BioSpace BioPharm Exec
Wednesday, March 31, 2010
The New Decade Finally Begins

It's been an historic month in American politics, and I'm not just talking about former president Bush wiping his hands clean. on former president Clinton's shirt. It's health care reform, of course! Whatever your political stripes, it was, as our Vice President reminded us, indeed a big f@$&ing deal.

With health care reform comes a major victory for PhRMA and the Biotechnology Industry Organization (BIO) -- a regulatory pathway for follow-on biologics that guarantees 12 years of exclusivity for innovator products. That victory is particularly impressive if you consider that the lengthy exclusivity period was opposed along the way by a very senior committee chairman (Henry Waxman), the Federal Trade Commission, and the White House itself. It's an indication of just how powerful a lobbying force biotechnology, and BIO in particular, have become.

Indeed, the drug industry played reform very well throughout the process, and in the end backed the right horse. The $80 billion in Medicare part D "donut hole" concessions made by PhRMA. should be more than made up in new business and an agreement not to seek price concessions elsewhere. And it puts public attention more squarely on the insurance industry as the recalcitrant bad guys in the process. More...

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It's funny how the needle on clinical results often seems to swing one way or another for almost the entire industry at certain times. The last month has been largely negative. The failure of Medivation and Pfizer's Alzheimer's drug was significant not only because it was highly anticipated and because it marks another high-profile, late-stage blowup for an Alzheimer's drug, but because of the specific circumstances. The drug, dimebon, produced some amazing phase 2 results--but in one relatively limited trial conducted exclusively in Russia. This isn't the first time Russian data have proved...ummm...not easily reproducible outside the country.

Then there are some other big failures--AstraZeneca's small-molecule alternative to Avastin, Recentin, didn't hold up in a head-to-head study in colon cancer, while Avastin itself didn't fare well in prostate cancer. Pfizer seems to have had a run of bad luck, including recent failures in breast and lung cancer. Human Genome Sciences also had a lung cancer setback, but Abraxis claimed one of the few victories this month with its NSCLC candidate.
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Medivation, Inc. (MDVN)(JOBS), Pfizer Inc. (PFE) (JOBS) Drug Dimebon Fails Phase 3 Alzheimer's Study
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Vernalis PLC (VNLS) Dives as Pain Drug Fails Clinical Test; V3381 Misses Primary Endpoint in Neuropathic Pain
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Abraxis BioScience, Inc.: ABRAXANE Meets Primary Endpoint in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer
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AstraZeneca PLC (AZN)'s (JOBS) Recentin Fails Phase 3 Trial, Hurts Shares
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Roche Holding AG (RHHBF.PK), Genentech (RHHBY)'s Avastin Fails in Prostate Cancer Study
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More Bench To Clinic News
BioWorld's The Future of Biotech Report BioWorld's The Future of Biotech Report: Try it for free! This comprehensive report into the future of our industry provides expert advice from some of the best minds in biotechnology. You also receive biotech's most respected news source, BioWorld Today for a 4-week trial! You're under no obligation to buy anything – Your FREE REPORT and FREE 30-DAY TRIAL will be delivered electronically to your inbox when you respond to this special offer. More... BayBio2010 BayBio2010: Life Science Innovation: Drivers and Barriers. April 7. BayBio2010 is a one-day conference focusing on Northern California's strength in life sciences innovation. This conference will examine the fundamental questions of who pays for biotech innovation and why in this unprecedented environment. It will focus on how the current financing environment and new sources of capital affect business models, development and commercialization strategies. More...
More job cuts have been announced as AstraZeneca seeks to streamline...even as it pays Merck $647 million to reacquire full rights to a collection of cardiology drugs, including Brilinta. And a big cutback at Exelixis displaces more talented researchers, among others.
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AstraZeneca PLC (AZN) (JOBS) Shuffles, Eliminates 550 Delaware R&D Jobs
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1,200 Jobs Axed by AstraZeneca PLC (AZN) (JOBS) in UK
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Exelixis, Inc. (EXEL) (JOBS) Announces Restructuring; Reduces Workforce by Approximately 40%, or 270 Employees
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250 Jobs Gone as Warner Chilcott, PLC (WCRX) Exits Mason, Ohio
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MiddleBrook Pharmaceuticals, Inc. Plans Massive Layoffs, CEO Resigns
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The fight for Facet Biotech has finally reached a conclusion, with Abbott swooping in to offer more money than Biogen Idec had been willing to put up in its hostile bid. Perhaps that took the fight out of Biogen...it successfully skirted another proxy battle with Carl Icahn by agreeing to appoint two new directors, one from Icahn Partners. But in case you're worried there is too much peace in the kingdom, a new fight is heating up over OSI Pharmaceuticals, which has rejected a hostile $3.5 billion bid from Astellas. Anyone else want to step up?
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Biogen Idec, Inc. (Massachusetts) (BIIB) Reaches Deal with Icahn; Avoids Proxy Fight
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Abbott Laboratories (ABT) (JOBS) to Buy Facet Biotech (JOBS) for $722 Million
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OSI Pharmaceuticals, Inc. (OSIP) Board Rejects Astellas Pharma Inc. (JOBS) $3.5 Billion Bid
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Teva Pharmaceutical Industries Limited (TEVA) to Acquire Ratiopharm for Nearly $5 Billion
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GlaxoSmithKline (GSK) Up as Novartis Corporation (NVS) Drops Generic Advair in U.S.; Novartis Hands Back U.S. Rights to VR315 to Vectura Limited
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Effectively collaborates with Group TAHs and TAHs to ensure 1) Therapeutic area specific best-in-class knowledge, application, and molecule strategic context is reflected in Medical Science Expertise; 2) that Medical Science resources and deliverables meet and exceed their expectations of context, project team participation and behavior, quality and timeliness of deliverables etc.
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Another company has managed to slip through the IPO window, though it bloodied itself on the broken glass. Much like Anthera, AVEO Pharmaceuticals was forced to slash its offering price from a targeted $13 to $15 per share to just $9, and to raise less money than expected. And even so, the share price has withered in the aftermarket. So what do you think, Tengion? Fluidigm? You still want to try this? Nevertheless, companies are managing to raise decent amounts of private capital, as some of the month's deals show.
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AVEO Pharmaceuticals, Inc. (AVEO) Announces Pricing of Its Initial Public Offering
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Private UK Drug Firm Archimedes Pharma Raises US $100 Million; Former Enzon Pharmaceuticals, Inc. (ENZN) Head Appointed as CEO; US Commercial Operations to be Established
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French Biotech Neovacs SA Targets 20 Million Euros in IPO
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NGM Biopharmaceuticals, Inc. Raises $51 Million in Series B Financing and Appoints New Board Member
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Rhythm Pharmaceuticals Announces $21 Million Series A
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Thieves cut a hole in the roof of a Lilly warehouse, loaded pallets holding $75 million worth of antipsychotic drugs into a tractor trailer, and drove off with the lot. It's a stunning indication of how fungible pharmaceuticals have become on the worldwide black market: After all, this wouldn't have been an attractive target if the thieves didn't think they could successfully move this volume of product. Companies around the world are likely reviewing security measures.

