Bristol-Myers
Squibb Company (NYSE: BMY) and Pfizer
(NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA)
has issued a Complete Response Letter (CRL) regarding the New Drug
Application (NDA) for ELIQUIS® (apixaban) for the
prevention of stroke and systemic embolism in patients with nonvalvular
atrial fibrillation.
The CRL requests additional information on data management and
verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer
will work closely with the FDA on the appropriate next steps for the
ELIQUIS application. The FDA has not requested that the companies
complete any new studies. FDA and the companies are committed to working
expeditiously to address the outstanding questions and move the
application forward.
“There is a significant unmet need to reduce the risk of stroke in
patients with atrial fibrillation,” said Elliott Sigal, M.D., Ph.D.,
Executive Vice President and Chief Scientific Officer, Bristol-Myers
Squibb. “We believe that the two large trials called ARISTOTLE and
AVERROES have established the therapeutic profile for ELIQUIS and
demonstrated a meaningful advance over the standard of care.”
The companies continue to progress the ELIQUIS application for stroke
prevention in atrial fibrillation in markets outside of the U.S.,
including the European Union and Japan, based on the ARISTOTLE and
AVERROES studies. These studies evaluated ELIQUIS in approximately
24,000 patients with atrial fibrillation, including patients who are
expected or demonstrated to be unsuitable for vitamin K antagonist (VKA)
therapy. The companies are committed to an ongoing clinical development
program for ELIQUIS, which is projected to include nearly 60,000
patients worldwide across multiple indications and patient populations
and includes a total of nine completed or ongoing, randomized,
double-blind Phase 3 trials.
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 February 2012, the
companies announced that the FDA had extended the action date for the
ELIQUIS NDA for prevention of stroke and systemic embolism in patients
with atrial fibrillation by three months to June 28, 2012 based on a
major amendment to the NDA.
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 approval for an indication in stroke prevention in patients
with atrial fibrillation or that any such approval will be received
within the time period 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 June 25, 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, the uncertainties
inherent in research and development; the companies’ ability to address
the comments in the CRL expeditiously and to the satisfaction of the
FDA; 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 such indications as well as
their decisions regarding labeling and other matters that could affect
the availability or commercial potential of such indications; and
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.
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