Volume 14, Issue 7 | February 15, 2010

                 cwweekly




        Inside this issue:
I       Features
        ...
February 15, 2010
                                     cwweekly

ISSN 1528-5731
Editorial                                 ...
cww
                                           | feature |


             MDS Pharma to be Split,
    Sold to Ricerca and ...
employees from the Montreal office
will become home-based employees
under the new corporation.

MDS put its early-stage CR...
cww
                                | feature |


            UBC Opens First Office
                in Asia-Pac




     ...
Asia-Pacific office because it has a ro-
bust pharmaceutical community that
we currently support and have for
years, both ...
cww
industry briefs                 | industry briefs |




                        CROs                                  ...
I                         "Our West Coast clients operate in a
                                             hotbed of biop...
cww
                                   | company profile |


                        Contract Research Organization
     A...
I                                           I                        where trials are run—in Central and
                 ...
I
       What are your
    plans for the future?
We definitely want to maximize what
we can get from existing countries,
b...
cww
                                       | drug & device pipeline news |

 Company                Drug/Device           ...
Company               Drug/Device         Therapeutic Area        Status                      Sponsor Info
 Dynavax       ...
cww
                                                    | trial results |


Cardiovascular                              (1...
infections, were generally similar be-
tween the two arms. Amgen plans to
file for regulatory approval by
the end of 2010....
cww
                                                 | biotech review |


                   I                        said...
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Centerwatch East Horn 2010

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An overview of how EastHORN - Clinical Services in CEE came about.

