Squibb Company (NYSE: BMY) and Pfizer
(NYSE: PFE) announced today that the U.S. Food and Drug Administration
(FDA) has extended the action date by three months for the New Drug
Application (NDA) for Eliquis® (apixaban) for the prevention
of stroke and systemic embolism in patients with atrial fibrillation.
The new Prescription Drug User Fee Act (PDUFA) goal date is June 28,
Subsequent to the filing of the NDA, the companies submitted additional
information about the Eliquis clinical program to the FDA, which
constitutes a major amendment to the application and will require
additional time for review. The companies will continue to work closely
with the agency to support the continued review of the NDA for Eliquis.
At this stage there are no plans for an FDA advisory committee meeting
to review the NDA for 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 (EU) for the prevention of venous
thromboembolic events (VTE) in adult patients who have undergone
elective hip or knee replacement surgery.
Eliquis is being investigated within the EXPANSE Clinical Trials
Program, 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 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
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 February 29, 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, including the ability to meet
anticipated clinical trial completion dates and regulatory submission
and approval dates; decisions by regulatory authorities 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 competitive
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.
MacKay Jimeson, 212-733-2324