ELIQUIS® (apixaban) Approved In Japan For The Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

Wed Dec 26, 2012 7:30am EST

* Reuters is not responsible for the content in this press release.


PRINCETON, N.J. & NEW YORK--(Business Wire)--
Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced today
that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved
ELIQUIS® (apixaban) for the prevention of ischemic stroke and systemic embolism
in patients with nonvalvular atrial fibrillation (NVAF). ELIQUIS is a novel
anticoagulant that has demonstrated risk reductions versus warfarin in three
important outcomes of stroke, major bleeding and all-cause death. ELIQUIS is an
oral direct Factor Xa inhibitor, part of a novel therapeutic class. This is the
third approval for ELIQUIS for the prevention of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation, following approvals in the
European Union and Canada. 

"Today`s approval of ELIQUIS is the result of our shared vision with Pfizer to
introduce a differentiated treatment option to reduce the burden of stroke in
patients with nonvalvular atrial fibrillation," said Charles Bancroft, executive
vice president, Intercontinental Region and Japan, and chief financial officer,
Bristol-Myers Squibb. "We are confident in the clinical profile of ELIQUIS and
look forward to making this important medicine available to patients in Japan." 

"The approval in Japan marks the third regulatory approval for ELIQUIS within
six weeks," said John Young, president and managing director, Pfizer Primary
Care Business Unit. "We are excited by this momentum and confident that our
combined cardiovascular leadership and expertise with BMS will lead to a
successful introduction of this important medicine to patients and physicians in

The approval of ELIQUIS in Japan is supported by the pivotal Phase 3 trial,
ARISTOTLE, which evaluated the safety and efficacy of ELIQUIS versus warfarin in
18,201 patients with NVAF, including 336 patients from Japan. Additionally, the
safety and efficacy of ELIQUIS in Japanese patients were evaluated in a
subanalysis of the ARISTOTLE study, which demonstrated results consistent with
the overall study. The application for ELIQUIS for the prevention of ischemic
stroke and systemic embolism was submitted in Japan on December 21, 2011. 

The companies continue to progress the ELIQUIS application for stroke prevention
in atrial fibrillation in other markets. On September 26, 2012, The U.S. Food
and Drug Administration (FDA) acknowledged receipt of the ELIQUIS New Drug
Application (NDA) resubmission to reduce the risk of stroke and systemic
embolism in adult patients with NVAF. 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. 

About Atrial Fibrillation

Atrial fibrillation is the most common cardiac arrhythmia (irregular heart
beat). The lifetime risk of developing atrial fibrillation is estimated to be
approximately 25% 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, atrial
fibrillation is responsible for approximately 20% of all strokes in Japan.
Atrial fibrillation-related strokes are more severe than other strokes, with an
associated 30-day mortality of 24% and a 50% likelihood of death within one year
in patients who are not treated with an antithrombotic. 

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.
Bristol-Myers Squibb and Pfizer will be engaged in providing medical information
with proper use of medicines. 

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, 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. 

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 ELIQUIS will
become a commercially successful product in Japan or that it will receive
regulatory approval in the U.S. or other markets. 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.


The information contained in this release is as of December 26, 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 ELIQUIS (apixaban) that
involves substantial risks and uncertainties. Such risks and uncertainties
include, among other things, (i) the uncertainties regarding the commercial
success of ELIQUIS in Japan for the prevention of stroke and systemic embolism
in patients with nonvalvular atrial fibrillation;(ii) the companies` ability to
address the comments in the complete response letter from the U.S. Food and Drug
Administration (FDA) 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
ELIQUIS for the prevention of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation as well as their decisions regarding labeling
and other matters that could affect the availability or commercial potential of
that indication; 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

Laura Hortas (Media), 609-252-4587
John Elicker (Investors), 609-252-4611
Pfizer Inc.
MacKay Jimeson (Media), 212-733-2324
Suzanne Harnett (Investors), 212-733-8009

Copyright Business Wire 2012