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Centerwatch East Horn 2010

  1. 1. Volume 14, Issue 7 | February 15, 2010 cwweekly Inside this issue: I Features MDS Pharma to be Split, Sold to Ricerca and Private Investment Firm UBC Opens First Office in Asia-Pac I Industry Briefs CROs Patient Recruitment Technology I Company Profile An interview with Malgorzata Szerszeniewska, M.D., CEO EastHORN Clinical Services I Drug & Device Pipeline News I Trial Results Cardiovascular Gastroenterology Neurology Oncology I Biotech Review For the latest clinical research news and views, visit Clinical Trials Today at www.centerwatch.com.
  2. 2. February 15, 2010 cwweekly ISSN 1528-5731 Editorial Steve Zisson Sara Gambrill Molly Rowe Drug Intelligence Tracy Lawton Production Steven Hasomeris Danielle Wooding Jason Greeno For inquiries regarding subscriptions: (866) 219-3440, option 0 customerservice@centerwatch.com For inquiries regarding advertising: (617) 948-5123 melissa.nazzaro@centerwatch.com contents To order article reprints: (617) 948-5126 rick.lavallee@centerwatch.com CenterWatch editorial office: (617) 948-5100 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Fax: (617) 948-5101 MDS Pharma to be Split, Sold to Ricerca editorial@centerwatch.com and Private Investment Firm CWWeekly is published weekly by CenterWatch, 100 N. Washington St., Ste. 301, Boston, MA 02114. Annual UBC Opens First Office in Asia-Pac subscription price starts at $249. Clinical Trials Listing Service™ Industry Briefs . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 This service provides an international listing of clinical trials currently enrolling patients. CROs (513) 754-1705 www.centerwatch.com Patient Recruitment CenterWatch Publications and Products Technology I State of the Clinical Trials Industry I China: A New Era of Innovation in Drug Development I Japan: Opening the Door to Global Clinical Trials Company Profile . . . . . . . . . . . . . . . . . . . . . . . . . . .9 I Asia-Pacific’s Growing Role in Global Clinical Trials I Central and Eastern Europe: Outsourcing Trends and An interview with Malgorzata Szerszeniewska, M.D., CEO Growth Opportunities in Clinical Trials EastHORN Clinical Services I Directory of Drugs in Clinical Trials I Becoming a Successful Clinical Research Investigator I Protecting Study Volunteers in Research Drug & Device Pipeline News . . . . . . . . . . . . . . . .12 I A Guide to Patient Recruitment and Retention I The CRA’s Guide to Monitoring Clinical Research I The CRC’s Guide to Coordinating Clinical Research Trial Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 I Understanding the Informed Consent Process Cardiovascular I Volunteering for a Clinical Trial I Research Practitioner Gastroenterology I The CenterWatch Monthly I JobWatch Neurology Oncology Biotech Review . . . . . . . . . . . . . . . . . . . . . . . . . . .16 SM
  3. 3. cww | feature | MDS Pharma to be Split, Sold to Ricerca and Private Investment Firm feature M DS announced cGMP manufacturing and scale-up, plans to divide and IND-enabling toxicology. MDS MDS Pharma Pharma will add molecular profiling, Services, the pharmacology/DMPK and drug safety c o m p a n y ’s assessment to its list of services. early-stage contract re- “The addition of these facilities and search organization (CRO), and sell it personnel complement Ricerca’s exist- off to two separate companies for $45 ing facility in Concord, Ohio, and po- million, according to published reports. sition us as a global, preferred provider The transactions are expected to close of discovery and development services. by April. We have intimate working knowledge of these facilities; all are steeped in Ricerca Biosciences of Concord, decades of experience and expertise,” Ohio, has agreed to purchase MDS said Ricerca chairman and CEO Ian Pharma’s discovery through phase IIa Lennox in a statement. operations in Bothell, Washington; Lyon, France; and Taipei, Taiwan. Neither deal includes the sale of MDS A new corporation primarily owned Pharma’s King of Prussia, Pa., executive by private investment firms Bain office or its early clinical research and Capital Ventures and SV Life Sciences bioanalysis operations in Montreal, will purchase MDS’ development Quebec. The Pennsylvania office will and regulatory services consultancy, close immediately, and the Montreal as well as five early-stage facilities operations will be decommissioned in Ireland, Nebraska, New Jersey, over the next year with final close oc- Arizona and Switzerland. curring in early 2011. Approximately 225 employees will be laid off as a re- Ricerca is an early-stage CRO with sult of the closure, while another 50 capabilities in discovery and medicinal jobs will be eliminated from MDS chemistry, API process chemistry, Pharma Services’ other locations. Forty Can your EDC system dispense medication? Ours can. www.perceptive.com/eclinical Feature CWWeekly | 3
