Dendreon Going to the Big Dance

A biotech story that I've been following since I started on this beat around four or five years ago is about to go through what's referred to in the biotech world as a major "binary event". In other words, if things go well, the stock could skyrocket. If things go badly, then the stock could tank.

Dendreon goes before an FDA Advisory Committee next Thursday seeking a recommendation for FDA approval of the first-ever therapeutic cancer vaccine. It's called Provenge and, as its name might suggest, it's for advanced prostate cancer. Unlike a preventive vaccine which is given before you come down with something, a therapeutic vaccine like Provenge is given after you've been diagnosed with advanced prostate cancer.

There are several therapeutic cancer vacines in development, but Dendreon's is the closest to possibly coming to market. Dr. Mark Monane, the biotech analyst at Needham & Co., first introduced me to Dendreon at one of the firm's biotech investment conferences. I was just getting acquainted with the sector and was looking for CEOs to interview for a broad-based introduction to a biotech piece I was working on. Dendreon's Dr. Mitchell Gold agreed to participate. While we were chatting before the camera was set up, Dr. Gold mentioned that his family had been devastated over the years by various forms of cancer. He's also a former practicing urologic oncologist. I filed the information away in the hope that sometime in the near future I could do a personal profile on Dr. Gold and his family and his professional quest for a treatment for prostate cancer. For several months Dr. Gold declined my requests to do that story, but eventually he came around and the end result was - what I think - a very powerful piece about him, his family, the company and the drug. Since then, Dr. Gold and Dendreon have kept a much lower profile in the media as they've continued development of Provenge and continued navigating the regulatory approval process. But next week they'll be thrust into the spotlight.

The FDA briefing documents for the panel meeting could be posted on the FDA's website on Tuesday or Wednesday. Then, investors and analysts will try to determine based on the make-up of the committee and the issues and questions put forth which way it might turn out. But these things are very difficult to predict. Because the market value is so small, trading in Dendreon shares will almost certainly be halted during the meeting next Thursday. Ahead of the meeting the stock has already been trading at new intra-day lows. It's a very popular biotech stock to short or bet that it will go down. I remember sitting at a table at a rare Dendreon analyst meeting a few years ago and someone from a Connecticut hedge fund leaned over and whispered in my ear "It (Provenge) doesn't work." The bears say the clinical trials have been too small and the survival benefit seen early on was just happenstance. The bulls say the drug is safe and effective and could be a blockbuster. Look at the DNDN chart ... the bears are winning. But a positive vote by the panel next week could send the shorts running for cover. It could also depend on whether the vote is close or lopsided.

Prostate cancer is the second most common cancer among men. It's incidence is expected to increase as boomers age. And there's nothing available to patients once they've been on Sanofi-Aventis' chemotherapy drug Taxotere or the generic docetaxel. Next Thursday afternoon we will find out if those men could soon have a new alternative in Provenge. Next Wednesday, after I get back from the American College of Cardiology conference, we'll be airing a story about Dendreon and Provenge.


Questions? Comments?