50 (12/3) Bavarian Nordic Private placement of 1 .05S DKK205 Bavarin Nordic raised $36.2M in a placement A/S (Denmark; shares ($36.2) of 1 .05M shares at DKK195 apiece (12/3) CSE:BAVA) BioSante Registered direct 10.6U $18 BioSante raised $18M through an offering of Pharmaceuticals offering stock and warrants priced at $1 .70 each, with Inc. (BPAX) each unit consisting of one common share and one five-year warrant to purchase half of an additional share with an exercise price of $2; Rodman & Renshaw LLC acted as the exclusive placement agent (12/29); the com- pany also extended its $25M committed equi- ty financing facility with Kingsbridge Capital Ltd. (12/28) Ceapro Inc. Private placement 1 .6S $0. 129 Ceapro raised $129,668 by offering 1 . 6M (Canada; shares at 8 cents each to its directors (12/14) CDNX:CZO) Cleveland Registered direct 1 .4S $8.39 Cleveland BioLabs is raising $8.39M through BioLabs Inc. sale the registered direct sale of 1 . 4M shares (CBLI) priced at $5.99 each; HFP Capital Markets LLC and Rodman & Renshaw LLC served as co- placement agents (12/28) Crucible Private placement ND ND Crucible received start-up capital in an undis- International closed amount; the funding gives Crucible a Biotechnologies post-money valuation of $14M (12/3) Corp. (subsidiary of Microbix Biosystems Inc.; Canada; TSX:MBX) Curaxis Equity purchase 14.5S $10.7 Curaxis agreed to a $25M equity purchase Pharmaceutical agreement and line of credit agreement with Southridge Corp. (OTC Partners II; the initial amount sold is 14.5M BB:CURX) shares at 74 cents each for $10.7M in proceeds (12/9)BioWorld® State of the Industry Report 2011 73
  • 75. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) DARA Registered direct 0.0048U $4.8 DARA raised $4.8M by offering 4,800 units BioSciences Inc. offering priced at $1 ,000 each, with each unit consist- (DARA) ing of one Series A share convertible into 400 common shares, one Class A warrant to pur- chase 200 common shares, and one Class B warrant to purchase 200 shares; Ladenburg Thalmann & Co. Inc. served as the placement agent (12/30) Genta Inc. (GNTA) Investment N/A $5 Genta received $5M from a control account related to its $25M private placement of con- vertible notes issued in March 2010 (12/16) International Investment and 0.333S $0.5 International Stem Cell raised about $500,000 Stem Cell Corp. equity facility by selling 333,333 shares at $1 .50 each to (ISCO) Aspire Capital Fund LLC, which also agreed to provide a $25M facility that can be accessed over the next three years (12/14) Lorus Private Placement 1 .6S C$1 .7 Lorus closed a private placemnt of 1 .6M com- Therapeutics Inc. (US$1 .69) mon shares priced at C$1 . 05 per share for (Canada; TSX:LOR) gross proceeds of about C$1 .7M. About 1 .4M shares were subscribed by Herbert Abramson, a director of the company, and his aggregate holding increased to about 41% of the issued and outstanding common shares (12/2) Medivir AB Private placement of 2.25S $40.6 Medivir raised $40.6M in a private placement (Sweden; B-series shares (12/6) SSE:MVIRB) Molecular Private placement 100S $45 Molecular Insight entered into a financing Insight commitment from Savitr Capital, which is pay- Pharmaceuticals ing 45 cents per share; the financing is tied to Inc. (MIPI) the company’s filing for Chapter 11 bankruptcy (12/13) Neurologix Inc. Investments N/A $7 Neurologix received $7M from Corriente (OTC BB:NRGX) Advisors, GE Pension Trust and Palisade Capital Management LLC (12/7) OctoPlus NV (the Private placement 3.3S E4 ($5.2) OctoPlus raised $5.2M by placing 3.3M shares Netherlands; with new and existing investors, including Amsterdam:OCTO) CEO-elect Jan Egberts (12/21) Oxford Private placement of 400S £20 Oxford offered 400M new shares at 5 pence BioMedica plc common stock ($31 .7) each to raised $31 .7M (12/14) (UK; LSE:OXB) Pharming Group Placement of non- N/A $25.5 Pharming agreed to receive $25.5M from NV (the convertible debt Socius CG II Ltd. in return for the notes and Netherlands; notes and equities equities (12/6) Euronext:PHARM) Plethora Private placement 8.2S $1 . 1 Plethora raised $1 . 1M by issuing 8.2M shares Solutions (12/6) Holdings plc (UK; LSE:PLE)74 BioWorld® State of the Industry Report 2011
  • 76. Other Financings Of Public Biotech Companies Company Type Of Number Of Amount Investors; Placement Agents; Details (Symbol)# Financing Shares, Units Raised (Date)@ Or Warrants (M) (M) Provectus Equity financing 1U $1 Provectus received a $1M investment from Pharmaceuticals facility and invest- Lincoln Park Capital Fund LLC, which also set Inc. (OTC BB:PVCT) ment up a $30M committed equity financing facili- ty (12/29) Rosetta Private placement of 2.5S $2.5 Rosetta raised $2.5M by selling 2.5M shares Genomics Ltd. stock and warrants at $1 each, plus 1 .25M five-year warrants with (Israel; ROSG) an exercise price of $1 .30 and 625,000 war- rants with an exercise price of 1 cent; Rodman & Renshaw LLC acted as the placement agent (12/1) Thrombogenics Private placement of 2.9S $75 Thrombogenics raised $75M through the Inc. (Belgium; shares placement of 2.9M shares at $25.42 each BR:THR) (12/6) Notes: This chart does not include real estate or manufacturing plant financings, or debt deals done to replace existing debt. # Unless otherwise indicated, shares are traded on the Nasdaq exchange; @ Refers to the date of the press release. ** Denotes the date the item ran in BioWorld International. Currency conversions are based on exchange rates at the time of the deal. The date indicated refers to the BioWorld Today issue in which the news item can be found. N/A = Not applicable; ND = Not disclosed. AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange.BioWorld® State of the Industry Report 2011 75
  • 77. Venture Capital And Other Investments In Private Biotechnology Companies In 2010 TOTAL: $$4,483M Company Location Date Amt. (M) Details JANUARY Acetylon Boston 1/12 $2 Acetylon received a $2M investment from a new Pharmaceuticals undisclosed private investor Inc. Acton Marlborough, 1/7 $15 Acton completed a $15M round of financing led by Pharmaceuticals Mass. Sequoia Capital Inc. Adocia SA Lyon, France 1/13 E14 Adocia raised $20.3M in a second funding round ($20.3) Alnara Cambridge, 1/28 $35 Alnara raised $35M in a Series B round; investors Pharmaceuticals Mass. were MPM Capital, Frazier Healthcare Ventures, Inc. Third Rock Ventures and Bessemer Venture Partners BIND Cambridge, 1/14 $11 BIND raised $11M in a Series C round led by DHK Biosciences Mass. Investment, with participation by all existing Inc. investors, Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners and Nano- Dimension, as well as new private investors BioLeap Inc. New Hope, Pa. 1/13 $5 BioLeap raised $5M in venture financing from Adams Capital Management and Quaker BioVentures Cantab Cambridge, UK 1/26 £5 Cantab received a three-year, $8. 1M investment- Pharmaceuticals ($8. 1) from Celtic Pharma Holdings Advisors LLP plc Cornerstone Cranbury, N.J. 1/27 $6. 18 Cornerstone raised $6. 18M in a Series B-4 private Pharmaceuticals equity financing; C.W. Downer & Co. served as the Inc. placement agent, with Althea Partners LLC leading the investment Elevation San Diego 1/22 $30 Elevation raised $30M in a Series A round; inves- Pharmaceuticals tors were TPG Growth, Care Capital and Mesa Inc. Verde Venture Partners, as well as Canaan Partners Eribis Stockholm, 1/27 ND Eribis received an undisclosed amount of financ- Pharmaceuticals Sweden ing from Karolinska Development AB AB EyeGate Waltham, Mass. 1/11 $22.6 EyeGate raised $22.6M in a Series D financing; Pharma Inc. investors were Ventech, Innoven Partners and Medicis Capital, along with Natixis Private Equity and Emerging Capital F-star Biotech- Vienna, Austria 1/6 E8 F-star raised $11 .5M in a third closing of a Series A nologische ($11 .5) round; investors were MP Healthcare Venture Forschungs-und Management, Merck Serono Ventures, Atlas Entwicklungsges Venture, Aescap Venture, Novo Ventures and TVM mbH Capital GlobeImmune Louisville, 1/19 $17.5 GlobeImmune raised $17.5M in a Series E round; Inc. Colo. investors were Generali Financial Holding and BSI SA Intercept New York 1/26 $25 Intercept raised $25M in Series B funding from Pharmaceuticals Genextra SpA Inc.BioWorld® State of the Industry Report 2011 76
  • 78. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Kolltan New Haven, 1/21 $10 Kolltan raised $10M in a Series B round led by Pharmaceuticals Conn. Celtic Therapeutics Holdings LP Inc. Liquidia Research 1/20 $20 Liquidia raised $20M through the Series C round Technologies Triangle led by Canaan Partners Inc. Park, N.C. Molecular Norwood, 1/13 $12.5 Molecular Biometrics completed a $12.5M Series B Biometrics Mass. financing led by Atlas Venture; other participating Inc. investors included Safeguard Scientifics Inc. and Oxford Bioscience Partners Ohr Pharma- Dover, Del. 1/20 $1 Ohr raised $1M through the private placement of ceutical Inc. common stock and new warrants to holders of its Series F warrants PhaseBio Research 1/8 $25 PhaseBio raised $25M in a Series B round; inves- Pharmaceuticals Triangle tors were New Enterprise Associates, OSI Inc. Park, N.C. Investment Management, Hatteras Venture Partners, Johnson & Johnson Development Corp. and Fletcher Spaght Ventures ProChon Woburn, Mass. 1/21 $3.95 ProChon closed a $3.95M convertible bridge loan Biotech Ltd. from ProChon Holdings BV and the Musculo- skeletal Transplant Foundation ProFibrix BV Leiden, the 1/8 E5 ProFibrix secured a loan from SenterNovem Netherlands ($7.4) Prometheus San Diego 1/8 $210 Prometheus executed a $260M senior secured Laboratories credit facility consisting of a $210M term loan and Inc. a $50M revolving credit line SymBio Tokyo 1/29 $7.7 SymBio completed a $7.7M second tranche of its Pharmaceuticals Series D round of financing Ltd. Terpenoid Coralville, Iowa 1/27 $1 .5 Terpenoid raised $1 .5M through a Series A financ- Therapeutics ing from a group of Iowa investors led by Iowa Inc. First Capital Fund II LP VentiRx San Diego 1/12 $25 VentiRx raised $25 in an extension to its Series A Pharmaceuticals round; investors ARCH Venture Partners, Domain Inc. Associates and Frazier Healthcare Ventures partic- ipated; it was led by MedImmune Ventures Inc. FEBRUARY Advanced Louisville, Ky. 2/24 $0.25 Advanced Cancer received $250,000 from the Cancer Kentucky Economic Development Partnership Therapeutics Board’s Commonwealth Seed Capital group Bioscience Indianapolis 2/22 $0.4 Bioscience received $400,000 from the Bio- Vaccines Inc. Crossroads Indiana Seed Fund CancerGuide Durham, N.C. 2/5 $10.5 CancerGuide completed the first part of a $10.5M Diagnostics round Inc. Cornerstone Cranbury, N.J. 2/8 $6.2 Cornerstone closed a Series B-4 private equity Pharmaceuticals financing of $6.2M Inc. Diffusion Charlottesville, 2/1 $5.9 Diffusion closed on $5.9M in additional private Pharmaceuticals N.C. financing, which was a combination of private LLC equity and convertible notes to existing investorsBioWorld® State of the Industry Report 2011 77
  • 79. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Direvo Cologne, 2/3** E6 Direvo raised $8.4M in a second funding round led Industrial Germany ($8.4) by TVM Capital GmbH and NRW Bank Biotechnology AG Eleven Bio- Cambridge, 2/17 $35 Eleven raised $35M in a Series A financing co-led therapeutics Mass. by Flagship Ventures and Third Rock Ventures Inc. EUSA Pharma Doylestown, 2/5 $25 EUSA secured a $25M credit facility from Oxford Inc. Pa. Finance Corp. Glide Oxfordshire, 2/11 £2.7 Raised $4.3M in its fourth financing round; inves- Pharmaceutical UK ($4.3) tors were Hygea VCT plc and Oxford Technology Technologies Ltd. Immune London 2/18 £8.65 Immune Targeting raised $13.66M in a Series A Targeting ($13.66) financing; investors were HealthCap, London Systems Ltd. Technology Fund, Novartis Venture Fund and Truffle Capital (2/18) Merus BV Utrecht, the 2/3 E21 .7 Merus raised $30.3M in a Series B round; investors Netherlands ($30.3) were Novartis, Pfizer Inc., Bay City Capital, Life Sciences Partners and Aglaia Oncology Fund Mirrx Copenhagen, 2/5 ND Mirrx closed on a seed financing round Therapeutics Denmark AS Oxford Oxford, UK 2/2 £17.4 Oxford raised $27.8M from existing investors, Nanopore ($27.8) including Lansdowne Partners, IP Group and Technologies Invesco Perpetual Ltd. Pearl Redwood, 2/2 $15 Pearl raised $15M through a convertible loan facili- Therapeutics Inc. Calif. ty set to convert to equity at the time of a $40M Series C financing expected to close in the third quarter; investors were Clarus Ventures, New Leaf Venture Partners and 5AM Ventures PolyTherics Ltd. London 2/18 £3 PolyTherics raised $4.74M in a financing round led ($4.74) by Imperial Innovations Group, Longbow Capital and The Capital Fund Sistemic Ltd. Glasgow, 2/5 $1 Sistemic closed a Series A round with ChimeraBio Scotland and the Scottish Enterprise Co-Investment Fund Somnus Bedminster, 2/12 $15 Somnus raised $15M in a Series A preferred stock Therapeutics N.J. financing led by CTI Life Sciences Fund with the participation of Care Capital LLC Tioga San Diego 2/18 $18 Tioga raised $18M in its second round; investors Pharmaceuticals were Genesys Capital Partners, Forward Ventures, Inc. New Leaf Venture Partners and BB Biotech Ventures Viroblock SA Geneva, 2/4 ND Viroblock raised an undisclosed amount of Series Switzerland B funding MARCH Affectis Martinsried, 3/23 E3.3 Affectis raised $4.48M in the first part of a Series Pharmaceuticals Germany ($4.48) D financing; investors were LSP, Aescap Venture, AG KfW, Bayernkapital and EMBL Ventures78 BioWorld® State of the Industry Report 2011
  • 80. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Antisense Regensburg, 3/17** E13 Antisense raised $17.8M from existing investors, Pharma GmbH Germany ($17.8) including MIG Verwaltungs AG, GA Global Asset Fund GmbH and Co., as well as management and private investors Aquapharm Oban, Scotland 3/24 £4.2 Aquapharm raised $6.3M from Aescap Venture, Biodiscovery Ltd. ($6.3) Tate & Lyle Ventures, Highlands and Islands Enterprise and NESTA Archimedes London 3/3 £65 Archimedes Pharma raised $96.9M in a round led Pharma Ltd. ($96.9) by new investor Novo Growth Equity; other inves- tors were Warburg Pincus Bone Biologics Thousand 3/11 ND Bone Biologics received an undisclosed invest- Inc. Oaks, ment for preferred shares from the Musculo- Calif. skeletal Transplant Foundation, which now owns 51% of the company; MTF also will provide a line of credit Eureka Hercules, Calif. 3/11 $3.7 Eureka raised $3.7M from angel investors and Genomics Corp. other private individuals Genetix Cambridge, 3/12 $35 Genetix raised $35M in a Series B round; investors Pharmaceuticals Mass. were Third Rock Ventures, Genzyme Ventures, Inc. TVM, Forbion and Easton Genticel S/A Toulouse, 3/10 E13. 1 Genticel raised $17.7M in a round led by AGF France ($17.7) Private Equity; other investors were the Institut Regional de Devloppement Industriel, Amundi Private Equity Funds, Edmond de Rothschild Investment Partners and FSI France Investment’s InnoBio fund Myotec Cambridge, UK 3/2 E5.6 Myotec received a $7.6M investment from Therapeutics ($7.6) Imperial Innovations Group plc and Invesco Ltd. Perpetual NGM Biopharma- South San 3/16 $51 NGM raised $51M in a Series B round; investors ceuticals Inc. Francisco were the Column Group, Tichenor Ventures LLC, Prospect Partners, Rho Ventures and other new and existing investors Omthera New York 3/9 $6.5 Omthera closed a $6.5M Series A round led by Pharmaceuticals Sofinnova Partners Inc. OriGene Rockville, Md. 3/19 $16 OriGene raised $16M in a Series B financing led by Technologies IDG-Accel, SBI & TH Venture Capital Enterprise and Inc. Zero2IPO; other investors were Morningside Venture Investments and President International Development Corp. Phico Cambridge, UK 3/30** £1 .8 Phico raised $2.7M from institutional investors Therapeutics ($2.7) and business angels Ltd. Promedior Malvern, Pa. 3/16 $12 Promedior raised $12M in a Series C financing led Inc. by Forbion Capital Partners, with participation from Morgenthaler Ventures, HealthCare Ventures, Polaris Venture Partners and Easton Capital Rhythm Boston 3/16 $21 Rhythm raised $21M in a Series A equity financing PharmaceuticalsBioWorld® State of the Industry Report 2011 79
  • 81. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Saladax Bethlehem, Pa. 3/8 $8.4 Saladax raised $8.4M through a Series C preferred Biomedical offering led by Excel Venture Management; other Inc. investors were Ben Franklin Technology Partners and the Life Sciences Greenhouse of Central Pennsylvania, as well as a number of angel inves- tors Scancell Nottingham, 3/30** £2.31 Scancell raised $3.5M in a placing and open offer Holdings plc UK ($3.5) of 5. 1M shares SpePharm Amsterdam, 3/5 E11 SpePharm raised $15M in a financing through an Holding BV the ($15) investment from Paladin Labs Inc., as well as TVM Netherlands Capital, Signet Healthcare and Paul Capital Healthcare Ubiquigent Ltd. Dundee, 3/4 $4.5 Ubiquigent received $4.5M in start-up funding Scotland from Stemgent Inc. Vaxart Inc. San Francisco 3/5 $12.5 Vaxart closed a $12.5M Series B financing led by Care Capital LLC APRIL Achaogen South San 4/8 $56 Achaogen raised $56M in a Series C financing Francisco AiCuris GmbH Wuppertal, 4/15 E50 AiCuris raised $75M through an investment from & Co. Germany ($75) German businessmen Andreas and Thomas Strungmann, of Santo Holding Affimed Heidelberg, 4/30 E20 Affimed raised $26.48M in a Series C financing led Therapeutics Germany ($26.48) by aeris Capital, BioMedInvest, LSP Life Sciences AG Partners, Novo Nordisk A/S and Orbimed AltheaDx Inc. San Diego 4/14 $6 AltheaDx raised $6M in a Series A financing led by Telegraph Hill Partners Altheos Inc. South San 4/6 $20 Altheos raised $20M in a Series A round led by Bay Francisco City Capital; other investors were Novo A/S, Canaan Partners, Life Science Angels and Atheneos Capital Amplyx San Diego 4/9 $1 .5 Amplyx completed its initial round of $1 .5M Series Pharmaceuticals A preferred financing with investments from Inc. Golden Seeds LLC, Life Science Angels and Tech Coast Angels Aragon San Diego 4/23 $22 Aragon raised $22M in a Series B financing with Pharmaceuticals Aisling Capital, OrbiMed Advisors and the Column Inc. Group Biocartis SA Lausanne, 4/9 E30 Closed a Series B equity financing round raising Switzerland ($41 .3) $41 .3M from its current shareholder base and new investors that included the Debiopharm Group and Johnson & Johnson Development Corp. BioProtein Jouy-en-Josas, 4/29 E0.52 BioProtein raised $686,378 from existing share- Technologies France ($0.686) holders Catabasis Cambridge, 4/22 $39.6 Catabasis raised $39.6M in a Series A round led by Pharmaceuticals Mass. SV Life Sciences, Clarus Ventures and MedImmune Inc. Ventures; Advanced Technology Ventures also participated Cellular Madison, Wis. 4/28 $40.6 Cellular Dynamics closed on a $40.6M Series B pri- Dynamics vate equity round International Inc.80 BioWorld® State of the Industry Report 2011
  • 82. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Foundation Cambridge, 4/15 $25 Foundation raised $25M in a Series A financing Medicine Inc. Mass. from Third Rock Ventures Gemin X Malvern, Pa. 4/21 $16 Gemin X raised $16M in a Series D round; investors Pharmaceuticals were Caxton Advantage Life Sciences Fund LP and Inc. Sanderling Venture Partners HemaQuest Boston 4/22 $12 HemaQuest raised $12M in a Series B financing Pharmaceuticals round led by new investor, Aberdare Ventures Inc. Hunter Sydney, 4/1 A$9.2 Hunter Immunology is raising up to $9. 1M in a Immunology Australia ($9. 1) round led by the IB Australian Bioscience Fund and Ltd. Soho Pharmaceuticals Immunovov BV S-Hertogen- 4/28 ND Immunovo was formed from seed funding from bosch, the Biox Biosciences BV and Lupus Ventures BV Netherlands Lycera Corp. Cambridge, 4/29 $11 Lycera raised $11M in a second tranche of a Series Mass. A financing MGB Glasgow, 4/28** £2 MGB received $3. 1M in start-up funding from an Biopharma Scotland ($3. 1) angel syndicate led by Archangel Informal Ltd. Investments Ltd., TRI Cap Ltd., Barwell plc and the Scottish Co-Investment fund Mirina Corp. Seattle 4/27 ND Mirina closed a Series A-1 round led by Versant Ventures; other investors were Alexandria Real Estate Equities, ARCH Venture Partners, OVP Venture Partners and WRF Capital Nautilus Bridgewater, 4/14 ND Nautilus received an undisclosed amount of Neurosciences N.J. financing from Galen Partners Inc. Oncos Helsinki, 4/30 E4 Completed a $5.5M investment from HealthCap Therapeutics Finland ($5.5) Ltd. Rheonix Inc. Ithaca, N.Y. 4/22 $12.6 Rheonix raised $12.6M in a Series A financing Sagent Schaumburg, 4/9 $40 Sagent raised $40M through two tranches of a Pharmaceuticals Ill. strategic Series B financing; a $10M investment was made by Zhejiang Hisun Pharmaceutical Co. Ltd. and the remaining $30M was contributed by an unnamed China-focused private equity invest- ment fund Selecta Watertown, 4/6 $15 Selected completed a $15M Series C financing; Biosciences Mass. investors were Polaris Venture Partners, Flagship Ventures, NanoDimension and Timothy A. Springer Virxsys Corp. Gaithersburg, 4/20 $9.8 Virxsys raised $9.8M of a planned $45M venture Md. round Xenome Ltd. Brisbane, 4/23 A$10 Xenome completed a convertible note financing Australia ($9.28) for $9.28M from funds associated with Queens- land BioCapital Fund and GBS Venture Partners MAY AgneBio Inc. Indianapolis 5/13 $0.3 AgneBio raised $300,000 from BioCrossroads’ Indiana Seed FundBioWorld® State of the Industry Report 2011 81
  • 83. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Alvine San Carlos, 5/27 ND Abbott Biotech Ventures Inc. joined InterWest Pharmaceuticals Calif. Partners, Panorama Capital, Prospect Venture Inc. Partners, Sofinnova Ventures, Black River Asset Management and Flagship Ventures in a Series A extension round Aposense Ltd. Petach Tikva, 5/25 $3 Aposense is raising $3M from existing sharehold- Israel ers Arch Toronto 5/10 $0.7 Arch raised $700,000 by issuing 1 .4M shares at 50 Biopartners cents each Inc. Caprotec Berlin 5/17 �4 Caprotec closed a $5. 1M Series B round with exist- Bioanalytics ($5. 1) i n g i n v e s t o r s C r e a t h o r Ve n t u r e , I B B GmbH Beteiligungsgesellschaft, ERP Startfonds and pri- vate investors Cardoz AB Stockholm, 5/11 SEK100 Cardoz closed a Series A round led by Forbion Sweden ($13.3) Capital Partners with new investor Ysios Capital Partners and existing investors HealthCap CureVac Tubingen, 5/11 �27.6 CureVac raised $35.25M in a round with dievini GmbH Germany ($35.25) Hopp BioTech Holding GmbH & Co. KG Exosome New York 5/19** $20 Exosome raised $20M in a Series A round co-led Diagnostics Inc. by NGN Capital and Forbion Capital Partners Funxional Cambridge, UK 5/27 £10 Funxional completed a Series B round from Therapeutics ($12.2) Ventech, Index Ventures and Novo A/S Ltd. Logical Waltham, Mass. 5/28 $16.9 Logical closed on a $16.9M Series C round led by Therapeutics SV Life Sciences and including Burrill & Co., Novo Inc. A/S and Novitas Capital NeuroThera- Chicago 5/21 $43 NeuroTherapeutics raised $43M in a Series B peutics Pharma round; investors were Fidelity Biosciences, MPM Inc. Capital, SR One and Pfizer Inc., as well as Novo Ventures and Thomas McNerney & Partners NormOxys Inc. Wellesley, 5/25 $17.5 NormOxys raised $17.5M in a Series B-1 financing; Mass. investors were Index Ventures and Care Capital Noxxon Berlin 5/28 �33 Noxxon closed a $40.8M Series D round led by Pharma AG ($40.8) NGN Capital, with participation from TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, Seventure Partners, VC Fonds Technologie Berlin GmbH, Dow Venture Capital, F C P O P M e d i c a l B i o H e a l t h Tr e n d s , I B G Beteiligungsgesellschaft SachsenAnhalt mgH, the Dieckell Group and others Oxford Oxford, UK 5/3 $26 Oxford Immunotec closed the second tranche of a Immunotec $26M investment by New Leaf Venture Partners; Ltd. other investors of the Series D financing included Kaiser Permanente Ventures, Clarus Ventures, Wellington Partners, National Technology Enterprises Co., SPARK Ventures, DFJ Esprit, Oxford University and The Dow Chemical Co. Pacira Parsippany, N.J. 5/12 $11 .25 Pacira received a $11 .25M credit facility from GE Pharmaceuticals Capital, Healthcare Financial Services Inc.82 BioWorld® State of the Industry Report 2011
  • 84. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Pro-Cure York, UK 5/25 £0.7 Pro-Cure received further funding of more than Therapeutics ($1) $1M as a follow-on to a late 2008 investment; Ltd. investors were Yorkshire Cancer Research and the Yorkshire & Humber Equity Fund managed by YFM Venture Finance Ltd. Pronota NV Ghent, Belgium 5/19 �1 .3 Pronota raised $1 . 59M in its Series B financing ($1 .59) from MP Healthcare Venture Management Inc. Stratatech Madison, Wis. 5/4 $3 Stratatech closed a $3M round of funding com- Corp. prised of convertible notes from current investors T2 Biosystems New York 5/26 $15 T2 Biosystems raised $15M in a Series C financing led by Physic Ventures; other investors are Arcus Ventures, RA Capital, Camros Capital and WS Investments, plus Flagship Ventures, Polaris Venture Partners, Flybridge Capital Partners and Partners Healthcare Tesaro Inc. Boston 5/27 $20 Tesaro raised $20M in a Series A led by New Enterprise Associates and company management, and there’s another $40M from NEA in reserve for future investment rounds TPP Global Edinburgh, 5/20 £9.6 TPP raised $13.8M through investors that included Development Scotland ($13.8) Scottish Venture Fund Valcor Vancouver, 5/26 ND Valcor received an undisclosed amount of seed Therapeutics British financing from GrowthWorks Capital Ltd. Inc. Columbia JUNE Ablexis LLC San Francisco 6/2 $12 Ablexis raised $12M in a Series A round led by Third Rock Ventures, with an additional invest- ment from Pfizer Venture Investments Action Pharma Holte, 6/4 E5 Action Pharma raised $6.25M in the round AS Denmark ($6.25) Agile Princeton, N.J. 6/16 $45 Agile raised $45M through a Series B preferred Therapeutics stock financing co-led by Investor Growth Capital Inc. and Care Capital, with participation from ProQuest Investments Akebia Cincinnati 6/17 $5 Akebia raised $5M in the second tranche of its Therapeutics $16M Series A round Inc. Aquinox Vancouver, 6/18 $25 Aquinox raised $25M in a Series B financing led by Pharmaceuticals British Ventures West Capital Inc. Columbia Andromeda Yavne, Israel 6/18 $17.5 Teva Pharmaceutical Industries Ltd. decided to Biotech Ltd. exercise its option to invest in Andromeda at a company per-money valuation of $170M BIND Cambridge, 6/29 $12.4 BIND raised $12.4M in a Series C-1 round; investors Biosciences Mass. were Endeavour Vision, Polaris Venture Partners, Inc. Flagship Ventures, ARCH Venture Partners, NanoDimension and DHK Investments Bio-Path Houston 6/8 $7 Bio-Path signed an equity purchase agreement for Holdings Inc. up to $7M with Lincoln Park Capital Fund LLC Complix NV Hasselt, 6/4 E5 Complix completed a Series A round led by Belgium ($6.25) Vesalius Biocapital and LRM, with CRP Sante, plus existing investors and management also partici- patingBioWorld® State of the Industry Report 2011 83