  4. 4. employees from the Montreal office will become home-based employees under the new corporation. MDS put its early-stage CRO division on the block last summer, after selling its late-stage operations to INC Research. The company originally said it would ramp up its focus on early stage operations and even expanded its Taiwan unit (the facility that is now being purchased by Ricerca) in June. Plans changed in September when MDS decided to sell off Pharma Serv- ices in its entirety and focus on the company’s medical imaging business, MDS Nordion. After several months of searching for an appropriate buyer, MDS warned investors earlier this month that the sale of the early-stage business will likely garner lower sale proceeds than previously expected, due to “contin- ued deterioration of market condi- tions, the declining early stage customer base and new developments in the ongoing strategic review process.” MDS told investors that some customers have expressed concern about the company’s restructuring and decreased focus on early stage, result- ing in a reduction of orders and rev- enues. As a result, the sale proceeds may not be enough to fund a distribution to shareholders. cww CMS European Medicines Agency FDA Health Canada HHS W W W. P O S TA P P R O VA L . O R G N ICE Feature CWWeekly | 4
  5. 5. cww | feature | UBC Opens First Office in Asia-Pac U nited BioSource office, he will focus on expanding feature C o r p o r a t i o n ’s UBC’s operations in Japan. (UBC’s) new office in Tokyo, Japan, is The Asia-Pacific region, especially the company’s first Japan, has grown increasingly impor- office in that coun- tant to UBC as both regional and try and in all of worldwide clients have requested in- Asia-Pacific. creased services there. The contract research organization “We’ve been doing work for Japanese (CRO), which has 26 offices world- companies for a long time, and they’re wide, has conducted work in all of some of our best customers—in both Asia-Pacific but did not have a legal the rest of world and in Japan,” Leder entity there until now. UBC CEO Ethan said. “We felt it was important—not Leder said the Japan office will have just with those Japanese companies but a staff of 12 by the end of this with some of the other ex-Japan com- year, with almost all of those new to panies that are developing drugs and UBC. These employees will support marketing drugs in- country—to be on UBC’s investigator training and certifi- the ground.” cation services as well as ongoing clinical research monitoring in the Whereas many CROs have opened region. UBC has 1,450 employees offices in other Asia-Pacific countries worldwide. where there is a large potential patient population, UBC does not rely heavily The company has hired Kumpei on patient recruitment because the Kobayashi as country manager. company focuses on late-stage projects Kobayashi began his career as a re- that already have enrolled patients. search scientist and most recently man- aged operations for i3 Japan. In “Right now, Japan is the most log- addition to managing the Japanese ical place for us to set up our first Feature CWWeekly | 5
  6. 6. Asia-Pacific office because it has a ro- bust pharmaceutical community that we currently support and have for years, both in the states, in Europe and in Japan. We think we can build off of that Asia-Pacific location, and, if need be, look at other segments of that re- gion for offices,” Leder said. GlaxoSmithKline (GSK) highlighted Japan’s importance to the drug devel- opment industry in the company’s year-end earnings conference call last week. GSK CEO Andrew Witty told investors that he expects Japan to be “big business” for the company in the future. UBC plans to aggressively grow its global footprint in 2010, Leder said, but where the company expands will depend on existing clients. “Since inception, we’ve had $220 mil- lion in institutional blue-chip equity invested in our company. We’re a pri- vate company, so we’re exceedingly well capitalized. The purpose of that is to be able to do what makes sense, when it makes sense,” Leder said. “On the one hand, we’re not driven by quarterly expectations. On the other hand, we’re not under-capitalized. We’re well capitalized, so we can make the necessary investments in capital, resources and people. Our goal is to take our good clients and be able to service them. “ UBC acquired two companies in Eu- rope last year, expanding both its serv- ices and service areas. Leder said the company will likely look at expanding more in central and western Europe in the coming months. “It would not surprise me if we are as active [in 2010] as we were last year,” Leder said. cww For more information on spon- sor and CRO activity in the Asia-Pac region, see the Febru- ary issue of The CenterWatch Monthly. Feature CWWeekly | 6
  7. 7. cww industry briefs | industry briefs | CROs services. Neither company released financial terms of the deal. Indian contract research organization (CRO) SIRO Clinpharm is partnering Under the terms of the agreement, Bio- with South Korean CRO DreamCIS to Clinica will provide data management expand SIRO’s services in the Asia- services to Cephalon’s global clinical Pacific region. trial operations. Cephalon’s U.S.