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VIDEODendreon: Just What the Bulls Ordered
Public drama cannot hide the effectiveness, profitability of Provenge.
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Rumors were flying (my favorite was “surprise 2:1 stock split”), but the 2 likely ones were someone distributing a fake negative press release, or someone pushing the wrong button. I have no confirmation of any rumor, by the way.
By close of business today, I expect those 3 minutes will be out of sight and out of mind.
It’s a shame those 3 minutes happened at all, because the trading drama really takes away from the astonishingly good data Dendreon presented yesterday. I’ve been a longtime bull on the company, and the data were better than even I hoped. The trial was a clear win in terms of meeting the FDA’s thresholds for approval. The trial was also a clear win, in my opinion, in terms of creating a compelling clinical story leading to significant adoption by urologists and oncologists.
I’ve written about Dendreon at some length here, and have been covering the company for about 9 years. The short story is they have an active immunotherapy for cancer called Provenge. It's a treatment for late-stage prostate cancer that trains a man’s immune system to fight cancer. This has been a dream of cancer docs for a long time, but Provenge is the first drug of its kind to show Phase III pivotal data acceptable to the FDA.
In 2007, Dendreon had what I thought was approvable data from 2 clinical trials. An FDA advisory panel thought the drug should have been approved, too. They voted 13-4 that the drug was effective, and 17-0 that it was safe.
Judging by comments made by the panelists, I thought either 9 or 10 of the 17 thought it should be approved. The FDA, in an unprecedented action for a drug to treat a life-threatening condition, went against the panel’s recommendation for approval.
Two years later, data from a third Phase III trial became available. It proved the FDA should have listened to its advisory panel, because the drug showed once again it is unequivocally safe and effective. Dendreon said this a couple of weeks ago in a press release, which got the stock running, but the full data were made available yesterday at the American Urology Association (AUA) conference.The press release has the vital stats, and Dendreon has the key slides on their web site. My goal this morning is not to walk through the data - my firm’s own notes and those of other analysts have done that job. I want to make a couple of observations of what this means going forward.
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