  • 85. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Corridor Baltimore 6/18 $15 Corridor raised $15M through a Series A round led Pharmaceuticals by Quaker Bioventures, and including Domain Inc. Associates, Quaker BioVentures, MedImmune Ventures, NewSpring Capital, Maryland Health Care Product Development Corporation, Ben Franklin Technology Partners, Acidophil LLC and Red Abbey Venture Partners Cytheris SA Paris 6/8 $15 Cytheris completed a $15M Series D financing; investors were CDC Entreprises, Bioam Gestion France, Caisse de depot et Placement du Quebec, CDC Innovation, Credit Agricole Private Equity and Forbion Capital Partners Constellation Cambridge, 6/2 $22 Constellation raised $22M in a Series B round led Pharmaceuticals Mass. by SR One and including Third Rock Ventures, the Inc. Column Group, Venrock and Altitude Life Science Ventures Ensyce Houston 6/14 $1 .5 Ensyce raised $1 .5M in funding from the State of Biosciences Inc. Texas Emerging Technology Fund FerroKin San Francisco 6/18 $12 FerroKin closed a $12M financing round from BioSciences Inc. existing investors Burrill & Co., Celgene Corp., Clarus Ventures and MP Healthcare Venture Management and new investor Healthcap Ventures FoldRx Cambridge, 6/16 $29 FoldRx raised $29M in venture funding; investors Pharmaceuticals Mass. were Novo Ventures and Morgenthaler Ventures, Inc. which joined HealthCare Ventures, Fidelity Biosciences, TPG Biotechnology, Alta Partners and Novartis Venture Funds Galera St. Louis 6/16 ND Galera completed a Series 1 financing led by Therapeutics BioGenerator, with participation from Galera LLC Angels LLC and Analytical Bio-Chemistr y Laboratories Inc. Igenica Inc. Burlingame, 6/11 $24 Igenica raised $24M in a Series B financing led by Calif. The Column Group, OrbiMed Advisors and 5AM Ventures Incline San Diego 6/23 $43 Incline raised $43M through a Series A round led Therapeutics by Frazier Healthcare Ventures and including par- Inc. ticipation from 5AM Ventures, Technology Partners, Adams Street Partners, Saints Capital Partners and Emergent Medical Partners Inotek Beverly, Mass. 6/14 $18 Inotek raised $18M through a financing led by Pharmaceuticals Devon Park Bioventures; other investors were Rho Inc. Ventures, Care Capital, Pitango Venture Capital, MedImmune Ventures and Bio*One Capital Mucosis BV Groningen, the 6/2 E3 Mucosis received a credit line of $3.7M from Netherlands ($3.7) Agentschap NL Nereus San Diego 6/23 $20 Nereus raised $20M through a round led by HBM Pharmaceuticals BioVentures and included Alta Partners, Forward Inc. Ventures, Gimv, Advent International, Pacific Venture Group, Roche Venture Fund and Astellas Venture Management Neurokine Vancouver, 6/3 $0.2 Neurokine raised $200,000 in connection with the Pharmaceuticals British re-appointment of Hassan Salari to the company’s Inc. Columbia board84 BioWorld® State of the Industry Report 2011
  • 86. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Otonomy Inc. San Diego 6/11 $10 Otonomy raised $10M in a Series A round from Avalon Ventures Pacific Menlo Park, 6/21 $50 Pacific Biosciences received $50M through an Biosciences Calif. investment from Gen-Probe Inc. Pharnext SAS Paris 6/10 E4.8 Pharnext raised $5.8M in a Series A round with ($5.8) Truffle Capital Precision Pittsburgh 6/21 $35 Precision raised $35M in a Series D financing led Therapeutics by Bain Capital Ventures and includes partici- Inc. pation by The Hillman Co., Adams Capital Man- agement, Quaker BioVentures, Longitude Capital, Birchmere Ventures and TVM Capital (6/21) Predictive Sunnyvale, 6/17 $25 Predictive raised $25M through a Series C round Biosciences Calif. with ProQuest Investments, Flybridge Capital Partners, Highland Capital Partners, Kaiser Permanente Ventures and New Enterprise Associates PTC South 6/8 $5.4 PTC received a $5.4M Seeding Drug Discovery Therapeutics Plainfield, N.J. Award from The Wellcome Trust Inc. Quark Fremont, Calif. 6/11 $10 Quark raised $10M in venture funding from exist- Pharmaceuticals ing investors including SBI Holdings Group Inc. QR Pharma Inc. Radnor, Pa. 6/3 $0.5 QR Pharma received a $500,000 investment from BioAdvance and additional funding from angel investors, closing a seed round of $2.4M Tetraphase Watertown, 6/2 $45 Tetraphase raised $45M in its latest round, led by Pharmaceuticals Mass. Excel Venture Management, with participation Inc. from existing investors CMEA Ventures, Fidelity Biosciences, Flagship Ventures, Mediphase Venture Partners and Skyline Ventures Veracyte Inc. South San 6/11 $28 Veracyte raised $28M in a Series B financing led by Francisco Domain Associates, with participation from Kleiner Perkins Caufield & Byers, TPG Biotech and Versant Ventures Zymeworks Inc. Vancouver, 6/30 C$3.2 Zymeworks raised $3M in venture funding led by British ($3) CTI Life Sciences Fund LP Columbia JULY Advanced Cancer Louisville, Ky. 7/2 $10 Advanced Cancer secured $10M in investments Therapeutics LLC from high net-worth individuals and institutions Agennix AG Planegg/ 7/26 �15 ($19.3) Agennix entered an agreement with shareholder Munich, dievini Hopp BioTech holding GmbH & Co. KG for a Germany $19.3M loan at an interest rate of 6% per annum Biosystems Paris 7/20 $2.7 Biosystems closed a $2.7M round of funding International SAS Calistoga Seattle 7/1 $40 Calistoga raised $40M in a Series C financing led Pharmaceuticals by Quogue Capital LLC, along with Alta Partners, Inc. Amgen Ventures, Frazier Healthcare, Three Arch Partners and Latterell Venture Partners Calithera San Francisco 7/9 $40 Calithera raised $40M in a Series A round led by Biosciences Inc. Morgenthaler Ventures, with participation from U.S. Venture Partners, Advanced Technology Ventures, Delphi Ventures and Mission Bay CapitalBioWorld® State of the Industry Report 2011 85
  • 87. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Cara Therapeutics Shelton, Conn. 7/22 $15 Cara raised $15M in a Series D round led by Rho Inc. Ventures, with participation from Alta Biopharma, Ascent Biomedical Ventures, CT Innovations, Devon Park BioVentures, Healthcare Private Equity, Mitsubishi International Corp. and MVM Life Science Partners Cerenis Toulouse, 7/27 �40 ($51 .9) Cerenis raised $51 .9M in a Series C round led by Therapeutics SA France Fund for Strategic Investment CMP Therapeutics London 7/30 �1 .5 ($1 .96) CMP raised $1 . 96M through a convertible loan Ltd. from Inventages Venture Capital Euthymics Cambridge, 7/22 $24 Euthymics raised $24M in a Series A round from Bioscience Inc. Mass. Novartis Venture Fund and Venture Investors as well as Hambrecht & Quist Capital Management LLC, GBS Venture Partners and the State of Wisconsin Investment Board Excelimmune Woburn, Mass. 7/8 $4.5 Excelimmune raised $4.5M in a new financing HemaQuest Seattle 7/29 $4 HemaQuest raised $4M in a Series B by Latterell Pharmaceuticals Venture Partners, bringing the total to $16M; other Inc. investors were Aberdare Ventures, De Novo Ventures, Forward Ventures and Lilly Ventures Immune Design Seattle 7/27 $32 Immune Design raised $32M in Series B funding Corp. led by ProQuest Investments and including the Column Group, Versant Ventures and Alta Partners InVasc Atlanta 7/12 $3. 15 InVasc raised $3. 15M in an initial closing of its first Therapeutics Inc. institutional financing led by Trois I Investments Industriels Internationaux SA iPierian Inc. South San 7/9 $22 iPierian raised $22M in a Series B equity financing Francisco led by new investor Google Ventures; other inves- tors were Kleiner Perkins Caufield & Byers, Highland Capital Partners, MPM Capital and FinTech Global Capital Kymab Ltd. London 7/13 £20 ($30. 1) Kymab raised $30. 1M in a first round from the Wellcome Trust Metamark Genetics Cambridge, 7/14 $22 Metamark completed a $22M Series B round Inc. Mass. Nitric Bristol, Pa. 7/16 $6 Nitric closed a $6M financing led by inside inves- BioTherapeutics tors Inc. Pacific Biosciences Menlo Park, 7/15 $59 Pacific Biosciences raised $109M in a Series F Calif. financing, including a $50M investment by Gen- Probe Inc., which was disclosed in June Pantec Ruggell, 7/21 CHF20 ($19) Pantec raised $19M in two private financing Biosolutions AG Liechtenstein rounds with StemCell Holding AG as lead investor Poxel SA Lyon, France 7/9 �16 ($20.2) Poxel raised $20.2M in a Series A round led by Edmond de Rothschild Investment Partners and including the InnoBio fund, which is managed by CDC Entreprises and Credit Agricole Private Equity Reata Irving, Texas 7/12 $78 Reata added $78M in a Series G round led by Pharmaceuticals CPMG Inc. and Novo A/S Inc.86 BioWorld® State of the Industry Report 2011
  • 88. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Tethys Bioscience Emeryville, 7/22 $33 Tethys raised $33M, of which $23M was venture Inc. Calif. funding and $10M was a working capital loan; investors were Greenspring Associates Inc., Paul Capital Investments and current investors; the loan was provided by Oxford Finance Corp. and Silicon Valley Bank Trevena Inc. King of Prussia, 7/14 $35 Trevena raised $35M in a Series B round led by Pa. New Enterprise Associates and Polaris Venture Partners; it also included Alta Partners, Healthcare Ventures and Yasuda Economic Development Corp. Vicept Malvern, Pa. 7/1 $16 Vicept secured $10M to complete a total $16M Therapeutics Inc. Series A led by Vivo Ventures, Sofinnova Ventures and Fidelity Biosciences Zogenix Inc. San Diego 7/14 $40 Zogenix secured a $35M debt facility led by Oxford Finance Corp., which included Silicon Valley Bank; the facility consists of a $25M term loan and a $10M revolving line of credit; in addi- tion to the $25M loan, the company is now getting a $15M investment from Clarus Ventures, Domain Associates, Scale Venture Partners, Thomas, McNerney & Partners, Abingworth Management and Chicago Growth Partners AUGUST Anchor Cambridge, 8/23 $10 Anchor raised $10M in an initial close of its Series B Therapeutics Mass. financing; investors were Novartis Option Fund, TVM Capital and HealthCare Ventures Cardioxyl Chapel Hill, 8/3 $15 Cardioxyl raised $15M in funding from Aurora Pharmaceuticals N.C. Funds and New Enterprise Associates Inc. CeNeRx Biopharma Research 8/16 $13 CeNeRx raised $13M in a Series C round with Inc. Triangle Park, investors Perseus Soros BioPharmaceutical Fund, L N.C. Capital Partners and Pappas Ventures Complete Mountain View, 8/20 $39 Complete Genomics raised $39M in its Series E Genomics Inc. Calif. financing; Sands Capital led the round and was joined by existing investors Essex Woodlands, OVP Venture Partners, Prospect Venture Partners, OrbiMed Advisors, Highland Capital Management and Enterprise Partners Dicerna Watertown, 8/12 $25 Dicerna raised $25M in Series B financing led by Pharmaceuticals Mass. Domain Associates LLC with existing investors Inc. Oxford Bioscience Partners, Skyline Ventures and Abingworth LLP participating Endocyte Inc. West Lafayette, 8/31 $10 Endocyte entered into a loan and security agree- Ind. ment with MidCap Financial and Silicon Valley Bank for access to up to $15M; it received the first tranche of $10M and the rest comes based on mile- stones Jennerex Inc. San Francisco 8/20 $8.6 Jennerex completed a fully subscribed private placement financing with existing stockholders and new investorsBioWorld® State of the Industry Report 2011 87
  • 89. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Lineagen Inc. Salt Lake City 8/31 $5 Lineagen raised an additional $5M in a Series A round, bringing the total raised to $10.8M; inves- tors were PrairieGold Venture Partners, Sanderling Ventures, vSpring Capital and Mesa Verde Venture Partners Mercator Wellesley, 8/13 $2 Mercator raised $2M in seed financing from eight Therapeutics Inc. Mass. unnamed investors Otonomy Inc. San Diego 8/30 $38.5 Otonomy raised $38.5M in a Series B round led by Novo Ventures and RiverVest Venture Partners, who were joined by Domain Associates and TPG Biotech Pathway San Francisco 8/11 $4.5 Pathway raised $4.5M as the fourth tranche of its Therapeutics Ltd. Series A private equity placement led by GBS Venture Partners and CM Capital Investments, with co-investors the Breast Cancer Research Trust, the Trans-Tasman Commercialisation Fund and the New Zealand Venture Investment Firm Swift Biosciences Ann Arbor, 8/13 $3 Swift raised $3M in a Series A financing led by the Inc. Mich. venture firm DFJ Mercury; other investors were several Michigan-based individual investors who helped launch the company in January 2010 Syndax Waltham, Mass. 8/12 $6 Syndax raised $6M by offering convertible notes Pharmaceuticals and warrants to its Series A venture investors Inc. Taligen Cambridge, 8/24 $10 Taligen closed a $10M tranche of its Series B round Therapeutics Inc. Mass. from existing investors Clarus Ventures, Alta Partners, Sanderling Ventures and High Country Ventures Tetralogic Malvern, Pa. 8/11 $32 Tetralogic raised $32M in a Series C financing led Pharmaceuticals by Clarus Ventures; other investors were Hatteras Inc. Venture Partners, Amgen Ventures, Healthcare Ventures, Latterell Venture Partners, Novitas Capital, Quaker Bioventures and the Vertical Group SEPTEMBER Accumetrics Inc. San Diego 9/2 $7 Accumetrics raised $7M in the second half of its first financing round, bringing the total raised to $23.5M Alethia Montreal 9/8 C$9.6 ($9.2) Alethia raised $9.2M in a Series A financing; inves- Biotherapeutics tors were AgeChem Venture Fund, BDC Venture Inc. Capital, GO Capital and Epicentre Technologies Corp. Cardoz AB Stockholm, 9/16 $3.7 Cardoz raised another $3.7M in a second close of Sweden a Series A financing, bringing the total to SEK124M ($17M); it was led by Forbion Capital Partners and included Ysios Capital Partners and HealthCap Celator Princeton, N.J. 9/2 $20 Celator raised $20M in a Series D round led by Pharmaceuticals Thomas, McNerney & Partners; other investors Inc. were Domain Associates, Ventures West Capital, Quaker BioVentures, TL Ventures, GrowthWorks Capital and BDC Venture Capital88 BioWorld® State of the Industry Report 2011
  • 90. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Cylene San Diego 9/24 $12 Cylene raised another $12M in its Series C round; Pharmaceuticals investors were Sanderling Ventures, HBM BioVentures (Cayman) Ltd., Novartis BioVenture Fund, BioVentures Investors, Lilly Ventures, Mitsui & Co. and Morningside Venture Investments Ltd. CytomX Santa Barbara, 9/23 $30 CytomX raised $30M in a Series B round led by Therapeutics Calif. Third Rock Ventures and including VC Roche Venture Fund DecImmune Cambridge, 9/28 $1 DecImmune secured a $1M equity investment Therapeutics Inc. Mass. from Astellas Venture Management, Amgen Ventures and HealthCare Ventures Good Start Genetics Boston 9/14 $18 Good Start completed an $18M Series A round led Inc. by OrbiMed Advisors, Safeguard Scientifics Inc. and SV Life Sciences Horizon Discovery Cambridge, UK 9/29 £6.25 ($9.88) Horizon has closed a $9.88M Series C financing Ltd. led by DFJ Esprit; other investors were Roche Venture Fund, Jonathan Milner and David Evans Immatics Tubingen, 9/22 E53.8 ($70.6) Immatics raised $70.6M in a third private round; Biotechnologies Germany investors were MIG AG, AT Impf, dievini Hopp GmbH Biotech Holding, Wellington Partners and other shareholders Immune Targeting London 9/16 $9.04 Immune Targeting added Esperante Ventures to Systems Ltd. its Series A syndicated, boosting the total raised to $22.7M iPierian Inc. South San 9/9 $6 iPierian raised an additional $6M in the second Francisco close of its Series B round, bringing the total to $28M; SR Once, Biogen Idec New Ventures and undisclosed additional ventures participated NeurAxon Inc. Toronto 9/30 $14 NeurAxon closed a debt financing of debentures convertible into existing class B preferred shares for a total of about $14M; investors include CTI Life Sciences Fund, the Ontario Capital Growth Corp., Delphi Ventures, OrbiMed Advisors LLC, Ventures West Capital Ltd., H.I.G. Ventures, BDC Venture Capital, NeuroVentures Fund and NeurAxon CEO Lawrence Bloch NewBridge Dubai, United 9/21 $12 NewBridge closed a $12M Series B financing, bring- Pharmaceuticals Arab Emirates ing the total amount raised to date to $16M; the FZ-LLC round was led by Kuwait Life Sciences Co., with participation by Burrill Life Sciences Capital Fund III LP Okairos Basel, 9/15 E16 ($20.8) Okairos completed a Series B private financing Switzerland round totaling $20.8M; it was led by Versant Ventures and joined by the Boehringer Ingelheim Ve n t u r e F u n d ; a l l e x i s t i n g i n v e s t o r s - BioMedPartners, LSP and Novartis Venture Funds - also participated in the round OpGen Inc. Gaithersburg, 9/28 $17 OpGen raised $17M in a Series B round led by jVen Md. Capital; other investors were CHL Medical Partners, Highland Capital Partners, Mason Wells Biomedical and Versant Ventures Pevion Biotech Ltd. Bern, 9/8 CHF10 ($9.9) Pevion raised $9.9M in venture funding from BZ Switzerland Bank, BB Biotech Ventures and Core CapitalBioWorld® State of the Industry Report 2011 89
  • 91. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Phenex Ludwigshafen, 9/22 E17.2 ($22.4) Phenex closed a Series C round, raising a total of Pharmaceuticals Germany $22.4M AG Protagen AG Dortmund, 9/8 E10 ($12.7) Protagen raised $12.7M in its second round; inves- Germany tors were NRW Bank, MIG Fonds, S-Capital, S-Venture Capital and KfW Q Chip Ltd. Cardiff, Wales 9/14 E2 ($2.57) Q Chip closed a $2.57M round Relypsa Inc. Santa Clara, 9/14 $70 Relypsa raised $70M in its new Series B financing Calif. led by OrbiMed Advisors LLC, with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners Rhythm Boston 9/9 $19 Rhythm raised a total of $40M in a Series A financ- Pharmaceuticals ing, with $21M of the total being accounted for in Inc. March; the first closing was led by MPM Capital and New Enterprise Associates, with Third Rock Ventures joining in the expanded round S*BIO Pte Ltd. Singapore 9/24 $5 S*BIO received a $5M investment by Mitsui Ventures Sorbent Sunnyvale, 9/14 $21 .8 Sorbent closed a $21 .8M Series B round; investors Therapeutics Inc. Calif. were AgeChem, CMEA Capital, ARCH Venture Partners, Sofinnova Ventures and the Dow Chemical Co. Stratos Genomics Seattle 9/8 $4 Stratos raised $4M in a Series A round led by Fisk Inc. Ventures and including Stratos Group LLC TetraLogic Malvern, Pa. 9/29 $5 TetraLogic added $5M to its previously Pharmaceuticals announced $32M Series C; Pfizer Ventures joined Corp. the syndicate of existing investors led by Clarus Ventures Tigris Bonita Springs, 9/29 $6.5 Tigris raised $6.5M in a Series C convertible pre- Pharmaceuticals Fla. ferred stock round led by Neil Flanzraich; other Inc. investors were Wexford Spectrum Investors LLC and Sonostar Capital Partners LLC; Riverbank Capital Securities Inc. acted as placement agent Tobira Manalapan, N.J. 9/30 $31 Tobira raised $31M in a Series B round led by Novo Therapeutics Inc. A/S; other investors were Domain Associates LLC, Frazier Healthcare Ventures, Montreux Equity Partners and Canaan Partners Zyngenia Inc. Gaithersburg, 9/9 $15 Zyngenia raised $15M through New Enterprise Md. Associates in a Series A extension round OCTOBER Amsterdam Amsterdam, 10/6 E15 ($20.75) Amsterdam raised $20.75M in an equity offering Molecular the with Advent Venture Partners, Gilde Healthcare Therapeutics Netherlands Partners, Credit Agricole Private Equity and Holding NV Forbion Capital Partners aTyr Pharma Inc. San Diego 10/26 $23 aTyr raised $23M in a Series C round led by Domain Associates and including Alta Partners, Polaris Venture Partners and Cardinal Partners Cerenis Toulouse, 10/22 $13.9 Cerenis raised $13.9M in a second close of its Therapeutics SA France Series C led by IRDI-IXO; other investors were Strategic Investment Fund and all previous inves- tors90 BioWorld® State of the Industry Report 2011
  • 92. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Convergence Ltd. Cambridge, UK 10/5 $35.4 Convergence raised $35.4M after being spun out by GlaxoSmithKline plc; investors were Apposite Capital, New Leaf Venture and SV Life Sciences ContraFect Corp. New York 10/27 $14.2 ContraFect closed a $2.2M Series A financing, led by Equity Source Partners LLC, and a $12M Series B financing, led by Maxim Group LLC Dicerna Watertown, 10/22 $4 Dicerna raised $4M in a second closing of its Therapeutics Inc. Mass. Series B round, raising a total of $29M from exist- ing investors Oxford Bioscience Partners, Skyline Ventures, Abingworth and Domain Associates and new investor SR One Dipexium New York 10/20 $1 .4 Dipexium raised $1 .4M in an offering of its Class A Pharmaceuticals Member Interests in a multiple-closing transaction LLC starting July 23 Innovacell Innsbruck, 10/7 E4.3 ($6) Innovacell received $6M through its shareholders Biotechnologie AG Austria Metabolic Solutions Kalamazoo, 10/22 $23.5 Metabolic Solutions raised $23.5M in a Series D Development Co. Mich. round led by Hopen Life Sciences with support from Southwest Michigan First Life Science Fund Noxxon Pharma AG Berlin 10/13 $2.8 Noxxon raised another E2M ($2.8M) in a Series D round, bringing the total raised to E35 Pathwork Redwood City, 10/7 $30 Pathwork closed a $30M Series C financing led by Diagnostics Inc. Calif. Alta Partners, with participation from existing investors Abingworth, Advent Venture Partners, Novus Ventures, Propsect Venture Partners and Venrock Pearl Therapeutics Redwood City, 10/19 $69 Pearl raised $69M in a Series C financing; inves- Inc. Calif. tors were Vatera Healthcare Partners, Clarus Ventures, New Leaf Venture Partners and 5AM Ventures Prolong South 10/13 $30 Prolong secured $30M in funding from an undis- Pharmaceuticals Plainfield, N.J. closed investor LLC Regulus La Jolla, Calif. 10/29 $10 Regulus received a $10M equity investment from Therapeutics Inc. partner Sanofi-Aventis Group SA as part of their microRNA-based drugs for fibrosis deal Synosia Basel, 10/13 $30 Synosia raised $30M in a third round with partner Therapeutics Switzerland UCB leading the financing with a $20M invest- ment; other investors were Versant Ventures, 5AM Ventures, Novo A/S, Aravis Venture, Investor Growth Capital and Swiss Helvetia Fund NOVEMBER Aires Pharma- San Diego 11/15 $20 Aires raised $20M in a Series B round led by MPM ceuticals Inc. Capital, and including ProQuest Investments Beech Tree Labs Providence, R.I. 11/17 $7 Beech Tree raised $7M in a Series B round Inc. Biodesix Inc. Broomfield, 11/11 $7. 1 Biodesix raised $7. 1M through existing investors Colo. Ceregene Inc. San Diego 11/12 $11 .5 Ceregene closed a Series D round worth $11 .5M in preferred stock; it was led by Hamilton BioVentures and Alta Partners with MPM Capital and Investor Growth Capital participatingBioWorld® State of the Industry Report 2011 91
  • 93. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details Cerulean Pharma Cambridge, 11/16 $24 Cerulean raised $24M in a Series C round led by Inc. Mass. Lilly Ventures, and including Polar Venture Partners, Venrock, Lux Capital and Bessemer Venture Partners Coronado New York 11/5 $21 .6 Coronado raised $21 .6M through a financing led Biosciences Inc. by Paramount BioCapital Inc. Delenex Zurich, 11/15 CHF13.5 ($14.8) Delenex secured $14.8M in a Series A round led by Therapeutics AG Switzerland SV Life Sciences, HBM BioCapital, HBM BioVentures, BioMedInvest and VI Partners Helix Therapeutics Newhaven, 11/24 $2.5 Helix raised $2.5M through an investment from LLC Conn. Canaan Partners and Connecticut Innovations Hutchison London 11/9 $12.5 Hutchison raised $12.5M via a private investment MediPharma from Mitsui & Co. Ltd. Holdings Ltd. Karyopharm Newton, Mass. 11/4 $20 Karyopharm raised $20M through a Series A Therapeutics Inc. financing from Chione Ltd. Mind-NRG SA Geneva, 11/3** E1 .5 ($2. 1) Mind-NRG raised $2. 1M in an initial investment Switzerland from Index Ventures Mtm Laboratories Heidelberg, 11/9 E7 ($9.7) Mtm raised an additional $9.7M in its Series C AG Germany round led by HBM BioVentures Ltd., Wellington Partners and Gilde Healthcare Partners, with a con- sortium including National Technology Enterprises Co., Heidelberg Innovation and private investors RedHill Biopharma Tel Aviv, Israel 11/9 $10 RedHill raised $10M in a private placement Ltd. Sutro Biopharma San Francisco 11/18 $36.5 Sutro raised $36.5M in a Series C led by Skyline Inc. Ventures; other investors were the corporate ven- ture arms of Eli Lilly and Co. and Amgen Inc., SV Life Sciences and Alta Partners Syntaxin Ltd. Oxford, UK 11/12 £18 ($29) Syntaxin closed a $29M financing that included Abingworth, SROne, LSP, Johnson & Johnson Development Corp. and Quest, as well as Lundbeckfond Ventures and Ipsen and Seventure Verastem Inc. Boston 11/17 $16 Verastem closed a $16M Series A round led by Longwood Founders Fund; Bessemer Venture Partners, Cardinal Partners and MPM Capital joined in the financing Xention Ltd. Cambridge, UK 11/24 £8 ($12.7) Xention raised $12.7M in a Series D financing led by Seroba-Kernel Life Sciences Ltd., and including existing investors Forbion Capital Partners, Credit Agricole Private Equity, MVM and BTG International DECEMBER Aarden Indianapolis 12/27 $0.25 Aarden received $250,000 from BioCrossroads Pharmaceuticals Indiana Seed Fund Inc. Ablaris Pasadena, Calif. 12/21 $3 Ablaris received $3M in start-up money and may Therapeutics Inc. receive an additional $500,000 from its founder Arrowhead Research Corp. Bellicum Houston 12/22 $3 Bellicum raised $3M in convertible note funding Pharmaceuticals from new and existing investors; the notes will Inc. convert to Series B preferred stock92 BioWorld® State of the Industry Report 2011
