BioSpace BioPharm Exec
Wednesday, May 27, 2009
Biotech's Green Shoots

What an eventful month! Since the last Biopharm Executive went out, there's been plenty of excitement. Here are just a few highlights:

    • Human infection with H1N1 virus spread around the globe, sparking debate about vaccination strategies and public health approaches to sharing out limited stocks of Tamiflu.

Takeaway: Joe Biden-style hysteria pretty quickly gave way to a backlash in which public health officials were accused of crying wolf. To me, though, this looks like a great practice run for something more lethal down the road. We're facing tough issues already--about how much swine flu vaccine to create, for instance, knowing it will take away from regular influenza vaccine production, as well as how to equitably distribute antivirals. Hopefully, this will make us recognize one key problem with our current public health system: Long-term, making vaccines in chicken eggs makes about as much sense as fueling cars with corn. We can do better.

    • The 2009 BIO International Convention took place in Atlanta with about 14,000 attendees--down rather sharply from the prior year, when there were over 20,000.

Takeaway: Low turnout probably had less to do with flu fears than it did with the economy and the simple fact that there's a bit less biotech to be convened these days. I was one of those people who didn't make it, unfortunately, but there was some excellent blogging going on--so much so that I feel as if I hardly missed a thing, except the rain. (Yes, .pdf readers, those are all helpful blog links.) More...

Even though the much-anticipated American Society of Clinical Oncology (ASCO) meeting is taking place at the end of the month, much of the most interesting clinical news of recent weeks concerned non-cancer big pharma drugs. But hey! We go where the stories are. AstraZeneca grabbed the spotlight with results from the pivotal PLATO study, which indicate--at least from what we've been told so far--that Brilinta (another classic pharma product name) is better than the Bristol Myers-Squibb/Sanofi-Aventis blockbuster Plavix at reducing the risk of stroke and heart attack in patients with acute coronary syndrome. With Plavix facing U.S. generic competition in 2011 and likely competition from Lilly/Daiichi Sankyo's Efient, the stakes are huge. -KT

AstraZeneca PLC (AZN) Shares Leap After Its Drug Beats Plavix in Test
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Exelixis, Inc. (EXEL) Drug Shows Promise in Brain Cancer-Study
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Roche (RHHBY)'s (JOBS) Avastin Shows Promise in Early Brain Cancer-Study
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Novartis AG (JOBS) Eyes Blockbuster Sales for New Lung Drug
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Eli Lilly and Company (LLY): Multiple Types of Heart Attacks Reduced by Prasugrel in TRITON-TIMI 38 Trial
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Eli Lilly and Company (LLY) Starts Big Studies for Alzheimer's Candidate
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More Bench To Clinic News
SafeBridge Consultants SafeBridge Consultants announces two training offerings (may be taken separately or consecutively) The SafeBridge original Potent Compound Safety "Boot Camp" (Boot Camp I) is a comprehensive two-day course in pharmaceutical potent compound safety focused on training EH&S and related professionals in critical technical concepts and proactive safety programs in pharmaceutical industrial hygiene, occupational and environmental toxicology, analytical chemistry, and risk communication. Aptuit Aptuit is a pharmaceutical services company focused on streamlining and supporting the drug development process for biotech and pharma innovators. Aptuit has been engineering a better drug development process by amassing a staff of consummate professionals, breakthrough technologies, facilities and new ideas to offer its clients seamless and globally integrated services.
These are still dark days. The past month witnessed the shutdown of Northfield Labs and Renovis, and the likely bankruptcy or liquidation of Genta and Targeted Genetics. But there have been hints of improvement--fewer layoffs, for one thing. And there was even an announcement that Pfizer is doing some hiring around its stem cell research program (OK, only about 15 people, but still...). It may be too soon to call a bottom in pharma bloodletting, but the pace seems to have slowed. That, at least, is good news. In other career news, Kathleen Sebelius became the last member of Obama's cabinet to be confirmed and sworn in, on the eve of his 100th day in office. -KT

