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

Update: Eliquis (apixaban) Now FDA Approved - December 28, 2012

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

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Aug 20, 2012 - 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
Media
Laura Hortas, 609-252-4587
laura.hortas@bms.com
or
Investors
John Elicker, 609-252-4611
john.elicker@bms.com
or
Pfizer Inc.
Media
MacKay Jimeson, 212-733-2324
MacKay.Jimeson@pfizer.com
or
Investors
Suzanne Harnett, 212-733-8009
Suzanne.Harnett@pfizer.com

 

 

Posted: August 2012

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