-based data management staff will support The two CROs will offer clinical trial these efforts. The deal expands management, medical writing, feasibil- Cephalon’s plans to use BioClinica’s ity and patient planning, pharmacovig- Express electronic data capture product ilance, post marketing surveillance, as its default data capture system. data management, biostatistics and quality assurance services to clients in BioClinica also reported its fourth South Korea and worldwide. The spe- quarter and full-year 2009 earnings last cific terms of the alliance were not week. Service revenues for the quarter made public. were flat from the fourth quarter 2008 at $14.9 million. Income from continu- "Looking at the increasing number ing operations was $943,000, or $0.06 of global clinical trials and the rapid per fully diluted share, compared with growth in the Asian clinical trials income of $1.7 million for the same pe- market, we were looking at associating riod 2008. ourselves with a CRO having a global exposure," said DreamCIS president Service revenues for the full-year were Won-Jung Choi in a statement. $57.4 million, compared with $56.2 million for the same period 2008. In- SIRO Clinpharm has offices in India, come from continuing operations, net Israel, Europe and the U.S. The of taxes was $3 million, or $0.20 per company formed a similar alliance fully diluted share, as compared with with regulatory services firm Cam- $5.8 million, or $0.40 per fully diluted bridge Regulatory Services last fall share, for the same period 2008. to provide regulatory expertise to clients conducting clinical trials in The CRO expects full-year 2010 serv- Europe. ice revenue to be in the range of $61 million to $65 million, with earnings I per share in the range of $0.25 to $0.29 per share. BioClinica signed a three-year, multi- million dollar partnership with bio- pharmaceutical company Cephalon for clinical trial technology and support Industry Briefs CWWeekly | 7
  8. 8. I "Our West Coast clients operate in a hotbed of biopharmaceutical innova- Pivotal Research Centers, a site man- tion. BBK's on-site consultation better agement organization (SMO) owned ensures their trials are primed for suc- by UK CRO Premier Research Group, cess with early recruitment strategies, has been signed by Cornerstone Phar- technology, training, and tactical im- maceuticals as an SMO for its single- plementation support," said BBK agent phase I/II clinical trial. The study founding principal Joan Bachenheimer will take place at Pivotal’s Peoria, in a statement. Ariz., location. I Technology PPD’s full-year income from opera- Phase Forward’s fourth quarter rev- tions fell 32% in 2009, the contract enues jumped 22% but profits went research organization (CRO) re- down, the company reported. ported. Revenues for the year were also down from $1.55 billion in 2008 The technology company’s Q4 rev- to $1.42 billion. enues increased to $58.8 million, up from $48.3 million in the same quar- Full-year 2009 income was $192.9 ter 2008. Net loss for the quarter was million, compared with $282.4 mil- $68,000, or $0.00 per diluted share, lion in 2008. Diluted earnings per compared with net income of $2.7 share for 2009 were $1.34, compared million, or $0.06 per diluted share, in with diluted earnings per share of the same period last year. $1.56 for the same period last year. Phase Forward attributed the drop in PPD’s fourth quarter net revenues profitability to impairment charges dipped slightly to $357.4 million, and acquisition costs. The company compared with $363.1 million in the acquired Waban Software and fourth quarter of 2008. Income from Maaguzi last year, as well as Cov- operations was $23.9 million, com- ance’s interactive voice and web re- pared with $71.7 million for the same sponse services business. period in 2008. Full-year revenues in 2009 were Earlier this month, the company com- $213.3 million, up 25% from $170.2 pleted the sale of its biomarker serv- in 2008. Net income for the year ices division, PPD Biomarker was $8 million, or $0.18 per diluted Discovery Sciences, to Montreal-based share, compared with $13.8 million, Caprion Proteomics. PPD next plans or $0.32 per diluted share, to spin off its compound partnering in 2008. cww business, creating two independent public companies. Only the CRO business will maintain the PPD name. Patient Recruitment Patient recruitment company BBK Worldwide opened an office in Los Angeles to meet growing demand for patient recruitment services there and worldwide. The company opened a Japan office in 2009, and this new West Coast location will help BBK better serve clients there and in the Pa- cific time zone. The company also has offices in Boston, London and Prague. Industry Briefs CWWeekly | 8
  9. 9. cww | company profile | Contract Research Organization An interview with Malgorzata Szerszeniewska, M.D., CEO ompany profile EastHORN Clinical Services in CEE I Year founded: 2004 as Unimed, What is the background Renamed in 2009 Employees: 40 of EastHORN and how Contractors: 30 across Europe did you get involved? Offices: Czech Republic, Poland, Romania, Bulgaria; home-based staff in Serbia, Ukraine, Russia This company was founded as Unimed # phase I units: 1 at Thomayer in 2004 by Dr. Ales Horacek and University Hospital changed management in May 2009. I’d # of beds: 6 wards, 28 beds been working with the founder for six Contact: Leonard Gold, director years as a partner of my previous com- of business development, panies—Covance and AbCRO. It was North America natural that I would join them after the Chris Birch, director of business acquisition of AbCRO by PPD, as I pre- development, Europe and fer to work in a