Bwt07302010

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FRIDAY VOLUME 21 , NO. 146
JULY 30, 2010 PAGE 1 OF 7

How Much Is Genzyme Worth? Earnings Roundup
Sanofi Bid Rumored at $18.7B Celgene 2Q Earnings Beat
By Jennifer Boggs Street, AMAG Falls Short
Assistant Managing Editor By Donna Young
Shares of Genzyme Corp. continued climbing Thursday Washington Editor
amid rumblings of a possible $70-per-share bid from Sanofi- Hot off of its $2.9 billion bid for Abraxis BioScience
Aventis SA, but whether $18.7 billion is a fair takeout price Inc., Celgene Corp. beat earnings and revenue estimates
for the Cambridge, Mass.-based biotech clearly remains up for the second quarter on strong sales of its multiple
for debate. myeloma drug Revlimid (lenalidomide), which were up 48
Granted, Sanofi’s rumored offer – expected to come in percent from a year ago, at $587. 1 million.
the form of a “bear hug” letter to Genzyme’s board in the “The fundamentals of our core myeloma business
next couple of days, according to unnamed sources cited in remain very strong,” CEO Robert Hugin told investors and
the Financial Times – marks a nearly 30 percent premium analysts Thursday during a conference call. Growth in
to company’s closing stock price prior to last week’s initial the U.S, where Revlimid is approved in combination with
buyout speculation. But that might not be enough to dexamethasone as a second-line treatment for multiple
tempt Genzyme’s shareholders, which include Carl Icahn, myeloma and also for patients with transfusion-dependent
an activist investor notorious for driving up the prices of anemia due to low- or intermediate-1-risk myelodysplastic
biotech deals. syndromes, was driven by “increasing new patient starts
As chairman of ImClone Systems Inc. in 2008, Icahn and duration gains,” Hugin said.
See Genzyme, Page 3 See Earnings Roundup, Page 4

Huntington Hits Ireland Wants to Tap U.S.
Huntington’s Joins Illnesses Venture Capital Expertise
Where MMPs May Play Role By Cormac Sheridan
By Anette Breindl BioWorld Today Correspondent
Science Editor DUBLIN, Ireland – Despite a budget deficit that will
New research has implicated a previously unsuspected balloon this year to almost 20 percent of gross domestic
class of proteases in Huntington’s disease: matrix product (GDP), the Irish government is hoping to lure some
metalloproteinases, or MMPs. of America’s top venture capital fund managers across the
There’s “no real consensus” on the role of normal Atlantic with a €250 million (US$323 million) sweetener.
huntingtin protein, Robert Hughes told BioWorld Today. It Next September, Enterprise Ireland, the government
appears to be neuroprotective; it may be involved in vesicle agency responsible for developing indigenous firms, will
trafficking. But like a well-behaved child, regular huntingtin seek expressions of interest from U.S. venture capital
gets less attention than its problem sibling. “The bulk of the funds willing to establish a base in Ireland. At minimum
attention . . . has been on the mutant form of the protein.” it is seeking matching private sector funds, although the
What mutant huntingtin does is in one sense all the total available for investment could eventually climb even
clearer: It kills neurons in a brain area known as the striatum, higher than the €500 million target figure.
