U.S. FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and for the

  U.S. FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein
  Thrombosis (DVT) and Pulmonary Embolism (PE), and for the Reduction in the
  Risk of Recurrent DVT and PE Following Initial Therapy

  *Eliquis demonstrated noninferiority in the primary efficacy endpoint of
    recurrent symptomatic venous thromboembolism (VTE) or VTE-related death
    versus enoxaparin/warfarin in the AMPLIFY trial
  *Eliquis demonstrated superiority in the primary safety endpoint of major
    bleeding versus enoxaparin/warfarin in the AMPLIFY trial

Business Wire

PRINCETON, N.J. & NEW YORK -- August 21, 2014

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today
announced the U.S. Food and Drug Administration (FDA) has approved a
Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT
and PE, and for the reduction in the risk of recurrent DVT and PE following
initial therapy. ^ Combined, DVT and PE are known as VTE. It is estimated that
every year, approximately 900,000 Americans are affected by DVT and PE.

“We are pleased that Eliquis is now available as an effective treatment option
for DVT and PE,” ^ said Douglas Manion, M.D., Head of Specialty Development,
Bristol-Myers Squibb. “Eliquis offers oral dosing, no routine coagulation
testing, ^ and does not require the use of a parenteral anticoagulant or
bridging during initiation.”

“DVT, which may lead to PE, can be a serious medical condition, with PE
requiring immediate medical attention for treatment. ^ Once a VTE has
occurred, approximately 33 percent of patients are at risk of a recurrence
within 10 years,” said Steve Romano, senior vice president, Head of Medicines
Development Group for Global Innovative Pharmaceuticals, Pfizer Inc. “The
Bristol-Myers Squibb and Pfizer alliance is committed to delivering important
treatment options to patients and physicians.”

The full Prescribing Information for Eliquis includes Boxed Warnings for the
increased risk of thrombotic events in patients who prematurely discontinue
Eliquis; and for the increased risk of epidural or spinal hematoma, which may
cause long-term or permanent paralysis, in patients using Eliquis and
undergoing spinal epidural anesthesia or spinal puncture.

Eliquis increases the risk of bleeding and can cause serious, potentially
fatal, bleeding. Please see the complete Boxed Warnings and additional
Important Safety Information in this press release.

The FDA approval of Eliquis for the treatment of DVT and PE, and for the
reduction in the risk of recurrent DVT and PE following initial therapy, is
based on data from the global AMPLIFY and AMPLIFY-EXT studies.

The AMPLIFY study, a randomized, double-blind trial, was designed to
demonstrate the efficacy and safety of Eliquis for the treatment of DVT and
PE, and included patients with confirmed symptomatic DVT or PE (2,609 for
Eliquis and 2,635 for standard of care, ^ which was initial enoxaparin
treatment for at least five days, overlapped by warfarin therapy
[International Normalized Ratio (INR) range 2.0-3.0] orally for six months).

In the AMPLIFY study, Eliquis 10 mg twice daily for one week followed by 5 mg
twice daily for six months demonstrated efficacy comparable to standard of
care in treating DVT and PE patients for the primary efficacy composite
endpoint of recurrent, symptomatic VTE, or VTE-related death (2.3% vs. 2.7%,
relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18;
P-value<0.0001 for noninferiority).

Eliquis demonstrated superiority in the primary safety endpoint of major
bleeding versus standard of care (0.6% vs. 1.8%, relative risk 0.31; 95% CI,
0.17 to 0.55; P<0.0001 for superiority). Major bleeding was defined as
clinically overt bleeding that was accompanied by one or more of the
following: a decrease in the hemoglobin level of 2 g/dL or more; a transfusion
of two or more units of packed red blood cells; bleeding that occurred in at
least one of the following critical sites: intracranial, intraspinal,
intraocular, pericardial, intra-articular, intramuscular with compartment
syndrome, retroperitoneal; or bleeding that was fatal.

For the secondary safety endpoint in the AMPLIFY study, the event rates for
clinically relevant nonmajor bleeding (CRNM) were fewer in Eliquis-treated
patients compared to standard of care-treated patients (3.9% vs. 8.0%). CRNM
was defined as overt bleeding that did not meet the criteria for major
bleeding but was associated with a medical intervention, contact with a
physician, interruption of the study drug, or discomfort or impairment in
carrying out daily activities.

In AMPLIFY, the discontinuation rate due to bleeding events was 0.7% in the
Eliquis-treated patients compared to 1.7% in enoxaparin/warfarin-treated
patients.

About DVT and PE

DVT is a blood clot in a vein, usually in the lower leg, thigh, or pelvis,
which partially or totally blocks the flow of blood. PE is a blood clot
blocking one or more vessels in the lungs. DVT causes multiple symptoms
including pain, swelling, and redness, and more importantly, can progress to
PE, which carries the risk of sudden death.

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, including results from seven Phase 3
clinical trials.

ELIQUIS Important Safety Information

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.

Important Safety Information

WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF
THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA



(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.



Consider the benefits and risks before neuraxial intervention in patients
anticoagulated or to be anticoagulated.

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 anti-platelet 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 CYP3A4 and P-gp
    increase exposure to apixaban and increase the risk of bleeding. For
    patients receiving ELIQUIS doses greater than 2.5 mg twice daily, the dose
    of ELIQUIS should be decreased by 50% when it is coadministered with drugs
    that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole,
    itraconazole, ritonavir, or clarithromycin).  For patients receiving
    ELIQUIS at a dose of 2.5 mg twice daily, avoid coadministration 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 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, please visit www.bms.com.

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. To learn more, 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 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 the approval of these additional indications in the U.S.
will lead to increased commercial success or that Eliquis will be approved for
any other additional indications. 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, 2013, 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 August 21, 2014. 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’s (apixaban’s)
potential benefits and about additional indications for Eliquis in the U.S.
for the treatment of DVT and PE, and for the reduction in the risk of
recurrent DVT and PE following initial therapy, 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 regarding the commercial
success of the additional indications in the U.S.; whether and when regulatory
authorities in other jurisdictions will approve applications for these
potential additional indications, as well as their decisions regarding
labeling and other matters that could affect the availability or commercial
potential of such potential additional indications; 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, 2013 and in
our subsequent reports on Form 10-Q, including in the sections thereof
captioned “Risk Factors” and “Forward--10-Looking Information 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 atwww.sec.gov and www.pfizer.com.

Contact:

Bristol-Myers Squibb
Media:
Danielle Halstrom, 609-252-3403
danielle.halstrom@bms.com
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
Ryan Asay, 609-252-5020
ryan.asay@bms.com
or
Pfizer Inc.
Media:
Jennifer Kokell, 212-733-2596
jennifer.kokell@pfizer.com
Investors:
Ryan Crowe, 212-733-8160
ryan.crowe@pfizer.com
 
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