BMS, Pfizer wrap apixaban stroke trial early on positive verdict

Bristol-Myers Squibb and Pfizer decided to close out a late-stage clinical trial of their heart drug apixaban--a potential megablockbuster --a couple of months ahead of schedule after concluding they had achieved the kind of results they had hoped for when they launched the study three years ago.

An independent monitoring committee concluded that the anti-clotting drug was better than aspirin in preventing strokes and systemic embolism among atrial fibrillation patients unable to take warfarin, the standard therapeutic for the condition. And the two companies said that the drug's safety profile in comparison to aspirin was "acceptable." Only the headline results were made available, with researchers reserving the data for a future scientific meeting.

While warfarin has long been in use, it's been linked to a number of adverse events that prevent patients from taking it when needed. Drug developers have been racing to develop new anti-clotting therapies as the market for that category is projected to swell to $12 billion, according to a report in the Wall Street Journal.

Apixaban is an important drug for BMS, which Barclays believes can earn upwards of $3.6 billion a year in revenue. It also is central to Pfizer's efforts to gain approvals for a new generation of blockbusters. Pfizer gambled $250 million upfront and promised BMS $750 million in milestones when it licensed the therapy in 2007.

Conducted in 36 countries, the study was coordinated by the Population Health Research Institute at McMaster University and at Hamilton Health Sciences. BMS and Pfizer have submitted the drug for European approval and have another late-stage trial underway that combines apixaban and warfarin.

- check out the BMS release
- here's the story from the Wall Street Journal

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