BioSpace BioPharm Exec
Wednesday, August 26, 2009
Biotech's Dog Days

Ah, the dog days of summer...those long, glorious days that make it impossible to get the kids to sleep before 10 PM. They're called the dog days, by the way, because Sirius, the Dog Star and the brightest star in the heavens, used to rise before the sun during the hottest period of summer, at least in the northern hemisphere. The ancient Greeks used to sacrifice a brown dog to the star, thinking its rage was the cause of all the hot weather.

Some of the brightest stars in biotech's firmament are causing a bit of trouble right now, too, and experiencing not a little rage. There's been a dearth of dealmaking over the past month, but at least one big argument about an existing partnership: Biogen Idec is not the least bit happy about how it's being treated by Elan, now that the latter company is all cuddly with Johnson & Johnson. More...

More By Karl Thiel

Genzyme is having a bad month. Its manufacturing facility for its flagship product Cerezyme has been under fire from FDA since a warning letter was issued in February, and it has been recently revealed that the agency plans yet another reinspection of the Boston-area plant. Genzyme, meanwhile, said that it will have to scrap 80% of the in-process Cerezyme made at the plant, resulting in a significant write-down. To make matters worse for the company, FDA is allowing Shire to treat patients with its own Gaucher's disease therapy under a treatment protocol that will become part of that company's rolling NDA submission. And Protalix BioTherapeutics subsequently got a phase 3 treatment protocol approved for its own plant cell-expressed version of the Gaucher's disease replacement enzyme, allowing it to also treat patients in the U.S. and elsewhere. Certainly more competition is likely to be good for Gaucher's patients--particularly given the shortages now looming due to Genzyme's production problems--but it could spell long-term trouble for the company. -KT

Eli Lilly and Company (LLY) (JOBS) Halts Development of Arzoxifene for Bone Loss
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Human Genome Sciences, Inc. (HGSI) Achieves Lupus Drug Goals With DSG's EDC
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AVANIR Pharmaceuticals (AVNR) Phase 3 Drug Meets Main Study Goal; Stock Soars
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Shire Pharmaceuticals Group plc (SHPGY)'s New Gaucher Drug Moves Closer to Market Following Positive Phase III Trial Results
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This according to a report in the Gray Sheet, as summarized on the In Vivo Blog: Daniel Schultz, director of FDA's Center for Devices and Radiologic Health (CDRH), is stepping down in the wake of some serious accusations. According the Gray Sheet report, this includes "coercing and intimidating staff into modifying device evaluations." Given that Schultz has been Director for five years, this could have some continuing fallout even after Schultz's departure. -KT

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The action of the past couple months has generally moved away from deal-making and toward public and private financings, but there are still some notable deals to report. Most interesting, though, is the aftermath from a deal that took place just as our last issue was going to press: Johnson & Johnson's decision to buy much of Elan's Alzheimer's pipeline for $1 billion, plus another $500 million in R&D funding.

Not so fast, said Biogen. Elan's agreement with J&J includes an option for the latter company to help finance the buyout of Tysabri rights in the event of a change in control at Biogen. That kind of leverage could change the calculus of any future takeover bids for Biogen, and Biogen says it constitutes a breach of its original agreement with Elan. The two companies are gearing up to fight the thing out in court, just as Elan is trying to finalize the agreement with J&J. Watch for further fireworks. -KT

Elan Corporation PLC (ELN) Sues as Biogen, Inc. (JOBS) Seeks Control Over Tysabri
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Clinical Data, CombinatoRx, Incorporated (CRXX) Strike Deal; Potential $252 Million in Milestones
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Forest Laboratories, Inc. (FRX) and AstraZeneca PLC (AZN) to Co-Develop and Commercialize a Late Stage Next Generation Anti-Infective
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GlaxoSmithKline (GSK) (JOBS), Vernalis PLC (VNLS) Sign up to $200 Million Cancer Deal
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BioMidwest Career Fair
BioMidwest Career Fair
Monday, September 14, 2009. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Chicago region. Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, bioinformatics, clinical data management, chemistry, regulatory affairs and research.
BioCapital Career Fair BioCapital Career Fair
Thursday, September 24, 2009. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the mid-Atlantic region. Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, biostatistics, clinical data management, chemistry, regulatory affairs, and research.
Just a few months ago, this little corner of Biopharm Executive wasn't just reporting selected highlights from the month's life sciences financing news; it was pretty much a comprehensive and unabridged overview that still struggled to fill the space. Now there's been such a rush of follow-on financings that I can only include a few particularly notable offerings and still leave room for the IPOs (!!)