  • 94. Venture Capital And Other Investments In Private Biotechnology Companies Company Location Date Amt. (M) Details BioRelix Inc. New Haven, 12/28 $2.4 BioRelix raised $2.4M through the sale of promis- Conn. sory notes and warrants Capricor Inc. Los Angeles 12/20 $2 Capricor received a $2M investment from Broadview Ventures and private individual inves- tors Catabasis Cambridge, 12/9 $14.5 Catabasis raised $14.5M in a second tranche in its Pharmaceuticals Mass. Series A financing from current investors, which Inc. include SV Life Sciences, Clarus Ventures, MedImmune Ventures and Advanced Technology Ventures Covagen AG Zurich, 12/1** CHF6.3 ($6.3) Covagen raised $6.3M in a Series A round led by Switzerland Seroba Bioventures; other investors were Edmond de Rotschild Investment Partners, MP Healthcare Venture Management Inc., Novartis Venture Fund and Ventech DBV Technologies Paris 12/20 E2 ($2.6) ALK-Abello invested $2.6M in DBV for the develop- ment of a peanut allergy vaccine Histogen Inc. San Diego 12/1 $4.65 Histogen completed its $10M Series A round from Secure Medical, Leonard Lavin, Lordship Ventures and Angus Mitchell; the initial $5.35M was raised in May 2008 Hutchison London 12/22 $7.7 Hutchison raised $7.7M in private funding from SB MediPharma China Venture Capital Ltd. Holdings Ltd. Noscira Madrid, Spain 12/30 E19 ($25. 1) Noscira raised $25. 1M through the sale of 3.8M shares to existing and new investors NovImmune SA Geneva 12/20 $20.6 NovImmune raised $20.6M additional in its Series B round Provesica Ltd. Cambridge, UK 12/17 £4 ($6.2) Provesica received $6.2M from Forbion Capital Partners and Seroba Kernal Life Sciences Ltd. PsiOxus London 12/16 £3.6 ($5.8) PsiOxus, formed through the merger of Myotec Therapeutics Ltd. Therapeutics Ltd. and Hybrid BioSystems Ltd., raised $5.8M in a financing led by Imperial Innovations Regenesance BV Amsterdam, 12/1 ND Regenesance raised an undisclosed amount of the seed financing from Life Sciences Fund Netherlands SuppreMol GmbH Martinsried, 12/2 $20.3 SuppreMol closed its $20.3M Series C round led by Germany MIG AG and BioMedPartners AG Notes: ** Denotes the date the item ran in BioWorld International. The date indicated refers to the BioWorld Today issue in which the news item can be found. Currency conversions reflect values at the time of a deal’s announcement.BioWorld® State of the Industry Report 2011 93
  • 95. Milestone Payments From Corporate Partners in 2010 TOTAL: $713.  4M 1 Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) JANUARY Alnylam Roche Group ND For the initiation of pre-investigational new drug applica- Pharmaceuticals (Switzerland) tion studies for an RNAi therapeutics product candidate Inc. (ALNY) (1/7) A.P. Pharma Affiliate of Paul $2.5 As part of an October 2005 agreement to sell its royalty Inc. (APPA) Capital Healthcare rights to Retin-A Micro and Carac to the affiliate (1/12) Astex AstraZeneca plc ND For the selection of a protein kinase B inhibitor clinical Therapeutics* (UK) candidate from Astex’s collaborative program with (UK) Cancer Research and Cancer Research Technology Ltd. (1/8) BioCryst Shionogi & Co. Ltd. $7 For marketing and manufacturing approval for intrave- Pharmaceuticals (Japan) nous peramivir to treat patients with influenza in Japan Inc. (BCRX) (1/14) BioFocus DPI* Janssen Pharma- E1 .6 For achieving success in its oncology target discovery col- (UK) ceutica NV ($2.3) laboration with Ortho Biotech Oncology Research & Development (1/13) Emisphere Novo Nordisk AS $2 For the start of a Phase I trial with a long-acting oral gluca- Technologies (Denmark) gon-like peptide-1 (NN9924) for Type II diabetes (1/14) Inc. (EMIS) Idera Merck KGaA $4.3 For the start of a Phase II study of EMD 1201081 in combi- Pharmaceuticals (Germany) nation with Erbitux in squamous cell carcinoma of the Inc. (IDRA) head and neck patients (1/20) Ligand NV Organon $1 For achieving a discovery milestone through a research Pharmaceuticals (subsidiary of collaboration that expired on Dec. 31 (1/11) Inc. (LGND) Merck & Co. Inc.) NovaBay Galderma SA $3.75 For the completion of formulation feasibility studies with Pharmaceuticals (Switzerland) NovaBay’s aganocide compounds for topical use, and for Inc. (AMEX:NBY) completing an exploratory clinical study for the treatment of adult acne (1/12) Perseid Astellas Pharma $5 For the achievement of a preclinical milestone under their Therapeutics Inc. (Japan) collaboration to co-develop and commercialize next-gen- LLC (subsidiary eration CTLA4-Ig therapeutics (1/20) of Maxygen Inc.; MAXY) Spectrum Allergan Inc. $1 .5 For achieving its enrollment target in the second of two Pharmaceuticals (NYSE:AGN) Phase III trials of apaziquone for non-muscle invasive Inc. (SPPI) bladder cancer (1/13) FEBRUARY Aradigm Corp. Zogenix Inc.* $4 For the first commercial sale in the U.S. of Sumavel (OTC BB:ARDM) DosePro injection needle-free delivery system (2/5) Bioniche Life Endo $8 For the licensing of rights to develop and market its non- Sciences Inc. Pharmaceuticals muscle-invasive bladder cancer product in North America (Canada; Holdings Inc. (2/16) TSX:BNC) (ENDP) Celldex TopoTarget A/S $3 Related to TopoTarget’s $350M deal with Spectrum Therapeutics (Denmark; CSE:TOPO) Pharmaceuticals Inc. for lymphoma drug belinostat; Inc. (CLDX) Celldex stands to receive 10% of TopoTarget’s sublicense income on the drug, up to $6M (2/17)BioWorld® State of the Industry Report 2011 94
  • 96. Milestone Payments From Corporate Partners Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) ChemoCentryx GlaxoSmithKline $10 For the start of a Phase I trial of CCX168, an oral small mol- Inc.* plc (UK) ecule designed to treat autoimmune diseases by targeting the C5a receptor (2/1) Five Prime Centocor Research ND For the selection of a therapeutic that will be pursued for Therapeutics & Development Inc. immunology-related indications (2/25) Inc.* Nabi Biopharma- GlaxoSmithKline $8 For completing the manufacture and transfer of specified ceuticals Inc. plc (UK) materials associated with the sale of the PentaStaph vac- (NABI) cine candidate (2/9) Spectrum Nippon Kayaku $16 In connection with a collaboration with Nippon for apazi- Pharmaceuticals Co. Ltd. (Japan) quone, it received $15M, and for a separate deal in South Inc. (SPPI) and Handok Korea with Handok, it received $1M (2/1) Pharmaceuticals Co. Ltd. (South Korea) Targeted Amsterdam $0.75 For filing for European marketing approval of Glybera Genetics Corp. Molecular (2/10) (PK:TGEN) Therapeutics BV* (the Netherlands) MARCH Affymax Inc. Takeda $5 For the start of Phase III testing of Hematide to treat ane- (AFFY) Pharmaceutical mia in chronic renal failure patients (3/11) Co. Ltd. (Japan) Alnylam Takeda $20 For the achievement of certain predefined objectives in Pharmaceuticals Pharmaceutical the transfer of Alnylam’s platform technology to Takeda Inc. (ALNY) Co. Ltd. (Japan) for the development of RNAi therapeutics (3/24) CBio Ltd. Novo Nordisk $1 For the recruitment of the 75th patient into the current (Australia; A/S (Denmark) 150-patient Phase II trial of XToll to treat autoimmune dis- ASX:CBZ) eases such as rheumatoid arthritis (3/12) Cel-Sci Corp. Byron $0. 125 As part of a licensing agreement that granted Byron exclu- (AMEX:CVM) Biopharma LLC* sive rights to market and distribute Cel-Sci’s Multikine in the Republic of South Africa (3/11) CombinatoRx Covidien plc $40 For the FDA approval of Exalgo to treat moderate to Inc. (CRXX) (NYSE:COV) severe pain in opioid-tolerant patients (3/3) Eli Lilly and Co. Anthera $3.5 Related to the initiation of the VISTA-16 trial for A-002 and Shionogi Pharmaceuticals (3/8) and Co. Ltd. Inc. (ANTH) (Japan) Isis Bristol-Myers $6 For the acceptance of initial regulatory filings to begin Pharmaceuticals Squibb Co. Phase I studies for BMS-PCSK9Rx (3/9) Inc. (ISIS) Lpath Inc. Merck KGaA $2 For Phase I Asonep data that showed lymphocyte counts (OTC BB:LPTN) (Germany) in the vascular space were reduced in a dose-related fash- ion in cancer patients (3/31) Palatin AstraZeneca plc $2.5 For the completion by Palatin of certain tasks this quarter Technologies (UK) relating to a program focused on compounds that target Inc. (AMEX:PTN) melanocortin receptors to treat obesity and related indica- tions (3/24) Seattle Genentech Inc. ND For Genentech’s submission of an investigational new Genetics Inc. (NYSE:DNA) drug application for an ADC using Seattle Genetics’ tech- (SGEN) nology for the treatment of cancer (3/4)BioWorld® State of the Industry Report 2011 95
  • 97. Milestone Payments From Corporate Partners Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) Vernalis plc Novartis AG $3 For the first dosing in a Phase II proof-of-concept clinical (UK; LSE:VER) (Switzerland) trial of AUY-922, an Hsp90 inhibitor, in a range of solid tumors (3/17**) APRIL AVEO Biogen Idec $5 For the selection of the first humanized antibody develop- Pharmaceuticals International GmbH ment candidate from its ErbB3 program (4/15) Inc. (AVEO) (subsidiary of Biogen Idec Inc.; BIIB) BioAlliance Strativa $20 For the FDA approval of Oravig to treat oropharyngeal Pharma SA Pharmaceuticals candidiasis in adults (4/19) (France; (subsidiary of Par Paris:BIO) Pharmaceutical Cos. Inc.) Cipher Ranbaxy $2 For reaching the enrollment midpoint in its Phase III safety Pharmaceuticals Pharmaceuticals study of CIP-Isotretinoin, the company’s formulation of Inc. (Canada; Inc. isotretinoin, which is used in the treatment of severe nod- TSX:DND) ular acne (4/2) Cleveland Biomedical Advanced $1 .93 For the exercise of milestone-based options on an exist- BioLabs Inc. Research and ing contract for selected tasks in the advanced develop- (CBLI) Development ment of Protectan CBLB502 (4/30) Authority of the Department of Health and Human Services Micromet Inc. Bayer Schering ND For the achievement of preclinical proof of concept for a (MITI) Pharma AG BiTE antibody to treat solid tumors (4/22) (Germany) Osiris JCR Pharmaceuticals $1 For development progress made advancing the stem cell Therapeutics Co. Ltd. (Japan) product Prochymal for the treatment of acute graft-vs.- Inc. (OSIR) host disease in Japan (4/29) XOMA Ltd. Takeda $1 For achieving a pre-established preclinical milestone (XOMA) Pharmaceutical under the companies’ 2006 antibody collaboration agree- Co. Ltd. (Japan) ment (4/16) MAY Abbott Biogen Idec Inc. $30 For the start of a Phase III trial comparing daclizumab to (BIIB) Avonex in relapsing-remitting multiple sclerosis (5/25) BioInvent Roche AG E10 For the start of an imaging study with the antibody International (Switzerland) ($12.38) TB-403 in patients with metastatic, treatment-refractory, AB (Sweden; colorectal and ovarian cancer (5/18) SSE:BINV) and ThromboGenics NV (Belgium; BR:THR) Evotec AG Boehringer E2 For the advance of a compound for neuropathic pain into (Germany; Ingelheim GmbH ($2.5) Phase I testing (5/20) FSE:EVT) (Germany) Immunomedics Nycomed A/S $5 As part of the 2008 collaboration to develop and commer- Inc. (IMMU) (Denmark) cialize subcutaneous veltuzumab in all noncancer indica- tions (5/26) Merck KGaA Clinical Data Inc. E12.5 For the FDA’s acceptance of the NDA filing for vilazodone (Germany) (CLDA) ($15.6) to treat major depressive disorder (5/25)96 BioWorld® State of the Industry Report 2011
  • 98. Milestone Payments From Corporate Partners Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) Pozen Inc. AstraZeneca plc $20 For the FDA’s approval of Vimovo, the gastric-friendly (POZN) (UK) non-steroidal inflammatory candidate (5/3) Vectura Group Novartis AG $7.5 For the start of two Phase III trials combining NVA237 with plc (PK:VEGPF) and (Switzerland) QAB149 for chronic obstructive pulmonary disease (5/11) Sosei Group Corp. JUNE Affymax Inc. Takeda $30 Affymax received $30M in development milestone pay- (AFFY) Pharmaceutical ments from Takeda as part of their exclusive global agree- Co. (Japan) ment to develop and commercialize Hematide to treat anemia in patients with chronic renal failure (6/23) AVEO Merck & Co. Inc. $8.5 For the start of a Phase II trial evaluating SCH 900105 to Pharmaceuticals treat non-small-cell lung cancer (6/8) Inc. (AVEO) CombinatoRx Sanofi-Aventis $0.5 For the start of a Phase IIb trial testing Prednisporin in Inc. (CRXX) Group SA (France) patients with persistent allergic conjunctivitis (6/8) Evotec AG Boehringer E2.5 For the selection of a candidate compound for predevel- (Germany; Ingelheim GmbH ($3.09) opment studies in an oncology program (6/18) FSE:EVT) (Germany) GW Pharma- Bayer Schering £10 For the UK approval of Sativax to treat spasticity due to ceuticals plc Pharma AG ($14.8) multiple sclerosis (6/22) (UK; LSE:GWP) (Germany) MorphoSys Centocor Ortho ND For the start of a Phase I trial of a HuCAL-derived antibody AG (Germany; Biotech Inc. in the therapeutic area of inflammatory and autoimmune FSE:MOR) diseases (6/23) Vitae Boehringer $14 For Boehringer’s move into Phase I testing with a small- Pharmaceuticals Ingelheim GmbH molecule 11bta-HSD-1 inhibitor (6/30) Inc.* (Germany) JULY Algeta ASA (Norway; Bayer Schering �5 ($6.4) For signed manufacturing and supply agreements for OSLO:ALGETA) Pharma AG (Germany) future commercial sale of Alpharadin to treat bone metas- tases (7/23) Amira GlaxoSmithKline plc ND For the successful progression of an Amira-discovered Pharmaceuticals (UK) 5-lipoxygenase-activating protein inhibitor into Phase II Inc.* development in patients with asthma (7/20) Cipher Kowa Pharmaceuticals $1 For reaching a cumulative sales milestone for its fenofi- Pharmaceuticals Inc. America Inc. brate product Lipofen (7/8) (Canada; TSX:DND) Cleveland BioLabs Biomedical Advanced $4. 1 For exercising an option regarding the development of Inc. (CBLI) Research and Protectan; it supports the manufacturing process of the Development compound and three additional registration batches of Authority the drug, plus additional animal studies (7/30) Curis Inc. (CRIS) Debiopharm SA $3 For the start of a Phase I trial of Debio 0932, a small-mole- (Switzerland) cule heat shock protein 90 inhibitor being tested for advanced solid tumors or lymphoma (7/7) Isis Pharmaceuticals GlaxoSmithKline plc $5 Related to the designation as a development candidate of Inc. (ISIS) (UK) a drug to treat an undisclosed rare and serious disease; Isis will develop the drug to Phase II proof of concept, at which time GSK has the option to license it (7/30) MorphoSys AG Novartis AG ND For the start of a Phase I trial testing a HuCAL-derived fully (Germany; FSE:MOR) (Switzerland) human antibody for musculoskeletal diseases (7/2)BioWorld® State of the Industry Report 2011 97
  • 99. Milestone Payments From Corporate Partners Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) Optimer Cempra $0.5 As a result of the continuing development of CEM-101 , a Pharmaceuticals Inc. Pharmaceuticals Inc. macrolide under investigation as a treatment of respirato- (OPTR) ry infections (7/9) Perseid Astellas Pharma Inc. $5 As part of a collaboration to co-develop and commercial- Therapeutics LLC (Japan) ize CTLA4-lg therapeutics (7/8) (subsidiary of Maxygen Inc.; MAXY) XOMA Ltd. (XOMA) AVEO Pharmaceuticals $0.75 For the start of a Phase II trial to evaluate its AV-299 anti- Inc. body for the treatment of non-small-cell lung cancer (7/27) AUGUST Evotec AG (Germany; Boehringer Ingelheim E2.5 For the selection of a candidate compound for pre-devel- FSE:EVT) GmbH (Germany) ($3.29) opment studies in an inflammation and immunology pro- gram (8/5) Idera Merck KGaA E3 ($3.8) For the start of a Phase Ib trial of IMO-2055 in combination Pharmaceuticals Inc. (Germany) with cisplatin, fluorouracil and Erbitux in first-line squa- (IDRA) mous-cell carcinoma of the head and neck (8/30) MorphoSys AG Novartis AG ND For the start of a Phase I trial of a HuCAL-derived antibody (Germany; FSE:MOR) (Switzerland) in the area of ophthalmology (8/3) SEPTEMBER Cardiome Pharma Merck & Co. Inc. $30 For the European approval of Brinavess, or intravenous Corp. (Canada; CRME) vernakalant, for use in converting recent onset atrial fibril- lation patients to normal sinus rhythm (9/3) Depomed Inc. (DEPO) Covidien plc (Ireland; $0.5 For the first acetaminophen/opioid analgesic formulation NYSE:COV) entering clinical development under their worldwide license agreement (9/29) GenVec Inc. (GNVC) Novartis AG ND GenVec achieved the first milestone in its $213.6M collabo- (Switzerland) ration with Novartis to develop treatments for hearing loss and balance disorders (9/15) ImmunoGen Inc. Sanofi-Aventis Group $1 For the start of testing of SAR566658, a treatment for can- (IMGN) (France) cer (9/22) Lipoxen plc (UK; Baxter International $2 For the filing of an investigational new drug application of LSE:LPX) Inc. a lead polymer polysialic acid-FVIII candidate (9/17) Neovacs SA (France; OSEO (French state E0.963 For its contract aimed at developing a TNF-Kinoid in rheu- Paris:ALNEV) innovation agency) ($1 .2) matoid arthritis (9/14) Rigel AstraZeneca plc (UK) $25 For the start of a Phase III program for oral Syk inhibitor Pharmaceuticals Inc. fostamatinib in rheumatoid arthritis (9/30) (RIGL) Seattle Genetics Inc. Agensys Inc. (affiliate ND For Agensys’ initiation of a Phase I trial with AGS-16M8F, an (SGEN) of Astellas Pharma antibody-drug conjugate for cancer (9/3) Inc.; Japan) Stellar Bayer Innovation ND For the agreement under which Stellar supplies Keyhole Biotechnologies Inc. GmbH (Germany) Limpet Hemocyanin (9/14) (CDNX:KLH) OCTOBER Ablynx NV (Belgium; Boehringer Ingelheim E3 ($4. 1) For the companies alliance to develop and commercialize BR:ABLX) GmbH (Germany) Nanobodies (10/4) Astex Therapeutics AstraZeneca plc (UK) ND For AstraZeneca’s selection of a candidate drug from the Ltd.* (UK) collaborative program aimed at identifying small-mole- cule inhibitors of beta-secretase, a key enzyme implicated in the progression of Alzheimer’s disease (10/26)98 BioWorld® State of the Industry Report 2011
  • 100. Milestone Payments From Corporate Partners Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) Depomed Inc. (DEPO) Janssen $5 For the delivery of a formulation of canagliflozin and met- Pharmaceutica N.V. form (10/25) (subsidiary of Johnson & Johnson) Flamel Technologies Merck KGaA E3 ($4. 1) As part of the companies’ partnership for the develop- SA (France; FLML) (Germany) ment of an extended-release formulation of interferon beta-1a (10/20) Incyte Corp. (INCY) Eli Lilly and Co. $19 For the start of a Phase IIb trial evaluating INCB28050 for the treatment of rheumatoid arthritis (10/21) Prosensa GlaxoSmithKline plc £7.5 ($11 .9) For the successful safety review in its Phase II open-label, Therapeutics BV* (UK) extension trial of GSK2402968 for Duchenne’s muscular (the Netherlands) dystrophy (10/14) Sucampo Abbott Japan Co. Ltd. $5 For the submission of a marketing application to Japanese Pharmaceuticals Inc. (Japan) authorities for approval of Amitiza in chronic idiopathic (SCMP) constipation (10/8) Vernalis plc (UK; Les Laboratoires E0.75 As part of a three-year oncology drug discovery collabora- LSE:VER) Servier (France) ($1 .045) tion initiated in May 2009; for achieving the desired potency and selectivity criteria in the program (10/7) Xencor Inc.* Boehringer Ingelheim ND For the regulatory submission of a monoclonal antibody GmbH (Germany) for cancer developed under a 2007 licensing agreement (10/13) NOVEMBER Bioniche Life Endo Pharmaceuticals $4 For Urocidin, a product of non-muscle-invasive bladder Sciences Inc. Inc. (ENDP) cancer that is refractory to current first-line therapy, (Canada; TSX:BNC) attaining a contractual efficacy goal from a Phase III FDA registration trial (11/18) Depomed Inc. (DEPO) Merck & Co. Inc. $2.5 For the development of sitagliptin and extended-release metformin (11/3) Idenix Pharma- Viiv Healthcare LLC $20 For the initiation of Phase IIb trials of GSK2248761 in HIV/ ceuticals Inc. (IDIX) (UK) AIDS (11/24) Incyte Corp. (INCY) Novartis AG $50 For the start of Phase III trials of INCB18424 to treat polycy- (Switzerland) themia vera (11/3) Inspiration Ipsen SA (France) $50 For the start of a Phase II/III study of its intravenous Biopharmaceuticals recombinant porcine factor VIII product, OBI-1 , for hemo- Inc.* philia (11/22) Ironwood Pharma- Almirall SA (Spain) $20 For positive results from a European Phase III trial of lina- ceuticals Inc. (IRWD) clotide for irritable bowel syndrome with constipation (11/8) Micromet Inc. (MITI) Bayer Schering E2.5 For the move of Micromet’s BiTE antibody MT112/BAY Pharma AG (Germany) ($3.5) 2010112 into formal preclinical development for solid tumors (11/9) NovaDel Pharma Inc. Mist Acquisition LLC $0.5 Pursuant to a 2009 agreement between the two compa- (OTC BB:NVDL) nies to manufacture and commercialize NitroMist in North America (11/5) Pharming Group NV Swedish Orphan E5 ($7) For the European Commission approval of Ruconest in (the Netherlands; Biovitrum AB (Sweden; acute attacks of hereditary angioedema (11/3) Amsterdam:PHARM) PK:SWTUY) Pozen Inc. (POZN) AstraZeneca plc (UK) $25 For the granting of marketing and pricing approvals for Vimovo in the UK (11/15) Vivalis SA (France; GlaxoSmithKline plc ND For the FDA’s acceptance of an investigational new drug Paris:VLS) (UK) application for an influenza vaccine produced in EB66 cells (11/30)BioWorld® State of the Industry Report 2011 99
  • 101. Milestone Payments From Corporate Partners Company Partner Amt. Details (Date) (Symbol)#* (Country) (M) XOMA Ltd. (XOMA) Kaketsuken Chemo- $2 As part of a November 2009 collaboration involving mul- Sero-Therapeutic tiple XOMA antibody research and development technolo- Research Institute gies (11/2) (Japan) DECEMBER Array BioPharma Celgene Corp. (CELG) $10 For plans to start a Phase I cancer trial with cFMS inhibitor Inc. (ARRY) ARRY-382 in the first quarter of 2011 (12/1) Benitec Ltd. Tacere Therapeutics $0. 162 For Benitec’s equity stake in Tacere in relation to a licens- (Australia; ASX:BLT) Inc.* ing agreement for gene silencing technology for hepatitis C (12/27) Catalyst Bioscience Pfizer Inc. $4 Under the terms of their collaboration to develop Inc.* improved recombinant human Factor VIIa variants for hemophilia and other bleeding disorders (12/17) Clinical Data Inc. Santen Pharmaceutical $2 For Santen’s filing of an investigational new drug applica- Co. (Japan) tion for ATL313, an adenosine A2A agonist for primary open angle gluacoma and ocular hypertension (12/23) Envoy Therapeutics Merck and Co. Inc. ND For executing its bacTRAP technology in diabetes-relevant Inc.* tissues (12/16) Icagen Inc. (ICGN) Pfizer Inc. $1 For Pfizer’s selection of a compound targeting the sodium ion channel Nav1 .7 to treat pain and related disorders (12/1) Ligand Pfizer Inc. $1 For Pfizer’s sublicensing of Tanaproget, a nonsteroidal Pharmaceuticals Inc. progesterone receptor agonist contraceptive (12/23) (LGND) MorphoSys AG Centocor Ortho ND For the filing of an application for a Phase I trial of a (Germany; FSE:MOR) Biotech LP (unit of HuCAL-derived antibody for inflammatory and autoim- Johnson & Johnson) mune diseases (12/23) Orexo AB (Sweden; Boehringer Ingelheim E6.5 For the selection of a development candidate from the SSE:ORX) GmbH (Germany) ($8.6) firms’ 2005 collaboration focused on pain and inflamma- tory diseases (12/17) Silence Therapeutics Quark $1 .5 In relation to the option agreement between Quark and plc (UK; LSE:SLN) Pharmaceuticals Inc.* Novartis for QPI-1002 (12/22) and Novartis AG (Switzerland) Zealand Pharma AS Helsinn Healthcare SA E0.5 As part of their November 2008 license agreement to (Denmark; CSE:ZEAL) (Switzerland) ($0.662) develop ZP1846 to treat chemotherapy-induced diarrhea (12/10) Notes: # Unless otherwise indicated, shares are traded on the Nasdaq exchange; * Private company. Currency conversions are based on exchange rates at the time of the deal. The date indicated refers to the BioWorld Today issue in which the news item can be found. ND = Not disclosed. ** Denotes the date the item ran in BioWorld International. AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange.100 BioWorld® State of the Industry Report 2011
