Dendreon's Provenge: The Latest On Cancer Drug
Everyone's favorite biotech--investors seem to either love it or hate it--was one of the presenters this morning at the UBS Global Life Sciences Conference in New York City. CEO Dr. Mitchell Gold once again did the honors. Generally speaking, biotech investors focus on milestones or key events in drug development.
The overwhelming majority of these companies don't sell anything yet and therefore, don't make money, so they don't trade on revenue and earnings like most established publicly-traded firms. Biotechs, especially the little guys, trade on the hope for the future. Emphasis on the word "hope".
I did not attend the conference, so I can't give you color about the Dendreon turnout or the breakout session that followed the formal presentation. For those unfamiliar with investment conferences like this one, companies make scripted PowerPoint presentations of about 30 minutes and then the executive goes to a smaller room to answer analyst and investor questions in what is usually a more free-wheeling, but still Reg FD-conscious discussion.
So, I just listened to the Webcast. Dr. Gold indicated the company will soon hit another milestone. He reported that Dendreon has "pre-enrolled" 490 men (out of a targeted 500) in the ongoing Phase 3, pivotal, all-important clinical trial of its prostate cancer therapeutic vaccine Provenge. The test is being conducted at 70 sites in North America and Dr. Gold said, "We'll be completing enrollment very shortly. And that's a major achievement for the organization."
Still, interim results from that study won't be available until the middle or second half of next year. The Food and Drug Administration has told Dendreon it might approve Provenge on positive survival data from that sneak-peak analysis or it could wait for the final results to be in which probably won't be available until 2009 or 2010.
No news on the partnership front. Dr. Gold says Dendreon continues to plan to go it alone in the U.S., but that it's looking for a commercial partner for Provenge in the rest of the world. He's been saying that for months and rumors from time to time swirl about that an announcement of a partnership is pending.
But with the volatile history of Provenge you have to wonder whether a company doesn't want to touch it with a 10-foot pole until the next set of data come in. On the other hand, if the data are good, whatever companies might be interested would then have to pay a heckuva lot more money to buy into Provenge.
As far as the controversy over the drug and the FDA's handling of it, Dr. Gold would only say, "Our goal is to fundamentally change the way that cancer is treated. Clearly there's been, umm, a lot of hope and I think discussion on whether these types of therapies (therapeutic cancer vaccines) are gonna have a role in the treatment of cancer. And we believe very strongly that they do. And the reason that we believe that is because the data supports a significant survival benefit in a patient population with a large unmet medical need. The physicians are very interested in getting these types of products available to them…."
Dendreon is based in Seattle where I am heading Friday for the Trojans vs. Dawgs (Huskies) game Saturday night. Blog at you on the other side of the weekend.
Questions? Comments? Pharma@cnbc.com