Not With A Bang

And so we bid a not-so-fond farewell to Dimebon. It is not as if anyone–anyone?–expected the last Pfizer/Medivation clinical study for Dimebon, this one in conjunction with Aricept, to provide anything more than a postscript. Still, the announcement of that Phase III failure, and the ending of the Pfizer/Medivation partnership, deserves a moment for contemplation of what may have been learned from this experience:
1) Data that seems too good to be true probably isn’t. 183 Russian patients can and were wrong. Was it the population? The trial execution? A power play by an oligarch? We will never know, but we do know this: No one will ever look at data from a small, nonrepresentative sample in the same way again.
2) Just because a Big Pharma endorses it doesn’t make it real. To have a company with Pfizer’s size and expertise bring in not only their inhouse talent, but also well-regarded independent reviewers, would seem a compelling exercise in due diligence. But that proxy for a wider-ranging trial turned out to be an illusion, and one which cost Pfizer hundreds of millions of dollars.
3) Diversification may not be foolproof, but it is helpful. Had Medivation been all about  Dimebon, they would be trading below cash value right now. But having inlicensed MDV3100, partnered with Astellas, and produced positive Phase III data in prostate cancer, Dimebon’s demise passed with little notice or comment. What could have been a disaster was barely even a distraction.
4) Phase IIb is not optional. Pfizer bought into Dimebon before Medivation’s inhouse ‘pivotal’ trial had ever reported. And they did not even mention the Medivation trial in public presentations, they knew it was going to be a failure. So why the overconfidence in their own trial program?
5) Which brings us to the observation that Big Pharma, to the degree to which anything can be said about such a nonunitary, heterogeneous conglomeration, combines a paralytic fear of risk-taking with an unwarranted arrogance regarding their expertise. Who else both underestimates and overestimates their capabilities in virtually the same corporate breath?

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2 Responses to Not With A Bang

  1. H. Christian Fibiger says:

    A major lesson from the Dimebon (perhaps more appropriately termed Timebomb) fiasco is that any company that makes decisions based on “positive” clinical data generated outside North America and Western Europe is taking enormous, and in my view, unacceptable risks. This is particularly the case in psychiatry and neurology where rating scales tend to be subjective and open to god knows what cultural influences. In evaluating partnering opportunities when I was at Lilly, Amgen and Biovail I was struck by the frequency with which data generated in countries outside North America and Western Europe conflicted directly with data obtained in the latter, India perhaps being the most frequent contributor to such discrepancies. As tempting as the lower costs and patient recruitment may be in these emerging markets, for the time being CNS focussed companies should stay away.

  2. The Targacept/Astra Zeneca TC-5214 depression program is another good example of that ‘non-traditional’ data risk: The Phase IIb trial, which was mainly done in India, produced results that seemed almost too-good-to-be-true, and based on the first two Phase III trial failure, indeed were.

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