  • 102. Grants and Awards Given to Biotech Companies in 2010 Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution FIRST QUARTER 2010 Ablynx NV Flemish agency |1 .2 Grant To support preclinical and clinical (Belgium; BR:ABLX) for Innovation by ($1 .6) work with ALX-0061 for autoimmune Science and and inflammatory diseases (2/22) Technology Achillion National Institute ND Phase I SBIR To study and characterize a back-up Pharmaceuticals of Allergy and grant series of compounds to the antibiotic Inc. (ACHN) Infectious Disease ACH-702 for tuberculosis (3/19) Adeona American Recovery $0.86 Grant For the ongoing Phase II/III trial of Pharmaceuticals and Reinvestment Trimesta for multiple sclerosis (1/11) Inc. (AMEX:AEN) Act Affiris AG* (Austria) Austrian Research |1 .2 Grant For a hypertension vaccine that will Promotion Agency ($1 .6) use Affiris’ Affitome technology to target angiotensin II, a peptide that can cause narrowing of the blood vessels (2/26) Amsterdam Dutch |4 Innovation To support the development of its Molecular government ($5.7) credit gene therapy treatment for Therapeutics* Duchenne’s muscular dystrophy (1/7) (the Netherlands) Arcadia National Institute $0.856 STTR grant To help fund Phase II development of Biosciences Inc.* of Diabetes and wheat varieties with reduced celiac Digestive and disease-causing proteins (2/17) Kidney Diseases and the American Recovery and Re- investment Act AVI BioPharma Inc. CureDuchenne and $0.5 Grants To support research and devel- (AVII) the Foundation to opment of the company’s exon-skip- Eradicate Duchenne ping drug candidates for the treatment of Duchenne’s muscular dystrophy (2/17) Carmot Michael J. Fox $2. 1 Grants For preclinical projects focused on Therapeutics Foundation for neuroprotective therapeutic targets Inc.*, Opsona Parkinson’s for Parkinson’s disease, including Therapeutics Ltd.* Research Carmot, Opsona and Intermed’s (Ireland), InterMed focus on inflammation and oxidative Discovery GmbH* stress, FoldRx and Pfizer’s focus on (Germany), FoldRx alpha-synuclein, plus Envivo’s pro- Pharmaceuticals gram looking at inhibitors of histone Inc., Pfizer Inc. deacetylase (1/20) and Envivo Pharmaceuticals Inc. Celsion Corp. Center for ND Grant For magnetic resonance imaging- (CLSN) Translational guided high intensity-focused ultra- Molecular Medicine sound to improve cancer chemotherapy (2/23) DeveloGen AG* Juvenile Diabetes $0.5 Grant For research of mechanisms for the (Germany) Research protection of beta cells (2/24) FoundationBioWorld® State of the Industry Report 2011 101
  • 103. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution GeneGo Inc.* National Institute $0.336 Phase I SBIR For creating a type of predictive sig- of General Medical grant nature for drug resistance (1/13) Sciences Hepregen Corp.* National Science $0.5 Phase II SBIR To support its work developing a Foundation grant human liver platform for high- throughput screening of drug- induced liver injury and drug-drug interaction (1/15) Horizon Discovery University of $0.5 Eurostars To research a novel class of inherited Ltd.* (UK) Torino (Italy) grant and somatic noncoding cancer-relat- ed single-nucleotide polymorphisms (2/17) Intellikine Inc.* Multiple Myeloma $1 Biotech To fund the early stage drug develop- and Tragara Research Investment ment of compounds and approaches Pharmaceuticals Foundation Award grant that show potential in treating multi- Inc.* ple myeloma (3/30) Isotechnika Pharma National Research C$0.237 Industrial For its non-immunosuppressive Inc. (Canada; Council ($0.23) Research cyclosporin analogue molecules pro- TSX:ISA) Assistance gram (3/5) Program grant Mirna Texas Emerging $5 Grant To develop miRNA therapeutics for Therapeutics Technology Fund multiple cancers (1/12) Inc.* NeurAxon Inc.* Michael J. Fox $0.267 Grant To fund research exploring neuronal Foundation for nitric oxide synthase inhibitors as a Parkinson’s potential treatment paradigm in Research Parkinson’s research (1/12) OncoTek Drug Ontario Institute ND Grant For preclinical development of PoLi- Discovery Inc. for Cancer PTX, an intraperitoneal ovarian can- (subsidiary of Research cer therapy (3/25) Receptor Thera- peutics Inc.*; Canada) Orphagen National $1 .2 Phase II SBIR To further characterize a class of Pharmaceuticals Institutes of grant small-molecule drugs that have the Inc.* Health potential to treat circadian rhythm sleep disorders and psychiatric ill- nesses such as anxiety, depression or psychosis (2/2) Pangu BioPharma Hong Kong ND Grant To fund research it is performing (Hong Kong; subsid- University of with the university in the identifica- iary of aTyr Pharma Science and tion and characterization of naturally Inc.*) Technology occurring splice variants of human tRNA synthetases (3/2) PDS Biotechnology National Cancer $1 .28 Phase II SBIR To complete studies required for an Corp.* Institute grant investigational new drug application for its lead human papillomavirus- cancer product (3/3) Pronota NV* Institute for the |1 .4 Grant To further validate and develop bio- (Belgium) Promotion of ($2) markers for the management of Innovation by heart failure (1/13) Science and Technology (Belgium)102 BioWorld® State of the Industry Report 2011
  • 104. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Sirion Biotech Federal Ministry |0.5 Two-year To d e v e l o p n e w t h e r a p e u t i c GmbH* (Germany) for Economics ($0.674) grant approaches against lymphoid tumors and Helmholtz and Technology (3/30) Zentrum Munchen (Germany) (Germany) Targacept Inc. Michael J. Fox $0.304 Grant To fund a project on development of (TRGT) Foundation for an alpha6-selective neuronal nicotin- Parkinson’s ic receptor imaging agent as a Research Parkinson’s disease biomarker (2/9) Terpenoid National $0.946 Phase II STTR To advance cancer drug candidates Therapeutics Inc.* Institutes of grant toward commercialization (1/27) Health and a Phase I SBIR grant Transposagen National Cancer $0.412 SBIR grant For its work developing a rat model Biopharmaceuticals Institute and of human colorectal cancer (1/26) Inc.* Kentucky economic development office Zyngenia Inc.* State of Maryland $2.5 Bioscience To support the new life sciences and Montgomery Strategy company that has 14 employees County grant (3/12) SECOND QUARTER 2010 Aestus National Institute $2 SBIR grant To fund clinical trials of Aestus’ treat- Therapeutics of Neurological ment for chronic neuropathic pain Inc.* Disorders and (6/10) Stroke Amarantus The Michael J. $3 Grant More than $3M was split among the Therapeutics Fox Foundation two companies and 15 university pro- Inc.* and for Parkinson’s grams (4/26); Amarantus reported it Biodesy LLC* Research received $350,000 from the founda- tion to study the efficacy of mesen- cephalic astrocyte-derived neuro- trophic factor (4/29) American Life Alzheimer’s Drug $0.248 Grant To allow for the manufacture of its Science Pharma- Discovery lead drug candidate for preclinical ceuticals Inc.* Foundation toxicology testing in preparation for Phase I trials (5/25) Amicus Alzheimer’s Drug $0.21 Grant To evaluate small-molecule, orally Therapeutics Discovery delivered pharmacological chaper- Inc. (FOLD) Foundation one compounds to treat Alzheimer’s disease (5/10) Avaxia National Institute $0.213 Phase I SBIR To support development of a novel Biologics Inc.* of Diabetes and grant antibody therapeutic for inflammato- Digestive and ry bowel disease (4/2) Kidney Diseases BioMarker National Cancer $1 Phase II SBIR To develop the SnapPath live tumor Strategies* Institute grant cell testing system (5/4)BioWorld® State of the Industry Report 2011 103
  • 105. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Ceregene Inc.*, Michael J. Fox $4.6 Grants Ceregene received $2.5M for Phase II Biovail Corp. Foundation testing of CERE-120, and Biovail and (Canada; MedGenesis received the rest to TSX:BVF) and Med- develop a glial cell line-derived neu- Genesis rotrophic factor (6/23) Therapeutix Inc.* (Canada) CLC Bio* (Denmark), Danish National $2 Grant For a three-year project to develop an Ion Torrent and Advanced Tech- integrated software and hardware Aarhus University nology Foundation solution for molecular diagnostics to Hospital more quickly and precisely diagnose patient DNA samples through advanced software (6/16) Critical Outcome National Research $0.3 Grant To support development of multiki- Technologies Inc. Council of Canada nase targets against acute myeloge- (Canada) Industrial Research nous leukemia (6/30) Assistance Program Evotec AG German Federal |1 .5 Grant To advance its H3 receptor antago- (Germany; FSE:EVT) Ministry of ($1 .98) nist program into the clinic (4/28) Education and Research Five Prime Fast Forward LLC, $1 Grant To develop a preclinical MS drug Therapeutics a subsidiary of the that targets the innate immune Inc.* National Multiple system (5/26) Sclerosis Society Inovio Biomedical State of $2.8 Grant To develop a DNA vaccine to treat Corp. (AMEX:INO), Pennsylvania hepatitis C virus (4/12) Drexel University, Cheyney University and the University of Pennsylvania IPierian Inc.* California Institute $1 .5 Basic Biology To provide valuable insights into the of Regenerative Award biological pathways and molecular Medicine targets involved in inducing pluripo- tent stem cells (5/3) Lentigen Corp.* National Institutes ND STTR grant For a program on Lentiviral gene of Health therapy for mucopolysaccharidosis (5/19) Leonardo Texas Emerging $2.5 Grant For a multistage drug delivery plat- Biosystems* Technology Fund form to improve the effectiveness of drug therapy, particularly for cancer (6/8) Living Cell Juvenile Diabetes $0.5 Grant For its ongoing Phase II trial of Technologies Ltd. Research Diabecell in New Zealand (4/28) (Australia; BE:LHI) Foundation International Mirna Cancer Prevention $10.3 Grant To advance its microRNA mimic dis- Therapeutics and Research covery platform and a pipeline of Inc.* Institute of Texas cancer drug candidates (6/22) MitoSciences Inc.* National Institutes $0.59 Grant To support the development of com- of Health panion diagnostic tests for antiviral drugs (5/14)104 BioWorld® State of the Industry Report 2011
  • 106. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution NanoBio Corp.* National Institutes ND Phase I To evaluate a potential therapeutic and University of of Health Technology intranasal vaccine for the treatment Michigan Transfer of hepatitis B (4/21) award Neoprobe Corp. Ohio’s Third $1 Grant To fund ongoing development of its (OTC BB:NEOP) Frontier Lymphoseek radiopharmaceutical Commission initiative (6/25) Oragenics Inc. National Science $0.5 Grant To support the company’s DPOLT (AMEX:ONI) Foundation Lantibiotic Synthesis Platform (6/15) Pluristem Office of the $2.5 Grant For research and development of Therapeutics Chief Scientist at PLX-PAD in critical limb ischemia and Inc. (PSTI) the Ministry of moderate-severe claudication (6/29) Industry, Trade and Labor of Israel PolyMedix Inc. National Science $0. 15 Grant To support the development of anti- (OTC BB:PYMX) Foundation microbial sutures (5/28) Prolor Biotech Inc. Israeli Office of $1 .6 Grant To support development of hGH-CTP, (Israel; AMEX:PBTH) the Chief Scientist a longer-acting version of human growth hormone (4/13) Protalix Bio- Office of the Chief $4. 1 Grant Up to $2.9M of the funds are for the Therapeutics Inc. Scientist of Israel’s advancement of early stage pipeline (Israel; AMEX:PLX) Ministry of Industry, product candidates, and up to $1 .2M Trade and Labor is for further development of taliglu- cerase alfa (5/18) Protein Potential National Institute $3 Phase II SBIR To support translational research to LLC* of Allergy and grant develop a vaccine for the prevention Infectious Diseases of malaria caused by the parasite Plasmodium vivax (4/20) Q Therapeutics Maryland Stem Cell $1 Grant To enable further study of Q’s human Inc.* and Johns Research Fund neural glial cell product Q-Cells in Hopkins University preclinical models of demyelinating disease (6/3) RegeneRx Bio- National Institutes $3 Grant To support clinical development of pharmaceuticals of Health’s National RGN-352 for patients who have suf- Inc. (AMEX:RGN) Heart, Lung and fered an acute myocardial infarction Blood Institute (5/14) Savara Inc.* Texas Emerging $1 .9 Grant For the commercialization of its dry- Technology Fund powder technology for treating asth- ma, lung cancer and other lung-based diseases (6/16) Signum Alzheimer’s $0.27 Grant To evaluate small-molecule, orally Biosciences Inc.* Drug Discovery delivered protein phosphatase Foundation 2a-modulatory compounds as dis- ease-modifying therapeutics for AD (4/1) Sirnaomics Inc.* National Cancer ND SBIR grants For multitargeted siRNA therapeutics Institute and using its nanoparticle-enhanced National Institute delivery technologies, with programs of Allergy and in cancer, respiratory infections and Infectious scarless wound healing (6/30) DiseasesBioWorld® State of the Industry Report 2011 105
  • 107. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Sorrento National Institute $0.3 Phase I To help generate and develop anti- Therapeutics of Allergy and Advanced body therapeutics and vaccines Inc. (OTC BB:SRNE) Infectious Technology against Staphylococcus aureus infec- Diseases STTR grant tions (5/24) Synedgen Inc.* U.S. Army $2.73 Grant To develop treatments for drug-resis- tant bacteria that affect troops injured in battle (5/13) TriLink BioTech- National Institutes $0.725 Phase II SBIR To continue the firm’s work on devel- nologies Inc.* of Health grant oping reagents to enhance the speci- ficity of DNA ligase (6/23) ZenBio Inc.* National Institutes ND Phase I SBIR To establish novel human cell-based of Health grant models of nonalcoholic fatty liver ` disease useful for basic research and as a potential drug development platform (4/22) THIRD QUARTER 2010 A&G National Cancer $1 .2 Phase II SBIR To develop a neutralizing therapeutic Pharmaceutical Institute grant antibody against GP88, a glycopro- Inc.* tein that plays a critical role in the development of human cancers (9/29) Acorda National, Heart, $1 Grant To support research on glial growth Therapeutics Inc. Lung, and Blood factor 2, an investigational agent to (ACOR) Institute treat heart failure (7/21) Addex Michael J. Fox $0.9 Grant To help fund a Phase II study of Pharmaceuticals Foundation ADX48621 to treat Parkinson’s dis- Ltd. (Switzerland; ease levodopa-induced dyskinesia SWX:ADXN) (9/9) Advanced National Cancer $3 Grant To advance its investigational drug Targeting Systems* Institute SP-SAP for cancer pain into clinical trials (9/24) Aeterna Zentaris National Institutes $1 .5 Grant NIH awarded University of Southern Inc. (Canada; TSX:AEZ) of Health California professor Jacek Pinski a three-year grant to conduct a Phase I/II study of AEZS-108 in patients with refractory prostate cancer (8/6) AgeneBio Inc.* Alzheimer’s Drug $0.24 Grant To develop a new class of small mol- Discovery ecules aimed at treating amnestic Foundation mild cognitive impairment (8/27) Applied Genetic FDA $1 Grant To fund a Phase II trial of alpha 1 anti- Technologies trypsin deficiency with recombinant Corp.* adeno-associated virus vectors at higher doses (9/17) ArGEN-X BV (the Institute for the |1 .5 ($2) Grant To accelerate preclinical develop- Netherlands) Promotion of ment of lead program ARGX-109 and Innovation by two further therapeutic monoclonal Science and antibody programs (9/28) Technology (Belgium) Asklepios Epilepsy Foundation $0.2 Grant As part of the Epilepsy Therapy Biopharmaceutical Project to advance its preclinical Inc. gene therapy for medically refractory epilepsy (8/24)106 BioWorld® State of the Industry Report 2011
  • 108. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Biodel Inc. (BIOD), Juvenile Diabetes $0.407 Research To evaluate the use of VIAject rapid- Stanford University Research grants acting injectable human insulin in and Oregon Health Foundation the treatment of diabetes (7/13) & Science University Bionovo Inc. (BNVID) National Center for ND STTR grant To fund the first phase in a planned and the University of Complementary and multiphase study to evaluate the California at Berkeley Alternative Medicine company’s plant-derived tissue selective estrogen receptor modula- tors for preventing obesity and meta- bolic syndrome (9/3) Bolder National Institute of $0.6 Phase I SBIR To demonstrate the feasibility of BioTechnology Inc.* Allergy and grant using the company’s long-acting Infectious Diseases interleukin-11 analogue to accelerate platelet recovery and improve sur- vival in a mouse model of acute radi- ation syndrome (8/19) Celsion Corp. (CLSN) National Institutes $0.2 Phase I SBIR To support the company’s efforts to of Health grant develop its heat-activated liposomal technology in combination with che- motherapy drug carboplatin in col- laboration with Duke University (9/3) Cognition Alzheimer’s Drug $0.229 Grant To develop small-molecule drugs Therapeutics Inc.* Discovery that block the action of toxic oligo- Foundation mers thought to be responsible for Alzheimer’s disease (8/19) Compendia National Institutes $1 .3 SBIR Fast To compile microRNA data into the Bioscience Inc.* of Health Track grant Oncomine platform, a compendium of cancer genomic profiles for target discovery and validation (9/1) Cortex Michael J. Fox ND Grant To test selected compounds from its Pharmaceuticals Foundation for Ampakine platform for their ability to Inc. (OTC BB:CORX) Parkinson’s restore brain function in animal mod- Research els of Parkinson’s disease (7/7) Cytokinetics Inc. National Institute $2.9 Grant To study CK-2017357 for myasthenia (CYTK) of Neurological gravis (7/27) Disorders and Stroke DecImmune National Institutes $2.2 SBIR grant To work on reducing tissue damage Therapeutics Inc.* of Health in ischemic reperfusion injury (9/28) Dynavax National $0.6 Grant To explore the feasibility of develop- Technologies Institutes of Health ing a universal vaccine to prevent Corp. (DVAX) infection by human papillomavirus (7/8) Dynavax National Institute of $17.6 Five-year To take a systems biology approach Technologies Corp. Allergy and grant to study the differences between (DVAX) Infectious Diseases individuals who do or do not respond to vaccination against the hepatitis B virus (9/1) Edge Therapeutics New Jersey $0. 1 Grant To further develop treatments for Inc.* Economic preventing secondary brain damage Development that occurs after hemorrhagic stroke Authority or traumatic brain injury (7/14)BioWorld® State of the Industry Report 2011 107
  • 109. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution GeneGo Inc.* National Institute on ND SBIR grant To develop an integrated systems Drug Abuse biology platform for research into the causes and treatment of tobacco dependence, nicotine addiction, smoking cessation and tobacco/nic- otine withdrawal (9/23) ImmuneRegen National Institute of $15 Five-year, For studies at the University of Biosciences Inc.* Allergy and continuation Rochester Medical Center of a num- Infectious Disease grant ber of drugs and other countermea- sures, including Homspera, for their effectiveness against radiation- induced injury (8/30) Lentigen Corp.* National Institutes ND Phase II SBIR To develop an experimental immu- of Health grant notherapy for melanoma (8/10) MabVax National Cancer $1 . 1; and $0. 15 Phase II STTR To support continued development Therapeutics Inc.* Institute grant; and an of the company’s project focused on SBIR grant the characterization of human anti- bodies to sialyl-Lewis A, or sLeA (8/11); and to support the manufac- ture and testing of the company’s sarcoma vaccine (8/18) MacroGenics Inc.* National Institutes $9.8 Grants To help advance its Dual-Affinity of Health ReTargeting, or bispecific antibody scaffold platform, as well as its port- folio of infectious disease product candidates (7/16) MorphoSys AG German Federal |1 Grant To advance the anti-CD38 antibody (Germany; FSE:MOR) Ministry of ($1 .25) MOR202 into clinical development Education and for multiple myeloma and to explore Research relevant biomarkers (7/7) Orphagen National Cancer $0.52 Phase I SBIR To develop a new class of small-mol- Pharmaceuticals Institute grant ecule drugs for the treatment of Inc.* adrenocortical and prostate cancers (8/11) Oxford BioMedica UK Motor Neurone |0.255 Research To support the further preclinical plc (UK; LSE:OXB) and Disease Association ($0.3175) grant evaluation of MoNuDin as a treat- VIB* (Belgium) ment for amyotrophic lateral sclero- sis (7/2) Pluristem European ND Grant from To study its PLX cell therapy product, Therapeutics Inc. Commission its Seventh derived from human placenta, to (PSTI) Framework treat diastolic heart failure (8/31) Program PolyMedix Inc. National Institutes $0.5 Grant To support the development of (OTC BB:PYMX) of Health defensin-mimetic antimicrobial com- pounds for the treatment of malaria (7/8) PTC Therapeutics FDA’s Office of $1 .6 Grant To support an ongoing Phase III Inc.* Orphan Products study of ataluren in patients with Development nonsense mutation cystic fibrosis (9/22) Repligen Corp. Friedreich’s Ataxia $0.436 Grants To support its research program to (RGEN) Research Alliance develop HDAC inhibitors for neuro- and Go Friedreich’s degenerative diseases (8/3) Ataxia Research108 BioWorld® State of the Industry Report 2011
  • 110. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution RXi National Institute ND SBIR grant For preclinical development of RNAi Pharmaceuticals of Allergy and therapeutics using RXi’s therapeutic Corp. (RXII) Infectious platform, which includes both novel Diseases RNAi compounds and advanced delivery technologies (7/14) Sangamo Michael J. Fox $0.9 Grant To support studies in nonhuman pri- BioSciences Inc. Foundation for mates for the development of a ZFP (SGMO) Parkinson’s therapeutic in Parkinson’s disease Research (7/2) Selecta Biosciences National Institute on $3 Grant To advance a therapeutic nicotine Inc.* Drug Abuse vaccine for smoking cessation and relapse prevention (8/17) Sernova Corp. National Research C$0.275 ($0.267) Grant To support study of the potential (Canada; CDNX:SVA) Council of Canada islet-sparing effect and optimal dose Industrial Research of islets to provide a long-term treat- Assistance Program ment for diabetics using the compa- ny’s Cell Pouch System in preclinical allograft models of diabetes (9/14) Signum Biosciences National Institute of $0.684 SBIR Phase I To develop G-protein coupled recep- Inc.* Arthritis and grants tor modulating therapeutics Musculoskeletal and designed to treat common skin dis- Skin Diseases orders (9/21) Soligenix Inc. (OTC FDA’s Office of $1 .2 Three-year For its ongoing confirmatory Phase III BB:SNGX) Orphan Products clinical trial of orBec in acute gastrointestinal Development research graft-vs.-host disease (8/24) grant Tocagen Inc.* National Brain ND Grant To develop its investigational treat- Tumor Society ment for glioblastoma multiforme, which is designed to deliver a pro- drug-activator gene to brain cancer cells (8/5) YM BioSciences Inc. National Institutes $0.65 SBIR grants To help develop treatments for pul- (Canada; AMEX:YMI) of Health monary arterial hypertension using and Pulmokine Inc.* compounds originating from YM’s small-molecule library (9/30) FOURTH QUARTER 2010 4SC AG (Germany; European Union $7.6 Grant To investigate the link between peri- FSE:VSC), Anaxomics odontal disease and rheumatoid Biotech* (Spain) and arthritis (12/23) a number of European universities Acadia The Michael J. Fox $0.3 Grant For the development of Nurr1-RXR Pharmaceuticals Foundation agonists for the treatment of Inc. (ACAD) Parkinson’s disease (11/10) Adolor Corp. (ADLR) Michael J. Fox $0.363 Grant To support the development of selec- Foundation for tive centrally acting mu opioid recep- Parkinson’s tor antagonists for the treatment of Research I-DOPA-induced dyskinesia associat- ed with Parkinson’s disease (11/5) Affiris AG (Austria) Michael J. Fox $0.475 Grant For preclinical development of a vac- Foundation cine, PD01 , against Parkinson’s dis- ease (12/17)BioWorld® State of the Industry Report 2011 109
  • 111. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Agenta National Institutes $1 . 1 SBIR grant To develop a biologically activated Biotechnologies of Health and membrane to improve healing after Inc.* National Institute of oral surgery (11/11) Dental and Craniofacial Research AiCuris GmbH & Co. Ministry of $1 . 1 Research Three-year grant to support the proj- (Germany), Squarix Innovation, Science grant ect “Innovative Antibiotics made in (Germany) and the and Research of NRW” aimed at development of new Universities of North Rhine- antibiotics effective against life-thre- Bochum, Dusseldorf Westphalia aning multiresistant bacteria such as and Bonn the hospital agent MRSA (11/30) Allon Therapeutics Michael J. Fox $0.625 Grant To conduct preclinical research that Inc. (Canada; TSX:NPC) Foundation for will help determine the potential of Parkinson’s the company’s lead neuroprotective Research drug, davunetide (12/1) Altravax Inc.* National Institute of $1 .2 SBIR grants For research on antibody-inducing Allergy and vaccines against HIV-1 (10/6) Infectious Diseases Amicus Michael J. Fox $0.5 Grant For the development of a next-gener- Therapeutics Inc. Foundation for ation pharmacological chaperone to Parkinson’s treat Parkinson’s disease (12/10) Research Aphios Corp.* National Institute of ND Phase I Fast To support preclinical development Aging Track SBIR of PKC activator APH-0703 for grant Alzheimer’s disease (12/1) Athersys Inc. (ATHX) Michael J. Fox $0. 14 Grant To advance research and develop- Foundation for ment of its MultiStem product plat- Parkinson’s form as a potential treatment for Research Parkinson’s disease (11/5) Avid Biotics Inc.* National Institutes $1 Grant For the development of the compa- of Health ny’s Avidocin platform for narrow spectrum antibacterial proteins (10/15) Beech Tree Labs U.S. Quality $0. 164 Grant To fund a third program in nicotine Inc.* Therapeutic craving (11/17) Discovery Project program Bexion National Cancer $1 .5 Phase II SBIR To identify and select optimized Pharmaceuticals Institute grant SapC-DOPS formulations and treat- LLC* ment methods for glioblastoma mul- tiforme for advancement toward clinical testing (10/11) BioAlliance Pharma French state ND Grant For two new applications of its muco- SA (France) Research National adhesive Lauriad technology (12/16) Agency, ANR, and Medicen Paris Region and Atlanpole BrainStorm Cell Office of the Chief $0.75 Grant For its adult stem cell therapy pro- Therapeutics Inc. Scientist (Israel) gram (12/21)110 BioWorld® State of the Industry Report 2011
