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Bristol-Myers Squibb and Pfizer to Present New Data on Eliquis® (apixaban) at the ESC Congress 2014PRINCETON, N.J. and NEW YORK --(Business Wire)-- 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 (News - Alert) 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.
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
WARNINGS AND PRECAUTIONS
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
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.
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