| Wednesday, September 28, 2011 | |  |
 Too Big to Succeed?
There's an interesting editorial in Pharmalot this week, by Pharmaceutical Business Research Associates president Daniel Hoffman. In it, he suggests that mass layoffs have changed pharma companies for the worse...perhaps irrevocably...by depriving them of their most flexible and creative employees.
As he puts it, "the dishonest and unfair approaches the industry has taken to downsizing have left it with many people who are small-minded, politically savvy and safe playing...
"Many of the people remaining in operations deliberately choose not to ask big or important questions, lest their colleagues perceive any fundamental doubt as a threat. The truly adept manage to avoid taking a position on even the most mundane matters, lest someone else equate perceptive questions with disloyalty. Some even find it wise to feign ignorance concerning the elephants in various rooms. The combination of such simulated ignorance, together with the genuine version among the inexperienced survivors, makes the task of determining the smartest guy in the room a purely theoretical exercise." More...
More By Karl Thiel
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| |  | Off-label use of Roche's Avastin has reportedly caused infection and blindness in some patients treated for age-related macular degeneration (AMD). As a result, the Dept. of Veterans Affairs has banned use of the drug for this indication, pending further investigation. This should be good news for Roche, because it would much rather have doctors using the far more expensive drug Lucentis for wet AMD -- and it appears that the complications from Avastin came not from the drug itself but by it becoming tainted when divided up by pharmacists into smaller doses. But Regeneron and its Eylea drug for wet AMD also appear to be beneficiaries of the controversy, at least to judge by stock price.
Meanwhile, AstraZeneca's ultra-potent lipid drug Crestor failed to prove superiority to the granddaddy of all cholesterol-lowering drugs, Pfizer's Lipitor. Crestor had a numeric advantage in plaque reduction but it wasn't statistically significant, and that isn't likely to hold much weight given physicians' extensive clinical experience with Lipitor...and the fact that it is going generic next year. -KT | | | |  | There is more downsizing news this month, but much of it comes not from big pharma companies scaling back but instead from small biotechs running into trouble. Pacific Biosciences, Enzon, Dendreon, and Oxigene are among the companies cutting staff in an effort to save money. Vertex, at least, is bucking the trend and expanding.
One person who isn't having a problem finding demand for his skills is Trevor Mundel, chief of drug development for Novartis. He is leaving the company to become executive director of The Bill & Melinda Gates Foundation's Global Health Program. He'll be succeeding another former drug company exec, Tachi Yamada, who was head of R&D at GlaxoSmithKline before dedicating five years to the Gates Foundation. Mundel will get a very high-profile position but a comparative shoestring budget--less than $2 billion a year.
-KT | | | |  | Austrian antibody company f-Star just raised its Series A round in January 2010, when it first signed on Merck Serono as an investor. Apparently impressed, Merck Serono is now back less than two years later with a deal potentially worth over $700 million. The companies are collaborating on antibody-derived therapeutics against inflammatory disease targets. Evotec's headline deal with Roche concerns a selective MAO-B inhibitor that has been handed back and forth several times, first as a drug for smoking cessation and now as a potential Alzheimer's treatment. And Bristol-Myers Squibb -- which has been loudly insisting lately that it can succeed with a pharmaceutical-only focus -- has been bolstering its pipeline (or as the company has it, adding to its "String of Pearls,") through deals with Ambrx and Ono Pharmaceutical Co. These are indeed varied pearls--the Ambrx deal concerns compounds for diabetes and heart failure, while its deal with Ono covers a cancer drug first obtained through Bristol's acquisition of Medarex, with Ono getting Japanese rights to the rheumatoid arthritis drug Orencia.
-KT | | | |  |  | • BioMidwest (Grand Rapids, Michigan)
Witt/Kieffer
Chief Operating Officer - Van Andel Institute
Success in this environment will require an entrepreneurial executive with financial acumen and managerial skills to provide strategic direction in the development and execution of business and operational plans to realize the Institutes vision. The COO will be a systems thinker, with demonstrated business savvy and fifteen years of progressive management experience in a research operation or similar enterprise.
