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Wednesday, September 29, 2010
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 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...
More By Karl Thiel
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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.
-KT
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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.
-KT
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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.
-KT
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• Genetown (Lexington, Massachusetts)
Cubist Pharmaceuticals, Inc.
Director/Senior Director Strategic Sourcing Program
This role is responsible for developing and driving the vision for and growth of the Strategic Sourcing Program for Cubist Pharmaceuticals, Inc. and will be responsible for providing leadership for at least one other Senior Strategic Sourcing professional as well as the current Procurement Department which is staffed by a Senior Purchasing Manager and a Buyer.
• Biotech Bay (Foster City, California)
SciClone Pharmaceuticals, Inc.
VP of Manufacturing
The successful candidate will provide technical leadership, strategic direction and oversight for successful planning and execution of all technical and manufacturing activities associated with SciClones pharmaceutical products (process, analytical, and formulation development, validation, technology transfer, manufacturing, and supply chain logistics) at contract development and manufacturing organizations.
• BioForest (Vancouver, Canada)
WEX Pharmaceuticals Inc.
Senior Director of Clinical Development
Lead the planning, development, implementation and interpretation of the Company's clinical trials. Provide scientific and regulatory oversight to project teams. Act as study director for the Company's clinical trial of TTX in chemotherapy-induced neuropathic pain.
• BioMidwest (Chicago, Illinois)
Takeda Pharmaceuticals
Director, CSO Communication
The objective of the Director, CSO Communications is to ensure effective internal and external communications for Takeda's global research amp; development (Ramp;D) entities, primarily supporting the Chief Scientific Officer and the Chief Scientific Officer Office (CSOO).
Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!
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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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Biotech Bay Career Fair
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.
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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.
-KT
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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.
-KT
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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.
-KT
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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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