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Share Name | Share Symbol | Market | Type |
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Bristol Myers Squibb Co | NYSE:BMY | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.18 | 0.40% | 44.88 | 45.37 | 44.34 | 44.73 | 21,281,897 | 00:58:53 |
Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) announced today that 22 abstracts (late-breaking, rapid-fire, oral and poster presentations) will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance’s commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) patient populations. In addition, data from the AEGEAN (Assessment of an Educational and Guidance Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study evaluating adherence among NVAF patients further extends the Alliance’s commitment to patient care.
“The Bristol-Myers Squibb and Pfizer Alliance is pleased to share 22 abstracts, which include important Eliquis data from both clinical trials and real-world analyses, at one of the world’s largest and most influential cardiovascular meetings,” said Douglas Manion, M.D., head of specialty development, Bristol-Myers Squibb.
“Clinical trial data are important in evaluating a medication’s efficacy and safety under well-controlled circumstances, and their findings can be supplemented by real-world data on the use of a product for approved indications in routine clinical practice,” said Rory O’Connor, M.D., senior vice president and head of Global Medical Affairs, Global Innovative Pharma Business, Pfizer Inc.
The complete list of Bristol-Myers Squibb and Pfizer Alliance presentations is included below. Abstracts can be accessed on the ESC Congress 2015 website.
TitlePresentingAuthor/Type
Date/Time(BST)
Location/Session Randomized TrialsAssessment of an Educational and Guidance Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation (AEGEAN)Session: Atrial Fibrillation / Pacing
Gilles Montalescot / Hot Line OralAug. 3017:16-17:28
London – Main Auditorium Steven Lip /Discussant Review
Aug. 3017:28-17:35
London – Main Auditorium Panel DiscussionAug. 3017:28-17:38
London – Main Auditorium Real-World Data AnalysesReal-World Comparison of Major Bleeding Risks among Non-Valvular Atrial Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban: Cohorts Comprising New Initiators and/or Switchers from WarfarinSession: Anticoagulation and atrial fibrillation III
Gregory Lip, et al / PosterAug. 3014:00-15:30
Poster Area – Poster AreaMajor Bleeding, Hospitalization Rates and Healthcare Costs among Non-Valvular Atrial Fibrillation Patients Naïve to Oral Anticoagulation and Newly Treated with Novel Oral AnticoagulantsSession: Impact of the environment on anticoagulation in non-valvular atrial fibrillation
Steven Deitelzweig, et al /Oral, Rapid Fire
Aug. 3014:09-14:18
Holland Park – The HubReal-World Comparison of Bleeding Risks among Non-Valvular Atrial Fibrillation Patients on Apixaban, Dabigatran, Rivaroxaban: Cohorts Comprising New Initiators and/or Switchers from WarfarinSession: Impact of the environment on anticoagulation in non-valvular atrial fibrillation
Gregory Lip, et al / Oral, Rapid FireAug. 3014:45-14:54
Holland Park – The HubLower Risk of Myocardial Infarction in Atrial Fibrillation Patients Treated with Vitamin K Antagonist than in Combination with Acetylsalicylic Acid (ASA) or ASA AloneSession: Oral anticoagulants still in the focus
Christina Jiyoung Lee, et al /Moderated Poster
Aug. 3111:20-11:37
Tunis – Village 7Patient Profile in Non-Valvular Atrial Fibrillation (NVAF) and Stroke: Findings from a Real-World Setting in SpainSession: Atrial fibrillation III
Cinira Lefevre, et al / PosterSept. 18:30-12:30
Poster Area – Poster AreaReal-World Comparison of Major Bleeding Risk among Non-Valvular Atrial Fibrillation Patients Newly Initiated on Apixaban, Dabigatran, Rivaroxaban or WarfarinSession: Anticoagulation and atrial fibrillation III
Gregory Lip, et al / PosterSept. 114:00-18:00
Poster Area – Poster AreaReal-World Bleeding Risk among Non-Valvular Atrial Fibrillation (NVAF) Patients Prescribed Apixaban, Dabigatran, Rivaroxaban and Warfarin: Analysis of Electronic Health RecordsSession: Anticoagulation and atrial fibrillation III
Lin, et al / PosterSept. 114:00-18:00
Poster Area – Poster AreaPatient Profile of Oral Anticoagulation (OAC) Use in People with Nonvalvular Atrial Fibrillation (NVAF): Findings from REACT-AF 2 Study in UK Primary Care DataSession: Anticoagulation and atrial fibrillation I
Andrew Maguire, et al / PosterSept. 114:00-18:00
Poster Area – Poster AreaManagement of Anticoagulation in Patients with Non-Valvular Atrial Fibrillation in General Practice in UK: Evolution and Characteristics of Patients Not Treated with Antithrombotic TherapySession: Anticoagulation and atrial fibrillation II
Essra Ridha, et al /Poster
Sept. 114:00-18:00
Poster Area – Poster AreaManagement of Anticoagulation in Patients with Nonvalvular Atrial Fibrillation in General Practice in UK: Evolution and Characteristics of Patients Treated with Antiplatelet Therapy AloneSession: Anticoagulation and atrial fibrillation III
Essra Ridha, et al /Poster
Sept. 114:00-18:00
