New Phase 3 Results Published today in New England Journal of Medicine and Will Be Presented as a Late-Breaker at American Society for Hematology Annual Meeting
Bristol-Myers
Squibb Company (NYSE: BMY) and Pfizer
Inc. (NYSE: PFE) today announced the results of the Phase 3
AMPLIFY-EXT trial, which evaluated treatment with ELIQUIS®
(apixaban) over a one-year period compared to placebo for the prevention
of recurrent venous thromboembolism (VTE) in 2,486 patients who had
already completed 6 to 12 months of anticoagulation treatment for VTE,
including deep vein thrombosis (DVT) or pulmonary embolism (PE). In the
trial, extended treatment with ELIQUIS 2.5 mg and 5 mg twice daily,
demonstrated superiority versus placebo in the reduction of the
composite endpoint of symptomatic, recurrent VTE and death from any
cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the
ELIQUIS 2.5 mg and 5 mg groups, respectively, P<0.001), the primary
efficacy outcome of the trial.
ELIQUIS also was superior to placebo for the predefined secondary
efficacy outcome of recurrent VTE and VTE-related death (8.8% in the
placebo group, compared with 1.7% in both the ELIQUIS 2.5 mg and 5 mg
groups). Both of these endpoints, the primary and secondary efficacy
outcomes, were statistically significant (p<0.001).
The rate of the primary safety outcome of major bleeding was comparable
across treatment groups (0.2 % for ELIQUIS 2.5 mg; 0.1 % for ELIQUIS 5
mg and 0.5% for placebo). The rate of the composite of major bleeding
and clinically relevant non-major bleeding for the 5 mg treatment group
(4.3%) was higher versus the placebo group (2.7%), while the rate for
the 2.5 mg treatment group (3.2%) was similar to the placebo group. The
findings were published online today in The New England Journal of
Medicine and announced at a press briefing during the 54th Annual
Meeting of the American Society of Hematology (ASH).
“Up to 10 percent of patients will experience a recurrent venous
thromboembolism event after completing the currently recommended
six-to-twelve-month treatment period, suggesting the need for additional
prophylaxis,” said Dr. Giancarlo Agnelli, professor of internal
medicine, University of Perugia, Italy; director of the Department of
Internal and Cardiovascular Medicine and Stroke-Unit, University
Hospital, Perugia, Italy; and lead investigator of the study. “In the
AMPLIFY-EXT trial, which added an additional year of treatment, ELIQUIS
reduced the composite risk of recurrent venous thromboembolism and total
mortality without an increase in major bleeding versus placebo.”
About AMPLIFY-EXT
AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary
embolIsm and deep vein thrombosis with First-line therapY-EXTended
Treatment), a randomized, double-blind, multicenter trial, included
2,486 patients with prior VTE who had completed 6 to 12 months of
anticoagulation treatment for DVT or PE and for whom there was clinical
equipoise about the need for continued anticoagulation. Patients were
randomized to receive either ELIQUIS 2.5 mg or 5 mg, or placebo twice
daily for 12 months.
The primary efficacy outcome was the combined endpoint of symptomatic,
recurrent VTE (nonfatal DVT or nonfatal PE) and death from any cause.
Death was classified as VTE-related, cardiovascular-related, due to
bleeding, or due to other causes. For the primary efficacy outcome,
ELIQUIS demonstrated superiority versus placebo (11.6% in the placebo
group, compared with 3.8% and 4.2% in the ELIQUIS 2.5 mg and 5 mg
groups, respectively, P<0.001). For the primary efficacy analysis, as
agreed with regulatory authorities, patients lost to follow-up were
counted as having the primary outcome. For secondary analysis, such as
VTE or VTE-related death and for the safety analyses, patients lost to
follow-up were counted as not having an event.
ELIQUIS demonstrated superiority for the predefined secondary efficacy
outcome of recurrent VTE and VTE-related death (8.8% in the placebo
group, compared with 1.7% in both the ELIQUIS 2.5 mg and 5 mg groups).
Both of these endpoints, the primary and secondary efficacy outcomes,
were statistically significant (p<0.001). ELIQUIS demonstrated lower
all-cause mortality (placebo group was 1.7%, compared with 0.8% and 0.5%
in the ELIQUIS 2.5 mg and 5 mg groups, respectively), though the
difference was not statistically significant.
The primary safety outcome was major bleeding. Major bleeding rates were
low and ELIQUIS demonstrated comparable rates with placebo (0.5% in the
placebo group, 0.2% in the ELIQUIS 2.5 mg group, and 0.1% in the ELIQUIS
5 mg group). Rates of composite major bleeding or clinically relevant
non-major bleeding were 2.7% in the placebo group, 3.2% in the ELIQUIS
2.5 mg group, and 4.3% in the ELIQUIS 5 mg group.
In AMPLIFY-EXT, the rates of adverse events were similar across all
treatment groups. The efficacy and bleeding outcomes were consistent
across pre-specified subgroups.
About Venous Thromboembolism
Venous thromboembolism, or VTE, encompasses two serious conditions: deep
vein thrombosis (DVT), a blood clot in a vein, usually in the leg, that
partially or totally blocks the flow of blood; and pulmonary embolism
(PE), a blood clot blocking one or more vessels in the lungs. VTE
continues to be a major cause of morbidity and mortality, with
approximately 900,000 patients in the U.S. and approximately 1 million
patients in the EU diagnosed every year.
About ELIQUIS
ELIQUIS is an oral direct Factor Xa inhibitor, part of a new therapeutic
class. By inhibiting Factor Xa, a key blood clotting protein, ELIQUIS
prevents thrombin generation and blood clot formation. ELIQUIS is the
approved trade name for apixaban in Europe and the proposed trade name
in the U.S. In May 2011, Bristol-Myers Squibb and Pfizer announced the
first regulatory approval for ELIQUIS in the 27 countries of the
European Union plus Iceland and Norway for the prevention of venous
thromboembolic events (VTE) in adult patients who have undergone
elective hip or knee replacement surgery. On November 20, 2012,
Bristol-Myers Squibb and Pfizer announced the European Commission became
the first regulatory authority globally to approve ELIQUIS for the
prevention of stroke and systemic embolism in adult patients with
nonvalvular atrial fibrillation (NVAF) with one or more risk factors.
Bristol-Myers Squibb and Pfizer announced on December 6, 2012, that
Health Canada approved ELIQUIS for the prevention of stroke and systemic
embolism in patients with atrial fibrillation (AF).
The companies continue to progress the ELIQUIS application for stroke
prevention in atrial fibrillation based on the ARISTOTLE and AVERROES
studies. 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.
In addition to the AMPLIFY-EXT trial, ELIQUIS is also being investigated
in the AMPLIFY Phase 3 trial.
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 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
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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. 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 December 8, 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, (i) the uncertainties
inherent in research and development; (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 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 (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 8-K.
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