Sebelius Sworn in as Health and Human Services Secretary
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Keryx Biopharmaceuticals (KERX) Announces Appointment of Ron Bentsur as Chief Executive Officer
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PPD, Inc. (PPDI) Names David Grange as New Chief Executive Officer
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Carl Hull Becomes Chief Executive Officer of Gen-Probe Incorporated (GPRO)
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Novartis Corporation (NVS) Names Pharma Veteran Symonds CFO Designate
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Molecular Insight Pharmaceuticals, Inc. (MIPI) Appoints Daniel L. Peters as President and Chief Executive Officer
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More Career Track News
Crown Bioscience Crown Bioscience
is a US-based oncology service company committed to advancing anti-cancer therapeutics through the preclinical and drug development stages. Our multi-disciplinary team of experts, located in two research campuses in Beijing and Shanghai, provides an integrated service solution from your idea to an enabling IND, including: preclinical, translational and clinical capabilities. Visit www.crownbio.com or call us at 603-686-9330.
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There's been a lot of dealmaking over the past month, but times being what they are, many companies are choosing "option" arrangements that minimize upfront cash outlays--witness not just Novartis' deal with Elixer, but also its no-money-exchanged rights swap with Schering-Plough. Japanese pharmas continue their aggressive ways: Takeda, in the wake of Dendreon's success, is taking a second swing at cancer immunotherapies. Although its $50 million deal with Cell Genesys on GVAX didn't work out so well last year, it's taking a whirl with IDM Pharma, which was pretty much on life support when the acquisition was announced. And Biovail has been making big waves in neurology, buying up Wellbutrin XL and the Huntington's disease drugs Xenazine/Nitoman, and inking a big deal with ACADIA on a Parkinson's drug. -KT

Elixir Pharmaceuticals Signs Option Agreement with a Major Pharmaceutical Company, Novartis Corporation (NVS); Deal Could Exceed $500 Million, Completes $12M Equity Financing
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Novartis AG (JOBS) Assumes Rights to Schering-Plough Corporation (SGP) (JOBS) Respiratory Drug
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) to Acquire IDM Pharma, Inc. (IDMI) for $75 Million, Adding MEPACT(R) (Mifamurtide), the First Treatment Approved for Osteosarcoma in More Than 20 Years, to Its Oncology Franchise
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ACADIA Pharmaceuticals, Inc. (ACAD) in Pact with Biovail Corporation (BVF) for Parkinson's Drug; Acadia Entitled to Receive up to $395 Million
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Oxford BioTherapeutics and GlaxoSmithKline (GSK) Form Strategic Alliance to Develop Novel Cancer Therapeutic Antibodies; OBT Eligible for Total of $370 Million
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GlobeImmune, Inc. and Celgene Corporation (CELG) Announce $500M Strategic Global Oncology Alliance; GlobeImmune Will Receive $40 Million Upfront
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Roche (RHHBY) Partners With Tekmira Pharmaceuticals Corporation to Advance RNAi Product Candidates in $50 Million Deal
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Pharm Country Career Fair Pharm Country Career Fair
BioSpace is pleased to present the Pharm Country Career Fair on Thursday, June 11, 2009 at the Hanover Marriott in Bridgewater, NJ. Candidates attending the biotech job fair in New Jersey must have a four year degree and at least two years of industry experience. All candidates are pre-screened to ensure a good match between attending job seekers and companies exhibiting at the life science career fair.
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BioSpace is pleased to present the Biotech Beach Career Fair on Wednesday, June 24, 2009 at the Manchester Grand Hyatt from 1pm to 6pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Southern California region.
Seize the day! We've seen companies taking advantage of current events to help shore up their finances. Dendreon using its surging share price to raise $230 million is no big surprise--shareholders are no doubt glad the company could wait for such favorable terms. But we also saw start-up VaxInnate leverage worries about H1N1, promising that a prototype swine flu vaccine could be ready for early tests in as little as six weeks! And I couldn't help but note Johnson & Johnson's $1 billion acquisition of Cougar Biotechnology. That's not only interesting because of the size of the deal, but because Cougar was brought public to the OTC bulletin board in 2006 through its reverse merger into a shell corporation. When noting the extremely checkered track record of reverse mergers, I'll have to acknowledge this big exception!

