- Fourteen abstracts to be presented,
including new analyses from the ARISTOTLE®, AMPLIFY® and
AMPLIFY-EXT trials evaluating patients with nonvalvular atrial
fibrillation (NVAF) and venous thromboembolism (VTE)
- New global health economics and
outcomes research (GHEOR) assessing Eliquis cost effectiveness and
real-world comparative effectiveness research will also be
presented
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc.
(NYSE:PFE) announced today that they will present 14 abstracts
(oral and poster presentations) at the ESC Congress 2014, organized
by the European Society of Cardiology, to be held August 30 to
September 4 in Barcelona, Spain. The new clinical trial data and
GHEOR analyses assessing cost effectiveness and real-world use
reinforce the alliance’s commitment to the ongoing analysis of
Eliquis in both the NVAF and VTE patient populations.
The complete list of Bristol-Myers Squibb/Pfizer alliance
presentations is included below. Abstracts can be accessed on the
ESC Congress 2014 website.
Title Presenting Author/Type Date/Time (CEST)
Location/Session ARISTOTLE Biomarker Analyses
Galectin-3 is associated with worse clinical outcome in patients
with atrial fibrillation: A substudy from the ARISTOTLE trial
Session: Posters Sessions
Asberg, S./
Poster
31 Aug
14:00 - 18:00
Poster area - Central Village A new biomarker based risk score for
predicting major bleeding in atrial fibrillation - the ABC (age,
biomarkers, current disease) risk score
Session: Prediction and Prevention of
Atrial fibrillation (AF)
Hijazi, Z./
Moderated Poster
31 Aug
15:38 - 15:47
Moderated
poster corner- Central Village
The efficacy of apixaban compared to warfarin in patients with
atrial fibrillation with high coagulation activity despite
anticoagulant treatment
Session: Atrial Fibrillation: How to
improve prognosis?
Christersson, C./
Abstract Session
2 Sep
08:45 - 09:00
Tbilisi - Village 7 Interleukin-6 and C-reactive protein and risk
for cardiovascular events and death in anticoagulated patients with
atrial fibrillation
Session: Posters Sessions
Aulin, J./
Poster
2 Sep
14:00 - 18:00
Poster area - Central Village
AMPLIFY and AMPLIFY-EXT
Apixaban for the treatment of venous thromboembolism in cancer
patients: data from the AMPLIFY trial
Session: Posters Sessions
Agnelli, G./
Poster
2 Sep
08:30 - 12:30
Poster area - Central Village Analysis of the bleeding and
thromboembolic risk with concomitant use of antiplatelet treatment
in the AMPLIFY trial
Session: Refining antithrombotic therapy
in coronary artery disease
Cohen, A./
Moderated Poster
31 Aug
10:00 - 10:08
Moderated poster corner - Central Village Predictors of
hospitalization during extended treatment of venous thromboembolism
in the AMPLIFY-EXT trial
Session: Acute Pulmonary Embolism
Cohen, A/
Oral
30 Aug
11:18 - 11:36
Cairo Village
Indirect Treatment Comparisons and Economic Value
Analyses Efficacy and safety of apixaban versus edoxaban for
stroke prevention in NVAF patients: an indirect treatment analysis
Session: Novel Oral Anticoagulants:
Trials, Costs and Real Life Use
Lip GYH/
Oral
2 Sep
11:00 - 11:15
Vilinius Village Potential impact of apixaban on formulary budget
and clinical outcomes in non-valvular atrial fibrillation patients
Session: Novel Oral Anticoagulants:
Trials, Costs and Real Life Use
Kachroo, S./
Oral
2 Sep
11:30 - 11:45
Vilinius Village Cost-effectiveness of apixaban compared to
edoxaban for stroke prevention in non-valvular atrial fibrillation
Session: Posters Sessions
Lip GYH/
Poster
2 Sep
14:00 - 18:00
Central Village Comparison of apixaban, dabigatran and rivaroxaban
in the acute treatment and prevention of venous thromboembolism:
systematic review and network meta-analysis
Session: Venous Thromboembolism: What’s
New
Cohen, A./
Oral
2 Sep
17:15 - 17:30
Tbilisi Village Cost-effectiveness of apixaban compared to other
anticoagulants for the acute (6-month) treatment of venous
thromboembolism
Session: Venous Thromboembolism: What’s
New
Lanitis, T./
Oral
2 Sep
16:45 - 17:00
Tbilisi Village
Real World Data Analyses Real world
discontinuation among early users of apixaban, dabigatran,
rivaroxaban or warfarin among atrial fibrillation patients newly
initiated on anticoagulation therapy: tell of first 200 days
Session: Novel Oral Anticoagulants:
Trials, Costs and Real Life Use
Phatak, H./
Oral
2 Sep
12:15 - 12:30
Vilinius Village Warfarin discontinuation in patients with
unprovoked venous thromboembolism: a large U.S. insurance database
analysis
Session: Posters Sessions
Liu JXC/
Poster
2 Sep
8:30 to 12:00
Central Village
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 to reduce the risk of stroke and systemic embolism in
patients with nonvalvular atrial fibrillation in the United States,
European Union, Japan and a number of other countries around the
world. Eliquis is approved for the prophylaxis of deep vein
thrombosis (DVT) which can lead to PE (pulmonary embolism) in adult
patients who have undergone elective hip or knee replacement
surgery in the United States, European Union and a number of other
countries around the world. Eliquis is not approved for this
indication in Japan.
