BioSpace BioPharm Exec
Wednesday, January 26, 2011
Going Mobile

The 29th annual J.P. Morgan Healthcare Conference--the traditional kick-off to the biotech year--just wrapped up in San Francisco. I'll admit I wasn't one of the nearly 8,500 attendees cramming the Westin St. Francis's "look, ma, no fire codes!" hallways. I was, instead, one of over 120,000 attendees at the Consumer Electronics Show in Las Vegas, which took place around the same time. Those might seem like two entirely unrelated events, but it's a good reminder that all this great science, furious dealmaking, and financial derring-do is ultimately aimed at one endpoint: consumers.

There are hints that healthcare is moving towards the efficiency, mobility, and consumer control that marks much of what is going on in the electronics world. By all accounts, mHealth--the hip term for mobile health--had only a small presence at this year's J.P. Morgan conference, but there's been some interesting venture funding in the area and I predict it will play an ever increasing role over the next several years. More...

More By Karl Thiel

The big headline in this month's clinical news is Merck's vorapaxar, a blood clot drug in late-stage development that has been considered the most promising drug in the company's pipeline. Shortly after the company halted one clinical trial, it confirmed that an independent committee had determined the drug can cause bleeding in patients with a history of stroke and that it is inappropriate in this population. Merck lost about $8 billion in market cap.

Plexxikon got a lot of attention for its melanoma drug last year when a New York Times article suggested that it worked so well it was unethical to do a survival study. Now an interim analysis of the pivotal trial has indeed produced a survival benefit and the patients in the control arm have the option to cross over. Drug development can be brutal. Targacept, meanwhile, produced some fantastic mid-stage results last year for it candidate to treat major depressive order; now it has some solid looking signals in its second product for improving cognition in schizophrenia.
-KT

Merck & Co., Inc. (MRK) Says Clot Preventer has Bleeding Risk
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Plexxikon Inc., Roche Holding AG (RHHBF.PK) Report Overall Survival Benefit for Melanoma Patients in PLX4032 Phase 3 Trial
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Targacept, Inc. (TRGT) Announces Positive Top-Line Results from Phase 2 Trial of TC-5619 in Cognitive Dysfunction in Schizophrenia
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Ariad Pharmaceuticals, Inc. (ARIA)'s Drug Ridaforolimus Meets Main Goal In Phase III Trial Of Bone Sarcomas
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Lexicon Pharmaceuticals, Inc. (LXRX) Shares Jump on Positive Diabetes Study Results
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More Bench To Clinic News
FDA Deputy Commissioner Josh Sharfstein is leaving after just 21 months on the job. Once considered to be on the short list for the Commissioner's position, he's now going to be working for the state of Maryland. Many in industry won't be sad to see him go, as he's been closely associated with agency's increasing focus--some would argue its counterproductive overemphasis--on product safety. He is, among other things, responsible for initiating the review of the controversial diabetes drug Avandia.
-KT

FDA's No. 2 Deputy Commissioner Sharfstein to Resign
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Cephalon, Inc. (CEPH) Names New CEO
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Pfizer Inc. (PFE)'s Kindler Quits the Federal Reserve Bank of New York
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Drug Maker Teva Pharmaceutical Industries Limited (TEVA) Laying Off 200 Irvine Workers
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Valeant Pharmaceuticals International (VRX) Lays Off 500 Employees in Merger with Biovail Corporation (BVF)
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More Career Track News
Eli Lilly's deal with Boehringer Ingelheim is another example of the growing interest in risk-sharing partnerships and all the permutations they can take. In this case, the companies are putting together four diabetes drugs in a hopper--two from each company--and agreeing to share both the rewards of success and the costs of development (and to pay each other milestones).