Finally, I was intrigued to see Clovis raise $145 million in start-up funding. Led by Patrick Mahaffy and other ex-Pharmion execs, this is another swing at the good ol' in-licensing strategy. Perhaps Vanda's 11th-hour success (see below) has gotten investors more enthusiastic about this otherwise moribund business model. Then again, Mahaffey's personal track record of success with this strategy is pretty hard to argue with. -KT

VaxInnate Corporation Closes $30 Million Round of Financing; Wellcome Trust Leads Round
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Dendreon Corporation (DNDN) to Offer Shares to Back Vaccine Sale
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Johnson & Johnson (JNJ) (JOBS) to Acquire Cougar Biotechnology, Inc. (CGRB.OB) for About $970 Million
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Lonza Group Ltd. to Invest $150 Million in Genome Valley
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Clovis Oncology Raises $145 Million in Start-Up Financing
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Cempra Pharmaceuticals, Inc. Closes $46 Million Series C Financing
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Calistoga Pharmaceuticals Raises $30 Million in Series B Financing
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Sequenom landed itself with a big headache over its diagnostic test for Down's syndrome. It announced at the end of last month that launch of SEQureDx would be delayed because an employee "mishandled" data and test results. A shareholder lawsuit followed almost instantly. And Onyx Pharmaceuticals showed that partners aren't always simpatico--they're in a bitter legal tussle with Bayer over ownership of a close chemical cousin to the anti-cancer drug Nexavar, which Onyx says was discovered over the course of the companies' partnership and belongs to both parties. The sordid tale leading to the lawsuit is actually pretty engrossing, and you can see a brief summary here. -KT

GlaxoSmithKline (GSK) in Potential $1.9 Billion Tax Battle with IRS
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AstraZeneca PLC (AZN) (JOBS) Wins US Ban on Generic of Asthma Drug
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Johnson & Johnson (JNJ) Plans to Arbitrate Remicade Pact with Schering-Plough Corporation (SGP) (JOBS)
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Onyx Pharmaceuticals, Inc. (ONXX) (JOBS) Sues Bayer AG (BAY.F) Over Anti-Cancer Compound
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Obama Proposes Increased Funding for FDA
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Sequenom Inc. (SQNM) Shares Plummet After Delay of Downs Test
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Approvals, approvals! Long-suffering UCB finally got the green light for its rheumatoid arthritis drug, while VeroScience got its diabetes drug out the door (no mean feat these days). But the real shocker of the month was Vanda Pharmaceuticals, which got approval for its atypical antipsychotic drug Fanapt only nine months after having received a "not approvable" letter from FDA and having been written off by just about everybody (myself included). It's a great victory for the company, although Vanda, as well as UCB, now face new hurdles: will these new drugs gain meaningful market share in crowded therapeutic niches? Still, Vanda management must be feeling pretty good these days. And those activist investors looking to take over Vanda's board and sell off the company? Turns out they were satisfied with a one-day, 625% gain. Never mind, fellas! -KT

Vanda Pharmaceuticals, Inc. (VNDA) Surges on Fanapt FDA Approval; Stock Up +625.93% at Market Close
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UCB Group (UCBJF.PK) Soars as U.S. Clears Key Arthritis Drug
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VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes
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New Warnings for Genentech, Inc. (DNA), OSI Pharmaceuticals, Inc. (OSIP) Tarceva Cancer Drug
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FDA Adds Child Exposure Warnings to Solvay Pharmaceuticals, Inc., Auxilium Pharmaceuticals (AUXL) Testosterone Gel
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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.

You may contact Karl Thiel at Karl.thiel@biospace.com.

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