  • 112. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Complix NV* Agency for |1 .6 ($2. 1) Grant To accelerate development of thera- (Belgium) Innovation by peutic Alphabodies (12/22) Science and Technology (Flanders) Depomed Inc. Michael J. Fox ND Grant To support development of a gastric- (DEPO) Foundation for retentive extended-release tablet of Parkinson’s levodopa/carbidopa that targets Research constant blood levels of levodopa (10/12) Discovery National Institutes $0.58 Phase I Fast To support work on aerosolizing KL4 Laboratories Inc. of Health Track SBIR surfactant for neonatal respiratory (DSCO) grant distress syndrome (12/17) Embera National Institute on $3.9 Grant To fund the next stages of develop- NeuroTherapeutics Drug Abuse ment of EMB-001 for cocaine depen- Inc.* and Louisiana dence (10/4) State University Health Sciences Center Genfit SA (France; EuroTransBio |1 .2 ($1 .6) Grant To generate new drug candidates as Paris:ALGFT) part of a program to identify hits for an orphan nuclear receptor with anti- inflammatory properties (12/21) Hybrigenics SA Oseo Innovation $1 Refundable To allow Hybrigenics to complete (France; Paris:ALHYG) grant Phase IIa studies of oral inecalcitol for hormone-refractory prostate can- cer (12/3) InDanio Bioscience* Ontario Genomics ND Grant For its screening system for the com- (Canada) Institute plete human nuclear hormone recep- tor family (10/14) Insight Genetics National Cancer $0.2 Phase I SBIR To develop a companion diagnostic Inc.* Institute grant for lung cancer patients (11/10) InteRNA Dutch government |1 .3 ($1 .77) Innovation To support the development of miR- Technologies BV credit NA-based therapeutics for the treat- (the Netherlands) ment of melanoma (11/17) LifeGen National Institute on ND Phase I SBIR To identify a panel of genes in adi- Technologies LLC* Aging grant pose tissue that are regulated by a calorie-restricted diet (10/22) MorphoSys AG German Federal |0.85 ($1 . 18) Grant To support the establishment of a (Germany; FSE:MOR) Ministry of new technology platform for efficient and Proteros Education and structural characterization of anti- Biostructures Research body-antigen complexes (10/13) GmbH* (Germany) NanoBio Corp.* Bill & Melinda Gates $6 Grant To develop an intranasal vaccine for Foundation respiratory syncytial virus (11/30) NanoBio Corp.* and Department of $1 .5 Grant To study the use of nanoemulsion- University of Michigan Defense based therapies for protection Medical School against burn and wound infections (10/13) NeuroDerm Ltd.* Michael J. Fox $1 Grant To support the next clinical study (Israel) Foundation for with ND0611 , a dermal patch to treat Parkinson’s Parkinson’s disease (10/7) ResearchBioWorld® State of the Industry Report 2011 111
  • 113. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Neurokin SA (France) Agence Nationale de $0.46 Grant To help support the Strokinin project la Recherche aimed at improving the development of NK-102, a neuroprotective drug to treat stroke (11/30) Oligomerix Inc.* National Institute on $1 .6 SBIR Phase II For a program to discover small mol- Aging grant ecules and antibodies targeting tau protein oligomers for development of disease-modifying therapeutics against Alzheimer’s disease (11/12) Omeros Corp. National Institute on $3.6 Grant For clinical studies of the company’s (OMER) Drug Abuse addiction program (10/15) Optivia National Institutes $0.43 Phase I SBIR To develop a system for characteriz- Biotechnology Inc.* of Health grant ing the role transporter proteins play and University of in the disposition of drugs by the California, San liver (11/17) Francisco Oramed Office of the Chief NIS2.9 ($0.807) Grant To support development of Oramed’s Pharmaceuticals Scientist at the oral insulin and oral GLP-1 analogue Inc. (Israel; OTC Ministry of Industry, for diabetes (12/27) BB:ORMD) Trade and Labor of Israel PolyMedix Inc. (OTC U.S. Army Research $0.75 Phase II STTR To conduct further testing on antimi- BB:PYMX) and the Office grant crobial compounds (11/17) University of Massachusetts, of Amherst Prana Victorian Labor A$15 ($15. 14) Grant To begin a large-scale trial of PBT2, Biotechnology ltd. Government in an investigational treatment for (Australia; PRAN) and Australia Alzheimer’s disease and Huntinton’s the Mental Health disease (11/9) Research Institute Precision National Institute of $3 Grants To accelerate development of its BioSciences Inc.* Standards and Directed Nuclease Editor genome Technology, the engineering technology (12/17) Treasury Department, the National Institutes of Health and the state of North Carolina Profectus National Institutes $6.25 SBIR grants For the development of Transition BioSciences Inc.* of Health, Division State Vaccine technology for an HIV of AIDS; National vaccine (10/6); to optimize the com- Institute of Allergy pany’s portfolio of genetic adjuvants and Infectious (10/8) Diseases Progenics National Institutes $4. 1 Grant To support development of monoclo- Pharmaceuticals of Health nal antibodies against Clostridium Inc. (PGNX) difficile infection (10/7) ProtAffin AG* Austrian |2.7 ($3.7) Grant For the preclinical development of (Austria) Forschungs- lead anti-inflammator y product Forderungs- PA401 , a modified form of interleu- Gesellschaft kin-8, in respiratory disease (11/16)112 BioWorld® State of the Industry Report 2011
  • 114. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Pulmatrix Inc. Defense Advanced $5.7 Grant To support formulation development Research Projects and preclinical studies to evaluate Agency of the U.S. the spectrum and efficacy of lead Department of iCALM drug candidates (12/15) Defense Repligen Corp. Muscular Dystrophy $1 .4 Research To support the ongoing development Association grant of RG3039, an inhibitor of an RNA processing enzyme that targets increased production of survival motor neuron, a protein of deficient levels in patients with spinal muscu- lar atrophy (12/16) RFS Pharma LLC* National Institute of $0. 15 Grant To develop nucleoside reverse tran- Allergy and scriptase inhibitors with efficacy and Infectious Diseases safety profiles against drug-resistant of the National HIV-1 (11/9) Institutes of Health Rockland National Institutes ND Phase I SBIR To develop biosimilar antibodies Immunochemicals of Health grant (10/27) Inc.* Sangart Inc.* Department of $1 . 1 Grant To support the development of its Defense product platform based on the MP4 molecule designed to enhance the perfusion and oxygenation of oxy- gen-deprived tissues and provide targeted oxygen delivery to the cap- illaries (10/7) Sirona Biochem Canada’s Global ND Grant To cover expenses related to its sodi- Corp. (Canada; Commerce Support um glucose transporter inhibitor col- CDNX:SBM) Program laboration with TFChem SARI (11/30) Stratatech Corp.* Defense $3.95 Grant To fund the company’s Phase IIb trial Department’s Armed of its flagship StrataGraft living Forces Institute of human skin substitute tissue (10/8) Regenerative Medicine Stratatech Corp.* National Institute of $3.5 SBIR grant To expand the development of its Allergy and anti-infective living human skin sub- Infectious Diseases stitute (11/17) SuppreMol GmbH* German Federal |1 .6 ($2. 12) Grant To support a research project to (Germany) Ministry of explore the therapeutic potential of Education and SM101 in systemic lupus erythemato- Research sus (12/7) Synta U.S. Department of $1 Grant To fund clinical development of STA- Pharmaceuticals Defense 9584, a vascular disrupting agent Corp. (SNTA) (11/19) Taiga National Institutes $1 .7 SBIR grants To further develop an antibody pro- Biotechnologies of Health gram in the context of neutralizing Inc.* antibodies to influenza, and to fur- ther develop a universal donor blood stem cell line to treat AIDS; other grants are to scale up and character- ize its blood pharming technology and to test its immune enhancer in the context of HIV vaccines (10/22)BioWorld® State of the Industry Report 2011 113
  • 115. Grants and Awards Given to Biotech Companies Company* Funding Amount (US$M) Type Details (Date) (Country; Symbol) Institution Tekmira National Institutes $2.4 Grant To support research to develop RNAi Pharmaceuticals of Health therapeutics to treat Ebola and Corp. (Canada; Marburg hemorrhagic fever viral TSX:TKM) and infections using Tekmira’s lipid University of Texas nanoparticle delivery technology Medical Branch (10/14) Trophos SA (France) European Union |6 ($8) Grant To support MitoCare, which will investigate the efficacy and safety of TRO40303 in a Phase II study to treat cardiac ischemia-reperfusion injury in acute myocardial infarction patients (12/15) World Health Biomedical $10.4 Grants To assist developing countries with Organization Advanced Research pandemic influenza vaccine manu- and Development facturing infrastructure, training on Authority influenza vaccine manufacturing, and development and distribution of certain technologies for pandemic influenza vaccines (10/4) XenoPort Inc. (XNPT) The Michael J. Fox $0. 194 Grant To support a preclinical study of the Foundation for safety and efficacy of a prodrug of Parkinson’s acamprosate for L-dopa-induced dys- Research kinesia in Parkinson’s disease (11/24) Notes: * Indicates a privately held company. ** Denotes the date the item ran in BioWorld International. The date indicated refers to the BioWorld Today issue in which the news item can be found. Currency conversions reflect values at the time of a deal’s announcement. SBIR = Small Business Innovation Research; STTR = Small Business Technology Transfer. Unless otherwise indicated, symbols listed are on the Nasdaq market. AMEX = American Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.114 BioWorld® State of the Industry Report 2011
  • 116. BioWorld® C O R P O R AT E DEALSBioWorld® State of the Industry Report 2011 115
  • 117. Corporate Deals116 BioWorld® State of the Industry Report 2011
  • 118. State of the Industry: Corporate Deals2010 Biotech M&As and Collaborations: ‘No Big Deal’By Tom WallStaff Writer “No big deal.” follows. The totals listed include only transactions involving That describes the sluggish pace of merger, acquisition at least one biotechnology firm that were completed duringand collaboration activity in 2010 as well as any phrase. By 2010 or 2009. (Big pharma consolidation deals like 2009’sjust about every measurement, 2010 was slower than the $68 billion Pfizer acquisition of Wyeth and Merck’s $41previous year and lacked a genuine mega deal, like Roche billion merger with Schering-Plough are not included, forAG’s $46.8 billion acquisition of Genentech Inc. in 2009. example.) Dollar figures include up-front and any milestone There were fewer M&As for less money – 93 for $29.4 amounts. And because the financial details of transactionsbillion in 2010 compared to 98 for $62.3 billion in 2009. (See often are not disclosed, the dollar totals do not account forthe 2010-2009 M&As table, below.) every transaction. There were fewer biotech-pharma collaborations for But based on the information made public for the pastless money – 322 for $31 .9 billion in 2010 compared to 332 two years, deal-making slowed down in 2010.for $39.8 billion in 2009. (See the 2009-2010 Biotech-Pharma What happened?Collaborations table, below.) Analysts like Geoffrey Meacham and Cory Kasimov of J.P. And there were fewer biotech-biotech collaborations for Morgan said it wasn’t expected to be that way. In their “2011less money – 270 for $8.3 billion in 2010 compared to 318 Global Biotech Outlook,” they wrote earlier this year thatfor $9. 1 billion in 2009. (See the 2009-2010 Biotech-Biotech analysts and investors anticipated an uptick in M&A activityCollaborations table, below.) in 2010 “given that the digestion from the mega deals in Taken together, that’s a total of 685 deals in 2010 2009 was likely over and pharma was/is still inching closercompared to 748 in 2009. The 2010 deals totaled $69.6 to a number of major patent expiries.”billion compared to $111 .2 billion for 2009. But the uptick didn’t materialize. Meacham and Kasimov The source of these numbers and other lists in this point out likely causes as “. . . the acute focus on the pricingarticle is BioWorld Snapshots; a complete listing for 2010 environment in the U.S. and EU from healthcare reform and austerity measures as well as a higher perception of risk at2010-2009 M&As both the FDA and CMS.” Nor does the pace appear to be picking up as this is 2010 2009 written at the close of the first quarter of 2011 . There wereTotal M&As 93 98 22 completed M&As – which projected over the full yearM&As w. value 68 65 would be fewer than in 2010 – for about $3.2 billion – again, ifTotal value $29,414,810,000 $62,365,583,000 projected over a full year, less than 2010. The big completedAverage value $432,570,735 $959,470,508 deal so far in 2011 has been Amgen Inc.’s $1 billion pickup ofMean value $108,500,000 $40,900,000 BioVex Group Inc., although pending deals like the long, long,$10B+ 0 1 long awaited $20. 1 billion purchase of Genzyme Corp. by$1B-$10B 4 3 Sanofi-Aventis SA and Valeant Pharmaceuticals International$500M-$1B 11 7 Inc.’s hostile $5.7 billion takeover bid of Cephalon Inc. could$200-$500 11 8 boost the total substantially, when and if completed.2009-2010 Biotech-Pharma Collaborations 2009-2010 Biotech-Biotech Collaborations 2010 2009 2010 2009Total Collaborations 322 332 Total Collaborations 270 318Collaborations w. value 112 139 Collaborations w. value 60 82Total value $31,992,760,000 $39,882,831,000 Total value $8,348,332,000 $9,169,565,000Average value $285,649,643 $286,926,842 Average value $139,138,867 $111,823,963Mean value $181,000,000 $145,000,000 Mean value $21,400,000 $20,000,000$10B+ 0 0 $10B+ 0 0$1B-$10B 6 12 $1B-$10B 2 0$500M-$1B 15 13 $500M-$1B 1 5$200-$500 34 35 $200-$500 8 14BioWorld® State of the Industry Report 2011 117
  • 119. Corporate Deals $5.7 billion takeover of Cephalon Inc.Mergers and Acquisitions And Celgene Corp., of Summit, N.J., acquired take-out Despite the slow pace, 2010 produced its share of target Abraxis BioScience, Inc., of Los Angeles, in a $2.9memorable M&A moments. (See the 2010 Top 10 M&As table, billion cash and stock deal that gave the big biotech rights tobelow.) Abraxis’ nanoparticle albumin bound-based drug pipeline, One was Tokyo-based Astellas Pharma Inc.’s acquisition including star cancer drug Abraxane. The total up-front partof Melville, N.Y.-based OSI Pharmaceuticals Inc. After an of the deal values Abraxis at about $72 per share, a 17 percentunsuccessful $3.5 billion, or $52 per share, hostile takeover premium, with Celgene agreeing to pay about $2.4 billion inattempt, Astellas raised its offer to $4 billion and OSI agreed cash plus an additional $565 million in Celgene stock.to a friendly buyout. Celgene was a major “double-dealer” in 2010, in addition The deal boosted Astellas’ oncology franchise by adding to Abraxis picking up Gloucester Pharmaceuticals Inc. forOSI’s blockbuster cancer drug Tarceva (erlotinib) as well as a $640 million. So was Abbott, which paid more than $7 billionU.S. sales force, a pipeline of small molecules and discovery for Solvay Pharmaceuticals Inc. ($6.6 billion) and Facetcapabilities. Biotech ($430 million.) Other pharmas with two deals were Another was the relatively quiet $3.3 billion merger Eli Lilly and Co. (Alnara Pharmaceuticals Inc., $380 million),of Aliso Viejo, Calif.-based Valeant Pharmaceuticals Avid Radiopharmaceuticals Inc., $300 million) and Merck &International Inc. and Biovail Corp., of Mississauga, Ontario, Co. Inc., (Avecia Biologics, $180 million and SmartCells Inc.,to form a combined company called Valeant Pharmaceuticals $500 million.)International Inc. with corporate headquarters in Mississauga. But the most active deal-maker of 2010 was self-Valeant stockholders received 1 .7809 Biovail common proclaimed “transaction junkie” Cephalon Inc., which paidshares for each share of Valeant common stock outstanding. more than $1 billion in three deals: Mepha AG ($615 million);Shareholders also received a one-time dividend of $16.77 per Ception Inc., ($350 million); and, BioAssets Developmentshare of common stock. This year Valeant initiated a hostile Corp. ($42.5 million). 2010 Top 10 M&As Company Acquired Acquired By Or Merged Value Terms/Details With Solvay Pharmaceuticals Abbott $6.6B Abbott paid $6.6B to acquire Solvay, plus Inc. $440M if certain milestones are met OSI Pharmaceuticals Inc. Astellas Pharma Inc. $4.0B Astellas offered $4B to acquire OSI, up from an (OSIP) original $3.5B offer Valeant Pharmaceuticals Biovail Corp. (Canada; $3.3B The merged company will assume Valeants International Inc. TSX:BVF) name, but retain BioVails corporate structure (NYSE:VRX) and Canadian headquarters Abraxis BioScience Inc. Celgene Corp. (CELG) $2.9B Celgene acquired Abraxis for $2.9B in cash and (ABII) stock Genzyme Genetics (unit Laboratory Corp. of $925 M LabCorp acquired Genzyme Genetics for of Genzyme Corp.; GENZ) America (NYSE:LH) $925M in cash ZymoGenetics Inc. (ZGEN) Bristol-Myers Squibb $805 M Bristol-Myers acquired ZymoGenetics for $9.75 Co. per share, with 82.6M shares validly tendered Gloucester Celgene Corp. (CELG) $640 M Celgene paid $340M in cash and will owe Pharmaceuticals Inc. $300M to Gloucester shareholders for Istodaxs development and approval in the peripheral T-cell lymphoma indication Corthera Novartis AG $620 M Novartis acquired Corthera for $120M, plus up (Switzerland) to $500M in milestone payments Mepha AG Cephalon Inc. (CEPH) $615 M Cephalon purchased Mepha for $615.4M Movetis NV (Belgium; Shire plc (UK) $564 M Shire offered $564.6M for Movetis and share- BR:MOVE) holders had tendered 99. 18% of the companys shares during the initial acceptance period118 BioWorld® State of the Industry Report 2011
  • 120. Corporate Deals (15); Merck (14); and, Sanofi-Aventis (12.)Biotech-Pharma Collaborations The most active collaborator on the biotech side was Location, location, location: that’s what pops when you Evotec AG, of Hamburg, Germany. The company showed uplook at the top 10 Biotech-Pharma collaborations of 2010. All in five separate deals, including a potential $345.2 millionof the pharmas involved are from outside the U.S., with nine deal with AstraZeneca plc subsidiary MedImmune for aof the 10 from Europe. (See the 2010 Top 10 Biotech-Pharma biologic beta cell regeneration program. The other dealsCollaborations table, below.) were with Vifor Pharma Ltd. (Switzerland); Merck KGaA But break down all of last year’s 322 collaborations and (Germany); Shionogi & Co. Ltd. (Japan); and, Zhejiang Jingxinyou find that Pfizer Inc. of New York was most active, with 22 Pharmaceutical Co. Ltd. (China).deals. Pfizer was followed by Novartis (18); GlaxoSmithKline 2010 Top 10 Biotech-Pharma Collaborations Biotech Pharma Type/Product Area Terms/Details Value Company Company MacroGenics Boehringer Deal to discover, The agreement is worth $2. 16B, including $2. 16B Inc. Ingelheim GmbH develop and com- $60M within the first three years and (Germany) mercialize antibody- $210M for each of the 10 DART programs based therapeutics based on Macro- Genics’ Dual-Affinity ReTargeting platform Isis GlaxoSmithKline Option agreement Isis gets $35M up front, which it will amor- $1 .5B Pharmaceuticals plc (UK) involving RNA drug tize over the five-year agreement and Inc. (ISIS) discovery could get up to another $155M in pre- licensing milestones; after Phase II, GSK has the option to license the drug for further develop; total deal could be worth $1 .5B Rigel AstraZeneca plc Licensing agreement Rigel gets $100M up front, along with $25M $1 .27B Pharmaceuticals (UK) for worldwide rights in milestones this year; Rigel is eligible for Inc. (RIGL) to R788, a spleen up to $345M in development, regulatory tyrosine kinase inhib- and initial sales milestones, plus up to itor $800M in commercial milestones and a stepped, double-digit royalty Aileron Roche AG Deal to develop ther- Roche will pay Aileron at least $25M up $1 . 12B Therapeutics (Switzerland) apeutics based on front and $1 . 1B in milestone payments Inc. Aileron’s stapled pep- based on achieving drug candidates tides platform aimed against five undisclosed targets at targets previously considered undrug- gable Orexigen Takeda Partnership to market Takeda agreed to pay $50M up front for $1 .05B Therapeutics Pharmaceuticals Orexigen’s Contrave the right to copromote the drug, if Inc. (OREX) Co. Ltd. (Japan) in North America for approved, plus more than $1B in milestone obesity payments and a tiered double-digit royalty OncoMed Bayer Schering Deal to develop An agreement that brings $40M up front, $1 .04B Pharmaceuticals Pharma AG drugs targeting the with the potential for more than $1B in Inc. (Germany) Wnt signaling path- future milestones; the deal calls for up to way five compounds and up to $387.5M per compound in development, regulatory and sales milestones, plus double-digit royal- ties and certain co-development optionsBioWorld® State of the Industry Report 2011 119
  • 121. Corporate Deals Biotech Pharma Type/Product Area Terms/Details Value Company Company Transgene SA Novartis AG Exclusive option Novartis is paying $10M, plus up to $965M (France; Paris:TNG) (Switzerland) agreement for $955.9M in development, regulatory and Transgenes lung can- commercial milestones if it opts to move cer vaccine TG4010 forward with the product; Transgene also is eligible for royalties on worldwide prod- uct sales and retains co-promotion rights in certain countries, including France and China Avila Sanofi-Aventis SA Collaboration to Sanofi-Aventis paid $40M up-front in cash $810M Therapeutics (France) design targeted cova- and committed to as much as $770M in Inc. lent drugs against six milestones signaling proteins with relevance in oncology, with Sanofi moving forward five of the drugs and Avila retaining rights to one Regulus Sanofi-Aventis Partnership aimed at The deal is worth $750M, including $25M $750M Therapeutics Group SA (France) discovering microR- up front, as well as a $10M equity invest- Inc. NA-based drugs ment, plus $650M in milestone payments against four fibrosis and royalties targets Synosia UCB Pharma Agreement to devel- UCB is leading the companys third round $745M Therapeutics (Belgium) op two lead drugs for with $20M and is making an undisclosed treating Parkinsons up-front payment; the deal includes $725M disease in milestones follow-up period to date than control patients.Biotech-Biotech Collaborations Another potential billion-dollar collaboration was a While in a given year there are almost as many biotech- $1 .4 billion agreement – one of the largest target-basedbiotech collaborations as biotech-pharma collaborations, RNAi deal ever closed – between Dicerna Pharmaceuticalsthey are much smaller – with total value in 2009 and 2010 Inc., of Watertown, Mass., and Kyowa Hakko Kirin Co. Ltd.,about one quarter of the biotech-pharma type and average of Tokyo, to discover, develop and commercialize drugdeal value less than half. That said, last year’s three largest delivery systems and siRNA medications using Dicerna’sdeals exceeded or pushed the $1 billion mark, albeit with Dicer Substrate Technology for oncology targets. Dicernamilestone payments making up the bulk of the value. (See got only $4 million in up-front cash, but could get as muchthe 2010 Top 10 Biotech-Biotech Collaborations tables, next as $120 million in research funding and milestones for eachpage.) oncology target, with an option for as many as 10 targets. Demonstrating that it does more than acquisitions, Pushing the $1 billion mark was a $912 millionCephalon, of Frazer, Pa., put together one of the largest collaboration between Genentech Inc., of South Sanregenerative medicine transactions ever with partner Francisco, a unit of Roche AG, and Seattle Genetics Inc., ofMesoblast Ltd., of Melbourne, Australia. The companies Bothell, Wash. Genentech paid $12 million up front to applyagreed to a potential $1 .92 billion deal in which Cephalon got Seattle Genetics’ ADC platform to specific targets. Potentialexclusive worldwide rights to products based on Mesoblast’s milestones and maintenance fees could add $900 million.stem cell technology. Cephalon paid $130 million up front, The most active 2010 biotech-biotech collaborator, withbought about 20 percent of Mesoblast shares for $220 five separate deals, was International Stem Cell Corp., ofmillion, and added more than $1 .5 billion in milestones. Was Carlsbad, Calif. Right behind with four deals each were Biogenit worth it? In January 2011 the companies reported that each Idec, of Weston, Mass.; San Diego-based Cypress Bioscienceof the 45 patients in a Phase II trial who received a single Inc.; Genentech; Immunovaccine Inc., of Halifax, Nova Scotia;injection of Revascor into damaged heart muscle have had and, Worcester, Mass.-based RXi Pharmaceuticals Corp.less cardiac events, deaths and hospitalizations during the120 BioWorld® State of the Industry Report 2011
