Today's the day! Wal-Mart starts selling the first FDA-approved, over-the-counter weightloss pill today. GlaxoSmithKline says Alli should be on drugstore and discount store shelves everywhere by tomorrow. Alli is the diet pill that can have embarrassing gastrointestinal side effects.
Coincidentally, the launch occurs the day after an FDA Advisory Committee shut out Sanofi-Aventis' weightloss pill Zimulti. The panel thought the drug helps people lose weight, lower triglycerides, raise good cholesterol and possibly control blood sugar in Type 2 diabetics. But those benefits, the committee said, did not outweigh the psychiatric risks. Specifically depression, thoughts of suicide and actual suicides. Sanofi said four people who've taken the drug have killed themselves.
But the company adds all of them had either a history of problems and/or extenuating circumstances. For example--and I'm not making this up--the company told the panel yesterday that one victim was a man who was in the federal witness protection program and who was facing a pending, undisclosed major (court?) decision when he shot himself in his front yard. Now, there's a story.
The lopsided vote could also have an impact on the pipelines of Pfizer, Merck and Bristol-Myers Squibb which are developing similar drugs.
So, today I'm back in New York and hanging out at the Needham Biotech Conference where this morning I sat in on the Dendreon presentation by CEO Dr. Mitchell Gold. I also went to what's called the breakout session afterwards. For those who are unfamiliar with this type of investor conference, a breakout session is held in a smaller room where investors can pepper the CEO or another executive with questions. The presentations themselves are more formal and usually very boilerplate--i.e. pipeline, timeline, technology, data, financials, etc.
Over the years I've watched nearly a dozen of Dr. Gold's investor presentations. But this one was different. In the wake of the Provenge controversy, he spent much more time trying to educate the nearly 50 people in the room about how Provenge works and what he argued is the robustness of the results seen so far.
Gold said the company expects to complete enrollment in the 500 patient Provenge study this year. And he repeated that he expects interim results from that clinical trial in the middle to second half of next year. Dendreon recently said the FDA has told the company it'll accept positive survival data from this study for possible approval. Dr. Gold said the trial is "reasonably powered to achieve its endpoint (a goal of improved overall survival)" at the interim analysis.
Gold said the company is still looking for a Provenge corporate partner outside the U.S., but added, "The challenge will be to find a partner outside the U.S. that also doesn't want a piece of the U.S. market.". In the breakout, an unidentified investor pressed Dr. Gold for more info on a potential deal. "I can't talk about that," Dr. Gold said in response to a question about whether the company has been approached. But then he added this little nugget, "It's hard for anyone not to recognize the opportunity that's at hand."
Also during the breakout, Dr. Gold--a former practicing urologist and whose mother died in her 20s of breast cancer--made some rather candid general remarks about the disease. "Over the past 30 years," he said, "this country has made very little progress in cancer. I think it's a shame. If you look at what we spend on defense and compare that to what we put into cancer--the number two killer of Americans--it doesn't seem like the right alignment of resources."
Meantime, two companies that are also in the prostate cancer space are presenting at this conference: GPC Biotech and Pharmion which are partners on the former Bristol drug satraplatin. Patients who've failed on Sanofi's Taxotere or who don't want to take that drug because of its side effects would get satraplatin. An FDA decision could come on or before August 15th. But first it has to get past an FDA Advisory Committee on July 24th. In the wake of the Provenge Advisory Committee meeting and the one yesterday on Zimulti it will be interesting to see how that one turns out. And one week later another panel will take up Glaxo's Avandia.
As Linda Ellerbee used to say, "And so it goes."
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