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 Is FDA "Crushing" Biotech?
Is FDA's foot-dragging making the U.S. less globally competitive? That's what Senator Scott Brown recently suggested at the Biotechnology Industry Organization's (BIO) 12th annual CEO Biotech Conference in Boston. The Massachusetts Republican was obviously preaching to the choir in a state where biotech is a big part of the economy, but his outlook is shared by many in industry who see the agency's risk-averse demands for increasing amounts of clinical data, as well as arduous post-approval monitoring, as unnecessary burdens on innovation.
There's some truth behind those charges. This past month, executives at Orexigen threw up their hands in their struggle to bring the weight loss drug Contrave to market. They have met with FDA's Division of Metabolic and Endocrinologic Products in hopes of establishing a clear path that would allay concerns about potential cardiovascular risks and get the drug to market, but instead met with frustration. Orexigen proposed a study of 12,000 to 15,000 patients; FDA instead demanded a trial of 60,000 to 100,000, which the company called neither "necessary or feasible." The company sought approval in patient with reduced risk for heart problems, and FDA demurred. More...
More By Karl Thiel
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| |  | Last month we previewed some of the data we expected out of the American Society of Clinical Oncology (ASCO) annual meeting, and we highlight some results below. While many pundits said the meeting held fewer "wow" moments than previous years, there were certainly interesting results from Exelixis (which got buffeted by safety concerns on its prostate cancer drug Cabo despite impressive efficacy results), as well as from Ariad's bone sarcoma agent, the melanoma drugs vemurafenib and Yervoy from Roche and Bristol, respectively, Pfizer's impressive crizotinib, and others.
Outside of cancer, Vertex has raised a lot of excitement with a novel cystic fibrosis drug that appears very effective in a small subset of patients. The questions remain as to whether a combination therapy will prove effective in a much larger group of patients, and so far we don't have a clear answer. And if you are looking for a "wow" moment, the Pfizer/Bristol-Myers Squibb blood thinner Eliquis is looking like a blockbuster after proving superior to warfarin. -KT
| | | |  | Activists are once again affecting change in the biotech sector. Hedge fund Elliott Management didn't win its proxy battle with Actelion, but its efforts resulted in the appointment of a new COO and a change in the company's executive committee. And activist investor Carl Icahn is gunning for Forest Laboratories and its beleaguered chief executive Howard Solomon. Icahn has taken a nearly 7% stake in the company and made critical statements about the continuing efforts by Forest's board to defend Solomon, who the government is trying to oust after the firm pled guilty to marketing violations.
-KT | | | |  | Merck has made a major bid in follow-on biologics by licensing Hanwha's version of the anti-TNF drug Enbrel, which goes generic next October. Clovis Oncology and Pfizer are playing role-reversal when it comes to licensing--Clovis is acting as the deep pockets and taking on late-stage development risk for Pfizer's PARP inhibitor, while Pfizer is continuing to winnow down its research spending. Vertex is already thinking about its next moves in hepatitis C. And Roche's deal with Merck demonstrates the growing importance of molecular diagnostics in both improving research and in better targeting therapeutics.
-KT | | | |  |  | • BioMidwest (Olathe, Kansas)
Center for Animal Health Innovation
Chief Executive Officer
The CEO for the Center for Animal Health Innovation will have complete executive responsibilities for the Center. Overall responsibility for the public face of the Center. Managing the public relations and image of the Center for maximum professional effect. Overall P&L-like responsibility for the operation of the Center etc.
• Biotech Bay (Emeryville, California)
Novartis Institutes for BioMedical Research, Inc.
Group Leader, New Approaches to Antibacterial Discovery
As part of a strategic focus on discovering new antibiotics to treat multi-drug resistant Gram negative bacteria, the Infectious Diseases Area is seeking a talented and experienced scientific group leader to oversee an interdisciplinary effort directed at understanding small molecule penetration, distribution, metabolism, and efflux in bacterial cells.
• Genetown (Cambridge, Massachusetts)
Aileron Therapeutics, Inc.
Director / Senior Director, DMPK
Seeking an experienced leader to oversee all DMPK activities supporting the advancement of our multi-therapeutic pipeline of compounds through preclinical translation and into clinical development. The successful individual will have a proven track record of innovation and creativity, and a deep knowledge of new technologies and cutting-edge approaches to address in vivo pharmacology, drug metabolism and PK/PD issues.
• Biotech Beach (San Diego, California)
AVIVA Biosciences Corporation
Executive Vice President
The company is looking for an executive with a proven track record and strong leadership in the area of diagnostic equipment product development and commercialization. As an Executive Vice President the ideal candidate will also contribute strategic leadership input in the overall direction of the company, develop and implement new product strategies as well as sales and marketing strategies.
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| | |  |  Biotech Beach Career Fair
San Diego Marriott La Jolla, Thursday, September 22, 2011, 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. |  |  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. |
| |  | Tesaro is in-licensing a focused oncology pipeline and has attracted some impressive backing--including this $101 million Series B round led by Kleiner, Perkins. Intrexon raised the same amount in a Series E round aimed at advancing that company's "Better DNA" portfolio of genetic engineering solutions. And Rigel may prove to be a beneficiary of Pfizer's furious R&D downsizing: It got back rights to its allergy-induced asthma drug R343 as part of Pfizer's restructuring, and this apparent windfall helped the company raise a $130 million from investors.
-KT | | | |  | Takeda's best-selling drug Actos brought in about $5 billion in worldwide sales last year, but the diabetes drug is under pressure around the world even before it faces generic competition next August. France and Germany have pulled the drug off the market, pointing to its apparent link with an increase in bladder cancer risk. So far the U.S. FDA has not followed suit, but it has acknowledged heightened risk with heavy use. Johnson & Johnson is still having problems with bad odors permeating its products, reportedly from a chemical used in wooden shipping pallets.
-KT | | | |  | Orexigen has given up on getting its obesity drug approved after FDA at the present time, citing the agency's demand for a new trial that "would generate significantly more information than is necessary or feasible." The company will appeal through formal dispute resolution and concentrate on approval in other countries. Planned or not, that's the path Lilly, Amylin, and Alkermes took--they got EU approval for Bydureon while still working to meet FDA's demands for more data.
-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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