Bristol-Myers Squibb's agreement with Pharmasset is interesting in that involves to competitors partnering to put two novel drugs into a combination study. It's long been thought that the "cocktail" approach that has worked so well for treating HIV would yield similar benefits in cancer and--in this case--hepatitis C. But it's complicated for regulatory and competitive reasons. Usually combination trials involve one approved product and only one novel agent, so it's good to see industry innovating in this area.
-KT

Eli Lilly and Company (LLY) and Boehringer Ingelheim Corporation Announce Strategic Alliance to Bring New Diabetes Treatments to Patients Worldwide; Boehringer Ingelheim to Get 300M Euro; up to a Total of 625M Euro
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Genoptix, Inc. Announces Agreement to be Acquired by Novartis Corporation (NVS) for $470 Million
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Bristol-Myers Squibb Company (BMY) and Pharmasset, Inc. (VRUS) Enter into a Clinical Collaboration Agreement for Proof of Concept Combination Study in Patients Chronically Infected with Hepatitis C
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Theraclone Sciences, Inc. and Pfizer Inc. (PFE) Enter into Infectious Disease and Cancer Antibody Discovery Collaboration; Pfizer to Pay up to $632M
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Seattle Genetics, Inc. (SGEN), Pfizer Inc. (PFE) in $208 Million Antibody Tech Deal
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More Golden Handshakes News

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Pharm Country Career Fair Pharm Country Career Fair
Bridgewater Marriott Thursday, February 10, 2011, 11am - 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.
Genetown Career Fair Genetown Career Fair
Cambridge Marriott, Tuesday, February 22, 2011, 11am - 4pm Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Northeast region.
Some cool companies getting venture backing in the past month: Genocea is developing T cell-based vaccines, with a particular focus on both therapeutic and prophylactic vaccines for herpes simplex virus-2. Amgen and Pfizer are among the backers of TetraLogic, which is developing Smac mimetics--a class of small molecules with a name that's fun to say and with the potential to reactivate programmed cell death in cancer.
-KT

TetraLogic Pharmaceuticals Closes $23 Million Second Tranche of Series C Financing
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Genocea Biosciences Lands Massive $35M Series B Round
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Dendreon Corporation (DNDN) Announces Pricing of $540 Million Convertible Senior Notes Due 2016
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Pharmasset, Inc. (VRUS) Prices Public Offering of Common Stock
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GlaxoSmithKline (GSK) Offers to Give National Institute for Clinical Excellence (NICE) Rebate If Pfizer Inc. (PFE) Cancer Drug Better in Head to Head Clinical Trial
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More Money Talk News

In December, FDA began moving to remove the breast cancer indication from the Roche/Genentech blockbuster Avastin. But the company is not going down without a fight (even as some new evidence linking Avastin with an increased risk of congestive heart failure in breast cancer patients has emerged). The company has some allies in Congress, where some members question FDA's efforts at withdrawal and have moved for an investigation. Roche/Genentech argues that FDA is misinterpreting some data, and not giving weight to other. More importantly, they argue that FDA is risking setting a new approval standard that could stifle future drug development.
-KT
Genentech (RHHBY) Fires Back at FDA Over Avastin for Breast Cancer
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Johnson & Johnson (JNJ) Latest Headache Caused by its Women's Product
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Bristol-Myers Squibb Company (BMY) Recalls Avalide Blood Pressure Drug
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Alabama Judge Preps for Thousands of Pfizer Inc. (PFE), Chantix Lawsuits
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Spectrum Pharmaceuticals, Inc. (SPPI) to Make Biosimilar of Roche (RHHBY)'s Rituximab
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More Legal Briefs News
The stock market is usually pretty good at discounting the likelihood of near-term events, but it was apparently caught by surprise when FDA approved Clinical Data's Viibryd, a treatment for major depressive disorder. That probably says something about what investors expect from FDA these days--betting on outright approval apparently gives you craps-like odds. (And Clinical Data is up for sale, if you're interested. Randall Kirk, who owns over half the company, has had great success selling off other companies he's had an interest in, including Scios and New River Pharmaceuticals; he's planning on sticking with what works).

Meanwhile, investors hoping for the eventual approval of the weight-loss drug Qnexa were dealt a blow when FDA asked for data on birth defects associated with one of the two components of the drug. Even assuming Vivus can produce satisfactory data, it may take a while. -KT
FDA Wants Birth-Defect Data from VIVUS, Inc. (VVUS) for Qnexa
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FDA Rejects MannKind Corporation (MNKD) Diabetes Device, Afrezza
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FDA Panel Rejects Eli Lilly and Company (LLY) Pancreatic-Enzyme Replacement
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Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Company (LLY) Seek Expanded Use of BYETTA(R) Along with Basal Insulin
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New HRA Pharma "Morning-After" Pill Effective, Safe Say FDA Staff
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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.

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