  • 122. Corporate Deals 2010 Top 10 Biotech-Biotech Collaborations Biotech Biotech Type/Product Area Terms/Details Value Company Company Cephalon Inc. Mesoblast Ltd. Deal for exclusive Cephalon will pay $130M for the rights, $1 .92B (CEPH) (Australia; ASX:MSB) worldwide rights to plus milestones that could boost the deal’s products based on value to $1 .7B; Cephalon also will buy Mesoblast’s stem cell 19.99% of Mesoblast’s outstanding shares technology for a total of about $220M Dicerna Kyowa Hakko Partnership to dis- The deal potentially could garner Dicerna $1 .4B Pharmaceuticals Kirin Co. Ltd. cover, develop and more than $1 .4B and includes a $4M up- Inc. (Japan; FSE:KY4) commercialize drug front cash payment; Dicerna stands to gain delivery systems and up to $120M in research funding and devel- siRNA medications opment and commercial milestones for using Dicerna’s Dicer one oncology target, with the firms having Substrate Technology the option to expand the collaboration for for undisclosed up to 10 targets under similar terms oncology targets Genentech Inc. Seattle Genetics Deal for Genentech Terms call for Genentech to pay $12M up $912M (NYSE:DNA) Inc. (SGEN) applying Seattle front, with potential milestones and main- Genetics’ ADC plat- tenance fees that could exceed $900M form to an undis- closed number of specific targets Infinity Intellikine Inc. Global licensing deal The deal includes lead compound INK1197 $488M Pharmaceuticals for Intellikine’s pre- for inflammatory diseases, and is worth Inc. (INFI) clinical phos- $488.5M, including $13.5M up front and phoinositide-3 kinase two years of research funding, as well as delta and gamma $25M in development milestones and inhibitors $450M in regulatory and sales milestones Biogen Idec Inc. Neurimmune Biogen Idec acquired Biogen will pay $32.5M up front and as $427M (BIIB) Holding AG three preclinical much as $395M in contingent payments to (Switzerland) immunotherapy pro- Neurimmune for a subsidiary that includes grams focused on the worldwide rights to the programs Parkinson’s disease, Alzheimer’s disease and amyotrophic lat- eral sclerosis Cypress BioLineRx Ltd. Deal for the exclusive Cypress is paying BioLineRx $30M up front $365M Bioscience Inc. (Israel; TASE:BLRX) North American and potentially $335M in milestones (CYPB) development and commercialization rights to its antipsy- chotic compound CYP-1020 to treat schizophrenia Spectrum TopoTarget A/S Codevelopment and Spectrum licensed the rights for North $350M Pharmaceuticals (Denmark; commercialization America and India in exchange for $30M (SPPI) CSE:TOPO) deal for belinostat up front, $320M in milestones and 1M shares of Spectrum based on milestones Knopp Biogen Idec Inc. Deal to develop a Knopp will receive $80M in initial pay- $345M Neurosciences (BIIB) Phase III drug candi- ments and $265M in potential milestones, Inc. date for amyotrophic while Biogen Idec takes over development lateral sclerosis and potentially commercialization of KNS- 760704 in global marketsBioWorld® State of the Industry Report 2011 121
  • 123. Corporate Deals Biotech Biotech Type/Product Area Terms/Details Value Company Company Agios Celgene Corp. Preclinical collabora- The deal will bring Agios $130M up front, $250M Pharmaceuticals (CELG) tion in the area of including an equity investment; Agios also Inc. cancer metabolism could receive up to $120M in milestones, as well as royalties on sales Immune Design MedImmune Inc. Licensing agreement IDC gets an undisclosed up-front fee and is $212M Corp. for GLA, a toll-like entitled to up to $212M in milestones plus receptor 4 agonist, to royalties on any future product sales be used by MedImmune as a component in vac- cines against infec- tious diseases122 BioWorld® State of the Industry Report 2011
  • 124. Biotech Mergers And Acquisitions In 2010 Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) JANUARY AkaRx Inc. Eisai Co. Ltd. 12/18/09 1/7 $255 Eisai acquired AkaRx for $255M (FSE:EII) Biotest AG’s diag- Bio-Rad 10/23/09 1/6 E45 Bio-Rad acquired certain diagnostic busi- nostic businesses Laboratories Inc. ($67.6) nesses of Biotest AG (NYSE:BIO) DMI Life Imagine Media 1/27 1/27 ND Imagine acquired DMI in a deal that gave Sciences Inc. Ltd. (OTC BB:IMLE) DMI shareholders 90.52% of the combined company Specialty pharma- Sigma-Tau 11/9/09 1/28 $327 Enzon sold its business to Sigma-Tau for ceutical business Pharmaceuticals $300M plus up to an additional $27M of Enzon Inc. based on milestones Pharmaceuticals Inc. (ENZN) ESE GmbH Qiagen NV (the 1/12 1/12 $19 Qiagen acquired ESE for $19M in cash (Germany) Netherlands; QGEN) GL Biochem Commonwealth 9/3 1/4 ND Commonwealth agreed to acquire the par- Biotechnologies ent of GL Biochem and its associated busi- Inc. (CBTE) nesses Gloucester Celgene Corp. 12/7 1/15 $640 Celgene paid $340M in cash and will owe Pharmaceuticals (CELG) $300M for Istodax’s development and Inc. approval in the peripheral T-cell lymphoma indications Humalys SAS Vivalis (France; 1/11 1/11 E10.4 Vivalis acquired Humalys for $15. 1M (France) Paris:VLS) ($15. 1) through several installments Intradigm Corp. Silence 12/16 1/6 £20 Silence issued about 79.6M shares to Therapeutics plc ($32.6) acquire the entire share capital of (UK; LSE:SLN) Intradigm Metabasis Ligand 10/27 1/28 $3.2 Ligand bought it for $3.2M, plus milestone Therapeutics Pharmaceuticals payments Inc. (MBRX) (LGND) Minster Proximagen 1/4 1/4 £4.3 Proximagen offered 6 pence (10 cents) in Pharmaceuticals Neuroscience plc ($6.9) cash for each share plc (UK; LSE:MPM) (UK; LSE:PRX) Swedish Orphan Biovitrum AB 11/10 1/14 SEK3.656 Biovitrum issued SEK1 .7B worth of stock to International AB (Sweden; SSE:BVT) ($533. 1) fund 48% of the purchase, and paid th e rest in cash Symphony Dynavax 11/10 1/4 $20.4 Dynavax acquired the joint venture, Dynamo Inc. Technologies regaining rights to the HCV and cancer (joint venture Corp. (DVAX) programs, in exchange for about 13M between Dynavax shares and Symphony Capital) FEBRUARY Argenta Galapagos NV 2/2 2/2 E16.5 Galapagos is paying $23M to acquire Discovery Ltd. (Belgium; BR:GLPG) ($23) Argenta (UK)BioWorld® State of the Industry Report 2011 123
  • 125. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) Avecia Biologics Merck & Co. Inc. 12/17 2/1 $180 Merck agreed to acquire the biologics busi- (UK; part of Avecia ness for $180M Investments Ltd.) BioForm Medical Merz-Pharma 1/5 2/17 $243.6 Merz acquired BioForm for $5.45 per share Inc. (BFRM) Group (Germany) in cash BioSeek Inc. Asterand plc (UK; 11/18 2/18 $14 Asterand acquired BioSeek for $14M, with LSE:ATD) $1M payable by the issuance of Asterand shares and $13M payable in 2011 depending on the level of sales growth achieved by BioSeek in the 12 months ended Dec. 21 , 2010 Ception Inc. Cephalon Inc. 1/14/09 2/23 $350 Cephalon paid $100M for an option to (CEPH) acquire and then another $200M when it exercised the option Corthera Inc. Novartis AG 12/23/09 2/3 $620 Novartis acquired Corthera for $120M, plus (Switzerland) up to $500M in milestone payments Cytopia Ltd. YM BioSciences 10/6 2/1 C$10 YM BioSciences bought Cytopia in a (Australia; Inc. (AMEX:YMI) ($9.44) 7.2M-share deal worth $9.44M ASX:CYT) Histostem Co. Stem Cell 10/29 2/1 ND The companies merged with Histostem Ltd. (South Korea) Therapy acquiring a 60% controlling interest in International Inc. SCLL and SCLL acquiring a 90% interest in (OTC BB:SCII) Histostem Lead BioMarin 2/5 2/5 $100 BioMarin acquired Lead for $100M, includ- Therapeutics Pharmaceuticals ing $18M up front Inc. Inc. (BMRN) Pharmacos OPKO Health Inc. 2/18 2/18 ND OPKO acquired Pharmacos for an undis- Exakta SA de CV (AMEX:OPK) closed cash payment and shares of its (Mexico) common stock Serica Allergan Inc. 2/4 2/4 ND Allergan acquired Serica for an undis- Technologies (NYSE:AGN) closed amount Inc. Solvay Abbott 9/28 2/16 $6.6B Abbott paid $6.6B to acquire Solvay, plus Pharmaceuticals $440M if certain milestones are met Inc. Topigen Pharmaxis Ltd. 1/12 2/9 $20 Pharmaxis acquired Topigen in an all-stock Pharmaceuticals (Australia; ASX:PXS) transaction that included the issuance of Inc. (Canada) 3.2M Pharmaxis shares on closing with an additional 5M shares issued upon achieve- ment of milestones MARCH ApaTech (UK) Baxter 3/1 3/1 $330 Baxter acquired all of the outstanding International Inc. equity of ApaTech for total consideration of up to $330M, including $240M up front and $90M in sales milestones Ariston Manhattan 3/12 3/12 ND Manhattan completed a merger with Pharmaceuticals Pharmaceuticals Ariston that involves 7.06M shares up Inc. Inc. (OTC front, and up to $24.7M shares more BB:MHAN) depending on milestone achievements124 BioWorld® State of the Industry Report 2011
  • 126. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) Chay DMI Life Sciences 3/5 3/5 ND They merged to form Ampio Enterprises Inc. Inc. Pharmaceutical Inc. (OTC BB:CHYE) Dragon Chief Respect 1/25 3/27 $58 Han proposed to acquire the company for Pharmaceutical Ltd. (Hong Kong; 80 cents per share; Han currently owns Inc. (Canada; created by 39% of the company; he later offered 82 TSX:DDD) Dragon’s CEO and cents per share in cash and created the Chairman Yanlin entity Chief Respect Han) The discovery and Ricerca 3/8 3/8 ND Ricerca finalized its acquisition of the MDS preclinical busi- Biosciences LLC business ness of MDS Pharma Services Novexel SA AstraZeneca plc 12/23 3/3 $505 AstraZeneca acquired Novexel (UK) APRIL Arbor Investment 4/13 4/13 ND The investment group acquired Arbor, Pharmaceuticals group led by Jason naming Wild board chairman and Schutter Wild of JW Asset CEO Management LLC and Edward Schutter Facet Biotech Abbott 3/10 4/20 $430 Abbott offered $27 per share to acquire Corp. (FACT) Facet Biotech; the value of $430M is net of cash held by Facet GeneSeek Inc. Neogen Corp. 4/2 4/2 $13.8 Neogen purchased all the outstanding (NEOG) shares of GeneSeek for about $13.8M Haemacure Angiotech 3/23 4/7 ND Haemacure obtained authorization from Corp. (Canada; Pharmaceuticals the Superior Court of the Province of TSX:HAE) Inc. (ANPI) Quebec to sell its assets to Angiotech Mepha AG Cephalon Inc. 2/1 4/9 CHF662.4 Cephalon purchased Mepha for $615.4M (CEPH) ($615.4) Nitec Pharma AG Horizon 4/1 4/1 ND The companies merged and will be called (Switzerland) Therapeutics Inc. Horizon Pharma Inc.; the deal was an all- stock transaction SGM Biotech Inc. Mesa 4/29 4/29 $12 Mesa has acquired all outstanding shares Laboratories Inc. of SGM for $12M in cash (MLAB) Varian Inc. (VARI) Agilent 7/27 4/30 $1 .5B Agilent agreed to pay $1 . 5B in cash to Technologies Inc. acquire bioanalytical tools company Varian (NYSE:A) Verio Fate 4/8 4/8 ND Fate acquired Verio, which will become a Therapeutics Therapeutics Inc. Canadian subsidiary Inc. (Canada) MAY Aton Pharma Valeant 5/27 5/27 ND Valeant acquired Aton for an undisclosed Inc.* Pharmaceuticals amount International Inc. (NYSE:VRX)BioWorld® State of the Industry Report 2011 125
  • 127. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) ES Cell BioTime Inc. 4/30 5/4 $10.8 BioTime acquired ES Cell for 1 .38M com- International (AMEX:BTIM) mon shares valued at $10.8M, plus 300,000 Pte Ltd.* warrants to purchase additional shares (Singapore) MacuClear Inc.* Healthcare of 5/5 5/5 ND Healthcare completed an acquisition of Today Inc.* MacuClear OSI Astellas Pharma 3/1 5/18 $4B Astellas offered $52 per share, but the OSI Pharmaceuticals Inc. board rejected the offer, causing Astellas Inc. (OSIP) to take the bid straight to shareholders; the OSI board later said it would review the unsolicited tender offer, but it again reject- ed it; Astellas extended the offer to April 23 and then again to May 17; Astellas raised the offer from $3.5B to $4B and OSI agreed to a friendly buyout Phage New 5/25 5/25 ND Phage and New Technologies acquired all Biotechnology Technologies the assets of Phage Biotechnology, a debt- Corp.* Holdings Pte Ltd. or-in-possession in proceedings under (Singapore) and Chapter 11 bankruptcy, including a manu- Phage facturing facility Pharmaceuticals Inc. Worldwide Stago Group* 3/12 5/6 $90 Stago acquired the business for $90M, coagulation (France) including $67.5M at closing, $11 .25M on the business of first anniversary of closing and the remain- Trinity Biotech ing $11 .25M on the second anniversary plc (Ireland; TRIB) JUNE Activus Pharma Sosei Group 6/22 6/22 500 yen Sosei acquired Activus in an all-stock Ltd.* (Japan) Corp. (Japan) ($5.5) transaction Arginetix Inc.* Immune Control 6/18 6/18 ND Arginetix and Immune Control merged to Inc.* become Corridor Pharmaceuticals Inc., which received a $15M Series A endow- ment from Quaker Bioventures and other investors BexPharm* CrystalGenomics 6/1 6/1 ND CrystalGenomics merged with BexPharm, a Inc.* (South Korea) hospital specialty pharmaceutical compa- ny that imports and distributes foreign market approved drugs in Korea ProBioGen AG* Minapharm 6/17 6/17 E30.4 Minapharm completed the acquisition of (Germany) Pharmaceuticals* ($37.4) 95% of the share capital of ProBiogen (Egypt) JULY Alnara Eli Lilly and Co. 7/6 7/22 $380 Lilly acquired Alnara in an all-cash deal of Pharmaceuticals $180M up front and a potential $200M later Inc.* based on regulatory and commercial mile- stones Cequent MDRNA Inc. 4/2 7/21 $46 MDRNA acquired Cequent for $46M Pharmaceuticals (MRNA) Corp.*126 BioWorld® State of the Industry Report 2011
  • 128. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) CGI Gilead Sciences 6/28 7/8 $102. 1 Gilead bought CGI for $102. 1M Pharmaceuticals Inc. (GILD) Inc.* DiaDexus Inc.* VaxGen Inc. 4/15 7/30 $21 .7 VaxGen issued about 19.96M shares to cer- (OTC BB:VXGN) tain diaDexus stockholders and officers, as part of a transaction that gives BaxGen a total of 53M shares outstanding, of which diaDexus stockholders own 38% and VaxGen stockholders own 62% DMI Biosciences Ampio 4/22 7/27 ND Ampio acquired DMI for an undisclosed Inc.* Pharmaceuticals amount Inc. (OTC BB:AMPE) DOV Euthymics 2/16 7/22 $2 Euthymics acquired DOV for $2M Pharmaceutical Bioscience Inc.* Inc. (OTC BB:DOVP) HealthTronics Endo 5/7 7/12 $214.8 Endo acquired HealthTronics for $214.8M Inc. (HTRN) Pharmaceuticals Inc. (ENDP) Javelin Hospira Inc. 6/4 7/2 $145 Hospira completed its tender offer to pur- Pharmaceuticals (NYSE:HSP) chase all outstanding shares of Javelins Inc. (AMEX:JAV) common stock for $2.20 per share, or $145M Millipore Corp. Merck KGaA 3/1 7/16 $7B Merck acquired Millipore for $7B (NYSE:MIL) (Germany) TargeGen Inc.* Sanofi-Aventis 7/1 7/1 $560 Sanofi-Aventis acquired TargeGen for Group SA (France) $75M up front and $485M in milestones AUGUST Alcon Inc. Novartis AG 1/4 8/25 $10.2B Novartis offered $180 per share in cash for (NYSE:ACL) (Switzerland) the 156M shares of Alcon held by Nestle SA; Novartis now owns 77% of Alcon; in December, Novartis offered $168 per share for Alcon’s remaining shares BioGAL Ltd.* XTL Biopharma- 8/6 8/6 ND XTL acquired BioGAL, including the exclu- (Israel) ceuticals Ltd. sive license for the rights to a use-patent (Israel; TASE:XTL) on erythropoietin for the treatment of mul- tiple myeloma patients Blue Heron OriGene 8/16 8/16 ND OriGene acquired Blue Heron for an undis- Biotechnology* Technologies closed amount Inc.* Idun Conatus 8/2 8/2 ND Conatus acquired Idun for an undisclosed Pharmaceuticals Pharmaceuticals sum Inc.* (subsidiary Inc.* of Pfizer Inc.) Middlebrook Victory Pharma 5/18 8/4 $17.3 Victory acquired all assets of Middlebrook Pharmaceuticals Inc.* and assumed trade sales and other liabili- Inc. (PK:MBRKQ) ties Solstice US WorldMeds 8/16 8/16 $35 US WorldMeds acquired Solstice for $35M Neurosciences LLC* Inc.*BioWorld® State of the Industry Report 2011 127
  • 129. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) ZyStor BioMarin 8/19 8/19 $115 BioMarin paid $22M up front, and could Therapeutics Pharmaceutical pay another $13M once the first patient is Inc.* Inc. (BMRN) enrolled in a Phase III study, and another $80M based on regulatory milestones SEPTEMBER Bioniche Pharma Mylan Inc. (MYL) 7/16 9/8 $550 Mylan acquired Bioniche for $550M in cash Holdings Ltd.* (Ireland) Cyto Pulse Cellectis SA 9/10 9/10 $2.2 Cellectis acquired Cyto Pulse for $2.2M in Sciences Inc. (France; cash Paris:ALCLS) DeveloGen AG* Evotec AG 7/16 9/3 E26 Evotec acquired DeveloGen for $33.3M in (Germany) (Germany; FSE:EVT) ($33.3) cash, stock and earn-outs Penwest Endo Pharma- 8/11 9/20 $147.6 Endo acquired all of Penwests stock for $5 Pharmaceuticals ceuticals Inc. per share in cash Co. (PPCO) (ENDP) Sinuwave Ondine 9/16 9/16 ND Ondine completed the sale of a majority Technologies Biopharma Corp. interest in Sinuwave for an undisclosed Corp.* (Canada; TSX:OBP) cash payment Valeant Biovail Corp. 6/22 9/28 $3.3B The companies merged with Valeant stock- Pharmaceuticals (Canada; TSX:BVF) holders receiving a one-time cash dividend International of $16.77 per share and 1 .7809 shares of Inc. (NYSE:VRX) Biovail common stock in exchange for their holdings; Biovail stockholders own about 50.5%, and Valeant stockholders own about 49.5% of the combined entity, which will assume Valeants name, but retain Biovails corporate structure and Canadian headquarters VaxDesign Sanofi Pasteur 9/28 9/28 $60 Sanofi bought VaxDesign for $55M up Corp.* (France) front and another $5M contingent on fur- ther development of the MIMIC technology OCTOBER Abraxis Celgene Corp. 7/1 10/15 $2.9B Celgene acquired Abraxis for $2.9B in cash BioScience Inc. (CELG) and stock (ABII) Angioblast Mesoblast Ltd. 5/13 10/21 $164 Angioblast stockholders voted unanimous- Systems Inc.* (Australia; ASX:MSB) ly in favor of becoming a wholly owned subsidiary of Mesoblast, which paid $164M in stock for the remaining 60% of Angioblast it did not already own BioAssets Cephalon Inc. 10/26/09 10/25 $42.5 Cephalon paid $30M up front for an option Development (CEPH) to acquire BioAssets and paid another Corp.* $12.5M to buy the outstanding stock FoldRx Pfizer Inc. 9/2 10/7 ND Pfizer bought FoldRx with an up-front fee Pharmaceuticals and additional milestone payments Inc. Ion Torrent Life 8/19 10/5 $375 Life acquired DNA sequencing firm Ion Systems Inc.* Technologies Torrent for $375M in cash and stock Corp. (LIFE)128 BioWorld® State of the Industry Report 2011
  • 130. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) Movetis NV Shire plc (UK) 8/4 10/1 E428 Shire offered $564.6M for Movetis and (Belgium; ($564.6) shareholders had tendered 99. 18% of the BR:MOVE) companys shares during the initial accep- tance period PregLem Gedeon Richter 10/12 10/12 CHF6 Gedeon acquired all of the shares to Holding SA (sub- plc (Hungary; ($6.22) PregLem from Ipsen SA and PregLems sidiary of Ipsen SA; FSE:RIG1) other shareholders; Ipsen received $6.22M Paris:IPN) from the transaction ZymoGenetics Bristol-Myers 9/9 10/11 $805.35 Bristol-Myers acquired ZymoGenetics for Inc. (ZGEN) Squibb Co. $9.75 per share, with 82.6M shares validly tendered NOVEMBER AdnaGen AG Unnamed buyer 11/12 11/12 $83 OncoVista divested its majority holding of (Germany; subsid- AdnaGen, selling shares for $10M up front iary of OncoVista and $73M in potential milestone payments Innovative Therapies Inc.; OTC BB:OVIT) Biocompatibles BTG plc (UK; 11/22 11/22 £177.2 BTG acquired Biocompatibles for $284.5M plc (UK; LSE:BII) LSE:BGC) ($284.5) Biocontrol Ltd. Targeted 11/15 11/15 ND The companies merged with Biocontrol (UK) Genetics Corp. becoming a subsidiary (PK:TGEN) NeoPharm Inc. Insys 11/2 11/11 $135 Insys is accessing the public markets via a (NEOL) Therapeutics reverse merger with NeoPharm, which is Inc.* issuing 19.5M shares of common stock, plus 14.9M shares of preferred stock convertible into 35 shares of common stock apiece; Insys holds about 95% of the combined com- pany Osteotech Inc. Medtronic Inc. 8/18 11/12 $123 Medtronic offered $6.50 a share cash to (OSTE) (NYSE:MDT) acquire Osteotech Trubion Emergent 08/16 11/1 $135.5 Emergent bought Trubion for $96.8M up Pharmaceuticals BioSolutions Inc. front, plus a potential $38.7M in mile- Inc. (TRBN) (NYSE:EBS) stones, for a total value of $135.5M DECEMBER Avid Radiophar- Eli Lilly and Co. 11/9 12/22 $300 Lilly paid $300M to buy Avid, which could maceuticals earn $500M more based on a milestone Inc.* Genzyme Laboratory Corp. 9/14 12/2 $925 LabCorp acquired Genzyme Genetics for Genetics (unit of of America $925M in cash Genzyme Corp.; (NYSE:LH) GENZ) GTC LFB 10/20 12/7 $18.3 LFB took GTC private paying 30 cents per Biotherapeutics Biotechnologies share, or $18.3M Inc. (OTC BB:GTCB) SAS* (France) GTI Diagnostics* Gen-Probe Inc. 12/17 12/17 $53 Gen-Probe acquired GTI Diagnostics for (GPRO) $53M in cashBioWorld® State of the Industry Report 2011 129
  • 131. Biotechnology Mergers And Acquisitions Company Acquired By Or Date Date Value Terms/Details Acquired* Merged With* Reported Compl. (M)@ (Country; (Country; Symbol) Symbol) Hybrid Myotec 12/16 12/16 ND Myotec and Hybrid merged to form BioSystems Ltd.* Therapeutics PsiOxus Therapeutics Ltd. (UK) Ltd.* (UK) SmartCells Inc.* Merck & Co. Inc. 12/3 12/3 $500 Merck acquired SmartCells in a deal poten- tially worth $500M Sucampo AG Sucampo 12/30 12/30 $80 Sucampo Pharmaceuticals paid $80M to (Switzerland) and Pharmaceuticals acquire Sucampo AG and its subsidiary Sucampo AG Inc. (SCMP) Sucampo AG Japan from majority share- Japan holders Ryuji Ueno and Sachiko Kuno Notes: # This chart is intended to include not only mergers and acquisitions of entire businesses, but also of divisions or subsidiaries of those businesses, where appropriate. In general, it does not include acquisitions of single products or of manufacturing facilities. For those deals that are pending, and for which the acquiring company is issuing stock, the value of the transaction was calculated based on the closing price prior to the first announcement. For stock-based deals that have been completed, the final value was calculated based on the closing price before the merger’s completion was announced. * Private companies are indicated with an asterisk. ** Denotes the date the item ran in BioWorld International. @ Conversions of non-U.S. currencies are calculated using the rate on the date the transaction closed, or for pending deals, on the date it was announced. ND = Not disclosed Unless otherwise indicated, shares are traded on the Nasdaq exchange. AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BR = Brussels Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.130 BioWorld® State of the Industry Report 2011
  • 132. Biotechnology Company Deals With Pharmaceutical Companies In 2010 Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) JANUARY Alize Pharma Eli Lilly and Co. Research collaboration and Lilly will pay an undisclosed up- SAS (subsidiary license option agreement regard- front fee and both companies will of Alize Pharma ing Alize Pharma’s AZP-01 pro- collaborate on Alize’s AZP-1 proj- SAS) gram focused on the ect; in return, Lilly will be granted development of unacy-lated an exclusive option to license the ghrelin agonists for the treat- program according to predefined ment of Type II diabetes terms (1/26) Altea KAI Partnership for the preclinical Altea also granted KAI an option Therapeutics Pharmaceuticals and clinical develop-ment of cer- to receive a worldwide technology Corp.* Inc. tain KAI peptides using Altea’s license for further development PassPort transdermal delivery and commercialization of those system transdermal products, which would make Altea eligible for license payments, milestones and royalties (1/14) AnaptysBio F. Hoffmann-La Deal for the development of anti- AnaptysBio will generate antibod- Inc.* Roche Ltd. body therapeutics ies using its somatic hypermuta- (Switzerland) tion platform, and Roche will receive a worldwide license to develop those products; AnaptysBio will receive a signing fee and is eligible for milestones and royalties (1/12) Artery Roche AG Partnership of its preclinical The companies will jointly devel- Therapeutics (Switzerland) ApoA-1 peptide mimetic, AT5261 , op the cardiovascular product Inc.* with Roche through Phase I, at which point Roche may exercise an option to acquire worldwide rights (2/16) B3 bio Inc.* Roche Holdings Agreement to source and devel- Roche will have certain rights for AG (Switzerland) op early stage technologies further development and/or com- mercialization of such technolo- gies; Roche will increase its equity investment in b3 bio as well as providing development funds (1/22) BioCryst Merck Serono Agreement for stockpiling oppor- In October 2009, the FDA granted Pharmaceuticals (Switzerland); tunities for BioCryst’s influenza emergency use authorization for Inc. (BCRX) Hikma Pharma- antiviral peramivir in Europe, certain hospitalized patients with ceuticals plc (UK) Russia, Canada and Singapore; swine flu (1/12) the deal with Hikma is for the Middle East and the North African region, excluding Israel Cellectis SA Bayer HealthCare Licensing agreement for use of The global license includes the (France; Paris: (subgroup of Cellectis’ patent family use of the Institut Pasteur technol- ALCLS) Bayer AG; Germany) WO9011354 covering homologous ogy relating to homologous recombination aimed to intro- recombination to obtain and use duce new features into the certain transgenic animals in genome pharmaceutical research in all countries, including Japan (1/13)BioWorld® State of the Industry Report 2011 131
  • 133. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Crystal- AstraZeneca plc Research collaboration to discov- Cr ystalGenomics will receive Genomics Inc.* (UK) er and develop an anti-infective research funding from for use as a potential antibacteri- AstraZeneca for two years and will al agent be eligible for future milestones and royalty payments associated with development and commer- cialization of a drug candidate (1/14) Debiopharm Pfizer Inc. Agreement to co-develop tremeli- Debiopharm will conduct a new Group* mumab, an anti-CTLA4 antibody trial, while Pfizer will be responsi- (Switzerland) from Pfizer Inc. ble for commercialization; they will share any sales revenues (1/8) Edison Centocor R&D Licensing agreement for CNTO- Financial terms were not disclosed Pharmaceuticals Inc. 530 for clinical evaluation in rare (1/6) Inc.* mitochondrial and other neglect- ed diseases Ensemble Pfizer Inc. Strategic alliance to discover and Pfizer will provide up-front and Discovery Corp.* develop drug candidates against research payments and will have a number of pharmaceutical tar- the right to develop and commer- gets using Ensemble’s drug dis- cialize any products arising from covery platforms and Ensemblin the collaboration; Ensemble will compound libraries receive development milestones plus royalties (1/7) Envoy Merck & Co. Inc. Diabetes and obesity drug dis- Envoy will use its bacTRAP plat- Therapeutics covery collaboration form to identify proteins Inc.* expressed in certain cell types, and Merck will develop com- pounds to modulate the protein targets; Envoy gets an up-front fee, research funding, milestone payments and royalties (1/27) Evolva Holding Roche AG Agreement to create compounds Roche will pay Evolva an undis- SA (Switzerland; (Switzerland) for oncology and anti-infective closed up-front technology access SWX:EVE) targets using Evolva’s technology fee and ongoing research fees; platform Roche will take forward any com- pounds discovered and will poten- tially pay Evolva research and clinical milestone fees as well as royalties (1/5) Galapagos NV F. Hoffmann La- Deal for small-molecule and anti- Agreement is worth $579.6M (1/13) (Belgium; BR:GLPG) Roche Ltd. body treatments for chronic (Switzerland) obstructive pulmonary disease GenVec Inc. Novartis AG Deal to discover and develop GenVec is receiving $5M up front, (GNVC) (Switzerland) treatments for hearing loss and with the potential to bank more inner ear-related balance disor- than $206M in milestones plus ders based on GenVec’s adeno- undisclosed royalties; Novartis vector technology also has purchased $2M in GenVec common stock (1/20)132 BioWorld® State of the Industry Report 2011