leading to the involuntary motions, dementia and emotional “What we’re planning on doing here is further
problems that collectively mark Huntington’s disease, which internationalizing the venture capital base in Ireland,”
is caused by neuronal death in specific brain regions. Garrett Murray, senior investment adviser at Enterprise

See Huntington’s, Page 5 See Ireland, Page 6

INSIDE: CLINIC ROUNDUP: ACADIA, ANADYS, ANTHERA, ATHERSYS ..............................2
OTHER NEWS TO NOTE: APTUIT, ASTEX, CLEVELAND BIOLABS .......................6
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FRIDAY, JULY 30, 2010 BIOWORLD® TODAY PAGE 2 OF 7

Clinic Roundup Stock Movers
• Acadia Pharmaceuticals Inc., of San Diego, started 07/29/10
a Phase III trial of pimavanserin, a 5-HT2A receptor inverse
agonist, in Parkinson’s disease psychosis (PDP). The -020 Company Stock Change
Study is expected to enroll about 200 patients who will be
Nasdaq Biotechnology -$2.85 -0.35%
randomized on a one-to-one basis to receive oral doses of
Arena Pharmaceuticals +$0.66 +10.4%
either 40 mg of pimavanserin or placebo once daily for six
Genzyme Corp. +$1 .79 +2.6%
weeks. Patients also will continue to receive stable doses of
Metabolix -$2. 17 -13.2%
their existing dopamine replacement therapy. The study’s
ONYX Pharmaceuticals +$0.83 +3.4%
primary endpoint is antipsychotic efficacy, measured
Pharma Product Development -$1 .97 -7.7%
using a group of nine items from the hallucinations and
ViroPharma +$0.83 +7. 1%
delusions domains of the Scale for the Assessment of
Positive Symptoms. Acadia previously initiated two Phase (Biotechs showing significant stock changes Thursday)
III pimavanserin trials in PDP, the first of which missed
its endpoint last year, with the firm citing a higher-than- in other clinical assessment scores, patient responses vs.
expected placebo response. Data from the second study baseline disease severities, resolution of fatigue, steroid
have not yet been reported. Pimavanserin is partnered in utilization and time to flare. A blinded interim biomarker
North America with Toronto-based Biovail Corp. Shares of analysis will be conducted early in the study to establish
Acadia (NASDAQ:ACAD) gained 22 cents, or 20.4 percent, to the appropriate drug effect on B cells and to potentially
close Thursday at $1 .30. (See BioWorld Today, Sept. 2, 2009.) remove any arm that is not demonstrating a biologic effect.
• Anadys Pharmaceuticals Inc., of San Diego, reported • Athersys Inc., of Cleveland, and partner Angiotech
that six of six patients in the ANA598 200-mg twice-daily Pharmaceuticals Inc., of Vancouver, British Columbia,
arm who were randomized to stop all treatment at week 24 reported four months of post-treatment data from a Phase
in an ongoing Phase II trial maintained undetectable levels I trial of MultiStem, an allogeneic cell therapy product
of hepatitis C virus 12 weeks after stopped treatment. All designed for administration after myocardial infarction,
available patients from the ANA598 200-mg arm who were showing that it was well tolerated at all dose levels and
previously reported to have undetectable levels of virus at suggested improvement in heart function in treated
week 24 and continued on pegylated interferon and ribavirin patients. Each dose group showed improvement in mean left
also maintained undetectable levels at week 36. ANA598 is a ventricular ejection fraction (LVEF) compared to baseline,
direct-acting antiviral. and patients in the 50 million dose group had a statistically
• Anthera Pharmaceuticals Inc., of Hayward, Calif., significant absolute improvement in mean four-month
started a Phase IIb study, designated PEARL-SC, to test LVEF relative to baseline. Among patients with more severe
A-623, an inhibitor of B-cell activating factor, in systemic heart attacks, the 50 million and 100 million dose groups
lupus erythematosus (SLE). The study will enroll up to 600 each demonstrated better than a 25 percent improvement
patients randomized into three active treatment arms and in mean LVEF over baseline. The study evaluated a single
one placebo arm for a minimum of 24 weeks. The primary administration of MultiStem cells delivered via a catheter
endpoint is clinical improvement in the SLE responder index, into the damaged region of the heart two to five days
while secondary endpoints will include safety, improvement following percutaneous coronary intervention.

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Genzyme clarified as being in the range of $5 billion to $20 billion.
