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Bristol-Myers Squibb, Pfizer to Seek European Approval for apixaban in H1 '10

From M2 Europharma (December 7, 2009)

7 December 2009 - US-based Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE: PFE) said on Friday that they intend to submit an application for regulatory approval of apixaban in Europe for the prevention of venous thromboembolism (VTE) after orthopedic surgery in the first half of 2010.

Apixaban is a novel, oral, highly selective Factor Xa inhibitor, a new class of agents being studied for the potential to prevent and treat blood clots in the veins and arteries.

The application will be supported by ADVANCE-2 and ADVANCE-3, two clinical trials that evaluated apixaban versus the European dosing regimen of enoxaparin for prevention of VTE in patients undergoing orthopedic surgery. Results of ADVANCE-2 were first presented in July 2009 at the 22nd Congress of the International Society on Thrombosis and Haemostasis in Boston. The ADVANCE-3 data will be submitted for publication and presentation in 2010.

In 2007, the two companies entered into a worldwide collaboration to develop and commercialise apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. The companies said that this global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialisation with Pfizer's global scale and expertise in this field to maximise the potential benefits of apixaban for patients.

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Posted: December 2009