Macro Tsimmis

intelligently hedged investment

Dendreon (DNDN, again) update

Posted by intelledgement on Wed, 15 Apr 09

An article posted earlier today on the Financial Times website suggests “that FDA almost always requires multiple Phase III trials, making rare exceptions for drugs that are already on the market for different indications…. [A]s a bureaucracy, the agency would choose caution over risk, following rules and regulations as closely as possible with very few exceptions, and that in the case of a new chemical entity, it is expected that extra care would be taken to ensure that the proper decision is made.”

While technically, the just-completed 500-patient IMPACT study is the third Phase 3 trial Dendreon have conducted for Provenge, the first two were small studies and both failed to meet their primary endpoint, which—inappropriately, we would say—was time-to-progression for tumors. While retrospectively pooling the data from those two studies uncovered an apparent survivor benefit, that did not suffice to persuade the FDA to approve Provenge in 2007. And, the article cited one anonymous industry executive as opining, “the initial Phase III studies that pooled data from two studies together to form a larger trial is a point of concern, and would not be considered a second Phase III trial. The only Phase III trial that has [overall survival] as an endpoint is the IMPACT trial, and nothing will settle the question of whether the results can be reproduced, unless another well controlled Phase III trial is conducted.”

We’d like to dismiss this out of hand as totally contrary to what Dendreon were told in 2007…however, the FDA has already proven to be shaky at best in dealing with an innovative mode of treatment such as Provenge. Plus—yeah, we know it’s just a sleep remedy, not a therapy for a life-threatening illness—we still get tremors when we consider the Indiplon fiasco, where the FDA kept moving the goal posts after Neurocrine (NBIX) scored each touchdown until finally management realized they were throwing good money after bad…and no matter what hurdles they successfully cleared, the FDA were never going to approve. Pregnant animal studies for a drug not indicated for pregnant humans in a drug class not indicated for pregnant humans where none of the dozens of previously approved drugs in that class had been so burdened! There’s a message there for biotech investors, folks.

Even if this is needless worry, even if everything is copacetic, even if Provenge approval by June 2010 is in the bag, then we still believe the takeaway from 9 May 07 remains that we need to pay more attention to the incapability of the FDA to deal with innovation.

Dendreite conspiracy theorists maintain an elaborate fantasy construct of an epic plot to suppress Provenge hatched by shortsellers and big pharma drug companies and incorporating journalists who publish “bad” articles, advisory committee members who voted “no” on efficacy (one or two of whom do appear to have at least potential conflicts of interest, not that that necessarily proves their opinions insincere or their analysis tainted), analysts who issue negative opinions, and most critically, FDA staffers working at the behest of these evildoers. But we seriously doubt anyone in the FDA gives a hoot about the fate of chemotherapy. We believe the problem is simply that dedicated and well-meaning agency personnel have too much incentive to be cautious, and are conditioned to be so zealous at rejecting dirt that they can’t see the babies for the bathwater.

That condition is a threat not only to prostate cancer victims and Dendreon investors, but to the viability of a US-based biotech industry.

In the meantime, we believe that the immunotherapeutic mechanism Dendreon are employing works at some level with Provenge, and that whether or not the FDA ultimately require another Phase 3 trial, the IMPACT results will prove sufficient for them to approve at least a limited label use of Provenge for advanced prostate cancer patients who have no other options by next June. And we believe there is a significant likelihood that Dendreon’s immunotherapeutic mechanism will prove to have wide utility in fighting various and sundry cancers—breast, cervical, kidney, colon, et al—and that ultimately prophylactic treatments with successor immunotherapies might become standard for everyone.

If those eventualities pan out, it won’t make much difference if you bought DNDN stock at $4, $16, or $28, because it is headed way, way higher.

Previous DNDN-related posts:

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