smaller company with Asia/Pacific less overhead and greater flexibility. Tel #: (908) 317-2846 +44 1280 816919 The name change to EastHORN was a Email: leonard.gold@easthorn.eu re-branding— to make this name more chris.birch@easthorn.eu marketable and because we found out Web site: www.easthorn.eu that there are a lot of companies with the name Unimed in our countries— medical, private practices or outpatient Macedonia. As EastHORN, we started departments—and this made locating geographical expansion in Central and our company by a web search much Eastern Europe (CEE) and will con- easier. That was the reason for the tinue to grow in this direction. With name change. We also wanted to give headquarters in Czech Republic and more meaning to the name of the com- the largest operations there, we also es- pany and one that would express a bit tablished offices in Poland, Bulgaria of the company profile. and Romania. We have contacts in Ukraine, Russia and other Balkan Although the name of the company— countries, and we intend to open offices EastHORN—is new, this is a company there soon. It’s just the first step in our with a history, and we are building strategy to be able to cover all CEE EastHORN around this core business countries. developed by Unimed—this original company with headquarters in Czech Republic and initially focused on Czech Republic, Slovakia. They used to have some operations in Bulgaria and Company Profile CWWeekly | 9
  10. 10. I I where trials are run—in Central and Eastern Europe—not in the U.S. or the Why is the CEE What differentiates UK, and decisions are made by people who really know the local realities. region an important EastHORN from area for clinical trials? other CROs? I The reason CEE is so successful in We are a full service company. We What challenges clinical trials—meaning there are a lot have a phase I unit based in Thomayer do you face? of patients, motivated patients, moti- University Hospital in Prague. This vated investigators—is very sad, I is a big advantage because this unit I used to work in various countries. I would say. An under-invested health- is based in a hospital where you have started in Poland—this first wave of care system—a much lower level of access to not only healthy volunteers Central and Eastern European coun- public healthcare system than in west- but also patients as well as the hospi- tries in terms of clinical trial develop- ern countries—is the main contribut- tal facilities, such as imaging services ment. Five years or even 10 years later, ing factor for this situation. As long as or the ITU [intensive care unit] de- we had new countries appearing on we have this disproportion between partment. This differentiates us from the market, such as the Balkan coun- people’s needs and access to the med- phase I units located in Czech Repub- tries, with Russia and Ukraine ex- ical care, then we will have the lic and CEE. Management and our panding. There is a huge difference grounds for successful clinical trials. clinical staff are based in and comes between the situation several years ago Clinical trials are providing patients from the region with an excellent un- and now in all CEE countries. It’s not with access to new medicine and much derstanding of the local environment just related to the region itself but it’s better care. and culture and has tried and tested related in general to the changes in solutions to overcome challenges the drug development. Protocols are be- CEE is a very diverse region with over region brings. Although we seem to be coming more complicated, it’s more 20 countries. There are some countries a regional company, we are usually difficult to recruit patients, and regu- with much better economic states, like perceived as the company with a local lations are more demanding and Poland, Czech Republic and Hun- management style. changing all the time. Running clinical gary—European Union members. trials requires more resources from the These countries are becoming much Our biggest advantage that differenti- sites, investigators, CROs and spon- more problematic in terms of site sat- ates us from competitors is that the en- sors than in previous years as studies uration, patients’ willingness to par- tire corporate management has global become more complex despite ad- ticipate in the trials, as well as very pharma and CRO experience. Alan vances in technology. unfriendly and constantly changing Wood, who is chairman of the board, regulations, but there is still space for and I came from a global company, The biggest challenge specific to the expansion, for example, in the Balkan Covance, but Alan also has biotech region is the dynamism of changes, region. Also, Russia is not well-ex- pharma company experience. We which is not good for the clinical trials plored, considering the potential pa- manage this company in a way that is process because it requires long-term absolutely focused on anticipation and tient population, and there are other stability. We are changing much faster understanding of clients’ needs in a countries like former Soviet Republics than other countries and usually the different way from other local compa- Belarus, Kazakhstan and Azerbaijan, changes are improvements to attain nies. Comparing us with global com- which