-Apixaban Currently in Phase III Trials for Prevention of Venous
Thromboembolism and Prevention of Stroke Associated With Atrial
Fibrillation-
-Advanced Pre-Clinical Compounds Being Studied in Treatment of Metabolic
Disorders-
PRINCETON, N.J., and NEW YORK, April 26 /PRNewswire-FirstCall/ --
Bristol- Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE: PFE)
("companies") today announced a worldwide collaboration to develop and
commercialize apixaban, an anticoagulant discovered by Bristol-Myers Squibb
being studied for the prevention and treatment of a broad range of venous
and arterial thrombotic conditions. In a separate agreement, the companies
will also collaborate on the research, development and commercialization of
a Pfizer discovery program which includes advanced pre-clinical compounds
with potential applications for the treatment of metabolic disorders,
including obesity and diabetes.
Phase III trials are currently underway investigating the potential use
of apixaban in the prevention of venous thromboembolism (VTE), which
includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and the
prevention of stroke in patients with atrial fibrillation (AF). Phase II
trials are studying apixaban in the treatment of acute symptomatic DVT and
for the secondary prevention of cardiovascular events in patients with
acute coronary syndrome.
Terms of the apixaban agreement include an upfront payment of $250
million by Pfizer to Bristol-Myers Squibb. Pfizer will fund 60% of all
planned development costs effective January 1, 2007 going forward, and
Bristol-Myers Squibb will fund 40%. Bristol-Myers Squibb may also receive
additional payments of up to $750 million based on development and
regulatory milestones. The companies will jointly develop the clinical and
marketing strategy of apixaban, and will share commercialization expenses
and profits/losses equally on a global basis.
Pfizer will be responsible for all research and early-stage development
activities for the metabolic disorders program, and the companies will
jointly conduct Phase III development and commercialization activities.
Bristol-Myers Squibb will make an upfront payment of $50 million to Pfizer
as part of this agreement. The companies will share all development and
commercialization expenses along with profits/losses on a 60%-40% basis,
with Pfizer assuming the larger share of both expenses and profit/losses.
"By combining our company's long-standing strengths in cardiovascular
drug development and commercialization with Pfizer's global scale and
expertise in this field, we can maximize the potential benefits of apixaban
for patients. In addition, the metabolic disorders program complements
existing research efforts in another area of significant unmet medical need
where Bristol-Myers Squibb is quite active," said Jim Cornelius, chief
executive officer, Bristol- Myers Squibb. "This collaboration supports our
strategy to focus on serious diseases, maintain commercial emphasis on
specialists and high-prescribing primary care physicians, and work with
partners to offset the risks inherent with developing certain medicines."
"We're very pleased to collaborate with Bristol-Myers Squibb on the
worldwide commercialization of apixaban, which has the potential to be a
best- in-class product and would represent an excellent strategic fit with
our global cardiovascular franchise," said Jeffrey B. Kindler, chairman and
chief executive officer, Pfizer. "We see significant opportunities for an
orally active anticoagulant with the clinical profile apixaban has
demonstrated to date, particularly because of the clear need for new
treatments to combat thrombosis and stroke. This agreement demonstrates our
commitment to pursue revenue opportunities both through our business
development and external alliances as well as our internal research and
development pipeline."
About Venous Thromboembolism and Atrial Fibrillation
The process by which blood clots occur and travel through the veins is
known as venous thromboembolism (VTE), the collective term for deep vein
thrombosis (DVT) and pulmonary embolism (PE). In the U.S., it is estimated
that 2 million people develop DVT each year. DVT is the formation of a
thrombus (clot) in one of the deep, large veins of the body, such as in the
leg or pelvis. A thrombus that breaks free and travels through the
circulatory system is called an embolism. An embolism that lodges in a
pulmonary artery in the lungs results in pulmonary embolism (PE). PE is a
potentially fatal condition if not immediately diagnosed and treated.
Atrial fibrillation (AF) is an abnormal heart rhythm that affects
approximately 2.3 million people in North America and 4.5 million people in
Europe. The chief hazard of atrial fibrillation is the risk of stroke,
which is five times higher in people with AF than in those without AF. AF
is responsible for one out of every six ischemic strokes.
About Apixaban
Apixaban is a novel, oral, highly selective, direct factor Xa inhibitor
currently in Phase III development. Factor Xa plays a pivotal role in the
coagulation cascade and may represent a more targeted approach to
anticoagulation therapy compared to current treatments that affect multiple
factors in the coagulation pathway. The companies plan to file for U.S.
regulatory approval of apixaban for prevention of VTE in the second half of
2009 assuming the successful completion of clinical trials, with filings
planned for additional indications beginning in 2010.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare
products company whose mission is to extend and enhance human life.
About Pfizer
Pfizer discovers and develops innovative medicines to treat and help
prevent disease for both people and animals. We also partner with
healthcare providers, governments and local communities around the world to
expand access to our medicines and to provide better quality healthcare and
health system support.
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 the research, development and commercialization of 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 products described in this release will receive regulatory
approval, or that if approved, will be commercially successful. Nor is
there any assurance that any or all of the development, regulatory, and
sales milestones provided for in the agreement will be achieved. Also there
can be no guarantee that the companies will enter into the definitive
research, development and commercialization agreement relating to
early-stage compounds described in this release or that if there is a
definitive agreement that it will result in the discovery, development or
commercialization of products. 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, 2006, 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 April 26, 2007.
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 collaboration
between Pfizer and Bristol-Myers Squibb with respect to certain product
candidates, including their potential benefits and projected FDA filing
dates, 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 any
such product candidates as well as their decisions regarding labeling and
other matters that could affect the availability or commercial potential of
such product candidates; and competitive developments. In addition, there
is no assurance that Pfizer and Bristol-Myers Squibb will enter into the
definitive research, development and commercialization agreement relating
to early-stage compounds for the potential treatment of metabolic disorders
that is described in this release or, if such a definitive agreement is
entered into, that it will result in the discovery, development or
commercialization of products.
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,
2006 and in its reports on Form 10-Q and Form 8-K.
SOURCE Bristol-Myers Squibb Company, Pfizer Inc
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CONTACT:
Media: Jeff Macdonald, Communications,
+1-212-546-4824 or +1-917-371-0940, jeffrey.macdonald@bms.com, or
Investors: John Elicker, Investor Relations, +1-212-546-3775,
john.elicker@bms.com, both of Bristol- Myers Squibb Company; or
Media: Andy McCormick, +1-212-733-5469, or Vanessa Aristide,
+1-212-733-3784, or Investors: Ron Aldridge, +1-212-733-3685, all
of Pfizer Inc
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