Bristol-Myers SquibbMediaLaura Hortas, 609-252-4587orInvestorsJohn Elicker, 609-252-4611orPfizer Inc.MediaMacKay Jimeson, 212-733-2324orInvestorsSuzanne Harnett, 212-733-8009
(NYSE: BMY) and (NYSE: PFE) today announced that multiple data presentations on ELIQUIS (apixaban) will be presented at the European Society of Cardiology Congress 2012, August 25-29, 2012, in Munich, Germany. New data will be presented, including a prespecified subanalysis from the ARISTOTLE trial that evaluated the efficacy and safety of ELIQUIS compared to warfarin in relation to renal function in patients with nonvalvular atrial fibrillation. Results of this analysis will be presented during a Clinical Trial Update session on August 29, 2012 and accompanying webcast.
Details on this data analysis and other studies at the congress are as follows:
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). It estimated that more than 5.8 million Americans and 6 million individuals in Europe have atrial fibrillation. The lifetime risk of developing atrial fibrillation is estimated to be approximately 25 percent for individuals 40 years of age or older. One of the most serious medical concerns for individuals with atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, 15 percent of all strokes are attributable to atrial fibrillation in the U.S. Additionally, strokes due to atrial fibrillation are more burdensome than strokes due to other causes. Atrial fibrillation-related strokes are more severe than other strokes, with an associated 30-day mortality of 24 percent and a 50 percent likelihood of death within one year in patients who are not treated with an antithrombotic.
ELIQUIS is the approved trade name for apixaban in Europe and the proposed trade name in the U.S. ELIQUIS is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. In May 2011, Bristol-Myers Squibb and Pfizer announced the first regulatory approval for ELIQUIS in the 27 countries of the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
In addition to stroke prevention in patients with atrial fibrillation and the prevention of VTE in patients who have undergone total hip or total knee replacement surgery, ELIQUIS is being investigated in Phase 3 trials for the treatment of VTE.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.
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