Data Include Key Subanalyses from Pivotal ARISTOTLE Trial Examining Important Subgroups of Nonvalvular Atrial Fibrillation Population
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:
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Session Details
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Presentation Title
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Lead Author
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Sunday
August 26, 2012
8:30 – 12:30 CEST
Room Posters – Village 10(P553)
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Increased levels of D-dimer identify patients with atrial
fibrillation at high risk for bleeding an ARISTOTLE substudy
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Agneta Siegbahn, MD, PhD Uppsala University Uppsala, SE
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Sunday
August 26, 2012
8:30 – 12:30 CEST
Room Posters – Village 10(P551)
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NT-proBNP for risk stratification in atrial fibrillation
during treatment with apixaban or warfarin
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Lars C. Wallentin, MD, PhD Uppsala University Uppsala, SE
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Sunday
August 26, 2012
8:30 – 12:30 CEST
Room Posters – Village 10(P554)
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Effect of apixaban on all-cause mortality in atrial
fibrillation: an imputed placebo analysis
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John J.V. McMurray, MD University of Glasgow Glasgow, GB
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Sunday
August 26, 2012
8:30 – 12:30 CEST
Room Posters – Village 10(P558)
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High sensitivity troponin-T for risk stratification in atrial
fibrillation during treatment with apixaban or warfarin
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Lars C. Wallentin, MD, PhD Uppsala University Uppsala, SE
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Sunday
August 26, 2012
8:30 – 12:30 CEST
Room Posters – Village 10(P559)
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How well are atrial fibrillation (AF) patients in the real
world represented in the Contemporary Novel Oral
Anticoagulant (NOAC) AF trials?
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Teresa Simon Bristol-Myers Squibb Company Princeton, NJ,
U.S.
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Sunday
August 26, 2012
8:30 – 12:30 CEST
Room Posters – Village 10(P563)
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Cost-effectiveness of apixaban against other novel oral
anticoagulants (NOACs) for stroke prevention in atrial
fibrillation patients
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Gregory YH Lip, MD University of Birmingham Birmingham,
GB
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Sunday
August 26, 2012
14:00 – 18:00 CEST
Room Posters – Village 10(P1555)
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Heterogeneity in published evidence for stroke prevention in
patients with atrial fibrillation: a systematic review
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David E. Jakouloff, MD, PhD Bristol-Myers Squibb Company Rueil-Malmaison,
FR
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Sunday
August 26, 2012
14:00 – 18:00 CEST
Room Posters – Village 10(P1793)
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Cost of venous thromboembolism in hospitalized medically ill
patients
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Trudy Pendergraft Policy Analysis, Inc. Brookline, MA,
U.S.
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Sunday
August 26, 2012
14:00 – 18:00 CEST
Room Posters – Village 10(P1953)
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Apixaban after acute coronary syndrome in patients with heart
failure: insights from the APPRAISE-2 trial
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Jan H. Cornel, MD, PhD Medical Center Alkmaar Alkmaar, NL
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Monday
August 27, 2012
17:45 – 18:00 CEST
Room Reykjavik – Village 5(Oral Session: 3156)
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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
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John J.V. McMurray, MD University of Glasgow Glasgow, GB
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Tuesday
August 28, 2012
11:30 – 11:45 CEST
Room Tel Aviv – Village 7(Oral Session: 4045)
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Events after discontinuation of randomized treatment at the
end of the ARISTOTLE trial
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Christopher B. Granger, MD Duke University Durham, NC,
U.S.
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Tuesday
August 28, 2012
12:15 – 12:30 CEST
Room Tel Aviv – Village 7(Oral Session: 4048)
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Apixaban and warfarin are associated with a low risk of
stroke following cardioversion for atrial fibrillation:
results from the ARISTOTLE trial
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Greg C. Flaker, MD University of Missouri School of Medicine Columbia,
MO, U.S.
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Tuesday
August 28, 2012
14:00 – 18:00 CEST
Room Posters – Village 10(P5015)
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Discharge status of atrial fibrillation patients hospitalized
for ischemic or hemorrhagic stroke in the United States
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Teresa Simon Bristol-Myers Squibb Company Princeton, NJ,
U.S.
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Wednesday
August 29, 2012
9:30 – 9:45 CEST
Room Brussels – Village 7(Oral Session: 5294)
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Cost-effectiveness of apixaban against current standard of
care (SoC) for stroke prevention in atrial fibrillation
patients
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Paul Dorian, MD, MSc, FRCP University of Toronto Toronto,
CA
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Wednesday
August 29, 2012
8:45 – 9:00 CEST
Room Tallinn – Village 7(Oral Session: 5297)
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Increased levels of D-dimer in atrial fibrillation identify
patients with higher risk of thromboembolic events and death
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Christina Christersson, MD, PhD Uppsala University Uppsala,
SE
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Wednesday
August 29, 2012
8:46 – 8:57 CEST
Clinical Trial and Registry Update, Webcast
Room Munich – Central Village
(Oral Session: 5172)
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ARISTOTLE: Efficacy of apixaban as compared with warfarin in
relation to renal function in patients with atrial
fibrillation - Insights from the ARISTOTLE Trial
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Stefan H. Hohnloser, MD Goethe University Frankfurt, DE
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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
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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.

Bristol-Myers SquibbMediaLaura Hortas, 609-252-4587laura.hortas@bms.comorInvestorsJohn Elicker, 609-252-4611john.elicker@bms.comorPfizer Inc.MediaMacKay Jimeson, 212-733-2324MacKay.Jimeson@pfizer.comorInvestorsSuzanne Harnett, 212-733-8009Suzanne.Harnett@pfizer.com