BioSpace BioPharm Exec
Wednesday, October 28, 2009
No Sleep, But Plenty of REMS

When David Letterman went public with his sordid story of adultery and blackmail a few weeks ago, a few media outlets raised an interesting question: Why, exactly, is blackmail illegal? The individual acts behind typical blackmail--threatening to publicize embarrassing information and alternatively being paid not to publicize information--are both perfectly legal. Making a crime out of legal activities that transpire in the wrong order (solicitation of payment being the key) seems, from a certain perspective, a bit tortured.

I had a similar feeling when I recently read about Allergan's federal lawsuit against the Food and Drug Administration, seeking a ruling that would allow them to discuss off-label uses of Botox with physicians.

Why, exactly, is off-label promotion illegal? Or more specifically, why does the prohibition not interfere with First Amendment rights? I'm not a lawyer, so perhaps there are clearer legal arguments than I realize. But if that's the case, they've apparently never been tested in court before--no company that I know of has has raised First Amendment objections to FDA's off-label promotion rules before this.

What makes it more interesting is that Allergan is trying to More...

Genzyme is still feeling Protalix breathing down its neck as its rival Gaucher's disease therapy advances through the clinic. But at least it won't have to worry about the Amicus/Shire contender, which just failed pretty resoundingly in Phase 2. And positive new studies on Lucentis come along just as Genentech is being questioned by Sen. Herb Kohl (D-Wisc.) about its role in a Medicare reimbursement change on ophthalmologic uses of Avastin. Lucentis and Avastin, both Genentech drugs, are very similar, and eye docs use both of them in treating macular degeneration. But the tiny doses of Avastin used off-label cost only about $50, versus about $2,000 for Lucentis. Kohl is suspicious that a new rule cutting compensation to docs who use Avastin--and which may steer them toward Lucentis--may have come at the suggestion of the company itself. Genentech denies it. -KT

Two Phase III Studies of Genentech (South SF) (DNA)'s Lucentis Show Early and Sustained Improvement in Vision in Patients with Retinal Vein Occlusion
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Mixed Data for AstraZeneca PLC (AZN) (JOBS) and Bristol-Myers Squibb Company (BMY) (JOBS) Diabetes Drug in New Phase III Study
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Human Genome Sciences, Inc. (HGSI) (JOBS), GlaxoSmithKline (GSK) Report Progress With Lupus Treatment
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CombinatoRx, Incorporated (CRXX)'s Synavive (CRx-102) Maintains Efficacy Throughout 12 Month Phase 2 Knee OA Extension Trial
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Protalix Biotherapeutics's Gaucher Drug Meets Goal in Late-Stage Study
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Amicus Therapeutics, Inc. (FOLD)' (JOBS) Gaucher Drug Fails in Mid-Stage Trial
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More Bench To Clinic News
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We finally have a resolution to the seven-year-long saga of a former InterMune CEO and the fraud he committed in promoting the drug Actimmune. Scott "The Baron" Harkonen (that's a little Dune reference for you) was convicted of wire fraud for promoting the effectiveness of Actimmune as a treatment for idiopathic pulmonary fibrosis (IPF) in a press release, despite contradictory clinical evidence. The crime carries a maximum sentence of 20 years, although he's unlikely to get such a stiff term.

Meanwhile, some of the major drug companies are once again letting employees go, although at least not in the numbers we saw last year. Having completed its merger with Wyeth, Pfizer is--to the surprise of no one--starting to realize some of those vaunted synergies in the form of pink slips. -KT