Continued from page 1 Like most big pharmas, Sanofi is looking to beef up its
convinced investors to hold out for a higher offer following pipeline ahead of patent cliffs. The firm already warned
Erbitux (cetuximab) partner Bristol-Myers Squibb Co.’s investors that its core earnings might fall as much as 4
$60-per-share bid. A few months later, New York-based percent this year due to the entry of a generic version of
ImClone went to Eli Lilly and Co. for $70 per share, or about anticoagulant Lovenox (enoxaparin) onto the market. Late
$6. 1 billion, a more than 50 percent premium to ImClone’s last week, the FDA granted approval for the generic from
closing price prior to BMS’ initial bid. (See BioWorld Today, Momenta Pharmaceuticals Inc., though Sanofi has filed
Aug. 1 , 2008, and Oct. 7, 2008.) a lawsuit seeking preliminary injunction. (See BioWorld
A year earlier, Icahn added momentum to dissatisfied Today, July 26, 2010.)
investors at Gaithersburg, Md.-based MedImmune Inc., and In addition to its usually lucrative ERT franchise,
that firm ended up being sold to AstraZeneca plc for $15.2 Genzyme markets biosurgery drug Synvisc (hylan G-F 20)
billion – a 53 percent premium – a short time later. He failed, and renal drugs Renvela (sevelamer carbonate) and Renagel
however, to find an acquirer for another biotech, Biogen (sevelamer hydrochloride). The biotech, which reported
Idec Inc., for which he reportedly had set a $25 billion price total revenue of $1 .08 billion for the second quarter, had
tag. (See BioWorld Today, April 24, 2007, and Dec. 14, 2007.) about $974 million in cash as of June 30. ■
Genzyme, which might have seemed vulnerable to a
low-ball offer after a string of negative headlines over the
past year, finally reported some good news in the last three Clinic Roundup
months, with the FDA’s sooner-than-expected approval
of Lumizyme, the 4,000L version of Pompe disease drug • Bionovo Inc., of Emeryville, Calif., said it received final
Myozyme (aglucosidase alfa), and plans to get production guidance from European regulators to advance Menerba,
of other enzyme replacement therapies Cerezyme its lead candidate for menopausal symptoms, into Phase III
(imiglucerase alfa) and Fabrazyme (agalsidase beta) back trials. The company also has a meeting scheduled with the
up to capacity after the six-month shutdown last year. (See FDA to discuss the development of Menerba, an estrogen
BioWorld Today, June 17, 2009, and May 26, 2010.) receptor beta drug aimed at treating vasomotor symptoms
The company’s stock (NASDAQ:GENZ), which has risen associated with menopause.
since last week, topped $70 Thursday morning and closed • Bio-Path Holdings Inc., of Houston, dosed the first
at $69.79, up $1 .79. patient in a Phase I study of cancer drug candidate Liposomal
Had the big biotech not suffered the Cerezyme and Grb-2 in patients with acute myeloid leukemia, chronic
Fabrazyme manufacturing and supply issues, a fair takeout myelogenous leukemia, acute lymphoblastic leukemia or
value would be around $85 per share, according to Jefferies myelodysplastic syndrome. The dose-escalating study is
analyst Eun K. Yang, who still expects a higher offer from designed to determine safety and tolerability, as well as to
Sanofi to get a deal done. determine the optimal dose for further development. Five
At initial levels of around $75 per share, Genzyme doses will be tested, and the trial will enroll between 18 and
“would be interested in starting a potential acquisition 30 patients.
discussion,” Yang wrote in a research note, predicting • Dendreon Corp., of Seattle, said data from the pivotal
$85 per share as a likely selling point, “better reflecting a Phase III IMPACT study were published in The New England
turnaround value of the company.” Journal of Medicine, showing that cancer vaccine Provenge
Yet not all analysts are valuing Genzyme on the higher (sipuleucel-T) demonstrated a statistically significant
end. Christopher Raymond, of Robert W. Baird & Co., wrote improvement in overall survival compared to control in men
in a July 23, 2010, note that “we were hard pressed to reach a with asymptomatically or minimally symptomatic metastatic
value much higher than the low to mid $60s, which implies castration-resistant prostate cancer. Results showed
a total deal value in the $16 billion to $17 billion range.” Provenge extended median survival by 4.1 months compared
In the meantime, both Genzyme and Paris-based Sanofi to control (25.8 months vs. 21.7 months) and reduced the risk
have remained mum. Sanofi CEO Chris Viehbacher declined of death by 22.5 percent compared to control. Provenge was
to either confirm or deny that acquisition negotiations were approved in April. (See BioWorld Today, April 30, 2010.)