IMPORTANT SAFETY
INFORMATION
WARNINGS: (A) DISCONTINUING ELIQUIS IN PATIENTS WITH
NONVALVULAR ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS
ANTICOAGULATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL
HEMATOMA
(A) Discontinuing ELIQUIS places patients at an increased
risk of thrombotic events. An increased rate of stroke was observed
following discontinuation of ELIQUIS in clinical trials in patients
with nonvalvular atrial fibrillation. If anticoagulation with
ELIQUIS must be discontinued for a reason other than pathological
bleeding, coverage with another anticoagulant should be strongly
considered.
(B) When neuraxial anesthesia (epidural/spinal anesthesia) or
spinal puncture is employed, patients anticoagulated or scheduled
to be anticoagulated with low molecular weight heparins,
heparinoids, or Factor Xa inhibitors for prevention of
thromboembolic complications are at risk of developing an epidural
or spinal hematoma which can result in long-term or permanent
paralysis.
The risk of these events may be increased by the use of
indwelling epidural catheters for administration of analgesia or by
the concomitant use of drugs affecting hemostasis such as
nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation
inhibitors, or other anticoagulants. The risk also appears to be
increased by traumatic or repeated epidural or spinal
puncture.
Monitor patients for signs and symptoms of neurologic
impairment. If neurologic compromise is noted, urgent treatment is
necessary. Consider the potential benefit versus risk before
neuraxial intervention in patients anticoagulated or to be
anticoagulated for thromboprophylaxis.
CONTRAINDICATIONS
- Active pathological bleeding
- Severe hypersensitivity reaction to
ELIQUIS (apixaban) (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS
- Increased Risk of Stroke with
Discontinuation of ELIQUIS in Patients with Nonvalvular Atrial
Fibrillation: Discontinuing 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 patients
with nonvalvular atrial fibrillation. If ELIQUIS must be
discontinued for a reason other than pathological bleeding,
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. Patients should be made aware of signs or
symptoms of blood loss and instructed to immediately report 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.
Hemodialysis does not appear to have a substantial impact on
apixaban exposure. Protamine sulfate and vitamin K would not be
expected to affect the anticoagulant activity of apixaban. There is
no experience with antifibrinolytic agents (tranexamic acid,
aminocaproic acid) in individuals receiving apixaban. There is
neither scientific rationale for reversal nor experience with
systemic hemostatics (desmopressin and aprotinin) in individuals
receiving apixaban. Use of procoagulant reversal agents such as
prothrombin complex concentrate, activated prothrombin complex
concentrate, or recombinant factor VIIa may be considered but has
not been evaluated in clinical studies. Activated charcoal reduces
absorption of apixaban thereby lowering apixaban plasma
concentrations.
- 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.
ADVERSE REACTIONS
The most common and most serious adverse reactions reported with
ELIQUIS (apixaban) 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
5 mg twice daily, the dose of ELIQUIS should be decreased when it
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 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.
- 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.
About AMPLIFY, AMPLIFY-EXT and ARISTOTLE
AMPLIFY (Apixaban for the initial Management of
PuLmonary embolIsm and deep vein thrombosis as
First-line therapY), a randomized, double-blind,
multicenter trial, included 5,395 patients (2,691 were randomized
to Eliquis and 2,704 were randomized to standard of care, which was
initial enoxaparin treatment overlapped by warfarin therapy) with
confirmed symptomatic DVT or PE requiring treatment for six months,
and evaluated Eliquis therapy compared to standard of care. The
primary efficacy endpoint was the composite endpoint of recurrent
symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death.
The primary safety endpoint was the incidence of major bleeding
compared to standard of care.
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 (842 were randomized to Eliquis 2.5 mg, 815 were
randomized to Eliquis 5 mg and 829 were randomized to placebo) with
prior VTE who had completed six to 12 months of anticoagulation
treatment for DVT or PE, and evaluated Eliquis therapy compared to
placebo. The primary efficacy endpoint was reduction of the
composite of symptomatic, recurrent VTE and death from any cause.
The primary safety endpoint was the incidence of major
bleeding.
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, 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 Eliquis will receive approval
for these additional indications or, if approved, that these
additional indications will lead to increased commercial success.
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 20, 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 that involves
substantial risks and uncertainties about Eliquis, including
clinical trial data and GHEOR analyses relating to Eliquis and the
potential implications of such data and analsyses. Such risks and
uncertainties include, among other things, the uncertainities
inherent in research and development; uncertainities regarding the
impact of such data and analyses on the commercial success 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, 2013 and in its subsequent reports on Form 10-Q and
Form 8-K.
Bristol-Myers SquibbMedia: Danielle Halstrom,
609-252-3403, danielle.halstrom@bms.comInvestors:Ranya
Dajani, 609-252-5330, ranya.dajani@bms.comRyan Asay, 609-252-5020,
ryan.asay@bms.comorPfizer Inc.Media: Jennifer Kokell,
212-733-2596, jennifer.kokell@pfizer.comInvestors: Ryan
Crowe, 212-733-8160, ryan.crowe@pfizer.com
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