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BioSpace BioPharm Exec
Wednesday, December 14, 2011
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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

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
Genentech (RHHBY)'s Two-Drug Strategy Raises the Bar in Breast Cancer, Positive Phase III Results Reported

Latest Data on Novartis AG (NVS) Afinitor Confirms Efficacy

Gilead Sciences, Inc. (GILD)'s Cobicistat Shows Efficacy in Phase 3 Study

Regeneron Pharmaceuticals, Inc. (REGN)-Bayer HealthCare (BAY) Drug Matches Lucentis at 2 Years in Fewer Doses

GlaxoSmithKline (GSK) Drug Fails to Hit Goal in Breast Cancer Trial

More Bench To Clinic News
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
Icahn's $2 Billion Man Denner Starts Own Fund as Activists Shun Healthcare

Who is the Worst Biotech CEO? Can You Guess?

Auxilium Pharmaceuticals (AUXL) Appoints Adrian Adams Chief Executive Officer and President

AstraZeneca PLC (AZN) to Cut 1,150 Sales Jobs in US

More Career Track News
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
AstraZeneca PLC (AZN) Digs Deeper in China With Generics Buy

Biogen Idec, Inc. (Massachusetts) (BIIB) Teams With Samsung Corporation on $300 Million Biosimilar Venture

Pharmacyclics, Inc. (PCYC) Could Get $975 Million in Johnson & Johnson (JNJ) License Deal

MacroGenics, Inc. Inks Pharma Deal With Servier Worth Up to $450 Million

Roche (RHHBY) and PTC Therapeutics, Inc. Sign $490 Million Deal for Genetic Disease Program

More Golden Handshakes News

Top Jobs
• 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)

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)

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
arGEN-X Raises $37 Million in Oversubscribed Series B Round

Rib-X Pharmaceuticals, Inc. Files for $80 Million IPO

Forbion Capital Raises $50 Million to Invest in Health Companies

Fosun Pharma to Float up to $470 Million in Bonds

Cell Therapeutics, Inc. (CTIC) Announces Institutional Investors Purchase $20 Million of Preferred Stock and Warrants

More Money Talk News

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
Alexza Pharmaceuticals, Inc. (ALXA) Inhaled Antipsychotic May Pose Fatal Lung Risks, FDA Review

Roche (RHHBY) Pays $20 Million to Settle Whistleblower Lawsuit

Pfizer Inc. (PFE), Teva Pharmaceutical Industries Limited (TEVA) Accused in Suit of Keeping Generic Drug Off Market

FDA Cites Violations at Three Novartis AG (NVS) Plants

Pfizer Inc. (PFE) Loses Lipitor Patent

More Legal Briefs News
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
FDA Panel Gives Nod to Affymax, Inc. (AFFY) Drug for Anemia

FDA OKs Antares Pharma, Inc. (AIS) Overactive Bladder Gel

FDA: Boehringer Ingelheim Corporation's Pradaxa Benefit Outweighs Bleeding Risk

FDA Panel Backs Pfizer Inc. (PFE)'s Drug for Kidney Cancer

Pfizer Inc. (PFE)'s Kidney Cancer Drug May Not Be Effective, FDA Says

More Rockville Files News

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.

BioSpace, Inc.
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Phone: 877-277-7585
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BioSpace, Inc.
90 New Montgomery Street, Suite 414
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Phone: 877-277-7585
Fax: 415-576-9217

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