in the works during the company’s second-quarter earnings • Intra-Cellular Therapies Inc., of New York, said
call Thursday and also dodged a slyly worded question by a Phase Ib/II trial of ITI-007 met its primary endpoint,
one analyst seeking to gauge the pharma firm’s interest in demonstrating that the drug was safe and tolerable in
orphan drugs. patients with stabilized schizophrenia. Treatment with ITI-
But Sanofi has disclosed its intention to add to its pipeline 007 also yielded clinical signs consistent with antipsychotic
through acquisitions. “We always said we would avoid a and antidepressant efficacy, including a reduction in the
mega-merger,” Viehbacher told investors on the call. Instead, total Positive and Negative Syndrome Scale and the Calgary
Sanofi is aiming for “small to medium acquisitions,” which he Depression Scale for Schizophrenia.



Earnings Roundup A week later, updated data presented at EHA from the
Continued from page 1 firm’s MM-015 trial demonstrated a 58 percent reduced
Sales of Revlimid in Europe also produced “robust risk of overall progression in the non-stem-cell transplant
results, despite an increasingly challenging economic population, he added. (See BioWorld Today, June 15, 2010.)
environment,” he maintained. “Data from the podium from the MM-015, IFM and CALGB
Hugin noted that the second-line market share studies all demonstrated the progression-free survival
increased nearly 40 percent in the four major European advantage of continuous Revlimid therapy,” Hugin said.
markets where Revlimid is reimbursed, and in the UK, where Those three Phase III studies, he said, “represent the
the drug is reimbursed in the third-line setting, market share pillar of our myeloma strategy: the generation of supportive
was over 50 percent. “We are monitoring the environment data for early and continuous treatment of the disease.”
closely, and believe that our guidance appropriately reflects “We believe that we are just seeing the beginning of
the current economic reality,” he assured investors. the impact of the paradigm-changing data that support
In other international markets, Celgene also saw “strong continuous use of Revlimid,” Hugin said.
sequential growth, and is making good progress,” Hugin During the quarter, Celgene also had “substantial
said. progress” in advancing its other programs, including
The most significant commercial development for starting its first pivotal Phase III trial of its lead anti-
the quarter was Revlimid’s approval in June in Japan as a inflammatory product Apremilast in psoriatic arthritis and
second-line treatment for multiple myeloma. the initiation of the firm’s Phase I cancer clinical study of its
“Governmental reimbursement was achieved in dual mTOR kinaise inhibitor CC-223, he said.
less than a month of approval, accurately reflecting the “The significant progress in this quarter further
importance of Revlimid therapy in myeloma and a validation strengthens our belief that the same long-term growth
of the quality of the planning and execution of the Celgene comes best through an unwavering commitment to invest
team in Japan,” Hugin said. in multiple programs designed to produce breakthrough
Celgene currently is in the early stages of a “thoughtfully therapies for patients with serious unmet medical needs,”
planned” commercial launch in that country, which Hugin Hugin said.
noted is the second largest oncology market in the world. David Gryska, Celgene’s chief financial officer, noted
Revlimid’s marketing campaign in Japan includes global sales of the firm’s myelodysplastic syndrome
the introduction of Celgene’s RevMate risk management treatment Vidaza (azacitidine) also rose 43 percent to $132
distribution system, he explained. million, and its drug for newly diagnosed multiple myeloma,
“We believe that our long-term interests are best served Thalomid (thalidomide), also remained solid at $98 million.
by ensuring that hematologists in Japan are well educated Celgene’s non-GAAP total revenue increased by 36
on the effective and safe use of Revlimid to ensure a positive percent to $850 million, Gryska added.
first experience,” Hugin contended. “A proper foundation While strengthening Celgene’s hematology pipeline
will pay significant long-term dividends.” remains the firm’s “strategic imperative,” its intended
He argued that the investments Celgene has made in acquisition of Abraxis BioScience would “broaden our
Japan and other international markets will enable the firm therapeutic market into the solid tumor market,” Hugin
to “capture the full value of Revlimid and the many other said. (See BioWorld Today, July 1 , 2010.)
opportunities in our pipeline in all major markets.” He noted that Abraxis’ lead product, Abraxane, which
Given that new data are the “life-blood of hematology- is approved in the U.S. and other markets as a treatment
oncology products,” positive study results presented last for metastatic breast cancer, also has shown “significant
month at the annual meetings of the American Society of promise” in pancreatic and non-small-cell lung cancers.
