 | | Wednesday, December 14, 2011 | |  |
 Top 10: 2011 in Review
Here it is, our fourth annual Top 10 Year in Review -- a wholly subjective look at the 10 stories or trends that shaped the year in biotech. Drum roll, please...
#10 Bad PR. FDA has made an effort to get unapproved drugs off the market by offering incentives to the companies that choose to jump through the proper hoops and get formal approvals. That's just what K-V Pharmaceuticals did for hydroxyprogesterone caproate, a drug used to prevent preterm labor. And it duly hiked the price of its officially approved Makena...from about $10 a dose to $1,500. Even FDA, which doesn't officially concern itself with pricing, was shocked enough to say it wouldn't launch enforcement actions against pharmacists who chose to continue formulating the drug on the cheap. K-V finally balked, but not before drawing a lot of unwanted attention to themselves and others pursuing similar strategies a little less...aggressively. More...
More By Karl Thiel
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| |  | Good news in the fight against breast cancer, with Genentech showed marked improvement in progression-free survival in patients given a combination of two monoclonal antibodies--pertuzumab and Herceptin--plus chemo versus chemo alone. Also reported at the San Antonio Breast Cancer Symposium were new data on Novartis' Afinitor, which doubled progression-free survival in a sicker group of patients than those examined in the Genentech study when given along with Pfizer's estrogen-blocker Aromasin. Afinitor is already approved for kidney cancer.
Progression-free survival is great, but given the experience of Avastin--which also extended PFS but ultimately did not extend lifespan--FDA may insist on seeing survival data before it approves these drugs. The companies don't yet have those data. -KT | | | |  | Alex Denner, the man responsible for corporate raider Carl Icahn's activity in healthcare over the past five years, is launching off on his own. Credited with bringing in $2 billion to Icahn's coffers during his tenure, Denner will now try to replicate is success with his own hedge fund. Denner was behind successful efforts to engineer the sale or restructuring of companies like ImClone, Biogen Idec, and Genzyme, as well as some less successful activists efforts like his bid to gain seat on the board of Forest Laboratories.
Who is the worst biotech CEO of the year? Hint: Last year, he was voted the best. -KT | | | |  | | We see Big Pharma's attention turn increasingly to Asia. AstraZeneca is tapping the hot branded generics market with its buy of Guangdong BeiKang, which makes injectable antibiotics. That keeps Astra in the number two foreign drug company in China behind Pfizer. Merck has bought an R&D facility in Beijing, part of a five-year, $1.5 billion investment in Chinese R&D. Meanwhile, Samsung is looking to become a major player in biosimilars, and is taking 85% ownership of a joint venture with Biogen Idec, which will do all its manufacturing in Korea. -KT | | | |  |  | • Genetown (Waltham, Massachusetts)
Asahi Kasei Pharma Corp.
Vice President, Clinical Operations
Will coordinate and lead all Clinical Development Operations of Artisan Pharma under the direction of the President Product Development & Chief Medical Officer to ensure the successful and timely completion of the ART-123 clinical trials and all related clinical trial milestones. The VP will oversee compliance as well as clinical trial monitoring, clinical trial conduct, trial progress, trial safety evaluation, study design, trial protocol, trial publications as well as EC/IRB submissions etc.
• Biotech Bay (San Francisco Bay Area, California)
Biotecher
Business Development Director / Sr. Director - Diagnostics
Seeking a business development leader who is both a scientist and a pragmatist. He/she will have extensive business development experience and a proven eye for successfully identifying and initiating fruitful business opportunities. This is a key, strategic role for a creative and entrepreneurial business-strategist with diagnostic---and possibly also therapeutic---product experience who loves science but who also loves to apply it in the real world.
• Pharm Country (Bridgewater, New Jersey)
Sanofi
CTR Director
Provides the vision and overall strategy for the successful and timely Clinical development in TSU Fibrosis and Wound Repair. The CTR Director leads clinical research teams for implementation of studies of the highest quality by maintaining ethical values and regulatory compliance.
• Genetown (Billerica, Massachusetts)
Volcano Corporation
Vice President, OCT Programs
Primary focus is to commercialize an OCT system; responsibility also includes the oversight of the OCT business unit R&D. The individual will have all of the R&D groups managing the catheter, software and interface modules and be primary interface to manufacturing and systems business unit. The position will be located in Boston, MA area but will involve travel to other Volcano locations and customer sites.
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| | |  | | There's a lot of praise for arGEN-X's antibody platform,which the company says can rapidly produce potent antibodies to a target without the need for humanization or in vitro engineering, even against tough targets like G-protein coupled receptors. Rib-X is riding a resurgence of interest in infectious disease and and filed an IPO to help forward its pipeline of novel antibiotics. Rib-X uses a structure-based approach to study the interaction of drugs with 3-D models of the bacterial ribosome. -KT | | | |  | | Well, it finally happened. Pfizer's Lipitor patent has expired, and generics are now available in the U.S. It's the end of an era for Pfizer, which got a fifth of its massive revenue from this one product. Of course, Pfizer eagerly did what it could to delay this day. And some drug store chains, including Walgreens, are complaining that Pfizer has been a little too eager to keep the antidepressant Effexor XR off the generic market. A suit claims they obtained fraudulent patents, engaged in "sham" litigation, and colluded with Teva to delay entry of a generic. -KT | | | |  | | How many new molecular entities will FDA approve in 2011? The agency is looking to put on a strong finish to what has already been a good year. Pfizer's kidney cancer drug axitinib won't make the cut this year, but it did get a unanimous positive recommendation from an FDA panel. That's despite the fact the FDA looked pretty skeptical in its briefing documents. Axtinib (to be branded Inlyta) slowed progression but did not establish a survival advantage, but the panel felt that it looked as good as other drugs and, with its different side-effect profile, should be an available option for docs and patients. -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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