W. Scott Harkonen, Former Biotech CEO, Convicted of Wire Fraud
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As Pfizer Inc. (PFE)(JOBS)-Wyeth (WYE) (JOBS) Deal Wraps Up, Pfizer Said to Cut 15% of the Companies' Combined Workforce and Close Certain Wyeth Sites in New Jersey, Pennsylvania
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AstraZeneca PLC (AZN) (JOBS) Offers Buyouts To Its Entire Sales Force
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Roche Holding AG (RHHBF.PK) (JOBS) to Review Genentech (South SF) (DNA) (JOBS) Employees' Pay
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Bristol-Myers Squibb Company (BMY) (JOBS) to Close Facility, Cut 113 Jobs
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The Medicines Company (MDCO) (JOBS) President, COO John Kelley Resigns
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BioWorld Biofuels Report 2009 Just Released: The BioWorld Biofuels Report 2009! Brand new from BioWorld, the Biofuels Report 2009: Lane-Changing Trends and Fork-in-the-Road Dynamics chronicles, analyzes and projects the foremost and ancillary aspects of one of the most significant markets that will impact the future well-being of humanity and the environment, More... Seven Deadly Myths of Job References Seven Deadly Myths of Job References
Thinking about your prospects for landing that new job? You should think first about what your former boss and other references will say about you. There is no doubt, for many job seekers, a person's past will have a direct bearing on his or her future. More...
Most investors left it for dead less than a year ago, but Vanda has locked in some of the benefits of its hard work and good fortune by selling rights to its atypical antipsychotic drug Iloperidone to Novartis--from which Vanda licensed the compound in the first place. Now there's some value added! And GlaxoSmithKline's deal with Dutch company Prosensa shows that interest in RNA therapeutics is still alive and well. The giant biobucks figure in the headline ($680 million) of course describes the incredibly unlikely best-of-all-worlds scenario, but this is still a reasonably rich deal for a program aimed at four specific subtypes and the already orphan-designated Duchenne muscular dystrophy. Meanwhile, Onyx looks to expand into development of proteasome inhibitors--a relatively new therapeutic area opened up by the Millennium/Takeda product Velcade--with the acquisition of Proteolix. Onyx is making a big bet on Carfilzomib, a very promising but still relatively early stage (phase 2) drug. -KT

Sanofi-Aventis (France) (SASY.PA) Buys Wellstat Therapeutics Corporation's Type II Diabetes Drug PN2034 For Up To $350 Million
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OXiGENE (OXGN) (JOBS) to Buy VaxGen, Inc. (VXGN) for About $22 Million in Stock
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GlaxoSmithKline (GSK) in $680 Million RNA Deal with ProSensa B.V.
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Novartis Pharma AG (NVS) (JOBS) Acquires Exclusive Rights From Vanda Pharmaceuticals, Inc. (VNDA) for Commercialization of Fanapt in the United States and Canada; Novartis to Pay $200 Million Upfront
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Onyx Pharmaceuticals, Inc. (ONXX) (JOBS) to Acquire Private Biotech, Proteolix, Inc. (JOBS) for $851 Million
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Heptares Inks $200 Million Tech Pact with Novartis Corporation (NVS) (JOBS)
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GlaxoSmithKline (GSK) Forms Vaccine JV with Jiangsu Walvax
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Genetown Career Fair Genetown Career Fair
Sheraton Boston Wednesday, November 4, 2009. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Northeast region.
Regeneron Career Fair Regeneron Career Fair Sheraton Mahwah Tuesday, November 3, 2009. For this event Regeneron is ONLY looking for candidates with experience in the functional areas: Analytical Chemistry, Assay Development, Biochemistry, Formulation, Pharmacokinetics, Protein Chemistry, ...
Maybe media claims that Omeros is the first "true" biotech to make an IPO since February 2008 are true. If so, it's not an auspicious return to form. The stock not only dropped 13% on its first day but is as of this writing down about 35% from its IPO price. Still, things are not as bad as Yahoo! Finance would have it--the site is erroneously reporting that the company has a market cap of $19.4 million--a pretty attractive valuation for a company that just raised $68 million a few weeks ago.

I previously mentioned Vertex's intriguing plan to raise money by selling future milestone payments. Not only did they manage to complete a deal, but Valeant got in on the action, too, gladly paying former shareholders of Dow Pharmaceutical Sciences $115 million today in order to avoid $235 million in commitments down the line. -KT