Clinical Oncology (ASCO) and the European Haematology “The transaction provides the opportunity for us to
Association (EHA) will move Revlimid forward as the leverage our global commercial, clinical and regulatory
“standard of care” for continuous treatment for patients organization and further strengthen our pipeline with multiple
with multiple myeloma, Hugin said. candidates from the Abraxis proprietary MAb technology
“By every measure, these meetings were a great success portfolio,” Hugin said. He said Celgene remains “optimistic”
for Celgene products,” he declared, noting that Revlimid that it can close the deal in the next two to three months.
data were presented in more than 100 posters and more In other earnings news:
than 20 oral presentations at the ASCO and EHA meetings. • AMAG Pharmaceuticals Inc., of Lexington, Mass.,
In Celgene’s IFM and CALGB studies presented reported second-quarter revenues of $18.8 million, but
at ASCO, continuous Revlimid therapy demonstrated product revenues of its intravenous iron deficiency
“unprecedented” reduction in the risk of disease progression anemia treatment, Feraheme (ferumoxytol), fell short
in the post-stem cell transplant setting, with 54 percent and of analysts’ expectations at $16 million. Shares of AMAG
58 percent risk reduction, respectively, Hugin said. (See (NASDAQ:AMAG) plunged $4.54 Thursday, or 12.5 percent,
BioWorld Today, June 8, 2010.) to close at $31 .65. ■



Huntington’s unexpected new targets, Hughes said.
Continued from page 1 MMPs, he added, are not a group of proteases that
Mutant huntingtin has an extra string of glutamines were likely prior suspects in Huntington’s disease. Their
that leave the protein unable to fold into its normal identification “shows the power of unbiased screening.” ■
configuration, leaving it to form clumps instead. Digestive
enzymes called proteases recognize the mutant protein as
cellular trash and cut it for disposal. But while full-length Financings Roundup
mutant huntingtin is also detrimental to the cell, those
fragments appear to be even more toxic than the intact • CMP Therapeutics Ltd., of London, raised
protein itself. €1 .5million (US$1.96 million) through a convertible loan
Most of the work on the contribution of proteases to from Inventages Venture Capital to support continuing
Huntington’s has focused on two particular families of operations and the upcoming clinical trial of its lead
proteases: caspases and calpain, which were certainly a product for the common cold. The company also appointed
reasonable choice, as they are important in the major cell Neill Moray Mackenzie CEO. Mackenzie most recently
death pathways. served as senior vice president of business development
But, Linda Ellerby told BioWorld Today, comprehensive and corporate strategy at Medigene AG, of Martinsried,
screening “is more timely now in terms of what we are Germany, and also previously was the CEO for Roji Ltd., of
capable of doing.” So Hughes and Ellerby, who are at the London.
Buck Institute for Age Research, decided to use high- • Omeros Corp., of Seattle, secured a committed
throughput protein blotting to take a more comprehensive equity financing facility under which it may sell up to
look at the known proteases – all 500 and change of them $40 million of its shares of common stock to investor
– in Huntington’s disease. Azimuth Opportunity Ltd. over 24 months. Omeros said
The authors and colleagues used RNA interference it intended to use the proceeds from future sales of
to block the proteases, one by one, in cultured cells with securities under the facility, if any, for general corporate
mutant huntingtin. They found that 1 1 proteases led to the purposes.
formation of the smallest huntingtin fragments, which are
particularly toxic to cells. Nine of the 1 1 proteases appeared
to be toxic to striatal cells – the brain cell type affected in Other News To Note
Huntington’s disease.