  • 134. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Inspiration Ipsen SA Agreement for clinical develop- Ipsen will invest $259M to fund Pharmaceuticals (France) ment of the two lead products, clinical development; it will make Inc.* including Ipsen’s OBI-1 to treat an up-front pay-ment of $85M for congenital hemophilia A and 20% of Inspiration; for each mile- Inspiration’s IB1001 to treat acute stone payment, Ipsen will be bleeding in patients with hemo- entitled to receive more equity; if philia A all are reached, Ipsen will own 47% of Inspiration (1/22) Intrinsic Ortho-Clinical Licensing agreement for two No financial terms were disclosed Bioprobes* Diagnostics Inc. novel biomarkers for diabetes (1/22) KaloBios Sanofi Pasteur Partnership for Humaneered anti- Deal is worth $290M, including Pharmaceuticals (France) body fragment targeted against $35M up front and $255M in mile- Inc.* Pseudomonas aeruginosa infec- stones, plus royalties (1/12) tions Kinaxo Roche C o l l a b o r a t i o n u n d e r w h i c h Financial terms were not disclosed Biotechnologies Diagnostics Kinaxo will apply its phosphopro- (1/13) GmbH* (Germany) GmbH (Germany) teomics technology PhosphoScout to support target- ed treatment approaches under development at Roche MonoSol Rx* Strativa Licensing and development The new option agreements are Pharmaceuticals agreement that gives Strativa the an extension of the strategic rela- (division of Par option to license exclusive U.S. tionship between MonoSol Rx and Pharmaceutical commercial-ization rights for the Strativa, initiated in June 2008 Cos. Inc.) three additional oral soluble film (1/6) products to be developed using the PharmFilm technology OncoMethylome F. Hoffmann-La Agreement for MGMT gene pro- Financial terms were not disclosed Sciences SA Roche Ltd. moter methylation testing in a (1/7) (Belgium; BR: (Switzerland) Phase III trial of Avastin in newly ONCOB) diagnosed glioblastoma patients Priaxon AG* Boehringer Research deal to study mdm2/ Priaxon also would be eligible to Ingelheim p53 inhibitors for treating cancer receive $122.7M in milestone pay- (Germany) ments (1/20) Reata Kyowa Hakko Agreement focused on Nrf2- Deal includes $35M up front as Pharmaceuticals Kirin Co. Ltd. targeting bardoxolone part of $132M in development Inc.* (Japan) milestones, about half of which will be paid before the drug gains FDA clearance, plus $140M in sales milestones and escalating double- digit royalties (1/11) FEBRUARY Abbott Pierre Fabre SA Exclusive, worldwide licensing Pierre will receive an initial $25M (NYSE:ABT) deal to develop and commercial- up-front payment and research ize h224G11 in cancer indications funding; Abbott will lead develop- ment and commercialization; terms also include milestones and royalty payments (2/2) Adamis Colby Agreement to acquire exclusive Colby gains shares of Adamis Pharmaceuticals Pharmaceuticals license agreements for CPC-100, stock (2/26) Corp. (OTC BB: Co. CPC-200 and CPC-300, for the ADMP) potential treatment of human prostate cancerBioWorld® State of the Industry Report 2011 133
  • 135. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) AnaptysBio Merck & Co. Inc. Strategic collaboration to devel- AnaptysBio will generate antibod- Inc.* op novel antibody therapeutics to ies using its somatic hypermuta- a specified disease target tion technology platform; Merck will receive worldwide rights to develop and commercialize anti- bodies optimized by AnaptysBio, which has received an up-front sum and is eligible to receive mile- stone payments and royalties (2/9) Apeiron GlaxoSmithKline Licensing agreement for APN01 , a Deal is valued at up to $329.4M, Biologics AG* plc (UK) recombinant form of human plus it includes double-digit royal- angiotensin converting enzyme 2 ties (2/4) Ariana Pharma* Fovea Pharma- Fee-for-service collaboration deal Financial terms were not disclosed (France) ceuticals SA under which Ariana will use its (2/5) (France) KEM decision support platform to carry out systemic analysis of Fovea’s Prednisporin Phase II data Basilea Astellas Pharma Partnership for the late-stage Basilea will get $69.6M in an up- Pharmaceutica Inc. antifungal product isavuconazole front payment in exchange for AG (Switzerland; worldwide rights, except for SWX:BSLN) Japan, though the pharma holds a six-month option to add that terri- tory; there is a potential for CHF478M ($443.3M) more in development and sales mile- stones, plus significant double- digit, tiered royalties (2/25) BG Medicine Merck & Co. Inc. Research collaboration for the BG Medicine is eligible for certain Inc.* development and valid-ation of a payments upon achievement of novel biomarker with potential established milestones; financial application in the management of terms were not disclosed (2/18) lipid disorders Debiopharm Novartis AG Exclusive license deal for the In exchange for granting Novartis Group* (Switzerland) development, manufacture and worldwide rights, except for (Switzerland) commercialization of Debio 025 Japan, Debiopharm is entitled to receive an up-front fee, develop- ment and sales milestones, plus royalties (2/10) Delcath ChiFu Trading Research, distribution, sales and Delcath is eligible for milestone Systems Inc. Co. Ltd. (Taiwan) marketing agreement for its payments up to $1M, with the total (DCTH) Percutaneous Hepatic Perfusion value of the deal expected to be at System, granting ChiFu rights to least $10M (2/10) sell the system in Taiwan for use in hepatic malignancies in infec- tious disease upon Taiwan regu- latory approval Evotec AG Vifor Pharma Ltd. Agreement under which Evotec The deal is worth more than (Germany; (Switzerland) will provide integrated biology, $7.68M (2/3) FSE:EVT) chemistry and preclinical devel- opment activities for the project134 BioWorld® State of the Industry Report 2011
  • 136. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Merus BV* Novartis AG License option agreement for a The deal includes an equity com- (the Netherlands) (Switzerland) preclinical oncology program ponent in which Novartis partici- pated in Merus’ $30.3M Series B round; all told, the deal is worth more than $200M in up-front and milestone payments (2/3) NanoViricides TheraCour Licensing agreement for nanoviri- Up-front compensation was paid Inc. (OTC BB:NNVC) Pharma Inc. cides drug candidates against in restricted, preferred stock, dengue viruses, West Nile virus, which is convertible into shares of Japanese encephalitis virus, epi- common stock only in the event of demic kerato-conjunctivitis-caus- a change of control of the compa- ing viruses, Ebola and Marburg ny (2/24) viruses NasVax Ltd. Novartis AG Joint research and option for a NasVax also granted Novartis an (Israel; TASE:NSVX) (Switzerland) license agreement to investigate option to acquire a nonexclusive the feasibility of developing license to use VaxiSome in con- improved vaccines by incorporat- nection with certain Novartis vac- ing its adjuvant technology, cines (2/23) VaxiSome Optomagic Co. Shenogen Pharma Drug discovery collaboration to Financial terms were not disclosed Ltd.* (South Korea) Group (China) create small molecules targeting (2/11) modulators of ER-alpha 36, a membrane-associated estrogen receptor Qiagen NV Pfizer Inc. Agreement to develop a compan- Financial terms were not disclosed (the Netherlands; ion diagnostic test kit for (2/8) QGEN) PF-04948568 for glioblastoma multiforme QRxPharma Ltd. China Aoxing Agreement for development and Financial terms were not disclosed (Australia; PK: Pharmaceutical marketing of MoxDuoIV and (2/24) QRXPF) Co. Inc. (China) MoxDuoIR in China Regulus GlaxoSmithKline Deal to develop an miR-122 antag- Deal is worth $150M-plus, includ- Therapeutics plc (UK) onist in hepatitis C virus ing an up-front investment, plus a Inc.* convertible note that converts into equity and milestone pay- ments (2/26) Ricerca MDS Pharma Agreement to acquire the discov- Ricerca will acquire assets related Biosciences LLC* Services ery and preclinical business of to biochemical, cellular, tissue, MDS organ and animal assays for use in profiling the specificity and selec- tivity of drug compounds and in understanding their po-tential for adverse events (2/11) Rigel AstraZeneca Licensing agreement for world- Rigel gets $100M up front, along Pharmaceuticals plc (UK) wide rights to R788, a spleen with $25M in milestones this year; Inc. (RIGL) tyrosine kinase inhibitor Rigel is eligible for up to $345M in development, regulatory and ini- tial sales milestones, plus up to $800M in commercial milestones and a stepped, double-digit royal- ty (2/17)BioWorld® State of the Industry Report 2011 135
  • 137. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) SanBio Inc.* Teijin Ltd. (Japan) Exclusive licensing agreement to Teijin has taken an equity position develop and sell in Japan SB623 in SanBio as part of the agreement for recovery of lost function after (2/8) a stroke Starpharma Eli Lilly and Co. Agreement under which Lilly will fund an R&D program Holdings Ltd. Starpharma’s dendrimer drug with the aim of creating improved (Australia; ASX: deliver y technology will be drugs incorporating Starpharma’s SPL) applied to enhance compounds delivery technology, to be com- in Lilly’s pharmaceutical portfolio mercialized by Lilly (2/2) Viamet Novartis Option Deal to discover and develop Deal is worth more than $200M Pharmaceuticals Fund metalloenzyme inhibitors of (2/23) Inc.* interest to Novartis Vivalis (France; Kyoto Biken Rights agreement for Kyoto to Financial terms were not disclosed Paris:VLS) Laboratories Inc. evaluate its duck embry-onic (2/17) (Japan) stem cell-derived EB66 cell line for the production of viral vac- cines MARCH 4-Antibody AG* Boehringer Antibody discovery deal under The deal is worth $243M (3/17) (Switzerland) Ingelheim GmbH which 4-Antibody will use its (Germany) platforms to discover the anti- bodies against Boehringer’s tar- gets in various diseases Allergan Inc. Bristol-Myers Exclusive worldwide rights BMS is paying $40M up front in (NYSE:AGN) Squibb Co. agreement to develop, manufac- exchange for rights to AGN- ture and commercialize AGN- 209323 and backup compounds; 209323 the deal also includes develop- ment and regulatory milestones up to $373M, in addition to royal- ties on worldwide sales; ExonHit Therapeutics SA stands to gain $36M total from the deal (3/4) Amarillo Intas Executed a license and supply The study will include up to 520 Biosciences Inc. Pharmaceuticals agreement and plans to launch a patients with clinical signs and (OTC BB:AMAR) Ltd. (India) Phase III trial of ABI’s orally symptoms of influenza; Intas will administered interferon-alpha pay a royalty on net sales in India lozenges in India by the end of and Nepal (3/5) March AnaptysBio Undisclosed Strategic collaboration to gener- The company will be responsible Inc.* pharmaceutical ate antibody therapeutics to a for generating antibodies using its company specified disease target somatic hypermutation technolo- gy platform; the pharma company gets worldwide rights to develop and commercialize the antibodies generated, and AnaptysBio gets an up-front sum and is eligible to receive milestone payments and royalties (3/2) BioSeek LLC* Ono Pharma- Multiyear drug discovery collabo- Deal includes research funding ceutical Co. Ltd. ration for BioSeek to apply its and milestone payments; Ono (Japan) BioMAP platform to a specific retains worldwide rights to devel- Ono drug target op and sell all discovered prod- ucts (3/24)136 BioWorld® State of the Industry Report 2011
  • 138. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Cellectis SA Boehringer Licensing deal on the Euro-pean The license covers an Institut (France; Paris: Ingelheim GmbH patents to obtain, breed and use Pasteur technology for introduc- ALCLS) (Germany) animal models in pharmaceutical ing new features in genomes, for research throughout Europe which Cellectis has an exclusive license (3/26) Cellzome Ltd.* GlaxoSmithKline Collaboration to apply the epi- T h e d e a l i s w o r t h | 4 7 5 M plc (UK) genetics platform technology in ($644.3M), including | 33M up the discovery of oral small-mole- front (3/10) cule drugs for treating immuno- inflammatory diseases Columbia Watson Agreement for exclusive U.S. Watson is buying 11 .2M shares of Laboratories Pharmaceuticals rights to its bioadhesive proges- Columbia stock and will pay a roy- Inc. (CBRX) Inc. terone gel products alty on its sales of the gel product and any next- generation products (3/5) Medivir AB Daewoong Licensing agreement for its hepa- Daewoong will assume develop- (Sweden; Pharmaceutical titis B virus polymerase inhibitor ment and marketing rights in SSE:MVIRB) Co. Ltd. (South drug lagociclovir valactate South Korea, Japan and China, Korea) including Taiwan, Macao and Hong Kong, while Medivir has retained rights in the rest of the world; Medivir is entitled to an up- front payment and milestones, plus double-digit royalties (3/12) Morphogenesis Novartis AG Licensing agreement for one of Morphogenesis will receive mile- Inc.* (Switzerland) its cancer immunotherapies to stones and royalties on dog and Novartis’ animal health division cat products (3/25) NeurOp Corp.* Bristol-Myers Agreement to develop small mol- NeurOp gets $1 .5M up front, Squibb Co. ecules for depression and other research funding for two years central nervous system disor- and up to $74M in potential mile- ders, using NeurOp’s platform stones (3/31) targeted at the N-methyl-D- aspartate receptor NiCox SA Bausch & Lomb Deal for the development of the NiCox is banking an initial license (France; Paris:COX) Inc. glaucoma and ocular hyperten- payment of $10M, and it eventually sion drug NCX 116 could earn up to $169.5M more in development, regulatory and com- mercial milestones (3/4) Odyssey Lonza Agreement to make Odyssey’s Lonza also gains an option to cer- Thera Inc.* (Switzerland) protein-fragment complementa- tain exclusive global technology tion assay technology available licenses; Odyssey will receive an to life science and drug discovery equity investment, development researchers funding and milestones (3/10) Omeros Corp. Asubio Pharma Licensing agreement for a pre- Exclusive deal involves milestones (OMER) Co. Ltd. (unit of clinical phosphodiesterase-7 pro- and royalties (3/10) Daiichi Sankyo gram for movement disorders Co. Ltd.; Japan) Prometheus Bayer Schering Research collaboration and non- Prometheus will receive an up- Laboratories Pharma AG exclusive license agreement with front payment, R&D support and Inc.* (Germany) Bayer to partner its oncology testing fees and potential mile- diagnostic platform with Bayer’s stones, with total payments up to oncology pipeline $160M (3/18)BioWorld® State of the Industry Report 2011 137
  • 139. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Quatrx Shionogi Pharma Licensing agreement for ospemi- Quatrx will receive an up-front Pharmaceuticals Inc. fene, which is being developed payment of $25M and is eligible Co.* for postmeno-pausal vulvovagi- to receive in excess of $100M in nal atrophy development and regulatory mile- stone payments (3/3) Syntarga BV* Two undisclosed Research collaborations involv- ADCs will be evaluated based on (the Netherlands) pharma companies ing its antibody-drug conjugate various linker-Drug chemistries program, bringing its total phar- and a variety of antibodies (3/4) ma collaborations to five Tekmira Pfizer Inc. Research collaboration to evalu- Tekmira will be responsible for Pharmaceuticals ate Tekmira’s stable nucleic acid- preparing the formulations, and Corp. (Canada; lipid particle technology to Pfizer will evaluate the formula- TSX:TKM) deliver small interfering RNA tions in preclinical models (3/17) molecules provided by Pfizer To-BBB* GlaxoSmithKline Research collaboration to evalu- The technology is designed to (the Netherlands) plc (UK) ate the brain delivery of treat- enhance transport of medicines ments enhanced with To-BBB’s across the blood-brain barrier by G-Technology encapsulating those compounds into proprietary glutathione-coat- ed liposomes (3/4) Transgene SA Novartis AG Exclusive option agreement for Novartis is paying $10M, plus up to (France; Paris:TNG) (Switzerland) Transgene’s lung cancer vaccine $955.9M in development, regula- TG4010 tory and commercial milestones if it opts to move forward with the product; Transgene also is eligible for royalties on worldwide prod- uct sales and retains co-promo- tion rights in certain countries, including France and China (3/11) Transition Eli Lilly and Co. Rights agreement for preclinical Lilly will receive an up-front pay- Therapeutics compounds in the area of diabe- ment of $1M and will retain an Inc. (Canada; tes option to reacquire rights to the TTHI) compounds up until the end of Phase II; if Lilly exercises those rights, Transition would be eligi- ble for up to $250M in milestone payments and up to low double- digit royalties; otherwise, it gets low single-digit royalties (3/4) Traversa Sanofi-Aventis SA Research agreement for the vali- The companies will study short Therapeutics* (France) dation and development of interfering RNA complexed to Traversa’s RNAi delivery technol- PTD-DRBD, with the ultimate goal ogy PTD-DRBD of developing drugs (3/26) APRIL AMAG Takeda Deal for iron replacement therapy The $280M deal includes $60M up Pharmaceuticals Pharmaceutical Feraheme front; Takeda will be responsible Inc. (AMAG) Co. Ltd. for commer-cialization in Europe, Canada, Tu r k e y, the Commonwealth of Independent States and the Asia Pacific coun- tries, excluding Japan, China and Taiwan (4/2)138 BioWorld® State of the Industry Report 2011
  • 140. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Antares Uman Pharma Strategic alliance to develop and Antares retained rights to com- Pharma Inc. (Canada) commercialize Antares’ Vibex mercialize it outside of Canada, (AMEX:AIS) MTX to treat rheumatoid arthritis while Uman received an exclusive and related autoimmune condi- license to commercialize the prod- tions uct in Canada (4/28) Array Novartis AG Collaboration for MEK inhibitors The deal includes $45M up front, BioPharma Inc. (Switzerland) plus $422M in milestones; Array (ARRY) will co-develop ARRY-162 in one or more specific indications and fund a portion of development costs; the deal provides Array with dou- ble-digit royalties outside the U.S., and a higher royalty rate for U.S. sales (4/21) Biocortech* Marco Polo Licensing agreement to develop Marco Polo takes responsibility for (France) Pharmaceuticals BC-19 in treatment-resistant all further clinical development of (Luxembourg) depression BC-19 and for eventual commer- cialization or out-licensing; finan- cial terms were not disclosed (4/2) BioSante Undisclosed large Option agreement to obtain a Financial terms were not disclosed Pharmaceuticals multinational non-exclusive worldwide license (4/27) Inc. (BPAX) pharmaceutical for BioSante’s 2A/Furin technolo- company gy in the expression of antibod- ies Celtic Bellus Health Agreement in which Celtic will The deal includes up-front pay- Therapeutics* (Canada) acquire and license worldwide ments of $10M, and will fund 100% (U.S. Virgin rights related to the Phase III of Kiata’s development costs Islands) product Kiata for AA amyloidosis through its confirmatory Phase III study and other development activities, estimated at $20M (4/30) Clovis Ventana Medical Collaboration to develop a com- Financial terms were not disclosed Oncology Inc.* Systems Inc. panion diagnostic to CP-4126 for (4/23) clinical and commercial use Crucell NV GlaxoSmithKline Binding letter of agreement to Crucell will contribute its recombi- (the Netherlands; Biologicals SA collaborate on developing a sec- nant malaria vaccine candidate, CRXL) (Belgium) ond generation malaria vaccine Ad35-CS, and GSK will contribute candidate its late-stage malaria vaccine can- didate RTS,S/AS (4/7) CureDM LLC* Sanofi-Aventis Deal for CureDM’s approach to The deal is worth $335M in up- (France) treating diabetes by stimulating front and milestone payments, the body’s production of insulin- plus royalties (4/9) producing islet cells EyeGate GlaxoSmithKline Research collaboration to evalu- Specific terms were not disclosed Pharma Inc.* plc (UK) ate the delivery of several GSK (4/30) therapies to the anterior and pos- terior tissues of the eye using the EyeGate II delivery systemBioWorld® State of the Industry Report 2011 139
  • 141. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Isis GlaxoSmithKline Option agreement involving RNA Isis gets $35M up front, which it Pharmaceuticals plc (UK) drug discovery will amortize over the five-year Inc. (ISIS) agreement and could get up to another $155M in pre-licensing milestones – averaging about $20M for each of the five pro- grams; after Phase II, GSK has the option to license the drug for fur- ther development; the deal could be worth a total $1 .5B (4/1) MDRNA Inc. Pfizer Inc. Collaboration to evaluate MDRNA will formulate Pfizer’s oli- (MRNA) MDRNA’s di-alkylated amino gonucleotides in DiLA2 formula- acids platform and UsiRNA con- tions for in vivo preclinical structs for RNA interference evaluation to be performed at Pfizer (4/6) Mersana Teva Agreement for XMT-1107, a preclin- Teva agreed to pay $334M in up- Therapeutics Pharmaceuticals ical revival of the old antiangio- front and milestone payments, as Inc.* Ltd. genic drug fumagillin well as royalties, for rights to XMT- 1107 worldwide except in Japan; Teva also is covering all develop- ment costs except those specific to Japan (4/13) Metabolex Inc.* Takeda Pharma- Research collaboration on the Metabolex will provide protein ceutical Co. Ltd. evaluation and validation of pro- targets discovered through the (Japan) tein targets use of its target discovery tech- nologies; financial terms were not disclosed (4/14) MicuRx Pfizer Inc. Collaboration to discover novel Pfizer will provide an up-front Pharmaceuticals therapeutic agents to treat multi- payment, funding for the discov- Inc.* and drug-resistant tuberculosis ery and preclinical development, Cumencor and payments linked to the devel- Pharmaceuticals opment and commercialization of Inc.* any antibiotics developed through the collaboration (4/7) PregLem* HRA Pharma Agreement giving PregLem rights Financial terms were not disclosed (Switzerland) (France) to develop and commercialize (4/13) ulipristal acetate for benign gyne- cological disorders in North America Proximagen Upsher-Smith Development, license and subli- Upsher-Smith will undertake Neuroscience Laboratories cense agreement for tonabersat, development, filing and commer- plc (UK; LSE:PRX) Inc. which was recently acquired by cialization of tonabersat for epi- Proximagen through its acquisi- lepsy in North America, and tion of Minster Pharmaceuticals Proximagen will be entitled to roy- plc alty-free use of the data when developing tonabersat for Europe, where it is retaining full rights (4/14) Serenity Allergan Inc. Deal for worldwide rights to Ser- Financial terms were not disclosed Pharmaceuticals 120, a Phase III nasal spray for (4/2) LLC* nocturia140 BioWorld® State of the Industry Report 2011
  • 142. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Stemgent Inc.* Pfizer Inc. Collaboration and research Pfizer and Stemgent will form a licensing agreement to develop joint research committee to certain research reagents and review and evaluate the progress make them available to the global and handle other tasks (4/19) research community MAY AndroScience Orient Strategic partnership centering OEP is responsible for clinical Corp.* Europharma on the clinical development and study expenses related to the Co. Ltd. (Taiwan) commercialization of ASC-J9, a Phase IIb trial slated to start in topical acne product September and will secure rights as exclusive commercialization partner for Taiwan, Hong Kong, S o u t h Ko r e a , N e w Z e a l a n d , Australia and other select markets through Asia Pacific (5/24) Asterand plc Eisai Co. Ltd. Two-year collaboration under The agreement encompasses sci- (UK; LSE:ATD) (Japan) which BioSeek will apply its entific projects at Eisai sites in the BioMAP platform to advance Eisai U.S. and Japan (5/5) discovery projects in oncology and inflammation BioDelivery Kunwha License and supply agreement to Terms call for potential milestone Sciences Pharmaceutical develop and commercialize BEMA payments to BDSI of up to nearly International Co. Ltd. (South Fentanyl in South Korea $1 .3M, including an up-front pay- Inc. (BDSI) Korea) ment of $300,000; BDSI also will receive an ongoing royalty based on net sales (5/28) CardioDx Inc.* GE Healthcare Strategic alliance to advance and The GE Healthymagination Fund co-develop genomic-based diag- invested $5M in CardioDx as part nostic technologies to improve of a Series D round (5/14) the care and management of patients with cardiovascular dis- ease Clavis Pharma Ventana Medical License agreement for exclusive Specific financial terms were not ASA (Norway; Systems Inc. access to Clavis’ monoclonal anti- disclosed (5/3) OSLO:CLAVIS) body targeting human nucleoside transporter 1 and to the hybrid- oma cell line that produces the antibody Clinical Data Santen Exercised option to license Santen will pay $2M up front, and Inc. (CLDA) Pharmaceutical Clinical Data’s ATL313 for certain possibly milestone payments and Co. Ltd. (Japan) ophthalmic diseases royalties on sales (5/4) ElexoPharm Merck & Co. Inc. Agreement to develop com- Deal is worth up to $41 .65M, GmbH* (Germany) (Germany) pounds for cardiovascular diseas- including $1 .85M up front (5/18) es Epigenomics Warnex Medical Nonexclusive licensing agree- Warnex has obtained the rights to AG (Germany; Laboratories ment for Epigenomics’ colorectal establish a laboratory-developed FSE:ECX) (division of Warnex cancer biomarker Septin9 test for Septin9 and offer colorec- Inc.; Canada) tal cancer blood testing services in Canada (5/4) ErgoNex Pfizer Inc. Licensing agreement for the ErgoNex will receive milestone Pharma GmbH* Phase II pulmonary arterial hyper- payments and royalties, while (Switzerland) tension drug terguride Pfizer will support development and have worldwide rights out- side of Japan (5/13)BioWorld® State of the Industry Report 2011 141