Vertex Pharmaceuticals (CA) (VRTX) (JOBS) to Receive $155 Million in Cash Related to Future Telaprevir Milestone Payments
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Valeant Pharmaceuticals International (VRX) Buys-Out Rights to All Current and Future Income and Milestone Obligations From Former Dow Pharmaceutical Sciences (JOBS) Stockholders for $115M
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Omeros Corporation, First U.S. Biotech IPO Since February 2008, Sees Shares Drop 13 Percent in First Day
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Epizyme Closes $32 Million Series B Financing, Led by New Investor Bay City Capital
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Repros Therapeutics Inc. (RPRX) Announces Financing
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Auxilium Pharmaceuticals (AUXL) Completes Sale of 3.45 Million Shares of Common Stock Resulting in $115.7 Million in Net Proceeds
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Global Vaccine Development for World Health Symposium Global Vaccine Development for World Health Symposium will address the expanding need for discussion on regulatory guidelines for the development of vaccines for infectious diseases. Professionals from industry and worldwide regulatory agencies will present the current challenges and solutions around this critical field of global healthcare. More information and online registration. qPCR Symposium USA qPCR Symposium USA. The 3rd qPCR Symposium USA features keynote speech, presentations by experts on latest developments in the industry, applications and academic perspectives from eminent scientists. The Symposium is also hosting exhibition, poster session and related courses. For more information, visit www.qpcrsymposium.com.
The seemingly simple effort of reauthorizing the popular Small Business Innovative Research (SBIR) program has become remarkably dramatic. With an all-new October 30 deadline for the program about to expire (until Congress presumably resets the clock for a fifth time), the House and Senate Armed Services Committee got sick of waiting for the small business committees of the House and Senate to get their acts together and agree on a compromise bill. So they incorporated their own reauthorization--for the Department of Defense portion of the SBIR program only--into a defense bill. The other committees cried foul, so they settled for just a one-year extension. But at least one arm of the government is taking this program seriously. -KT

DOD SBIR Program Extended for 1 Year
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FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies
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Senators Introduce Access to Affordable Medicines Act to Close Labeling Change "Loophole"; Companion Bill to Senate Drug Price Competition Act of 2009 Introduced in House
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More Legal Briefs News
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Transformational Learning - Effective Knowledge Exchange. Sponsored by Pharmaceutical Compliance Forum. November 11 - 13, 2009, JW Marriott Hotel, Washington, DC. www.PharmaCongress.com
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FDA has been pretty busy over the past month announcing a flurry of approvals and a few high-profile Complete Response letters (aka Approvable letters, aka punts). Perhaps the biggest surprise was the delay on Amgen's osteoporosis drug denosumab, now trade-named Prolia. But the issues holding up launch are relatively minor (concerning post-marketing and risk-management plans), so the drug should be greenlighted soon. Not so lucky are Genentech and Biogen, which failed to get an expanded rheumatoid arthritis label for Rituxan because of concerns about progressive multifocal leukeoencephalopathy (PML, a rare brain infection that Biogen in particular has become very familiar with over the past few years). This is a bit of an odd call, given the extremely low incidence of PML in Rituxan patients and the fact that it is still approved for other rheumatoid arthritis settings, but nonetheless, the companies appear to have lost this battle.

Plus, I must mention that the victory of the month goes to Acorda, which saw its shares tank prior to an FDA Advisory Committee review of Fampridine-SR, its multiple sclerosis drug. The briefing documents released before the meeting were very negative indeed, questioning whether the drug's efficacy outweighed its risks, but the committee ultimately voted 12-1 in favor of efficacy and 10-2 in favor of safety. Now shares are back where they were prior to the release of the briefing documents. I wish Acorda good luck. It used to be that you could almost take a positive committee vote to the bank, but I'm not so sure that's true anymore. -KT

US FDA Delays Approval of Amgen (AMGN) (JOBS) Osteoporosis Drug
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Genentech (South SF) (DNA) And Biogen Idec, Inc. (Massachusetts) (BIIB) Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis
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Acorda Therapeutics (ACOR) (JOBS) Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
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FDA Approves Merck & Co., Inc. (MRK)'s (JOBS) GARDASIL(R) for Use in Boys and Young Men
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CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
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FDA Declines To Approve New Indication For Spectrum Pharmaceuticals, Inc. (SPPI) (JOBS) Fusilev; Shares Plunge
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FDA Approves GlaxoSmithKline (GSK)'s VOTRIENT(TM) for Advanced Renal Cell Cancer
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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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