• BioForest (Seattle, Washington)
The Pacific Northwest Diabetes Research Institute
President and Chief Executive Officer
The CEO will report to the Board of Trustees and will also serve as the Scientific Director of the Institute overseeing all scientific programs. The CEO will lead PNDRI in expanding its research activities by the recruitment of additional investigators. (S)he will also direct the new strategic alliance between PNDRI and Swedish Medical Center, the largest non-profit health-care provider in the greater Seattle area.
• Biotech Bay (Oakland, California)
Cerexa, Inc.
Senior Director, Clinical Development
Duties: Lead, develop and coach high performing project teams and direct reports, including medical monitors and medical writing function. Contribute and influence corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees. Analyze and interpret study data and prepare reports for FDA and publication Publish study data and present study data at professional conferences.
• Biotech Beach (San Diego, California)
Amylin Pharmaceuticals, Inc.
Vice President, Head of Quality
Duties: Provides management oversight of the global Quality organization. Establishes the proper environment to assure that there is a quality focus in all activities of the business. Leads Quality in establishing the systems and procedures necessary to assure quality in all cGMP, GCP, and GLP areas as well as commercial-related non-financial non-GXP areas.
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| | |  |  BioMidwest Career Fair
Chicago Marriott Oak Brook, Tuesday, October 4, 2011, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Midwest region. |  |  Pharm Country Career Fair
Bridgewater Marriott, Wednesday, October 5, 2011, 11am to 4pm Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the tri-state area. |
| |  | Many major pharma companies have their own venture capital arms -- GlaxoSmithKline's SR-One, the Novartis Venture Fund, Pfizer Venture Investments, and so on. Merck, until now, hasn't been among them. But the company has set aside $250 million for VC investment in pharmaceutical R&D. The company quietly entered the VC business earlier this year by establishing the Global Health Innovation Fund, dedicated to non-pharmaceutical investment. It has since enlarged that fund and now added the Merck Research Venture Fund, for a total commitment of $500 million. That's no small potatoes if you compare it to, say, Pfizer's $50 million-a-year commitment. But it comes at a time when Merck, like most pharma companies, is downsizing its internal R&D. Put those facts together and it indicates that while companies like to talk about creating entrepreneurial groups within their own walls, it's easier said than done.
-KT | | | |  | How much will the world of follow-on biologics resemble the dog-eat-dog world of traditional generics? We may learn a lot about the answer by watching Momenta and its generic version of the blood-thinner Lovenox. While approved as a conventional generic and not through the follow-on biologics pathway, the company's m-enoxaparin is nonetheless a good deal more complex than most small molecules. Complex enough, in fact, that Momenta believes no one else can make it with infringing the company's patents. It launched a preemptive suit against Teva earlier this year in hopes of stopping that company from launching a rival product, but it seemed caught by surprise when generic firm Amphastar got FDA approval for a generic Lovenox. It quickly sued, however, claiming infringement of the same two patents. Is Amphastar worried? Whether they choose to launch "at risk" will certainly tell us something.
-KT | | | |  | The FDA advisory panel on Xarelto had more than the usual level of drama. Xarelto is already approved for the prevention of deep vein thrombosis, but Bayer and J&J are looking to expand the label to include the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
It didn't look like FDA was having any part of it. The agency's review of the claims and draft questions for the committee bordered on hostile, and they came right out and recommended a "complete response" letter. Among their issues was the treatment Xarelto should have been compared to in clinical studies...FDA apparently would like to have see the drug measured up against Boehringer Ingelheim's Pradaxa, which has been on the market for less than a year. But the advisory committee members -- and some staffers -- seemed to feel this would be another case of moving the goalposts after the start of the game. The panel ultimately voted 9-2 in favor of the AF approval. FDA isn't obligated to follow the advice of its panels, goes the old cliche, but it usually does. In this case, however, I wouldn't count on it.
-KT | | | |  |
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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