BioSpace BioPharm Exec
Monday, December 21, 2009
Top 10: 2009 In Review

Some folks may have the decency to wait until the year actually ends to look backward. Not I. It's time for the second annual Biopharm Executive Top 10 Year in Review list, and I'm not going let a few remaining days in December get in my way.

So once again, here's my entirely subjective list of the stories and trends that I think most shaped the industry in 2009. Without further ado...

#10 Big Pharma Goes to China! While many big pharmas have a marketing presence in China and sometimes conduct clinical trials there, companies have only recently gotten serious about making China and other parts of Asia a base for research and a place to build a brand with local roots. Novartis led the way this year with a $1 billion plan to build its research presence, but Bayer, GlaxoSmithKline, and AstraZeneca are rapidly expanding their R&D presence in the region. Roche just recently announced it would be moving some of its research to Asia, too, and I don't think we've seen the end of this trend.

#9 Options Deals. These aren't new, but in the midst of a financial crisis, "show me" deals have become more popular than ever. There a numerous examples that took place during the year, although GlaxoSmithKline was particularly fond of them. The basic idea: Pay a little bit now to have the option, at a later date, to license a product at a pre-agreed price. It limits bidding wars, keeps prices down (presumably), shares the risk, and lets innovator companies raise money on programs that would be too early to attract a major deal. We'll be seeing more of these.

#8 H1N1. This was clearly a huge story in 2009, but it's hard to guess how history will look back on it. Will we remember the rapidity with which vaccines were developed and approved? More...

More By Karl Thiel

Elan has a lot riding on its Alzheimer's program, and one of its candidates sure looks a lot less promising after the two highest dose groups had to be discontinued on safety concerns. But Elan's stock barely missed a beat, in part because investors are more focused on bapineuzumab, in Phase 3, and in part because Elan already successfully cashed in a good deal of its Alzheimer portfolio's value to Johnson & Johnson earlier this year. Meanwhile, a number of reports from the San Antonio breast cancer symposium show some important progress on the world's second most common form of cancer.
-KT

Elan Corporation PLC (ELN) and Transition Therapeutics Inc. (TTH.TO) Drop Top Drug Doses After Nine Alzheimer's Patient Deaths
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Pfizer Inc. (PFE) Announces Neratinib Data In HER2 Positive Breast Cancer
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Roche (RHHBY) (JOBS) Unit Genentech (South SF) (RHHBY) (JOBS) and Biogen Idec, Inc. (Massachusetts) (BIIB) (JOBS) Meet Primary Endpoint on Phase III Study into Rheumatoid Arthritis Treatment
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Celgene (CELG) (JOBS) Investors Struggle with Confusing Data
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Celldex Therapeutics, Inc. Presents Positive Results from Phase 2 Study of the Antibody-Drug Conjugate (ADC) Product Candidate CDX-011 in Advanced Breast Cancer
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ImmunoGen, Inc. (IMGN) Announces Positive Trastuzumab-DM1 Clinical Data Reported at the San Antonio Breast Cancer Symposium
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CSU: Professional Biotechnology Project Management Certificate in Quality Assurance CSU: Professional Biotechnology Project Management Certificate in Quality Assurance: This new, online, graduate-level certificate has been co-developed with professionals from the American Society of Quality and the biotechnology industry. The certificate program incorporates four existing courses that are being offered together by the CSU for the first time, starting January 2010. Click here to learn more or contact 619-594-3954, rbhathal@mail.sdsu.edu. 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.
What's that? There's some hiring going on?! And in the case of Regeneron, we're talking about a substantial number of folks. Regeneron is expanding in New York--in East Greenbush and Tarrytown--and most of the new positions will be in research. It certainly seems that companies finding themselves in a position to hire right now are going to have some truly excellent candidates to choose from. That could turn out to be a nice competitive advantage for Regeneron down the road.
-KT

Regeneron Pharmaceuticals, Inc. (REGN) (JOBS) Plans $40M Expansion, Adding 400 Jobs
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GlaxoSmithKline (GSK) (JOBS) Plans to Rehire 40 to 50 Employees
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Thermo Fisher Scientific (TMO) Expands, Plans to Spend $5M to Create 104 New Jobs in North Carolina Over the Next Three Years
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Bristol-Myers Squibb Company (BMY) Says CFO Huet to Resign
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GlaxoSmithKline (GSK) (JOBS) Threatens to Shift Investment from UK
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H. Lundbeck A/S Names Sean Nolan as New CEO of its Lundbeck Inc. U.S. Subsidiary
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Infinity Pharmaceuticals, Inc. (INFI) Names Adelene Q. Perkins Chief Executive Officer
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Another month, another huge upfront payment--this time $200 million for Targacept's Phase IIb depression drug, an impressive enough sum even without the biobucks headline exceeding $1.2 billion. And AstraZeneca didn't stop there; its MedImmune division is shoring up its RSV franchise by licensing a collection of antibodies from Trellis. Meanwhile, it's interesting to see Pfizer, which steered clear of biologics longer than almost any other major drug company, get interested in enzyme replacement for an orphan disease. Its deal with Protalix, much like its recent interest in generics and follow-on biologics, shows that no attractive opportunity is going to be off-bounds. Seattle Genetics scored a nice deal on its CD30 antibody-drug conjugate program just days after Genentech canceled a collaboration on its CD40 antibody. And Novo Nordisk is locking up intellectual property around IL-21, forging a deal with longtime partner Zymogenetics, which says it's getting out of the immunology business.
-KT