probably sooner or later will be the Western standard in various areas panies that are present in the region, involved in clinical trials and are re- of our life. That is why things are not we are probably similar in terms of gions EastHORN is considering for the same today as they were a year quality and standards of service be- the future. ago in terms of regulations, the labor cause we are able to offer service on market and price and cost. the level of the global CRO through I think for the next five years at least the highly professional staff. But, we we will maintain somehow the same have a lot of advantages in terms of The biggest challenges relate to regu- benefit from doing clinical trials in flexibility of the company, our com- latory control and the very often neg- CEE considering cost-efficiency but it’s mitment to each and every client re- ative approach of our authorities to mostly related to time-saving. The re- gardless of size, our managerial the clinical trials business due to vari- gion offers much faster patient re- involvement in each and every project, ous reasons, including financial bene- cruitment and high quality of data and our efficient issues escalation and de- fits related to the trial. high work efficiency aligned with the cision-making process and responsive- Western business model. These are ness. This is completely different than crucial factors that differentiate our in the global companies. Another ad- region from other emerging countries. vantage is definitely cost-efficiency be- cause our overhead is very minimal. Our core management is based here Company Profile CWWeekly | 10
  11. 11. I What are your plans for the future? We definitely want to maximize what we can get from existing countries, but it’s becoming more difficult. That’s why we want to be able to run trials in other countries in the region that are not very well explored at this moment. We definitely want to work in the Balkan Peninsula—Serbia, Bosnia-Herzegovina, Montenegro— those countries have huge potential. We want to go to Belarus and then gradually explore other former Soviet republics. We will be focused on the future EU members, including Turkey, and maybe add Israel to our locations considering some similarities with CEE. This is our strategic plan for now, but, as a flexible company, we might change our plans depending on the sit- uation in the global and regional economies and other external factors like regulatory obstacles. We are con- sidering opening offices in some West- ern European countries as these locations are sometimes very much needed by our clients. We are thinking about other emerging markets that are unexplored at this moment but we consider them as a very high potential in the future. Definitely the Chinese market is something that we’d like to look at, but probably it will take more than three years as it needs a lot of time preparing the environment to open your business there. Africa is a region that is very difficult but, again, unexplored. Here, we do not have any precise plans in terms of coun- tries yet. cww Editor’s Note: Organizations featured in our profiles have been selected by CenterWatch editorial staff. If you would like to be considered for a profile, please send an email to editorial@centerwatch.com. Company Profile CWWeekly | 11
  12. 12. cww | drug & device pipeline news | Company Drug/Device Therapeutic Area Status Sponsor Info Bioheart MyoCell congestive heart Phase I trials initiated (954) 835-1500 (muscle stem cells) failure in Jordan www.bioheartinc.com Neogenix Oncology NPC-1C pancreatic or Phase I trials initiated (516) 482-1200 colorectal cancer www.neogenixoncology.com Psyadon ecopipam Lesch-Nyhan Phase I trials initiated (301) 919-2020 Pharmaceuticals disease in the U.S. www.psyadonrx.com ArQule ARQ 197 colorectal cancer Phase I/II trials (781) 994-0300 initiated www.arquke.com Penwest A0001 MELAS syndrome Phase IIa trials (845) 878-8400 Pharmaceuticals initiated enrolling 30 www.penw.com subjects in England Trigemina intranasal oxytocin chronic daily Phase IIa trials (650) 938-0898 headache initiated enrolling 80 www.trigemina.com subjects in the U.S. ArQule ARQ 197 germ cell tumors Phase II trials initiated (781) 994-0300 enrolling 41 subjects www.arquke.com in the U.S. Genta tesetaxel melanoma Phase II trials initiated (908) 286-9800 in Texas www.genta.com Osiris Therapeutics/ Prochymal (stem heart attack Phase II trials initiated (443) 545-1800 Drexel University cell therapy) enrolling 220 subjects www.osiris.com College of Medicine in the U.S. and Hahnemann University Hospital QR Pharma Posiphen Alzheimer’s disease Phase II trials initiated (484) 253-2296 www.qrpharma.com XOMA XOMA 052 type 2 diabetes Phase IIb trials (510) 204-7200 initiated enrolling 325 www.xoma.com subjects in the U.S. Kamada inhaled alpha-1 alpha-1 antitrypsin Phase II/III trials +972 8 9406472 antitrypsin deficiency initiated in Europe www.kamada.com Anthera A-002 acute coronary Phase III trials (510) 856-5600 Pharmaceuticals syndrome planned enrolling www.anthera.com 6,500 subjects internationally Chelsea Northera neurogenic Phase III trials (704) 341-1516 Therapeutics (droxidopa) orthostatic planned enrolling www.chelseatherapeutics.com hypotension 84 subjects internationally Drug & Device Pipeline News CWWeekly | 12