  • 143. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Glenmark Sanofi-Aventis Agreement for rights to develop Sanofi is paying $20M up front to Pharmaceuticals Group SA (France) and commercialize its vanilloid Glenmark, which also could bank SA (subsidiary receptor antagonist molecules, an additional $325M based on of Glenmark including GRC 15300, which is in achieving certain milestones, plus Pharmaceuticals Phase I for various pain condi- tiered double-digit royalties on Ltd.; India; tions, including diabetic neuro- sales; Sanofi will have exclusive BOMBAY:GLPHA) pathic pain and osteo-arthritic marketing rights for North pain America, European Union and Japan, subject to Glenmark’s right to co-promote the products in the U.S. and five Eastern European countries (5/4) Grifols SA Pharmalink AB Agreement to acquire various The acquisition includes Swedish (Spain; PK:GIFLF) (Sweden) forms of intellectual property regulatory approvals under the associated with the treatment of trade name Xepol, as well as U.S., post-polio syndrome European and Japanese patents that give Grifols exclusive rights to the treatment method (5/21) IntelGenx Corp. Cary Deal acquiring full rights to, and Cary has assigned to IntelGenx all (Canada; CDNX: Pharmaceuticals ownership of, CPI-300, a high- rights and interest in the regulato- IGX) Inc. strength formulation of bupropi- ry approvals and IntelGenx will be on hydrochloride responsible for the costs going forward (5/12) Labopharm Inc. Gruppo Angelini SpA Completed transaction to estab- Named Angelini Labopharm, the (Canada; DDSS) (Italy) lish a joint venture with Gruppo J V w i l l l a u n c h O l e p t r o , Angelini Labopharm’s once-daily formula- tion of trazodone indicated for major depressive disorder, in the third quarter (5/24) Micromet Inc. (MITI) Boehringer Ingelheim Global agreement to research, Micromet retained U.S. co-promo- (Germany) develop and commercialize a tional rights for the product; it will new BiTE antibody to treat multi- receive $6.6M cash up front, and ple myeloma could bank an additional $66M; Micromet also is eligible for a roy- alty comparable to profit split on U.S. product sales and a low dou- ble-digit royalty on ex-U.S. sales (5/6) Peregrine Stason Pharmaceuticals Agreements granting Stason cer- Peregrine’s lead TNT product can- Pharmaceuticals tain exclusive development and didate is Cotara (5/4) Inc. (PPHM) commercialization rights to Peregrine’s tumor necrosis thera- py technologies Polyphor Ltd.* Novartis AG Drug discovery collaboration to Novartis is paying Polyphor an (Switzerland) (Switzerland) use Polyphor’s Protein Epitope undisclosed up-front payment, Mimetics drug discovery technol- research funding and milestone ogy to identify compound candi- payments, plus royalties (5/7) dates against targets of interest142 BioWorld® State of the Industry Report 2011
  • 144. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Protox Therapeutics Kissei Pharmaceutical Agreement to develop and com- The deal includes $3M up front; Inc. (Canada; TSX:PRX) Co. mercialize injectable PRX302 in Protox also is eligible for a near- Japan for enlarged prostate and term milestone payment of $5M, other prostate diseases as well as progressive payments of up to $67M upon achievement of specific development, regulato- ry and commercial milestones; Protox also would receive a dou- ble-digit royalty plus a drug sup- ply fee based on product sales (5/3) Quintiles Nycomed GmbH Agreement under which The transfer follows Nycomed’s Transnational (Switzerland) Nycomed has transferred a decision to out-license a product Corp.* UK-based Healthcare Solutions to another pharmaceutical compa- Team to Quintiles ny in the UK (5/21) Response Genetics GlaxoSmithKline plc Nonexclusive license agreement The BRAF gene encodes B-Raf pro- Inc. (RGDX) (UK) granting GSK certain rights to its tooncogene serine/threonine-pro- PCR analysis technology and tein kinase; financial details were diagnostic expertise to assess not disclosed (5/12) BRAF gene mutations in human tumor samples Tekmira Bristol-Myers Squibb Multiyear, target validation deal, BMS will pay Tekmira $3M at sign- Pharmaceuticals Co. giving Bristol-Myers access to ing (5/11) Corp. (Canada; small interfering RNA molecules TSX:TKM) formulated by Tekmira in stable nucleic acid- lipid particles to silence target genes of interest Xanodyne Ferring Agreement divesting global The rights were bought for undis- Pharmaceuticals Pharmaceuticals Inc. rights for approved menorrhagia closed terms (5/11) Inc.* (Switzerland) drug Lysteda JUNE Aestus Therapeutic Astellas Pharma Inc. Exclusive, worldwide rights Financial terms were not disclosed Inc.* (Japan) agreement for FK614 to treat (6/29) postherpetic neuralgia Ascenta Sanofi-Aventis SA Collaboration for an early stage The deal includes up to $398M in Therapeutics Inc.* (France) cancer program that include two up-front and milestone payments, preclinical candidates designed plus tiered royalties on any prod- to target the p53 protein ucts that make it to market (6/7) BioWa Inc.* GlaxoSmithKline plc Two agreements, one amending a The second agreement provides (UK) 2007 deal to provide GSK with GSK with access to BioWa’s extended access to BioWa’s Complegent Technology for Potelligent Technology platform enhancing the complement- for research, development and dependent cytotoxicity of select commercialization of antibody GSK therapeutic antibodies; BioWa therapeutics with enhanced anti- will receive up-front and annual body-dependent cellular cytotox- fees, development milestone pay- icity ments and royalties on any mar- keted products (6/24)BioWorld® State of the Industry Report 2011 143
  • 145. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Diamyd Medical AB Ortho-McNeil-Janssen Deal to develop and commercial- Ortho-McNeil is paying Diamyd (Sweden; PK:DMYDY) Pharmaceuticals Inc. ize its recombinant glutamic acid $45M up front, plus up to $580M (unit of Johnson & decarboxylase-65 antigen-based in development and sales mile- Johnson) immuno-therapy to treat and pre- stone payments; the companies vent Type I diabetes will equally share development costs, and it includes royalties (6/23) Durect Corp. (DRRX) Hospira Inc. Deal to develop and market The companies will jointly fund Posidur remaining development costs, and Hospira holds commercialization rights in the U.S. and Canada; Hospira will make an up-front pay- ment of $27.5M and could pay up to $185M in milestone payments, as well as a royalty on product sales (6/9) Dyax Corp. (DYAX) Sigma-Tau SpA (Italy) Partnership to develop and com- Sigma Tau will pay Dyax $2.5M up mercialize ecallantide to treat front and will purchase $2.5M in hereditary angioedema through- equity shares at a 50% premium out Europe, North Africa, the above market value; Dyax also is Middle East and Russia eligible for more than $100M in development and sales mile- stones, and royalties equal to 41% of net sales (6/22) Eisai Inc. (FSE:EII) Helsinn Healthcare SA Licensing agreement for U.S. No financial terms were disclosed (Switzerland) commercialization rights to its (6/10) fixed-dose combination product in both oral and IV forms contain- ing netupitant and palonosetron, which is under investigation to prevent chemotherapy-induced nausea and vomiting EnGen Bio Inc.* Dyadic International Nonbinding term sheet for an Dyadic is eligible to receive a sub- Inc. outlicense on an exclusive stantial equity stake in EnGen Bio worldwide basis of Dyadic’s C1 (6/10) platform technology Entelos Inc.* Pfizer Inc. Nonexclusive, perpetual license The platform is designed to com- that gives access to Entelos’ bine physiology and individual Metabolism Physiolab platform behavior to support research on obesity and diabetes (6/25) Essen BioScience Nycomed A/S Joint discovery agreement to The companies will collaborate to Inc.* (Switzerland) identify small-molecule ion chan- screen, optimize and develop nel modulators as pain therapeu- modulators of voltage-gated ion tics channels (6/22) Ikano Therapeutics Upsher-Smith Agreement to obtain exclusive Upsher-Smith will assume all fur- Inc.* Laboratories Inc. global rights to ITI-111 , Ikano’s ther development, testing and nasal midazolam clinical study of nasal midazolam to manage acute repetitive sei- zure in patients with epilepsy (6/29) Marcadia Biotech Eli Lilly and Co. A glucagon analogue partnership Terms were not disclosed, but Lilly Inc.* gets worldwide commercializa- tion rights to lead preclinical can- didate MAR531 as well as related backup compounds (6/29)144 BioWorld® State of the Industry Report 2011
  • 146. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Marionomed Boehringer Ingelheim Licensing agreement extending Marionomed will receive an undis- Biotechnologie GmbH (Germany) the marketing of the antiviral closed up-front payment in the GmbH* (Austria) nasal spray to treat the common million Euro range, in addition to cold to all of Europe (except milestone payments and royalties Austria and UK), Russia and CIS, (6/29) South America, parts of Asia and Australia Metabolex Inc.* Ortho-McNeil-Janssen Deal to discover and develop Metabolex will receive an undis- Pharmaceuticals Inc. compounds for Type II diabetes closed up-front payment and (unit of Johnson & and other disorders could be eligible to receive devel- Johnson) opment, regulatory and commer- cial milestones up to $330M; Metabolex also is eligible for roy- alties (6/23) Metabolex Inc.* Sanofi-Aventis SA Collaboration for the research, The deal is worth $375M (6/28) (France) development, manufacture and commercialization of small mole- cules that modulate the G-protein coupled receptor 119 miRagen Santaris Pharma A/S Alliance to develop microRNA- MiRagen will gain access to Therapeutics Inc.* (Denmark) targeted medicines to treat car- Santaris’ Locked Nucleic-Acid plat- diovascular disease form to develop and commercial- ize single stranded LNA-based product; Santaris will receive a minority equity interest in miRa- gen and is eligible for undisclosed milestone payments plus royalties (6/24) Neurocrine Abbott Exclusive worldwide deal to The deal is worth more than Biosciences Inc. develop and commercialize $575M, including $75M up front (NBIX) elagolix to treat endometriosis- (6/17) related pain Neurocrine Boehringer Ingelheim Research and development deal The deal is worth more than BioSciences Inc. GmbH (Germany) for small-molecule GPR119 ago- $235M, including $10M up front, (NBIX) nists to treat Type II diabetes and plus royalties (6/18) other indications using Neurocrine’s technology platform SiNERG OncoMed Bayer Schering Pharma Deal to develop drugs targeting An agreement that brings $40M Pharmaceuticals AG the Wnt signaling pathway up front, with the potential for Inc.* more than $1B in future mile- stones; the deal calls for up to five compounds and up to $387.5M per biotherapeutic, or up to $112M per small molecule, in develop- ment, regulatory and sales mile- stones, plus double-digit royalties and certain co-development options (6/18) Orexo AB (Sweden; Ortho-McNeil-Janssen Alliance to develop two of its pre- Orexo will get an up-front pay- SSE:ORX) Pharmaceuticals Inc. clinical programs that target ment of $10M and will get another and Janssen pathways involved in arachidonic $11 .5M in research funding (6/2) Pharmaceutica NV acid metabolismBioWorld® State of the Industry Report 2011 145
  • 147. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Regulus Sanofi-Aventis Group Partnership aimed at discovering The deal is worth $750M, includ- Therapeutics Inc.* SA (France) microRNA-based drugs against ing $25M up front, as well as a four fibrosis targets $10M equity investment, plus $650M in milestone payments and royalties (6/23) Saladax Biomedical Bristol-Myers Squibb Multiyear development and com- Companies will collaborate glob- Inc.* Co. mercialization agreement for the ally on development and regulato- development of certain clinical ry approvals; Saladax received diagnostic tests to be used in exclusive global rights to com- conjunction with the develop- mercialize the assays it develops ment of certain therapeutic com- (6/22) pounds in the BMS pipeline TransTech Pharma Forest Laboratories Inc. Partnership to develop and com- TransTech is receiving a $50M up- Inc.* mercialize a new class of glu- front payment and is eligible to cose-lowering agents to treat receive royalties on worldwide diabetes sales; Forest is responsible for all development and commercializa- tion costs (6/9) Tranzyme Pharma Norgine BV (the Exclusive rights agreement to Norgine gains rights to the Phase Inc.* Netherlands) develop and commercialize III compound, being developed in Tranzyme’s ghrelin agonist, uli- gastrointestinal dysmotility condi- morelin in several ex-U.S. regions tions in acute care settings, in Europe, Australia, New Zealand, the Middle East, South Africa and North Africa; Tranzyme retains development rights in the U.S. and Asian countries; Norgine also will make an undisclosed equity investment in Tranzyme (6/17) Uluru Inc. (AMEX: Crawford Healthcare Deal under which Uluru and Crawford will pay up to $5. 1M for ULU) & Strakan Ltd. (UK) Strakan have divested their inter- the product, which will be shared International Ltd.* est in acne drug Zindaclin equally by Strakan (6/29) (Scotland) Vivalis SA (France; Sanofi-Aventis Group L i c e n s e a g r e e m e n t f o r t h e Vivalis will receive an up-front Paris:VLS) (France) Humalex antibody platform payment of $3.6M, plus another potential €35M in milestone pay- ments, as well as royalties (6/9) WisTa Laboratories Bayer Schering Pharma Collaboration to develop specific TauRx will use its technology plat- Ltd.* (subsidiary of AG (Germany) markers designed to aid in the form of ligands, specialized tau- TauRx diagnostics and management of directed assays and its animal Pharmaceuticals) tau protein-related Alzheimer’s models to optimize the develop- disease using brain-imaging tech- ment of ligands; diagnostic prod- nology ucts arising from the deal will be developed by Bayer, while com- pounds with therapeutic potential will be developed by TauRx (6/4) JULY Adimab Inc.* Novartis AG An antibody discovery partner- Details were not disclosed but (Switzerland) ship that involves Adimab’s most of Adimab’s deals involve yeast-based platform up-front fees, milestone payments and royalties, typically in the mid- single-digits (7/12)146 BioWorld® State of the Industry Report 2011
  • 148. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Aestus Eisai Co. Ltd. (Japan) Multiyear collaboration for the Financial terms were not disclosed Therapeutics research and development of (7/15) Inc.* treatments for psychiatric disor- ders Biolex Therapeutics Merial Ltd. Research and development col- The collaboration will combine Inc.* laboration to produce veterinary Biolex’s Lemna expression system vaccines with Merial’s expertise and com- mercial presence in veterinary vaccines (7/19) Biotica Technology Bristol-Myers Squibb Agreement for Biotica to acquire It provides additional product Ltd.* (UK) Co. intellectual property of bioengi- opportunities in new polyketide neering techniques for use in chemical classes and enhances lead optimization capabilities in manufacturing development (7/9) EUSA Pharma Inc.* Ohara Pharmaceutical Japanese development and com- EUSA will receive an up-front fee (UK) Co. Ltd. (Japan) mercialization rights for the can- and royalties (7/7) cer drug Erwinase Hawaii Biotech Inc.* Merck & Co. Inc. Licensing agreement for Hawaii Hawaii received an up-front pay- Biotech’s dengue vaccine pro- ment and will not collect further gram milestones or royalties (7/22) ImmunoVaccine Inc. Merck KGaA (Germany) Licensing agreement for EMD The product also will be incorpo- (Canada; CDNX:MIV) 640744, a survivin-targeted anti- rated into its liposome delivery gen-based cancer vaccine platform; terms were not dis- closed (7/13) Itero Watson Itero exclusively licensed world- Watson will cover all future costs Biopharmaceuticals Pharmaceuticals wide rights to its biosimilar and pay Itero a licensing fee, mile- Inc.* Inc. recombinant follicle stimulating stone payments and royalties hormone for infertility (7/16) Nitto Denko Corp. Quark Pharmaceutical Collaboration and license agree- The collaboration is designed to (Japan; FSE:ND5) Inc. ment for the development of develop siRNA drugs using RNAi siRNA therapeutics for the treat- technologies and structures by ment of fibrotic diseases Quark and Nitto Denko’s drug delivery technologies for thera- peutic concepts (7/19) OctoPlus NV Novartis AG Agreement relating to the use of OctoPlus will develop, up to in (the Netherlands; (Switzerland) OctoPlus’ controlled-release tech- vivo feasibility, a controlled- Amsterdam:OCTO) nology release formulation of an undis- closed compound using its drug delivery technology PolyActive (7/1) Qiagen NV Roche AG (Switzerland) Licensing agreement for intellec- Financial terms were not disclosed (the Netherlands; tual property covering the devel- (7/14) QGEN) opment of phosphoinositide 3-kinase, or P13K, assays Vastrata Ltd.* Mitovie Pharma Ltd. Exclusive, worldwide licensing Vastrata will receive payments (UK) (UK) deal covering VAS005/MVP009 linked to commercial success of for an undisclosed indication in the project (7/6) the field of women’s health X-Chem Inc.* Roche AG (Switzerland) Multiyear deal to apply X-Chem’s Roche will make up-front and platform to the discovery of drug research payments, plus success- candi-dates against several based discovery milestones and Roche targets technology access fees; X-Chem also is eligible for development milestones and royalties (7/2)BioWorld® State of the Industry Report 2011 147
  • 149. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) AUGUST Aileron Roche AG (Switzerland) Deal to develop therapeutics Roche will pay Aileron at least Therapeutics Inc.* based on Ailerons stapled pep- $25M up front and $1 . 1B in mile- tides platform aimed at targets stone payments based on achiev- previously considered undrugga- ing drug candidates against five ble undisclosed targets (8/25) Alectos Merck & Co. Inc. Collaboration to study a potential Alectos will receive up to $289M Therapeutics Inc.* non-amyloid approach to treat in an up-front fee and milestone Alzheimers disease payments; Merck gets worldwide, exclusive rights to research, develop and commercialize com- pounds that modulate the enzyme O-linked N-acetylglucosaminidase (8/12) Amplimmune Inc.* GlaxoSmithKline plc Strategic alliance for AMP-224, an The deal is worth $23M up front (UK) Fc-fusion protein of the B7-DC and as much as $485M in later ligand, which targets PD-1 payments (8/5) FivePrime GlaxoSmithKline plc Drug discovery alliance giving FivePrime will receive about $15M Therapeutics Inc.* (UK) GSK exclusive access to in 2010 from an up-front fee, the FivePrimes drug discovery plat- purchase of FivePrime equity by forms, specifically in the areas of GSK and payments related to the sarcopenia, cachexia and other research program (8/5) skeletal muscle disorders Immunomedics Inc. GE Healthcare License and collaboration agree- Terms were not disclosed, but GE (IMMU) ment for the evaluation of label- Healthcare will fund all costs relat- ing technologies based on ed to the collaboration (8/19) Immunomedics patented fluo- rine-18 peptide labeling method Impax Laboratories Perrigo Co. Collaboration to develop and The products and terms of the Inc. (APXL) commercialize two extended topi- agreement were not disclosed cal drug products (8/6) Nabi GlaxoSmithKline Completed a technology transfer Nabi is eligible to receive another Biopharmaceuticals Biologicals SA of program know-how associated $8M under the $46M deal for the Inc. (NABI) (Belgium) with the sale of the PentaStaph pentavalent S. aureus vaccine and vaccine candidate related assets (8/11) NextWave Tris Pharma Inc. Partnership to apply Tris drug Terms of the deal were not dis- Pharmaceuticals delivery technology to Next closed (8/13) Inc.* Waves central nervous system portfolio, and to develop another three CNS products Osteologix Inc. (OTC Servier Research Group Osteologix granted Servier an The rights are worldwide, except in BB: OLGX) (France) exclusive royalty-bearing license the U.S.; Osteologix will receive up to develop and commercialize NB to $15.8M in up-front and mile- S101 to treat postmenopausal stone payments; Osteologix is eli- osteoporosis, other bone and gible to receive up to $39.5M in joint disorders and dental indica- minimum royalty payments cred- tions itable against royalties on sales (8/3)148 BioWorld® State of the Industry Report 2011
  • 150. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Phylogica Ltd. AstraZeneca plc (UK) Deal with AstraZeneca under The deal is worth $1 .5 million over (Australia; ASX:PYC) which its MedImmune biologics the next 12 months for the screen- unit will search Phylogica’s pep- ing work, plus a further $98 mil- tide library for compounds that lion in milestones against the are active against Pseudomonas development of any product aeruginosa (8/25**) PregLem SA* Merck Serono SA Worldwide, exclusive licensing PregLem will develop the com- agreement for Bentamapidmod, an pound for the prevention of post- orally active Jun Kinase inhibitor, surgical abdominal adhesions and for an undisclosed amount endometriosis in patients with tubal ligation or comparable effec- tive contraception (8/12) Quark Novartis AG Deal granting Novartis an option Quark stands to bank $680M, Pharmaceuticals (Switzerland) to obtain an exclusive worldwide including $10M up front (8/19) Inc.* license to develop and commer- cialize QPI-1002, a p53 temporary inhibitor siRNA drug SureGene LLC* Medco Research Research collaboration to evalu- Terms were not disclosed (8/25) Institute LLC (subsid- ate whether variation in genetic iary of Medco Health biomarkers previously identified Solutions Inc.) by SureGene can help predict drug response for widely pre- scribed antipsychotic drugs in patients with serious mental ill- ness Vectura Group plc GlaxoSmithKline plc Worldwide, nonexclusive agree- Vectura will receive up to $31 .9M (UK; LSE:VEC) (UK) ment to license some of its dry in up-front and milestone pay- powder drug formulation patents ments, plus royalties (8/9) in relation to two late-stage development compounds in GSKs respiratory product pipe- line Xcellerex Inc.* SK Chemicals Co. Ltd. Memorandum of understanding Specific terms will be defined at a (South Korea) for an alliance to develop and later time (8/27) commercialize SK-developed vac- cines with Xcellerex’s FlexFactory biomanufacturing platform SEPTEMBER Acceleron Pharma Shire plc (UK) Agreement to develop drugs for The deal is worth a potential Inc.* rare muscle disorders, including $498M, including $45M up front, ACE-031 for Duchenne’s muscular plus royalties (9/10) dystrophy Acucela Inc.* Otsuka Pharmaceutical Agreement to co-develop and co- Specific terms were not disclosed Co. Ltd. (Japan) promote OPA-6566, an adenosine (9/28) A2a receptor agonist to treat glaucoma in the U.S. Anchor Ortho-McNeil-Janssen Development and commercializa- The deal is worth $480M in devel- Therapeutics Inc.* Pharmaceuticals Inc. tion deal focused on Anchor’s opment and regulatory mile- program targeting gpr39, a GPCR stones, plus an undisclosed involved in metabolic diseases up-front fee (9/10)BioWorld® State of the Industry Report 2011 149
  • 151. Biotechnology Company Deals With Pharmaceutical Companies Company* Company* Type/Product Area Terms/Details (Date) (Country; Symbol) (Country; Symbol) Asklepios Pfizer Inc. License agreement for certain AskBio is developing gene thera- BioPharmaceutical gene-delivery platform technolo- py-based clinical programs (9/14) Inc.* gies developed by AskBio for use in developing therapies for hepa- titis C virus Concordia Ono Pharmaceutical Exclusive rights deal to develop Concordia is eligible to receive Pharmaceuticals Co. Ltd. (Japan) and commercialize salirasib in additional payments based on Inc.* Japan in exchange for an undis- milestones, plus royalties on sales closed up-front payment in Japan (9/2) Kinaxo Daiichi Sankyo Co. Ltd. Long-term partnership in cancer Financial terms were not disclosed Biotechnologies (Japan) research under which Daiichi will (9/30) GmbH* (Germany) employ Kinaxo’s technology plat- form to support the development of its targeted cancer drugs Kythera Intendis (unit of Bayer Rights agreement to develop, Kythera will receive $43M up front Biopharmaceuticals HealthCare) manufacture and commercialize with a potential $330M in mile- Inc.* ATX 101 outside the U.S. and stone payments, plus royalties Canada for reduction of submen- (9/1) tal fat Ligon Discovery Bayer Schering Pharma Partnership for Ligon to apply its Financial terms were not disclosed Inc.* AG (Germany) s m a l l - m o l e c u l e m i c r o a r r a y (9/30) screening platform to discover candidates for new disease tar- gets OctoPlus NV (the Unnamed U.S.-based Feasibility agreement relating to OctoPlus will develop a con- Netherlands; pharmaceutical com- the