Data from AVERROES Trial of Investigational Drug Apixaban Will Be Presented During a Hot Line Session at Upcoming European Society of Cardiology Meeting
PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) 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 (AF) is the most common serious chronic arrhythmia, affecting about 4.5 million people in Europe and 2.2 million people in the United States.1 Patients with AF are at five times greater risk for stroke compared with the general population.2 Fifteen percent of all strokes are attributable to AF, and one quarter of all strokes in persons older than 80 years are attributable to AF.1
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.1 However, surveys of practice patterns in developed countries demonstrate that 40 percent to 50 percent of patients with AF who are at moderate or high risk for stroke do not receive VKA.1 The most common reason for not treating AF patients with a VKA appears to be concern about bleeding.1 Difficulties managing and maintaining therapeutic warfarin dosing, as well as the use of other prescription drugs that interfere with warfarin therapy are additional concerns.1 Currently, guidelines for the management of patients with AF recommend the use of aspirin for those who cannot take oral anticoagulants.3
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, 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.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of August 25, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a product candidate, apixaban, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for apixaban as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
BMS DISCLOSURE NOTICE: This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that apixaban will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 J Eikelboom, et al. Rationale and design of AVERROES: Apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment. Am Heart J; 2010;159:348-53.
2 Go AS et al. Prevalence of Diagnosed Atrial Fibrillation in Adults National Implications for Rhythm Management and Stroke Prevention: the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study. JAMA; 2001;285(18):2370-2375.
3 Fuster et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation. Circulation; 2006; 114:e257-e354
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