That's right, Cumberland broke what it claimed was an almost two-year long drought for pharma IPOs...which certainly bodes well, although as a profitable specialty pharmaceutical company, Cumberland's success in getting public, particularly given its tepid reception, doesn't exactly signal a green light for blue sky R&D-based biotech. Emdeon did somewhat better, although as a healthcare IT company it's playing in a different sector.

Meanwhile, Human Genome Sciences wins the "who would've thunk it?" award for successfully raising over $300 million in the wake of its lupus drug success. And there are some interesting conflicting signposts regarding the pharma sector from two of the world's richest men: Bill Gates (or rather, the Bill & Melinda Gates Foundation) is selling a broad number of big pharmas, while Warren Buffet is buying. -KT

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Onyx Pharmaceuticals, Inc. (ONXX) Announces Concurrent Offerings of Four Million Shares of Common Stock and $200 Million Principal Amount of Convertible Senior Notes
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Pharmaceutical Strategic Alliances 2009 Pharmaceutical Strategic Alliances 2009 focuses on the new business model of being big and small at the same time to enjoy the advantages of both. PSA features the most senior-level case studies for dealmaking and strategy available in the industry. Topics include Financing Pharma: Creative Ways Companies Are Funding Risk, Can Emerging Markets Fill in Pharma's Revenues/Growth Gap?, and The Pieces of Health Care Reform that Really Matter to Biopharma. qPCR Symposium USA qPCR Symposium USA. The 3rd qPCR Symposium USA features keynote speech, presentations by experts on latest developments in the industry, applications and academic perspectives from eminent scientists. The Symposium is also hosting exhibition, poster session and related courses. For more information, visit www.qpcrsymposium.com.
The Obama Administration's continuing effort to push through health care reform--seemingly, just about any kind of health care reform--brings to mind Otto Von Bismarck's famous remark that politics is the art of the possible. But the impossibility of passing even relatively uncontroversial legislation really makes me wonder what kind of bill can possibly reach the President's desk. Take the effort to reauthorize the popular Small Business Innovative Research (SBIR) program, which gives modest grants from the budgets of NIH, the Department of Defense, and several other government agencies to many start-up and early-stage life sciences company. The House and Senate recently passed two (quite distinct) reauthorization bills, but then punted on resolving the two into a final bill, instead offering up the third temporary continuation since the program officially ended last year. Remaining bones of contention chiefly concern the rules concerning grants to venture capital-backed companies and an option to skip Phase 1 grants for certain applicants. If this kind of thing can grind the legislative process to halt, can we be surprised how acrimonious major reform is? -KT

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We may not yet have a clear regulatory pathway for follow-on biologics, but FDA is apparently moving ahead with some decision-making on generic versions of biologic drugs nonetheless. Novartis got approval for Extavia, its version of the Bayer (former Chiron) multiple sclerosis drug Betaseron. Moreover, it got approval for a generic version of Astellas' transplant rejection drug Prograf (tacrolimus). Tacrolimus is a small molecule drug, not a biologic, but approving it required FDA to reject a petition from Astellas asking for special consideration on oral immunosuppressants, including the mandatory addition of additional bioequivalence studies for any would-be generics--a familiar refrain from the follow-on biologic debate.

Interestingly, while Novartis' generic tacrolimus was approved through its Sandoz division, which has long pursued biogenerics as a key growth strategy, Extavia is being marketed as a branded drug through Novartis' Pharmaceuticals Division.

Also note Amgen's key victory in getting at least a partial nod from an FDA advisory committee for its key osteoporosis drug denosumab. (Ignore the misleading headline from the New York Times--it was a partial endorsement; as we all well know, advisory committees don't approve or reject drugs). -KT

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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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