On Heels Of U.S. Approval, BMS, Pfizer Launch Eliquis Ahead Of Pradaxa In China
This article was originally published in The Pink Sheet Daily
Under a global collaboration, Bristol-Myers Squibb will co-commercialize Eliquis with Pfizer, but it must contend with Boehringer’s Pradaxa, which has a wider label in China.
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Bristol/Pfizer’s Eliquis secures an attractive FDA label for atrial fibrillation on three key fronts: superior stroke prevention, reduced major bleeding and reduced all-cause mortality. With its superiority in preventing hemorrhagic strokes, Eliquis has the clear lead in terms of safety. But Boehringer’s competing Pradaxa remains the only new oral anticoagulant with proven superiority for preventing purely ischemic strokes, which is the main goal of atrial fibrillation treatment.
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.
With China set to become the third largest pharmaceutical market in the world by 2011, and the second largest OTC market next year, Bayer Schering Pharma AG is well-positioned to benefit. Larger in China than most of its Western counterparts, with over $750 million in 2008 sales, accounting for an unusually high 4.8% of global health care revenues, Bayer has understood and adapted to the fundamental differences between the Chinese market and those closer to home