Three of the nine proteases were MMPs, and a fourth • Abraxis BioScience, Inc., of Los Angeles, and
interacted with a MMP, prompting the team to take a closer Specialised Therapeutics Ltd., based in Melbourne,
look at this group of enzymes as a whole. Australia, reported that MEDSAFE, the New Zealand Medicines
They found that one of the MMPs, MMP-10, directly and Medical Devices Safety Authority, has approved
cleaves mutant huntingtin. The other MMPs appear to play for marketing Abraxane (nanoparticle albumin-bound
a less direct role, but inhibiting them also reduced brain cell paclitaxel) for the treatment of metastatic breast cancer after
toxicity and motor problems in fruit flies that are engineered failure of anthracycline therapy. Abraxis previously granted
to have mutant huntingtin protein. exclusive marketing rights to Specialised Therapeutics for
The authors concluded from their experiments, which Abraxane in New Zealand. Specialised Therapeutics will start
were published in the July 29, 2010, issue of Neuron, that distribution upon receiving reimbursement approval from
“general inhibition of MMPs may be of therapeutic benefit in the New Zealand pharmaceutical reimbursement authority,
Huntington’s disease and that specific inhibitors of MMP-10 Pharmac. The drug is fully reimbursed for metastatic breast
may be particularly relevant to disease treatment.” cancer after failure of prior therapy in Australia under the
Huntington’s disease joins a growing roster of medical Pharmaceutical Benefits Scheme.
problems, including rheumatoid arthritis, cardiovascular • Anacor Pharmaceuticals Inc., of Palo Alto, Calif.,
disease, cancer and stroke, as a disease where targeting said partner London-based GlaxoSmithKline plc exercised
MMPs could be useful. Given that MMPs seem to rear their its option to obtain an exclusive license to GSK2251052
head everywhere that there’s a medical condition, several (formerly AN3365), a systemic antibiotic derived from
inhibitors of the enzymes already exist. Anacor’s boron chemistry platform. That option triggers
Whether targeting MMPs will ultimately pan out a $15 million exercise fee under the companies’ 2007
clinically is far from clear. collaboration, and Anacor also is eligible for further
The results of clinical trials using MMP inhibitors in development and commercialization milestone payments
other indications have by and large been rather dispiriting plus royalties. GSK will take over responsibility for further
to date. But the fact that their method was able to identify development the compound, which has shown activity
them at all is a testament to the fact that what he termed against multiresistant Gram-negative bacteria in early stage
“an agnostic approach” to target validation can unearth studies. (See BioWorld Today, Oct. 9, 2007.)



Ireland The initiative is part of the government’s “smart
Continued from page 1
economy” strategy, which puts science-based enterprise at
Ireland, told BioWorld Today. “We’ve now gotten to the point the heart of its industrial policy. However, public finances are
where it needs something extra.” in a torrid state because of falling tax revenues and a bank
U.S. investors would not only have access to deal bailout that will cost at least €25 billion. Science Foundation
flow in Ireland, but could use Dublin as a base to tap into Ireland, the main research agency, has had its budget cut to
opportunities in other parts of Europe. “We want to make it the extent that its ability to fund new initiatives, on top of
one of the places for venture capital in Europe,” he said. “It existing commitments, is extremely limited.
would be strategically extremely beneficial to have four or Even so, the government recently unveiled a new €259
five tier-one fund managers based out of Ireland.” million capital investment program for the country’s third
Enterprise Ireland has been a significant actor on the level institutions, which will be further boosted by another
local venture capital scene for more than a decade. Its latest €99 million in recurrent funding.
program, which commenced in 2007, has led to the creation Capacity development in bioscience, translational
of eight local funds with €525 million committed, more research and biomedical research will account for €204
than €140 million of which it supplied directly. million of the total.
