BioSpace BioPharm Exec
Wednesday, September 29, 2010
Is Cancer's "Penicillin Moment" FDA's Moment of Doubt?

In late August, the New England Journal of Medicine featured something remarkable: Results of a phase 1 study on a drug called PLX4032.

Usually, a phase 1 study isn't worth getting too excited about, but this was different. In a study of patients with metastatic melanoma--a late stage cancer in which survival is measured in weeks and current therapies do very little--nearly all treated patients experienced tumor reduction, with 81% having shrinkage of 30% or more. The drug targets patients with a specific mutation to the B-raf kinase, a new strategy made possible by relatively cheap and rapid sequencing and genotyping. Hailed by the BBC as "cancer's penicillin moment," enthusiasm is running high about this molecule, which was discovered by a private company called Plexxikon and partnered with Roche. More...

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Sanofi had high hopes for NV1FGF, which they hoped would treat critical limb ischemia by encouraging the growth of new blood vessels, but the drug proved no better than placebo in a phase 3 study. The failure of the drug, which has been in clinical development for 10 years, was (another) major setback for Vical, and makes Sanofi's pipeline look just a little wobblier. That's probably not enough to convince the French drugmaker to up its bid for Genzyme, but the pressure is on to get new products.
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Sanofi-Aventis (France) (SASY.PA), Vical Incorporated (VICL) Limb Ischemia Drug NV1FGF Fails in Late-Stage Test
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Seattle Genetics, Inc. (SGEN), Millennium: The Takeda Oncology Company Drug SGN-35 Shrinks Lymphoma Patients' Tumors in Study
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GlaxoSmithKline (GSK) Kidney Cancer Drug Shrinks Thyroid Tumors
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Transition Therapeutics Inc. (TTH.TO) and Eli Lilly and Company (LLY) Stops Diabetes Drug Development
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Idenix Pharmaceuticals, Inc. (IDIX) Hep C Drugs On Clinical Hold On Safety Concerns
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More Bench To Clinic News
The turmoil at Elan is too involved to summarize here, but the latest events in this soap opera involve two "dissident" directors seeking an independent investigation into the company's 2009 deal with Johnson & Johnson, an injunction from the Irish High Court to stop them, a 17-page defense released by CEO Kelly Martin, and an independent shareholder again seeking to nominate new directors. Finally, the original investigation into the J&J deal has come out and found that Elan is, to quote the old Irish Spring commercial, clean as a whistle. The board members who thought the firm conducting the investigation wasn't really independent have decided to resign. So is that the end of it? Tune in next week...

Speaking of J&J, the circus concerning that company's Tylenol and other consumer products continues. Colleen Goggins, head of the McNeil consumer healthcare group, has resigned--a move seemingly calculated, at least in part, to take attention away from her boss.

