Bristol-Myers
Squibb Company (NYSE: BMY) and Pfizer (NYSE:
PFE) today announced that the companies are planning to submit an
application for regulatory approval of apixaban in Europe for the
prevention of venous thromboembolism (VTE) after orthopedic surgery in
the first half of 2010. The application will be supported by ADVANCE-2
and ADVANCE-3, two clinical trials that evaluated apixaban versus the
European dosing regimen of enoxaparin for prevention of VTE in patients
undergoing orthopedic surgery. Results of ADVANCE-2 were first presented
in July 2009 at the 22nd Congress of the International Society on
Thrombosis and Haemostasis in Boston. The ADVANCE-3 data will be
submitted for publication and presentation in 2010.
Apixaban is a novel, oral, highly selective Factor Xa inhibitor, a new
class of agents being studied for the potential to prevent and treat
blood clots in the veins and arteries.
About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide
collaboration to develop and commercialize apixaban, an investigational
oral anticoagulant discovered by Bristol-Myers Squibb being studied for
the prevention and treatment of a broad range of venous and arterial
thrombotic conditions. 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
to maximize the potential benefits of apixaban for patients.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to
discovering, developing and delivering innovative medicines that help
patients prevail over serious diseases. For more information, please
visit www.bms.com.
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 relating
to the development and commercialization of certain products. 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 the product described in this release will be
submitted for regulatory approval in Europe and if submitted, receive
regulatory approval. There can be no assurance that, if approved, the
product will be commercially successful. Forward-looking statements in
the 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,
2008, its Quarterly Reports on Form 10-Q, and 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 Forward-Looking Statement
The information contained in this release is as of December 4, 2009.
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 a product
candidate, apixaban, including its potential benefits and plans to file
for regulatory approval in Europe for a specified indication, that
involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development; decisions by regulatory authorities regarding
whether and when to approve any drug applications that may be filed for
apixaban as well as their decisions regarding labeling and other matters
that could affect its availability or commercial potential; 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, 2008 and in its reports on Form 10-Q and Form 8-K.
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Media:BMS –Laura Hortas, 609-252-4587laura.hortas@bms.comORPfizer –MacKay Jimeson, 212-733-2324MacKay.Jimeson@pfizer.comORInvestors:BMS –John Elicker, 609-252-4611john.elicker@bms.comORPfizer –Jennifer M. Davis, 212-733-0717Jennifer.M.Davis@pfizer.com