The new initiative, known as Innovation Fund – Ireland, Initiatives receiving funding include a €17 million nano-
has no preset agenda in terms of sectoral coverage. So bioanalytical facility at Dublin City University; a €54 million
there is no guarantee that one of the funds will focus on life science center at University College Dublin; a €33 million
sciences, for example. “If you pre-ordain one should have medical science facility at the National University of Ireland,
life sciences from the start, you might have to compromise Galway; a €55 million medical sciences facility at Trinity
in terms of who you end up investing with,” Murray said. College Dublin; and a €19 million translational medicine
Nevertheless, it would be surprising if there was no facility at University College Cork. ■
place for life sciences in the initiative, as it remains a
priority area for the country’s research funding. Moreover,
pharmaceutical and biotechnology firms accounted for 28 Other News To Note
percent of the €288 million total private equity funding
raised by Irish firms last year. And drug delivery and medical • Aptuit Inc., of Greenwich, Conn., and Siena Biotech
device firms accounted for another 13 percent, according to SpA, of Siena, Italy, have signed a strategic partnership in
the Irish Venture Capital Association. which Siena Biotech will take a minority stake in Aptuit’s
Overseas investors, such as the Novartis Venture Italian operations in Verona, Italy. Aptuit will become
Fund, Inventages Venture Capital, Sofinnova Ventures, a provider of choice for Siena Biotech’s development
Orbimed Advisors, Longitude Capital and Abingworth LLP, pipeline. The companies plan to work collaboratively on
participated in deals led or co-led by Irish funds, without the development of Siena Biotech’s pipeline of compounds,
establishing a presence here. Murray said he expects those focused in three therapeutic areas: Alzheimer’s disease,
kind of deals to continue. Huntington’s disease and oncology. Financial terms were
“What this money is trying to achieve is to act as a not disclosed.
catalyst,” he said. “This is part of a jigsaw – it won’t work • Astex Therapeutics Ltd., of Cambridge, UK, reported
alone.” data from two papers published in the Journal of Medicinal
This attempt to tap into U.S. venture capital expertise Chemistry demonstrating the ability of its fragment-based
carries an implicit criticism of local venture capital funds, drug discovery platform, Pyramid, to identify small-molecule
which remain in the dark about the initiative. Peter Sandys, drugs. The first paper described fragment-based screening
chairman of the IVCA and managing partner at Dublin- of heat-shock protein 90 and subsequent structure-
based Seroba Kernel Lifesciences, told BioWorld Today that guided chemistry that improved the affinity of initial lead
the basic strategy has potential. “I believe it’s possible to compounds by more than a million-fold with the addition of
attract entrepreneurs and technologies to Ireland,” he said. only six atoms. The companion paper described how the lead
“Everything doesn’t have to be invented here – there’s great compound, AT13387, was optimized.
possibilities on that front.” • Cleveland BioLabs Inc., of Buffalo, N.Y., said the
However, he said that international VC funds have Biomedical Advanced Research and Development
already invested heavily in the Irish market. There remains, Authority exercised the $4. 1 million fourth milestone-
he said, too strong an emphasis on basic biology and based option on the company’s existing broad agency
target discovery in the country. “Working on targets, while announcement contract, originally valued at $15.6 million,
absolutely necessary, is not going to yield companies for for selected tasks in the advanced development of Protectan
a very long time,” he said. Greater emphasis is needed on (CBLB502). The fourth option supports the manufacturing
advancing molecules. “That’s how we can attract money process of the compound and three additional registration
and get companies going.” batches of the drug plus additional animal studies.



entered into a collaboration with Versartis Inc., of
Other News To Note Mountain View, Calif., to manufacture its once-monthly
human growth hormone VRS-317. SynCo also will provide
• The FDA Thursday alerted prescribers about the potential fill and finish services for the manufacture, testing and
for patients receiving the intravenous antibacterial drug release of formulated drug product vials. The deal expands
Cubicin (daptomycin), marketed by Cubist Pharmaceuticals an earlier collaboration with Versartis to manufacturer VRS-
Inc., of Lexington, Mass., to develop eosinophilic pneumonia, 859 (exenatide-XTEN), which recently entered a Phase I trial
a rare but serious condition where a type of white blood cells testing monthly doses of the compound in patients with
fill the lungs, potentially leading to progressive respiratory Type II diabetes.