Back on more familiar regulatory turf, Genzyme is likely to face enforcement action from FDA at its Allston manufacturing plant, which could include third-party oversight for an indefinite period...at considerable expense. That's upped the pressure on CEO Henri Termeer, and gives Carl Icahn more ammunition in his bid to get a slate of directors on Genzyme's board.
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Genzyme Corporation (GENZ) Faces FDA Enforcement Action
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Heist Nets $75 Million in Eli Lilly and Company (LLY) Drugs
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US Jury's Neurontin Ruling To Cost Pfizer Inc. (PFE) $142 Million
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King Pharmaceuticals®, Inc. Unit, Alpharma Inc. (ALO) to Pay $42.5 Million Over Kadian Claims
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US FDA Staff Says Novartis AG and Astellas Pharma Inc. May Need Wider Eczema Caution for Kids; New Reported Cases of Cancer and Infection
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More Legal Briefs News
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If clinical news was generally negative this month, regulatory news was much more upbeat. We noted in the last issue that this was going to be a busy month, and so it was. FDA offered up a relative smorgasbord of approvals and positive panel meetings (except Cell Therapeutics, but that was pretty much guaranteed already). Even the delays handed out to MannKind and Amylin/Lilly are unlikely to be lengthy obstacles to getting to market.
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FDA Approves Salix Pharmaceuticals, Ltd. (SLXP) Drug Xifaxan For Liver Failure Disorder
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US FDA Panel Rejects Cell Therapeutics, Inc. (CTIC) Lymphoma Drug
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Somaxon Pharmaceuticals, Inc. Announces FDA Approval of Silenor(R) (Doxepin) For The Treatment Of Insomnia
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FDA Delays Approval of Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) (JOBS) Diabetes Drug; FDA Requests Finalization of Product Labeling
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FDA Requests Additional Information Regarding AFREZZA in Complete Response Letter to MannKind Corporation (MNKD)
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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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