New research includes final data from AEGEAN, new real-world data analyses from the ACROPOLIS program, and sub-analyses from the pivotal ARISTOTLE program
Bristol-Myers
Squibb Company (NYSE:BMY) and Pfizer
Inc. (NYSE:PFE) announced today that 12 Eliquis abstracts
will be presented at the AHA Scientific Sessions 2016, to be held
November 12-16 in New Orleans. Among these abstracts, the Bristol
Myers-Squibb and Pfizer Alliance will present final data from the
randomized AEGEAN (Assessment of an Educational and Guidance
Program for
Eliquis Adherence in Nonvalvular
Atrial Fibrillation) study, highlighting adherence and persistence data
for nonvalvular atrial fibrillation (NVAF) patients treated with Eliquis
to reduce the risk of stroke. These data are based on an evaluation
of an additional education program versus standard of care patient
education. Additional post-hoc analyses from the pivotal ARISTOTLE (Apixaban
for Reduction In STroke and Other ThromboemboLic
Events in Atrial Fibrillation) study and retrospective real-world
data analyses from ACROPOLIS (Apixaban ExperienCe Through Real-WOrld
POpuLatIon Studies) will also be presented.
“We are proud to build on the growing body of clinical and real-world
evidence for the use of Eliquis,” said Rory O’Connor, M.D., Chief
Medical Officer, Internal Medicine, Pfizer Innovative Health. “At this
year’s AHA Scientific Sessions, we’ll also share data on patient
adherence to anticoagulant therapy, which is critical for the reduction
of stroke risk in patients with nonvalvular atrial fibrillation.”
“As part of our steadfast commitment to the ongoing evaluation of Eliquis,
we continue to gather insights from real-world practice to
complement the results we’ve seen in randomized clinical trials,” said
Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis,
Bristol-Myers Squibb. “These analyses form part of our ACROPOLIS global
real-world data program, which evaluates data from regions around the
world collected through medical records, insurance claims databases and
national health data systems to further inform healthcare
decision-making.”
The complete list of Bristol-Myers Squibb and Pfizer Alliance
presentations is included below. Abstracts can be accessed on the AHA
Scientific Session 2016 planner
.
Title
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Presenting
Author/Type
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Date/Time
(CST)
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Location/Session
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Phase 3 Clinical Trial Sub-Analyses
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Use of the Novel Biomarker-based ABC Bleeding Risk Score Over Time
in Atrial Fibrillation: Insights from the ARISTOTLE Trial
Session: Arrhythmia: Clinical Electrophysiology, Diagnosis and
Risk Stratification VII
|
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Hijazi et al./
Oral
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Nov. 14, 2:00-3:15 PM
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Science and Technology Hall, Clinical Science II Section
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Percutaneous Coronary Intervention and Antiplatelet Therapy on
Apixaban or Warfarin: Insights from the ARISTOTLE Trial
Session: Antiplatelet Therapy for PCI and ACS: Insights
from Large Trials and Registries
|
|
Kopin et al./ Poster
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Nov. 13, 3:45 PM
|
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Science and Technology Hall, Clinical Science Section
|
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Adherence and Persistence to Apixaban Treatment in Patients with
Non-Valvular Atrial Fibrillation is High and Similar with
Standard-of-care Patient Education or with an Additional Educational
Program: The Randomized AEGEAN study
Session: Cardiovascular Stroke
|
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Montalescot et al./
Oral
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Nov. 13, 5:45-5:55 PM
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Room 348-349
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A History of GI Bleeding is associated with Increased Risk of
Subsequent Bleeding, but not Stroke: Insights from the ARISTOTLE
Trial
Session: Treatment of Arrhythmias: Pharmacologic II
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Lopes et al./
Poster
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Nov. 15, 1:30 PM
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Science and Technology Hall, Clinical Science Section
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Risk Factors for Cause-Specific Mortality in Patients Anticoagulated
for Atrial Fibrillation: Insights From the ARISTOTLE trial
Session: Clinical Risk Factors and Novel Biomarkers:
Diagnostic, Prognostic, and Therapeutic Implications
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Sharma et al./
Rapid-Fire
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Nov. 15, 2:25 PM
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Science and Technology Hall, Population Science Theater
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Biomarkers Predict Cause of Death More Accurately than Clinical
Variables in Patients with Atrial Fibrillation on Oral
Anticoagulation – Results from the ARISTOTLE trial
Session: Chronic and Acute Ischemic Heart Disease
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Hijazi et al./
Rapid-Fire
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Nov. 15, 6:30-6:40 PM
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Room 228-230
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Real-World Data and Other Analyses
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Outcomes Associated with Warfarin Time in Therapeutic Range among
