Bristol-Myers Squibb and Pfizer Announce Global Real-World Data Program and Present New Analyses of Eliquis (apixaban) at the American College of Cardiology’s 65th Annual Scientific Session

PRINCETON, N.J. & NEW YORK–(BUSINESS WIRE)– Bristol-Myers
Squibb Company (NYSE: BMY) and Pfizer
Inc. (NYSE: PFE) announced today that 17 abstracts will be presented
at the American College of Cardiology’s 65th Annual Scientific Session
(ACC.16), to be held April 2-4 in Chicago, IL. The new analyses
contribute to the Bristol-Myers Squibb and Pfizer Alliance’s body of
evidence on the use of Eliquis to reduce the risk of stroke in
patients with nonvalvular atrial fibrillation (NVAF) and for the
treatment of patients with venous thromboembolism (VTE). Abstracts
include new analyses from Phase 3 ARISTOTLE and AMPLIFY clinical
studies, as well as a number of retrospective analyses of real-world
data. “The Alliance is pleased to present new analyses from both Phase 3
clinical trials and real-world databases at this important cardiology
conference,” said Douglas Manion, M.D., head of specialty development,
Bristol-Myers Squibb. “Clinical trial data help to evaluate the safety
and efficacy of Eliquis under well-controlled circumstances,
while real-world data can offer additional insight into the use of Eliquis
for its approved indications in routine clinical practice.”

The real-world data to be presented at ACC.16 are part of ACROPOLIS™ (Apixaban
ExperienCe Through Real-WOrld POpuLatIon
Studies), a global real-world data research program designed to
further evaluate the effectiveness and safety of Eliquis in
routine clinical practice. “Retrospective analyses of real-world data
add an important component to our knowledge of Eliquis and may
help to inform healthcare practitioners in their treatment decisions,”
said Rory O’Connor, M.D., senior vice president and head of Global
Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc.

A list of Alliance presentations is included below. Complete abstracts
can be accessed via the ACC.16 program planner: http://www.abstractsonline.com/pp8/#!/3874

About Eliquis

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By
inhibiting Factor Xa, a key blood clotting protein, Eliquis
decreases thrombin generation and blood clot formation. Eliquis is
approved for multiple indications in the U.S. based on efficacy and
safety data from seven Phase 3 clinical trials. Eliquis is a
prescription medicine indicated to reduce the risk of stroke and
systemic embolism in patients with nonvalvular atrial fibrillation
(NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may
lead to pulmonary embolism (PE), in patients who have undergone hip or
knee replacement surgery; for the treatment of DVT and PE; and to reduce
the risk of recurrent DVT and PE, following initial therapy.

ELIQUIS Important Safety Information and
Indications

ELIQUIS Important Safety Information

CONTRAINDICATIONS

• Active pathological bleeding
• Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic
  reactions)

WARNINGS AND PRECAUTIONS

• Increased Risk of Thrombotic Events after Premature
  Discontinuation: Premature discontinuation of any oral
  anticoagulant, including ELIQUIS, in the absence of adequate
  alternative anticoagulation increases the risk of thrombotic events.
  An increased rate of stroke was observed during the transition from
  ELIQUIS to warfarin in clinical trials in atrial fibrillation
  patients. If ELIQUIS is discontinued for a reason other than
  pathological bleeding or completion of a course of therapy, consider
  coverage with another anticoagulant.
• Bleeding Risk: ELIQUIS increases the risk of bleeding and can
  cause serious, potentially fatal, bleeding.
  • Concomitant use of drugs affecting hemostasis increases the risk
    of bleeding, including aspirin and other antiplatelet agents,
    other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs,
    and NSAIDs.
  • Advise patients of signs and symptoms of blood loss and to report
    them immediately or go to an emergency room. Discontinue ELIQUIS
    in patients with active pathological hemorrhage.
  • There is no established way to reverse the anticoagulant effect of
    apixaban, which can be expected to persist for at least 24 hours
    after the last dose (i.e., about two half-lives). A specific
    antidote for ELIQUIS is not available.
• Spinal/Epidural Anesthesia or Puncture: Patients treated with
  ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop
  an epidural or spinal hematoma which can result in long-term or
  permanent paralysis.

The risk of these events may be increased by the postoperative use of
indwelling epidural catheters or the concomitant use of medicinal
products affecting hemostasis. Indwelling epidural or intrathecal
catheters should not be removed earlier than 24 hours after the last
administration of ELIQUIS. The next dose of ELIQUIS should not be
administered earlier than 5 hours after the removal of the catheter. The
risk may also be increased by traumatic or repeated epidural or spinal
puncture. If traumatic puncture occurs, delay the administration of
ELIQUIS for 48 hours.

Monitor patients frequently and if neurological compromise is noted,
urgent diagnosis and treatment is necessary. Physicians should consider
the potential benefit versus the risk of neuraxial intervention in
ELIQUIS patients.

• Prosthetic Heart Valves: The safety and efficacy of ELIQUIS
  have not been studied in patients with prosthetic heart valves and is
  not recommended in these patients.
• Acute PE in Hemodynamically Unstable Patients or Patients who
  Require Thrombolysis or Pulmonary Embolectomy: Initiation of
  ELIQUIS is not recommended as an alternative to unfractionated heparin
  for the initial treatment of patients with PE who present with
  hemodynamic instability or who may receive thrombolysis or pulmonary
  embolectomy.

