NCI/FDA Conference
[David Miller's (www.BiotechStockResearch.com) take on the recent NCI/FDA conference. Have we seen the 30-% figure before? Doesn't it look too high? If true, MEDX must have squeezed PFE mightily. There was a substantial cash payment too when that deal was done, disguised as a technology access payment].
The FDA and the National Cancer Institute (NCI) sponsored a two-day conference on cancer immunotherapy. The standing-room-only conference has been interesting to watch, though I freely admit it helps to be an immunotherapy geek. The conference started yesterday and continues today.
Several FDA luminaries have presented at the conference, including new FDA Commissioner Dr. Andrew von Eschenbach. Immunotherapy has been a big focus of the NCI for a long time, with little success. I could write for pages about why I think this is the case, but I’ll spare you the geek trip (here’s a hint minyanville.com.
Instead, I will note the FDA folks said all the right things. They are encouraged by recent advances. They want to be a bridge to seeing these drugs on the market and not a barrier. Dr. von Eschenbach was especially insistent on this theme and on his belief that the dark days of immunotherapy are behind us.
This was all endlessly fascinating to shareholders of Cell Genesys (CEGE), Medarex (MEDX), and especially Dendreon (DNDN).
CEGE has its immunotherapy drug in a pair of Phase III trials in prostate cancer. The comapany has had little luck enrolling those trials in the US, so it is enrolling them now in Eastern Europe where money is “more persuasive” in obtaining enrollment.
Medarex has the immune system booster ipilimumab (CTLA-4). Your immune system is a delicate and balanced dance with immune activity strong enough to repel bad things and not strong enough to attack stuff that is supposed to be there. Ipilimumab essentially skews that balance to make the immune system more aggressive in the hopes the immune system will wake up and realize the tumor it’s been ignoring as “self” is actually an invader. NCI investigators were bemoaning the fact ipilimumab is not easily obtainable from Medarex for its pet experiments. That may come off as negative, but it is worth mentioning everyone is excited about the prospects for the drug.
I’ll note that Pfizer has a CTLA-4 inhibitor in development, too. A cross license gets Medarex an over 30% royalty on that drug. Medarex also has a roughly 50-50 development deal on ipilimumab with Bristol Meyers (BMY). Whichever drug is best, Medarex wins. My firm covers Medarex and thinks it is likely the company is purchased by Pfizer or Bristol if the upcoming pivotal trial data are good.
Dendreon, as you should be aware of by now, looks to have its panel meeting towards the end of March. Some believe it won’t be until May, but my firm thinks that is inaccurate. We’re hoping to learn for sure in the next week or so. A positive panel and subsequent May approval will be huge for this space, akin to when the monoclonal antibody (MAb) approach emerged from its similar dark times with the first approval of a humanized MAb. Once that happened, MAbs went from disappointment to the hottest thing in biotech both scientifically and from an investor perspective. I expect the same thing could happen to immunotherapies, though investors need to be careful since there is a lot of crap out there.
minyanville.com |