Millennium: The Takeda Oncology Company (JOBS) in $365M Deal for Seattle Genetics, Inc. (SGEN)'s (JOBS) Cancer Antibody
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Cubist Pharmaceuticals, Inc. (CBST) (JOBS) to Acquire Calixa Therapeutics, Inc. (JOBS) for $402.5 Million
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ZymoGenetics, Inc. (ZGEN) Forges $182 Million Antibody Deal with Novo Nordisk A/S (NVO)
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Celgene (CELG) (JOBS) to Buy Gloucester Pharmaceuticals, Inc. in Cancer Drug Deal; Celgene to Pay $340 Million in Cash, $300 Million in Milestones
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AstraZeneca PLC (AZN) (JOBS) to Pay Up to $1.24 Billion for Targacept, Inc. (TRGT) Drug
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Trellis Bioscience, Inc. Grants MedImmune (JOBS) License for Its Anti-RSV Antibodies in Deal Worth Potentially $338 Million
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Pfizer Inc. (PFE) (JOBS) Acquires Rights to Protalix Biotherapeutics's Gaucher Drug in Deal Worth $115M
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Dendreon took advantage of its strong stock price to lard its pantry, fill its coffers, and prepare to launch the world's first approved personalized active cellular immunotherapy. (That'd be its prostate cancer vaccine Provenge). Its secondary offering may raise over $400 million before all is said and done. Vertex is also gearing up for the eventual launch of its hepatitis C drug, returning to the well once again for another $500 million. And Facet, after a long battle, managed to fend off an unsolicited tender offer and threatened proxy battle from Biogen Idec. Only a small minority of shareholders turned over their shares, and the offer has expired. Now it's back to a quiet life of R&D for Facet...unless, of course, Biogen isn't done yet.
-KT

Dendreon Corporation (DNDN) (JOBS) Raises $356 Million for Manufacturing, Marketing of Prostate Cancer Drug
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Facet Biotech Seeks Other Offers After Biogen Idec, Inc. (Massachusetts) (BIIB) (JOBS) Bid Fails
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Vertex Pharmaceuticals (MA) (VRTX) Announces Exercise of Option by Underwriters of its Public Offering of Common Stock
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AVEO Pharmaceuticals, Inc. Files Registration Statement for Initial Public Offering
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China Nuokang Bio-Pharmaceutical Inc. (NKBP) IPO Prices Below Range, Raises $45 Million
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Cell & Gene Therapy Forum 2010 and Washington Vaccine Forum Phacilitate's Cell & Gene Therapy Forum 2010 and Washington Vaccine Forum will take place together for the 5th time in 2010. These 2 sector leading conferences run in parallel with all networking taking place in a shared exhibition area. 500+ senior level life sciences decision-makers have attended in each of the last 3 years. Event Sponsors Sangamo Biosciences, Lonza, Progenitor Cell Therapy, BioLife Solutions, DynPort Vaccine Company and Emergent BioSolutions CHI's 17th International Molecular Medicine Tri-Conference Shaping The Future CHI's 17th International Molecular Medicine Tri-Conference - Shaping The Future. February 3-5, San Francisco. 3,000 attendees, 1200 participating companies, 150 exhibitors As the need for better information, new technologies, improved strategies and competitive intelligence becomes ever more acute, this event provides compelling research insight into the future of molecular medicine.
The fate of healthcare reform hangs in the balance, especially with Sen. Joe Lieberman (I-Conn.) more ideologically aligned on the issue with his BFF Sen. John McCain (R-Ariz.) than with the Democratic Party he continues to caucus with. The means that a number of elements in the bill, like follow-on biologics legislation and drug R&D tax credits, are also up in the air.

But one thing we know: Reimportation has been killed once again. President Obama (and Sen. McCain, for that matter) originally campaigned in favor of reimportation, but it was the White House that helped kill a Senate bill that would have made it reality. Bitter irony? Craven pandering to lobbyists and campaign contributors? Pragmatic dealmaking? Honest brokering? Coming to their senses? You'll find a number of opinions out there (okay, I threw in the last one...) but it looks like on this issue, the life science industry is going to continue getting its way.
-KT

Reimportation Bill Fails in Senate
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Lieberman Stands in Middle of Health Care Debate
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AstraZeneca PLC (AZN) (JOBS) Fails to Win Judgment in Crestor Case
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ZymoGenetics, Inc. (ZGEN) Says Court Denies King Pharmaceuticals┬«, Inc. Motion; Court Dismisses all Motions on Trademark Suit
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Bristol-Myers Squibb Company (BMY) (JOBS) $125 Million Plavix Accord Is Approved
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The pharmaceutical industry is facing an impending patent cliff, when some of its biggest selling drugs will lose patent protection and become exposed to generic competition. While companies are seemingly investing as much into diversification as they are into R&D, a new Datamonitor report suggests that moving away from the core business of prescription drugs may not be the best strategy.
We can say one good thing about 2009: By my count, FDA approved more novel molecular entities (NMEs) this year than in 2008, which was in turn the agency's most productive year since 2004. I make the tally 25 as of mid-December, better by one than last year. (And I'm not counting H1N1 vaccines). How these new drugs rack up in terms of real innovation is more subjective, but that, of course, is out of FDA's control. All in all, it was a solid showing for the agency and for the industry. Let's keep the streak alive in 2010!
-KT

Dyax Corp. (DYAX) (JOBS) Gets FDA Approval For Genetic Disorder Drug
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US Panel Backs Wider Use of AstraZeneca PLC (AZN)'s (JOBS) Crestor
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Sanofi-Aventis (France) (SASY.PA) Recalls 800000 H1N1 Vaccine Over Potency
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FDA Approves Eli Lilly and Company (LLY)'s (JOBS) ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults
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Gilead Sciences, Inc. (GILD) (JOBS) Says FDA Advisory Committee Supports Use Of Aztreonam For Inhalation Solution For Patients With Cystic Fibrosis
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FDA Denies Approval for Theravance, Inc. (THRX)'s (JOBS) Pneumonia Drug
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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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