ADVERSE REACTIONS

• The most common and most serious adverse reactions reported with
  ELIQUIS were related to bleeding.

TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS

• ELIQUIS should be discontinued at least 48 hours prior to elective
  surgery or invasive procedures with a moderate or high risk of
  unacceptable or clinically significant bleeding. ELIQUIS should be
  discontinued at least 24 hours prior to elective surgery or invasive
  procedures with a low risk of bleeding or where the bleeding would be
  noncritical in location and easily controlled. Bridging
  anticoagulation during the 24 to 48 hours after stopping ELIQUIS and
  prior to the intervention is not generally required. ELIQUIS should be
  restarted after the surgical or other procedures as soon as adequate
  hemostasis has been established.

DRUG INTERACTIONS

• Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of
  cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) increase
  exposure to apixaban and increase the risk of bleeding. For patients
  receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose
  of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are
  strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole,
  itraconazole, ritonavir, or clarithromycin). In patients already
  taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with
  strong dual inhibitors of CYP3A4 and P-gp.
• Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use
  of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g.,
  rifampin, carbamazepine, phenytoin, St. John’s wort) because such
  drugs will decrease exposure to apixaban and increase the risk of
  stroke and other thromboembolic events.
• Anticoagulants and Antiplatelet Agents: Coadministration of
  antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic
  NSAID use increases the risk of bleeding. APPRAISE-2, a
  placebo-controlled clinical trial of apixaban in high-risk post-acute
  coronary syndrome patients treated with aspirin or the combination of
  aspirin and clopidogrel, was terminated early due to a higher rate of
  bleeding with apixaban compared to placebo.

PREGNANCY CATEGORY B

• There are no adequate and well-controlled studies of ELIQUIS in
  pregnant women. Treatment is likely to increase the risk of hemorrhage
  during pregnancy and delivery. ELIQUIS should be used during pregnancy
  only if the potential benefit outweighs the potential risk to the
  mother and fetus.

Please see full Prescribing Information, including BOXED WARNINGS and
Medication Guide, available at www.bms.com.

Indications

ELIQUIS is indicated to reduce the risk of stroke and systemic embolism
in patients with nonvalvular atrial fibrillation.

ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT),
which may lead to pulmonary embolism (PE), in patients who have
undergone hip or knee replacement surgery.

ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the
risk of recurrent DVT and PE following initial therapy.

About ACROPOLIS™

ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld
POpuLatIon Studies) is the Eliquis
(apixaban) global real-world data program designed to generate
additional evidence from routine clinical practice settings to further
inform healthcare decision makers, including healthcare providers and
payers. The ACROPOLIS program will include retrospective, outcomes-based
analyses from over 10 databases around the world, including medical
records, medical and pharmacy health insurance claims data, and national
health data systems.

Analyses of real-world data allow for a broader understanding of patient
outcomes associated with Eliquis outside of the clinical trial
setting, as well as insight into other measures of healthcare delivery,
such as hospitalization and costs.

About AMPLIFY

The AMPLIFY (Apixaban for the initial Management of PuLmonary
embolIsm and deep vein thrombosis as First-line therapY)
trial was a double-blind, randomized, multicenter study that compared
the efficacy and safety of Eliquis (at a dose of 10 mg orally
twice daily for seven days, followed by 5 mg orally twice daily for six
months) with those of conventional therapy in 5,395 patients with
symptomatic proximal DVT or symptomatic PE with or without DVT. The
primary efficacy outcome was the incidence of the adjudicated composite
of recurrent symptomatic VTE or death related to VTE that occurred by
the end of the treatment period. The primary safety outcome was
adjudicated major bleeding that occurred by the end of the treatment
period. ¹

About ARISTOTLE

ARISTOTLE (Apixaban for Reduction In STroke
and Other ThromboemboLic Events in Atrial
Fibrillation) was designed to evaluate the efficacy and safety of Eliquis
versus warfarin for the prevention of stroke or systemic embolism. In
ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis
and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized,
double-blind, multi-national trial in patients with nonvalvular atrial
fibrillation or atrial flutter, and at least one additional risk factor
for stroke. Patients were randomized to treatment with Eliquis 5
mg orally twice daily (or 2.5 mg twice daily in selected patients,
representing 4.7 percent of all patients) or warfarin (target INR range
2.0-3.0), and followed for a median of 1.8 years.

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 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 about
Bristol-Myers Squibb, visit us at BMS.com
or follow us on LinkedIn,
Twitter,
and YouTube.

About Pfizer Inc.: Working together for a healthier world^®

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care 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 one of the world’s
premier innovative biopharmaceutical companies, we 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. For more information, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer
and @Pfizer_News, LinkedIn, YouTube and
like us on Facebook at Facebook.com/Pfizer.

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.
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, 2015, 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 March 30, 2016.
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 Eliquis
(apixaban), including its potential benefits, that involves substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties inherent in
research and development, including, without limitation, the ability to
meet anticipated clinical trial commencement and completion dates as
well as the possibility of unfavorable clinical trial results; decisions
by regulatory authorities regarding labeling and other matters that
could affect the availability or commercial potential of Eliquis; 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, 2015 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the SEC
and available at www.sec.gov
and www.pfizer.com.

¹ Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the
treatment of acute venous thromboembolism. New England Journal of
Medicine. 2013;369:799-808.

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