Poster Area – Poster AreaClinical and Demographic Characteristics According to Dosage among Nonvalvular Atrial Fibrillation Patients Newly Initiated on Novel Oral AnticoagulantsSession: Anticoagulation and atrial fibrillation I
Cristina Masseria, et al / PosterSept. 114:00-18:00
Poster Area – Poster AreaEarly Assessment of Bleeding-Related Hospital Readmissions among Non-Valvular Atrial Fibrillation Patients Treated with the New Oral Anticoagulants Using an Electronic Medical Record Database in the U.S.Session: Anticoagulation and atrial fibrillation III
Steven Deitelzweig, et al / PosterSept. 114:00-18:00
Poster Area – Poster Area Phase 3 Clinical Trial SubanaylsesLess Non-Major Bleeding with Apixaban versus Warfarin among Patients with Atrial Fibrillation: Insights from the ARISTOTLE TrialSession: Impact of the environment on anticoagulation in non-valvular atrial fibrillation
Maria Cecilia Bahit, et al / Oral, Rapid FireAug. 3014:27-14:36
Holland Park – The HubEfficacy and Safety of Apixaban Compared with Warfarin in Relation to Renal Function over Time in Patients with Atrial Fibrillation: Insights from the ARISTOTLE TrialSession: Impact of the environment on anticoagulation in non-valvular atrial fibrillation
Ziad , et al / Oral, Rapid FireAug. 3014:36-14:45
Holland Park – The HubStroke and Bleeding Outcomes with Apixaban versus Warfarin in Patients with High Creatinine, Low Body Weight or High Age Receiving Standard Dose Apixaban for Stroke Prevention in Atrial FibrillationSession: Anticoagulation in non-valvular atrial fibrillation
John Alexander, et al / OralAug. 3014:37-14:54
Madrid – Village 4External Validation of the Biomarker-Based ABC-Stroke Risk Score for Atrial FibrillationSession: Predicting the future: the accuracy of risk scores
Ziad Hijazi, et al /Moderated Poster
Aug, 3116:50-17:07
San Marino – Village 2Management and Clinical Consequences of Major Bleeding in High-Risk Patients Following an Acute Coronary Syndrome. Is Aspirin the Problem? Insights from the APPRAISE-2 TrialSession: Flash news on antithrombotics
Emil Hagstrom, et al / Oral, Rapid FireSept. 19:33-9:42
Agora – Poster AreaDigoxin Use is Associated with Higher Mortality among Patients with Atrial Fibrillation with and without Heart Failure: Insights from the ARISTOTLE TrialSession: New insights in arrhythmias: mechanisms and treatment
Roberto Rordorf, et al / PosterSept. 114:00-18:00
Poster Area – Poster Area Indirect Treatment Comparisons and Economic Value AnalysesPotential Clinical Benefits and Cost Savings Associated with Inclusion of Apixaban in the Formulary for Treatment of Patients with Venous ThromboembolismSession: Thrombosis and coagulation
Melissa Hamilton, et al / PosterAug. 308:30-12:30
Poster Area– Poster AreaA Simulated Head-to-Head Comparison of Stroke and Major Bleeding with Apixaban versus Rivaroxaban in High-Risk NVAF PatientsSession: Atrial fibrillation and anticoagulation
Jack Ishack, et al /Poster
Aug. 3114:00-18:00
Poster Area – Poster AreaComparative Cost-Effectiveness of Oral Anticoagulants for Stroke Prevention in Non-Valvular Atrial Fibrillation Patients in the UKSession: Antithrombotic prophylaxis in atrial fibrillation
Tereza Lanitis, et al / Moderated PosterSept. 110:51-11:00
Moderated Poster Station – Poster AreaAbout 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 is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; 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 Indications and 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.
ELIQUIS 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:CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
DRUG INTERACTIONS
PREGNANCY CATEGORY B
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, available at www.bms.com.
About ARISTOTLE and APPRAISE-2
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.
APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2) evaluated Eliquis in patients at risk of ischemic events. It was designed to randomize approximately 10,800 patients with a recent acute coronary syndrome (ACS) to Eliquis 5 mg twice daily or placebo, in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to Eliquis. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.
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 or follow us on Twitter at http://twitter.com/bmsnews.
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, 2014, 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 24, 2015. 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, and clinical trial data 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; the ability to successfully commercialize 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, 2014 and in its subsequent reports on Form 10, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150824005495/en/
Bristol-Myers SquibbMedia:Kirby Hosea, 609-419-5071kirby.hosea@bms.comorInvestors:Ranya Dajani, 609-252-5330ranya.dajani@bms.comorBill Szablewski, 609-252-5894william.szablewski@bms.comorPfizer Inc.Media:Steven Danehy, 212-733-1538steven.danehy@pfizer.comorInvestors:Ryan Crowe, 212-733-8160ryan.crowe@pfizer.com
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