Veterans with Non-Valvular Atrial Fibrillation in the US, 2005-2015
Session: Issues in Atrial Fibrillation and Anticoagulation
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Liu et al./
Rapid-Fire
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Nov. 14, 12:10 PM
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Science and Technology Hall, Population Science Theater
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Real World Bleeding Risks in Non-Valvular Atrial Fibrillation
Patients with Heart Failure: Contemporary EHR Results Among
Prescribed Apixaban, Dabigatran, Rivaroxaban and Warfarin
Session: Issues in Atrial Fibrillation and Anticoagulation
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Masseria, C. et al./ Rapid-Fire
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Nov. 14, 12:20 PM
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Science and Technology Hall, Population Science Theater
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Real-World Comparisons of Major Bleeding Risk for Commercially
Insured Non-Valvular Atrial Fibrillation Patients Initiating
Apixaban, Dabigatran, Rivaroxaban, or Warfarin
Session: Patient Centered Outcomes Research in Atrial
Fibrillation and Anticoagulation
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Amin et al./
Poster
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Nov. 14, 2:00 PM
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Science and Technology Hall, Population Science Section
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Real World Comparisons of Major Bleeding Risk Stratified by CHA2DS2-VASc
Scores among Non-Valvular Atrial Fibrillation Patients Initiating
Apixaban or Warfarin
Session: Patient Centered Outcomes Research in Atrial
Fibrillation and Anticoagulation
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Lip et al./
Poster
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Nov. 14, 2:00 PM
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Science and Technology Hall, Population Science Section
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Performance of the Novel Biomarker-Based ABC-Stroke Risk Score over
Time in Patients with Atrial Fibrillation
Session: Arrhythmia: Clinical Electrophysiology,
Diagnosis and Risk Stratification V
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Hijazi et al./
Oral
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Nov. 14, 2:00 PM
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Science and Technology Hall, Clinical Science II Section
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Real-world Evaluation of Healthcare Resource Use and Costs of
Elderly Patients with Non-Valvular Atrial Fibrillation Treated with
Apixaban vs. Warfarin in the US
Session: Resource Intensity, Costs, and Cost-Effectiveness in
CVD
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Deitelzweig et al./
Poster
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Nov. 15, 1:30 PM
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Science and Technology Hall, Population Science Section
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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
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE
RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
|
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(A) Premature discontinuation of any oral anticoagulant,
including ELIQUIS, increases the risk of thrombotic events. If
anticoagulation with ELIQUIS is discontinued for a reason other than
pathological bleeding or completion of a course of therapy, consider
coverage with another anticoagulant.
|
(B) Epidural or spinal hematomas may occur in patients treated
with ELIQUIS who are receiving neuraxial anesthesia or undergoing
spinal puncture. These hematomas may result in long-term or
permanent paralysis. Consider these risks when scheduling patients
for spinal procedures. Factors that can increase the risk of
developing epidural or spinal hematomas in these patients include:
|
-
use of indwelling epidural catheters
-
concomitant use of other drugs that affect hemostasis, such
as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet
inhibitors, other anticoagulants
-
a history of traumatic or repeated epidural or spinal
punctures
-
a history of spinal deformity or spinal surgery
-
optimal timing between the administration of ELIQUIS and
neuraxial procedures is not known
|
|
Monitor patients frequently for signs and symptoms of
neurological impairment. If neurological compromise is noted, urgent
treatment is necessary.
|
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Consider the benefits and risks before neuraxial intervention in
patients anticoagulated or to be anticoagulated.
|
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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
.
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 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,
YouTube
and Facebook.
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
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and
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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.
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 November 10, 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, including
unfavorable new clinical data and additional analyses of existing
clinical data; 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
.
Bristol-Myers Squibb Media: Rob Perry, 407-492-4616, rob.perry@bms.com Investors: Timothy Power, 609-252-7509, timothy.power@bms.com orPfizer Inc. Media: Steven Danehy, 212-733-1538, steven.danehy@pfizer.com; Investors: Ryan Crowe, 212-733-8160, ryan.crowe@pfizer.com