Bristol-Myers Squibb Company and Pfizer report that preliminary results from the Phase 3 clinical trial of the investigational drug apixaban compared with acetylsalicylic acid in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the Hot Line session on August 31, 2010, in Stockholm Sweden. Atrial fibrillation is the most common serious chronic arrhythmia, affecting about 4.5 million people in Europe and 2.2 million people in the United States. Patients with AF are at five times greater risk for stroke compared with the general population. 15% of all strokes are attributable to AF, and one quarter of all strokes in persons older than 80 years are attributable to AF. In addition to treatments for heart rate and rhythm, treatment guidelines recommend that AF patients at moderate to high risk of stroke receive anticoagulation therapy with a vitamin K antagonist (VKA), such as warfarin. However, surveys of practice patterns in developed countries demonstrate that 40% to 50% of patients with AF who are at moderate or high risk for stroke do not receive VKA. The most common reason for not treating AF patients with a VKA appears to be concern about bleeding. Difficulties managing and maintaining therapeutic warfarin dosing, as well as the use of other prescription drugs that interfere with warfarin therapy are additional concerns. Currently, guidelines for the management of patients with AF recommend the use of aspirin for those who cannot take oral anticoagulants.

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the Biologics License Application (BLA) for ipilimumab for the treatment of adult patients with advanced melanoma who have been previously treated. The company also announced that the application has been granted a priority review designation by the FDA. Ipilimumab is Bristol-Myers Squibb's second drug under priority review by the FDA this year. A priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on FDA's six month goal for completing priority reviews, the projected FDA action date is December 25, 2010. The filing is based on results from the primary analysis of the pivotal MDX010-020 trial, which were published online in the New England Journal of Medicine and presented during a plenary session at the 46th Annual Meeting of the American Society of Clinical Oncology in June 2010. The study compared the overall survival rate of patients who received ipilimumab plus the gp100 vaccine (3 mg/kg and 1mg/kg every three weeks for four doses; n=403), ipilimumab alone (3 mg/kg every three weeks for four doses; n=137) and the control therapy of gp100 alone (n=136). Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities for the treatment of adult patients with previously treated advanced melanoma.

Bristol-Myers Squibb Company announced that belatacept, an investigational selective T cell co-stimulation blocker being studied for use in solid organ transplantation, will be the subject of seven oral clinical presentations related to kidney transplantation at the 23rd International Congress of The Transplantation Society, being held August 15--19, 2010, in Vancouver, British Columbia, Canada. In total, 18 abstracts from company-sponsored studies will be presented during the congress. Belatacept is currently under review with the U.S. Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and other health authorities, for use in adult patients receiving kidney transplants. On May 1, 2010, Bristol-Myers Squibb received a complete response letter from the FDA requesting 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The company is working with the FDA to provide that data, as well as answer some requests for information to support the manufacturing of belatacept and the proposed Risk Evaluation and Mitigation Strategy (REMS) program.