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Biotech Roundup: Pfizer's Fesoterodine, NCI/FDA Conference


This week in biotech: Pfizer's bladder drug and a cancer immunotherapy conference.


Pfizer's Fesoterodine

Pfizer (PFE)
paid a pretty penny ($210 mln cash) for the overactive bladder drug fesoterodine. This has never made any sense to me because the drug is not even close to best in class. In any case, the FDA sent Pfizer an approvable letter on fesoterodine. This will delay the drug. Pfizer indicates the issue is a manufacturing problem. No word whether this will fall into a Class One (two months) or Class Two (six months) response bucket.

This should benefit a few companies, notably Indevus (IDEV). This company and partner Esprit Pharma (private) will launch best-in-class Sanctura XR just after Labor Day this year – assuming the FDA approves the drug in August. They already market a twice-a-day (and otherwise inferior) formulation of the drug, with limited success. Sanctura XR is not only once-a-day, it has the best efficacy and side effect profile of all overactive bladder drugs.

Overactive bladder is about a $1.3 bln market that I expect will increase to $2 bln by the end of the decade – as long as the rampant free sampling that has been going on slows down. Whether Sanctura XR gets a percentage of that befitting a best-in-class drug depends on how well small Esprit and Indevus can sell the drug. Esprit is currently seeking a larger marketing partner to sell the drug through the primary care physician channel.

NCI/FDA Conference

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).

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.
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Position in DNDN, IDEV

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