  13. 13. Company Drug/Device Therapeutic Area Status Sponsor Info Dynavax Heplisav hepatitis B vaccine Phase III trials (510) 848-5100 Technologies initiated enrolling www.dynavax.com 2,000 subjects in North America QRxPharma MoxDuoIR acute post- Phase III trials (908) 506-2900 surgical pain initiated enrolling 140 www.qrxpharma.com subjects in the U.S. AVI BioPharma AVI-5038 Duchenne muscular Orphan drug (425) 354-5038 dystrophy designation granted www.avibio.com by the EMEA Talecris aerosolized congenital Orphan drug (919) 316-6300 Biotherapeutics alpha1-proteinase alpha1-antitrypsin designation by the www.talecris.com Inhibitor deficiency U.S. FDA Paladin Labs Abstral breakthrough NDS filed in Canada (514) 340-1112 cancer pain www.paladin-labs.com Lux Biosciences voclosporin non-infectious MAA filed with the (201) 946-0551 uveitis EMEA www.luxbio.com Lux Biosciences voclosporin non-infectious NDA filed with the (201) 946-0551 uveitis FDA www.luxbio.com Astra Zeneca Crestor heart attack FDA approved for (302) 886-3000 prevention new indication www.astrazeneca.com Daiichi Sankyo Benicar hypertension in FDA approved for (973) 359-2600 children new indication www.dsi.com integrated intelligence Integrating scientific and operational expertise with proprietary technology to generate, analyze and communicate real-world evidence. Learn more at unitedbiosource.com Drug & Device Pipeline News CWWeekly | 13
  14. 14. cww | trial results | Cardiovascular (125mg every six hours) for a 10-day placebo-treated patients over the 16 course of therapy. The trial met the hours post-drug administration Genzyme and ISIS reported positive primary endpoint of non-inferiority (p<0.05). This morphine-sparing results from a phase III study of with 91.7% of subjects treated with fi- effect was accompanied by a substan- mipomersen for the treatment of het- daxomicin achieving clinical cure tial decrease in the incidence of side ef- erozygous familial hypercholes- compared with 90.6% for Vancocin. fects often associated with morphine terolemia (heFH). This North Fidaxomicin also resulted in signifi- use, including an absence of vomiting American, randomized, double-blind, cantly lower recurrence rates: 12.8% and a 72% reduction in nausea placebo-controlled study enrolled 124 compared with 25.3% for the Van- (p<0.05). CR845 was safe and well subjects with heFH, pre-existing coro- cocin arm (p = 0.002) and higher tolerated. Cara plans to move forward nary artery disease and LDL-C levels global cure rates, defined as cure with with the development of CR845. greater than 100mg/dL. The subjects no recurrence within four weeks of received a 200mg dose of mipomersen completing therapy: 79.6% compared or placebo weekly for 26 weeks. The with 65.5%, respectively (p < 0.001). Oncology primary endpoint was reached, with a Fidaxomicin was well tolerated in the highly statistically significant 28% re- study. Optimer plans to file an NDA Amgen reported positive results from duction in LDL-cholesterol after 26 with the FDA in the second half of a phase III study of denosumab for weeks of treatment, compared with an 2010. bone metastases resulting from increase of 5% for placebo. Forty-five prostate cancer. This international, percent of the mipomersen-treated head-to-head, randomized, double group achieved LDL-C levels of less Neurology blind study enrolled 1,901 men with than 100mg/dL. The trial also met bone metastases from hormone-re- each of its three secondary endpoints Cara Therapeutics released positive fractory prostate cancer. The subjects with statistically significant reductions results from a phase II trial of CR845 received either 120mg of denosumab in apo-B, total cholesterol, and non for the treatment of post-operative subcutaneously every four weeks or HDL-cholesterol. Mipomersen was pain. This U.S.-based, double-blind, 4mg Zometa (standard of care) intra- well tolerated. The companies plan to placebo-controlled trial enrolled 46 fe- venously as a 15-minute infusion file for U.S. and European approval in male subjects who had undergone la- every four weeks. The primary en the first half of 2011. paroscopic-assisted hysterectomy. The point was to determine if denosumab subjects received a single intravenous is non-inferior to Zometa with respect infusion of 0.040mg/kg CR845 or to the first on-study skeletal-related Gastroenterology placebo following surgery and upon event (SRE). The composite endpoint reporting a moderate-to-severe pain of four SREs—fracture, radiation to Optimer issued positive results from a intensity level of 5 to 8 on a 0 to 10 bone, surgery to bone, and spinal cord phase III trial of fidaxomicin for the pain scale. Significant pain relief compression—was used to measure treatment of Clostridium difficile. This was observed in CR845-treated arm the effectiveness of denosumab versus double-blind, randomized, parallel over placebo from four to eight hours Zometa. Denosumab demonstrated group trial enrolled 535 adult subjects post-drug administration, as demo superiority over Zometa for both de- with confirmed infection across North strated by a significant change in pain laying the time to the first on-study America and Europe. The subjects re- intensity difference scores (p<0.05). SRE and reducing the rate of multiple ceived either fidaxomicin (200mg In addition, CR845-treated subjects SREs. Overall rates of adverse events every 12 hours) or oral vancomycin required 32% less morphine than and serious adverse events, including Contact Dr. David Ginsberg +1.610.975.9533 (office) +1.484.410.9429 (mobile) d.ginsberg@pierrelgroup.com FULL SERVICE INTERNATIONAL CRO ¦ 20 OFFICES IN N. AMERICA AND EUROPE Trial Results CWWeekly | 14
