ELIQUIS Meets Primary and Key Secondary Endpoints in Phase 3 ARISTOTLE Study

Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE announced today topline results of the Phase 3 ARISTOTLE trial of ELIQUIS®. In this study of patients with atrial fibrillation and at least one additional risk factor for stroke, ELIQUIS met the primary efficacy objective of non-inferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism. In addition, ELIQUIS met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin. ELIQUIS, a new oral direct Factor Xa inhibitor, is being developed by the alliance of Bristol-Myers Squibb and Pfizer. The companies expect to submit regulatory filings in atrial fibrillation in the U.S. and Europe in the third or fourth quarter of 2011. The detailed results of the ARISTOTLE study will be presented during the “Hot Line” session on August 28, 2011, at the European Society of Cardiology Congress 2011 in Paris.