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Elan Corporation PLC (ELN) Gets Director Opponents to Quit Board
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Johnson & Johnson (JNJ) Consumer Boss Retires as Tylenol Probe Widens
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Abbott Laboratories (ABT) to Cut 3,000 Jobs Following Solvay Pharmaceuticals, Inc. Deal
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GlaxoSmithKline (GSK) Picks Goldman, Sachs & Co. Partner for Next CFO
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Bristol-Myers Squibb Company (BMY) to Cut 3 Pct of Work Force
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More Career Track News
Genzyme is selling its genetic testing unit to LabCorp for $925 million, or two-and-a-half times last year's revenue. Genzyme Genetics is one of Genzyme's five independent business units and does mostly oncology and reproductive testing as well as some CRO work. The company is also seeking the sale of two other units, diagnostics and pharmaceutical intermediates. What this means for Genzyme's ongoing dance with Sanofi-Aventis is unclear. Selling off some of the business units may make an acquisition cleaner, but Genzyme's stated purpose is to raise more money to fund a stock buyback. Genzyme remains opposed to the $69-per-share bid, but parties from both companies have said they see a deal as likely.
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Genzyme Corporation (GENZ) to Sell Genetics Unit to Laboratory Corporation of America Holdings (LabCorp) (LH) for $925 Million; Genzyme Cutting 1,000 Jobs Over Next 15 Months
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Johnson & Johnson (JNJ) Aims to Buy Vaccine Maker Crucell N.V. (CRXL) for 1.75 Billion Euros ($2.3 Billion)
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Bristol-Myers Squibb Company (BMY) to Acquire ZymoGenetics, Inc. (ZGEN) For $885 Million
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Roche (RHHBY), reMYND Sign $637M Early-Stage Parkinson, Alzheimer Deal
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) And Orexigen Therapeutics, Inc. (OREX) Sign $1 Billion Obesity Pact
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BioCapital Career Fair BioCapital Career Fair
Marriott Bethesda North Hotel & Conference Center, Monday, October 18, 2010, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the mid-Atlantic region.
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San Francisco Airport Marriott, Monday, October 18, 2010, 2pm to 7pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the in the Bay area.
The trickle of IPOs continues, but perhaps more interesting are the companies not filing for a public offering. Relypsa and immatics have both raised large venture rounds that will allow them to take their lead products into phase 3 clinical trials. It used to be that the public markets were supposed to take up the heavy lifting at this point, but this won't be the first time companies have used venture funding to collect pivotal data. The question is how willing VCs will be to start funding companies if they know this is what it takes to get them to leave the nest.
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Relypsa, Inc. Raises $70 Million in Series B Financing
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immatics biotechnologies GmbH Raises EUR54 Million ($71 Million) to Advance its Late Stage Clinical Therapeutic Cancer Vaccine Portfolio
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Quark Pharmaceuticals Inc. Seeks Up to $20M IPO
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Anacor Pharmaceuticals, Inc. Files to Sell Up To $86.3 Mln in IPO
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Zogenix, Inc. Files for $90 Million IPO
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More Money Talk News

FDA has circulated a draft agenda for a meeting on biosimilars, to be held Nov. 2-3--a clear indication the agency is moving forward in its effort to establish a clear regulatory pathway for follow-on biologics. And there were some big legal settlements in the news, including two fairly rare admissions of guilt from Forest Labs and Allergan.
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GlaxoSmithKline (GSK) Says Roche (RHHBY)'s Herceptin Infringes Patents
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Guilty by Admission: Forest Laboratories, Inc. (FRX) Forfeits $313M for Selling Unapproved Drug
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Allergan Inc. (AGN) To Pay $600 Mln To Settle Botox Probe
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Senate Republicans Hate The Pay-To-Delay Ban
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FDA Schedules Meeting on Biosimilars
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More Legal Briefs News
Patients with multiple sclerosis have long wanted an oral pill to control relapses, and they have it now with the approval of Novartis' Gilenya. The drug carries some of the risks common to immune-supressing therapies, but it was quite effective in studies and appears to have a manageable risk profile, so Novartis looks to have a winner on its hands. The hope is that patients in the early stage of their illness will be more willing to take a pill than weekly injections, which may help the course of the disease.

Novartis' competitors are not feeling so good. Biogen Idec took the unusual step of proactively releasing a statement on the approval. Merck, which is close behind in this race for an oral therapy, suffered a major setback: European regulators rejected cladribine, citing an unfavorable risk-benefit ratio. That naturally has observers wondering if FDA will also look on the drug with a jaundiced eye.
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Novartis AG Gets First U.S. Approval for MS Drug Gilenya; Novartis Ahead of Merck KGaA (MKGAF.PK) in Race to Get to Market
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US Advisers Reject Arena Pharmaceuticals, Inc. (ARNA) Diet Drug Lorcaserin
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FDA Significantly Restricts Access to GlaxoSmithKline (GSK)'s Diabetes Drug Avandia; Europeans Pull Plug
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FDA Approves Savient Pharmaceuticals, Inc. (SVNT)'s KRYSTEXXA(TM) (pegloticase) for the Treatment of Chronic Gout in Adult Patients Refractory to Conventional Therapy
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Genentech (RHHBY), ImmunoGen, Inc. (IMGN) Receives Refuse to File Letter from FDA for Drug T-DM1
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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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