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Pfizer, Bristol-Myers win landmark European approval for Eliquis

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European regulators have stamped their approval on Eliquis (apixaban)--a likely blockbuster blood thinner and one of the top late-stage prospects in the pipeline for Bristol-Myers Squibb ($BMY) and its partner Pfizer ($PFE). The approval comes after the drug developers had been stiff-armed twice by the FDA, which has now set a March 17, 2013 PDUFA date on the therapy. 

It's hard to overestimate the critical importance of this drug for Bristol and Pfizer. Analysts expect that it can earn anywhere from $3 billion to more than $5 billion a year--provided it gets OK'd in the U.S. The regulatory delays have benefited some major league competition in the field that wrangled approvals earlier--Pradaxa and Xarelto--but analysts still see a big upside with the clear potential to dominate this critical drug market.

Today's approval of Eliquis in the EU is the result of a strong collaboration between Bristol-Myers Squibb and Pfizer to help address the unmet need for improved treatment options versus warfarin to reduce the burden of stroke in patients with nonvalvular atrial fibrillation," said Lamberto Andreotti, the CEO of Bristol-Myers Squibb. "With its compelling clinical profile, Eliquis represents the commitment of our partnership with Pfizer to scientific innovation and our shared vision of bringing innovative and meaningful medicines to patients."

The key to remember here is that there are some 6 million people in Europe and another 6 million in the U.S. who suffer from atrial fibrillation. Add in a 25% chance of developing this condition after the age of 40, and you'll see just how lucrative this franchise can be.

"Patients with atrial fibrillation have a five times greater risk of stroke and there remains a critical public health need for improved treatment options to reduce this risk," said Lars Wallentin, director of cardiology at Uppsala Clinical Research Centre and University Hospital in Sweden, in a statement.

- here's the press release
- read the Reuters story

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