  15. 15. infections, were generally similar be- tween the two arms. Amgen plans to file for regulatory approval by the end of 2010. cww Trial Results CWWeekly | 15
  16. 16. cww | biotech review | I said Perry Karsen, president and CEO. go through, the biotech has other At that time, the company will review options. Ernst & Young previously predicted its options for moving forward, in- pharma’s acquisition tastes in 2010 cluding the possibility of partnering or I would run toward international firms, seeking an initial public offering. particularly those that provide a toe- Apeiron Biologics licensed its lead hold in emerging markets, and players I program APN01, a recombinant form in the fragmented branded generics of human angiotensin converting space, which is ripe for consolidation. Spectrum Pharmaceuticals entered a enzyme 2 (ACE2), to London-based Cephalon’s $590-million purchase of co-development and commercializa- GlaxoSmithKline in a deal valued Mepha blends both flavors. Geo- tion agreement with Copenhagen, at up to €236 million (US$329.4 graphically, Frazer, Pa.-based Denmark-based TopoTarget for beli- million). That figure includes an initial Cephalon boasts strong ex-U.S. sales nostat, a histone deacetylase (HDAC) payment of €13.5 million, which capabilities in France, the UK, Ger- inhibitor, a deal worth a potential consists of an upfront payment and an many, Italy and Spain. Meanwhile $350 million plus royalties on any net equity investment in the Vienna, Aus- Aesch, Switzerland-based Mepha is sales. Under the terms, Spectrum li- tria-based firm, as well as milestone strongest in Switzerland, the Middle censed the rights to belinostat for payments. The company also would East and Africa, Portugal, Poland and North America and India, and an op- receive double-digit royalties on even- Ukraine. The two firms have little ge- tion for China, in exchange for an up- tual product sales. Apeiron completed ographic overlap, which Cephalon ex- front cash payment of $30 million, the deal without any venture capital ecutives said contributed to their potential milestone payments of up to investment, having raised almost €7 ability to win the “very competitive” $320 million, and 1 million shares of million from founders, friends bidding for Mepha’s business. The Spectrum common stock based on and angel investors. cww Mepha acquisition “fundamentally achieving certain milestones. Spectrum doubles” Cephalon’s presence in Eu- and TopoTarget will jointly fund de- rope and provides new distribution velopment activities, with 70% of clin- channels in Eastern Europe and south- ical trial costs to be taken on by east Africa, Cephalon chairman and Spectrum, and 30% by TopoTarget CEO Frank Baldino said during a con- for new trials to be initiated. ference call. The combined company will have 3,500 employees selling I products in 100 countries, and about 30% of its sales will come from ex- VaxGen’s shareholders shot down a U.S. sources, Baldino noted. proposed merger with Oxigene— just like a proposed merger with Raven Biotechnologies two years ago. Oxigene was hoping to get VaxGen’s I $33 million in cash for the bargain In the process of raising its third major price of $22 million. With lead drug venture round, Pearl Therapeutics Zybrestat (fosbretabulin) in a pivotal pulled in an early $15 million in fund- thyroid cancer trial and midstage ing to push its lead program, an in- trials for lung and ovarian cancers, haled bronchodilator combination for Oxigene needed money. Last fall, The stories included in Biotech chronic obstructive pulmonary dis- when the merger was first announced, Review have been provided to ease, into phase IIb testing next quar- CEO Peter Langecker said Oxigene CenterWatch with the full permis- ter. Existing investors Clarus Ventures, “could not raise this amount of capital sion of BioWorld Today and its New Leaf Venture Partners and 5AM publisher, AHC Media LLC. Copy- in a single transaction and at these right ©2010 AHC Media LLC. Ventures agreed to a convertible loan terms in today’s market.” And Vax- facility set to convert to equity in the Gen had no use for its cash: The BioWorld is located at 3525 biotech at the time of a Series C fi- biotech imploded after its AIDS Piedmont Road, Building 6, Suite nancing. Pearl anticipates closing on vaccine failed two phase III trials and 400, Atlanta, GA 30305 U.S.A. the $40-million round in the third an $877.5-million government Please call (800) 688-2421 or (404) quarter, which should “take us contract for an anthrax vaccine fell 262-5476 for more information through our phase IIb trials and to the apart. Oxigene said that while it was or visit www.bioworld.com. beginning of phase III” with PT003, “disappointed” the merger didn’t Biotech Review CWWeekly | 16

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