ELIQUIS® (apixaban) Data Analyses To Be Presented At European Society of Cardiology Congress 2012

Data Include Key Subanalyses from Pivotal ARISTOTLE Trial Examining Important Subgroups of Nonvalvular Atrial Fibrillation Population

Monday, August 20, 2012 10:16 am EDT

Dateline:

PRINCETON, N.J. & NEW YORK
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PFE

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (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:

Session Details Presentation Title Lead Author
Sunday

August 26, 2012

8:30 – 12:30 CEST

Room Posters – Village 10(P553)

Increased levels of D-dimer identify patients with atrial fibrillation at high risk for bleeding an ARISTOTLE substudy Agneta Siegbahn, MD, PhD, Uppsala University, Uppsala, SE
Sunday

August 26, 2012

8:30 – 12:30 CEST

Room Posters – Village 10(P551)

NT-proBNP for risk stratification in atrial fibrillation during treatment with apixaban or warfarin Lars C. Wallentin, MD, PhD, Uppsala University,

Uppsala, SE

Sunday

August 26, 2012

8:30 – 12:30 CEST

Room Posters – Village 10(P554)

Effect of apixaban on all-cause mortality in atrial fibrillation: an imputed placebo analysis John J.V. McMurray, MD, University of Glasgow, Glasgow, GB
Sunday

August 26, 2012

8:30 – 12:30 CEST

Room Posters – Village 10(P558)

High sensitivity troponin-T for risk stratification in atrial fibrillation during treatment with apixaban or warfarin Lars C. Wallentin, MD, PhD, Uppsala University,

Uppsala, SE

Sunday

August 26, 2012

8:30 – 12:30 CEST

Room Posters – Village 10(P559)

How well are atrial fibrillation (AF) patients in the real world represented in the Contemporary Novel Oral Anticoagulant (NOAC) AF trials? Teresa Simon, Bristol-Myers Squibb Company, Princeton, NJ, U.S.
Sunday

August 26, 2012

8:30 – 12:30 CEST

Room Posters – Village 10(P563)

Cost-effectiveness of apixaban against other novel oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation patients Gregory YH Lip, MD, University of Birmingham, Birmingham, GB
Sunday

August 26, 2012

14:00 – 18:00 CEST

Room Posters – Village 10(P1555)

Heterogeneity in published evidence for stroke prevention in patients with atrial fibrillation: a systematic review David E. Jakouloff, MD, PhD, Bristol-Myers Squibb Company, Rueil-Malmaison, FR
Sunday

August 26, 2012

14:00 – 18:00 CEST

Room Posters – Village 10(P1793)

Cost of venous thromboembolism in hospitalized medically ill patients Trudy Pendergraft, Policy Analysis, Inc, Brookline, MA, U.S.
Sunday

August 26, 2012

14:00 – 18:00 CEST

Room Posters – Village 10(P1953)

Apixaban after acute coronary syndrome in patients with heart failure: insights from the APPRAISE-2 trial Jan H. Cornel, MD, PhD, Medical Center Alkmaar, Alkmaar, NL
Monday

August 27, 2012

17:45 – 18:00 CEST

Room Reykjavik – Village 5(Oral Session: 3156)

Risk of stroke, systemic embolism or death according to heart failure and left ventricular function status in patients with atrial fibrillation: results of the ARISTOTLE trial John J.V. McMurray, MD, University of Glasgow, Glasgow, GB
Tuesday

August 28, 2012

11:30 – 11:45 CEST

Room Tel Aviv – Village 7(Oral Session: 4045)

Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial Christopher B. Granger, MD, Duke University Durham, NC, U.S.
Tuesday

August 28, 2012

12:15 – 12:30 CEST

Room Tel Aviv – Village 7(Oral Session: 4048)

Apixaban and warfarin are associated with a low risk of stroke following cardioversion for atrial fibrillation: results from the ARISTOTLE trial Greg C. Flaker, MD, University of Missouri School of Medicine, Columbia, MO, U.S.
Tuesday

August 28, 2012

14:00 – 18:00 CEST

Room Posters – Village 10(P5015)

Discharge status of atrial fibrillation patients hospitalized for ischemic or hemorrhagic stroke in the United States Teresa Simon, Bristol-Myers Squibb Company, Princeton, NJ, U.S.
Wednesday

August 29, 2012

9:30 – 9:45 CEST

Room Brussels – Village 7(Oral Session: 5294)

Cost-effectiveness of apixaban against current standard of care (SoC) for stroke prevention in atrial fibrillation patients Paul Dorian, MD, MSc, FRCP, University of Toronto, Toronto, CA
Wednesday

August 29, 2012

8:45 – 9:00 CEST

Room Tallinn – Village 7(Oral Session: 5297)

Increased levels of D-dimer in atrial fibrillation identify patients with higher risk of thromboembolic events and death Christina Christersson, MD, PhD, Uppsala University, Uppsala, SE
Wednesday

August 29, 2012

8:46 – 8:57 CEST

Clinical Trial and Registry Update, Webcast

Room Munich – Central Village

(Oral Session: 5172)

ARISTOTLE: Efficacy of apixaban as compared with warfarin in relation to renal function in patients with atrial fibrillation - Insights from the ARISTOTLE Trial Stefan H. Hohnloser, MD, Goethe University, Frankfurt, DE

About Atrial Fibrillation

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.

About ELIQUIS

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.

About the Bristol-Myers Squibb/Pfizer Collaboration

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.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

Bristol-Myers Squibb Forward-Looking Statement

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 approvals for an indication in stroke prevention in patients with atrial fibrillation or that any such approvals will be received within the time periods described in this release. There is also no guarantee that, if approved in this indication, apixaban 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, 2011, 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.

PFIZER DISCLOSURE NOTICE:

The information contained in this release is as of August 20, 2012. 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 various potential indications for ELIQUIS (apixaban), including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, (i) the uncertainties inherent in research and development; (ii) the companies’ ability to address the comments in the complete response letter (CRL) expeditiously and to the satisfaction of the Food and Drug Administration, (FDA}; (iii) decisions by the FDA and regulatory authorities in other jurisdictions regarding whether and when to approve drug applications that have been or may be filed for any such indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such indications; and (iv) 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, 2011 and in its reports on Form 10-Q and Form 8-K.

Contact:

Bristol-Myers Squibb
Laura Hortas (Media)
609-252-4587
laura.hortas@bms.com
John Elicker (Investors)
609-252-4611
john.elicker@bms.com
or
Pfizer Inc.
MacKay Jimeson (Media)
212-733-2324
MacKay.Jimeson@pfizer.com
Suzanne Harnett (Investors)
212-733-8009
Suzanne.Harnett@pfizer.com