Wednesday, August 27, 2008

Apixaban: Bad News Highlights Good Strategy

The delay announced yesterday to Pfizer and BMS's apixaban blood clot prevention therapy is certainly a setback for the two pharmas, though they presented the news--and the market reacted--relatively smoothly.

Apixaban--pitted here in a head-to-head against current standard Lovenox, from Sanofi-Aventis, for the prevention of venous thromboembolism in knee replacement surgery patients--just barely failed to show non-inferiority, thanks to a much better than expected result for Sanofi's drug (see the companies' release for the statistical details). This was the first of eight Phase III trials planned for the compound, and ongoing studies aren't affected by yesterdays news, BMS apixaban program head Jack Lawrence told Reuters.

But still, the failure will add at least several months or more to the drug's development program and with rivaroxaban from Bayer/J&J already a half-step ahead, every little bit helps. An NDA for the compound, an oral Factor Xa inhibitor, won't be filed in 2009 as planned.

All of which validates Bristol's decision to go halvesies on the apixaban program with Pfizer in the first place, in a deal we've been fans of since it was announced back in April 2007.

To reacquaint you with the terms: in exchange for $250 million upfront cash and up to $750 million in development and regulatory milestones Pfizer gets an equal share of profits and foots an equal share of commercialization expenses, and Pfizer will fund 60% of any development costs from January 1, 2007 onward. (BMS's similarly risk-sharing and lucrative pact with AZ in the diabetes space provoked our admiration only a few months earlier.)

So with each setback, Bristol's strategy--sharing risk on important projects and increasingly biotech-like--seems cannier. That said, it's fair to ask just how many snafus Bristol's reputation can take before those nine-figure upfront payments dry up: after all, its other big risk-hedging adventure was on the now-dead muraglitazar PPAR deal with Merck & Co. back in 2004, which brought in $100 million upfront and at least $55 million in milestones before stumbling at FDA.

And it's not only Bristol among Big Pharma that's spreading the risk--and possibly the massive reward--on late stage development projects. We'll have more to say in the next IN VIVO about Eli Lilly's $300 million financing deal with TPG-Axon and Quintiles' NovaQuest on its two lead (Phase III) Alzheimer's disease treatments.

And who can forget our multiple pleas for your input on Amgen's potential future deal for denosumab? Certainly the project is now less risky/more expensive since Phase III results in its post-menopausal osteoporosis study were positive, but as Amgen's most important pipeline product in years perhaps (some day) the biggest sign that at least a few Big Pharma (and Big Biotech) now think differently about clinical and commercial risk.

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