failure and death. An FDA review identified seven cases of • VaxGen, Inc. has reported the completion of its
eosinophilic pneumonia between 2004 and 2010 “most likely” merger with diaDexus Inc., both of South San Francisco,
associated with Cubicin. Shares of Cubist (NASDAQ:CBST) lost which was initiated in early June. As part of the transaction,
24 cents Thursday, to close at $21.68. VaxGen issued approximately 19,960,534 shares to certain
• Cytori Therapeutics Inc., of San Diego, received diaDexus stockholders and officers. VaxGen now has
European approval of its optimized tissue processing 53,067,057 shares of common stock issued and outstanding,
technology PureGraft 250/PURE for autologous fat grafting of which pre-transaction diaDexus stockholders and
procedures. officers own approximately 38 percent and pre-transaction
• Isis Pharmaceuticals, Inc., of Carlsbad, Calif., VaxGen stockholders continue to own approximately 62
has earned a $5 million milestone payment from London- percent. DiaDexus LLC (as the successor entity to diaDexus
based GlaxoSmithKline related to the designation as a Inc. in the transaction) will be a wholly owned subsidiary of
development candidate of a drug to treat an undisclosed VaxGen. (See BioWorld Today, June 1 , 2010.)
rare and serious disease. Isis will develop the drug to Phase • Vertex Pharmaceuticals Inc., of Cambridge, Mass.,
II proof of concept, at which time GSK has the option to reported that it remains on track to complete a new drug
license it. Earlier this year, Isis signed a $1 .5 billion RNA drug application for its hepatitis C virus (HCV) protease inhibitor
discovery alliance with GSK. Structured as an option deal, telaprevir later this year. But it also recently submitted the
Isis got $35 million up front and could get up to another nonclinical and the chemistry, manufacturing and controls
$155 million in pre-licensing milestones, averaging about sections of its NDA to the FDA as part of a rolling NDA
$20 million for each of five programs. (See BioWorld Today, submission for telaprevir. In May, the company reported
April 1 , 2010.) positive data from its first Phase III trial of telaprevir: 75
• Millennium, of Cambridge, Mass., a unit of Takeda percent of patients achieved a cure, or sustained viral
Pharmaceutical Co. Ltd., reported correlative science data response, after receiving 12 weeks of telaprevir plus SOC
derived from an analysis of archived tumor samples from followed by SOC alone, compared to just 44 percent of
patients in the pivotal Phase II PINNACLE trial testing Velcade patients receiving only SOC (p < 0.0001). (See BioWorld
(bortezomib) in relapsed/refractory mantle cell lymphoma. Today, May 27, 2010.)
The samples were tested for pre-specified biomarkers for • XOMA Ltd., of Berkeley, Calif., said the Committee for
their association with time to progression and response Orphan Medical Products of the European Medicines Agency
to treatment with Velcade. Research showed that elevated (EMA) has adopted a positive opinion and recommends the
expression of NFKB p65 or low levels of PSMA5 were granting of orphan medicinal product designation for XOMA
associated with longer time to progression and showed a 052, an antibody to interleukin-1 beta, for the treatment of
trend in better responses, while elevated levels of p27 were Behcet’s disease. In June, the company reported positive
associated with longer overall survival. Data also showed results from an open-label pilot study of XOMA 052 in Behcet’s
that the poor outcomes in MCL predicted by elevated levels disease patients who were suffering from vision-threatening
of Ki-67 were not overcome by Velcade monotherapy. Results disease exacerbations, known as uveitis, despite maximal
from the study were published in Leukemia & Lymphoma. doses of immunosuppressive medicines.
• Optimer Pharmaceuticals Inc., of San Diego,
submitted a marketing authorization application for
fidaxomicin, a macrocycle, which inhibits the bacterial Is Your Company
enzyme RNA polymerase, to the European Medicines Agency
under the European Union’s centralized procedure as a
Featured in This Issue?
treatment for Clostridium difficile infection. Optimer plans to Promote it on your website or in your investor kit!
submit a new drug application to the FDA later this year.
• Rosetta Genomics Ltd., of Rehovot, Israel, signed an For high-quality reprints of articles about your
exclusive distribution agreement for three of its diagnostic company, please contact Stephen Vance at (404)
tests with Genekor SA, of Athens, Greece. 262-5511, or stephen.vance@ahcmedia.com
• SynCo Bio Partners, of Amsterdam, the Netherlands,


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