Bristol-Myers Squibb and Pfizer Announce New Data on Stroke Prevention in Atrial Fibrillation to be Presented at American Heart

  Bristol-Myers Squibb and Pfizer Announce New Data on Stroke Prevention in
  Atrial Fibrillation to be Presented at American Heart Association 2012
  Scientific Sessions

    Data Include Key ELIQUIS Subanalyses from Pivotal ARISTOTLE Trial and
    Real-World Data on Stroke Prevention Treatment in Atrial Fibrillation

Business Wire

PRINCETON, N.J. & NEW YORK -- November 02, 2012

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today
announced that a large number of data presentations sponsored by the companies
on ELIQUIS^® (apixaban) and the treatment of atrial fibrillation will be
presented at the American Heart Association 2012 Scientific Sessions, November
3-7, 2012, in Los Angeles, California. Among the presentations are two
prespecified subanalyses from the ARISTOTLE trial: a more detailed analysis of
ISTH major bleeding with ELIQUIS versus warfarin and an evaluation of the
safety and efficacy of ELIQUIS versus warfarin in patients with prior warfarin
experience (warfarin-experienced compared with warfarin-naïve). Also being
presented is a subanalysis from ARISTOTLE of the safety and efficacy of
ELIQUIS versus warfarin in patients with prior coronary artery disease. The
ARISTOTLE trial evaluated the efficacy and safety of ELIQUIS, an
investigational compound for the prevention of stroke or systemic embolism, in
patients with nonvalvular atrial fibrillation compared with warfarin.

Company-sponsored real-world data analyses providing relevant insights on
management of atrial fibrillation and experience with warfarin, such as the
correlation between bleeding and discontinuation, warfarin outcomes in the
real-world compared to trial data, and early ischemic outcomes after warfarin
initiation will also be presented.

Details on the ARISTOTLE data analyses and real-world data analyses at the
congress are as follows:


ARISTOTLE SUBANALYSES
Session Details    Presentation Title                Lead Author
Monday

November 5, 2012
                    Apixaban in Patients with Atrial   Maria Cecilia Bahit,
10:45–11:00 PST    Fibrillation and Prior Coronary   MD, ECLA, Rosario,
                    Artery Disease: Insights from      Argentina
Abstract Oral       the ARISTOTLE Trial
Session

Room 403a
Monday

November 5, 2012    Apixaban versus Warfarin in
                    Patients with Atrial               David A. Garcia, MD,
11:15-11:30 PST    Fibrillation in Relation to       University of New
                    Prior Warfarin Use: Insights       Mexico, Albuquerque, NM
Abstract Oral       from the ARISTOTLE Trial
Session

Hall A-10
Tuesday

November 6, 2012
                    Reduction in Bleeding with
3:00–4:30 PST       Apixaban versus Warfarin is        Elaine M. Hylek, MD,
                   Consistent Across Subgroups and   Boston University,
Abstract Poster     Locations: Insights from the       Boston, MA
Session             ARISTOTLE Trial

Kentia Hall, Core
2, Poster Board:
2068
OUTCOMES RESEARCH/REAL-WORLD DATA
Session Details    Presentation Title                Lead Author
Sunday

November 4, 2012

9:30–11:00 PST      Post-Discharge Stroke in           Bao Liu, Ph.D., School
                   Patients With Atrial              of Public Health, Fudan
Abstract Poster     Fibrillation: A Follow-Up Study    University, Shanghai,
Session             in Major Cities of China           China

Kentia Hall, Core
2, Poster Board:
2117
Sunday

November 4, 2012

3:00–4:30 PST       The Association Between Bleeding   Xianying Pan,
                   and Warfarin Discontinuation in   Bristol-Myers Squibb,
Abstract Poster     Patients with Atrial               Wallingford, CT
Session             Fibrillation

Kentia Hall, Core
2, Poster Board:
2094
Monday
                    Exposure to Warfarin and the
November 5, 2012    Risks of Stroke and Bleeding       Alpesh Amin, MD,
                    Events among Patients with         University of
9:30–11:00 PST     Non-Valvular Atrial               California, Irvine,
                    Fibrillation: Real-World vs.       Irvine, CA
Best of AHA         Clinical Trial
Specialty
Conferences
Tuesday

November 6, 2012

9:30–11:00 PST      Impact of Bleeding on Length of    Alpesh Amin, MD,
                   Stay and Total Cost in Atrial     University of
Abstract Poster     Fibrillation Patients              California, Irvine,
Session                                                Irvine, CA

Kentia Hall, Core
2, Poster Board:
2176
Tuesday

November 6, 2012

9:30–11:00 PST      Evaluation of Patient-Reported
                   Disease Burden of Atrial          Liu Xianchen, Pfizer
Abstract Poster     Fibrillation                       Inc., New York, NY
Session

Kentia Hall, Core
2, Poster Board:
2177
Tuesday

November 6, 2012
                    Utilization Patterns of
9:30–11:00 PST      Anticoagulants in Non-Valvular     Melissa Hamilton, MPH,
                   Atrial Fibrillation after the     Bristol-Myers Squibb,
Abstract Poster     entry of Novel Oral                Princeton, NJ
Session             Anticoagulants in the United
                    States
Kentia Hall, Core
2, Poster Board:
2175
Wednesday

November 7, 2012
                    Early Effects on Ischemic          Laurent Azoulay, Ph.D.,
9:15–9:30 PST      Strokes After Initiation of       M.Sc., Jewish General
                    Warfarin in Patients With Atrial   Hospital, Montreal,
Abstract Oral       Fibrillation                       Canada
Session

Room 511
Wednesday

November 7, 2012

9:30–11:30 PST      Tolerability of Apixaban —         Ria Kundu, MD,
                   Insights From A Meta-Analysis of  University of Toledo,
Abstract Poster     Discontinuation Rates in           Toledo, OH
Session             Randomized Trials

Kentia Hall, Core
2, Poster Board:
2051

About Atrial Fibrillation

Atrial fibrillation is the most common cardiac arrhythmia (irregular heart
beat). It is 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 plus Iceland and Norway
for the prevention of venous thromboembolic events (VTE) in adult patients who
have undergone elective hip or knee replacement surgery.

The companies continue to progress the ELIQUIS application for stroke
prevention in atrial fibrillation based on the ARISTOTLE and AVERROES studies.
On September 21, 2012, Bristol-Myers Squibb and Pfizer Inc. announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) adopted a positive opinion recommending that ELIQUIS be
granted approval for the prevention of stroke and systemic embolism in adult
patients with nonvalvular atrial fibrillation and with one or more risk
factors for stroke. On September 26, 2012, The U.S. Food and Drug
Administration (FDA) acknowledged receipt of the ELIQUIS (apixaban) New Drug
Application (NDA) resubmission to reduce the risk of stroke and systemic
embolism in adult patients with nonvalvular atrial fibrillation. The FDA has
deemed the resubmission a complete response to its June 22, 2012 Complete
Response Letter (CRL) that requested additional information on data management
and verification from the ARISTOTLE trial. The FDA Prescription Drug User Fee
Act (PDUFA) date is March 17, 2013.

ELIQUIS is also 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 November 2, 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) from the Food and Drug Administration
expeditiously and to the satisfaction of the 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
 
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