Bristol-Myers Squibb and Pfizer to Highlight Commitment to Reducing the Risk of Stroke Caused by Non-Valvular Atrial Fibrillation (NVAF) and Treating Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) at ESC Congress 2017

Eliquis® (apixaban) Clinical Data Include Results from a Phase 4 Trial – EMANATE – to be Featured in Late-Breaking Science Sessions Analyses from the ACROPOLIS™ Global Real-World Data Program Provide Insight into the Anticoagulation of a Broad Range of NVAF Patients at Risk for Stroke Friday, August 18, 2017 - 6:59amEDTBristol-Myers Squibb Company...

Eliquis® (apixaban) Clinical Data Include Results from a Phase 4 Trial – EMANATE – to be Featured in Late-Breaking Science Sessions

Analyses from the ACROPOLIS™ Global Real-World Data Program Provide Insight into the Anticoagulation of a Broad Range of NVAF Patients at Risk for Stroke

Friday, August 18, 2017 - 6:59am
EDT

Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that 15 abstracts have been accepted for presentation at the ESC Congress 2017, organized by the European Society of Cardiology, on August 26-30 in Barcelona, Spain. Investigational data from the EMANATE [Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with non-valvular atrial fibrillation (NVAF)] clinical trial will be presented during the Late-Breaking Science hot line session and official ESC press conference. EMANATE is a Phase 4 clinical trial exploring Eliquis® (apixaban) versus standard of care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist) in patients with NVAF expected to undergo cardioversion to re-establish a regular heart rhythm.

In addition, analyses from ACROPOLIS™ (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) – the real-world data program which aims to contribute to the growing body of evidence related to anticoagulation – will be presented at this year’s ESC Congress. These analyses focus on the use of Eliquis in routine clinical practice, including in NVAF patient populations considered at high risk or particularly vulnerable to stroke or major bleed due to age, risk prediction scores, and other cardiovascular comorbidities.

“We are proud to share both clinical trial results and real-world data analyses that continue to support the medical community in the advancement of patient care and add to the body of evidence for Eliquis as a treatment for DVT/PE and for reducing the risk of stroke in NVAF patients,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “These data supplement our pivotal trial results, providing additional insight into how Eliquis performs in specific clinical settings such as cardioversion and broad patient populations representing common clinical practice settings.”

“As physicians evaluate options for reducing stroke risk in patients with non-valvular atrial fibrillation, they often face questions about the effectiveness and safety of therapies in day-to-day practice,” said Rory O’Connor, M.D., Chief Medical Officer, Pfizer Innovative Health. “Real-world data analyses, such as the results shared at this year’s ESC Congress, allow us to better understand the usage of Eliquis and other anticoagulants in a variety of settings and alongside clinical data, and have the potential to help healthcare providers make more informed decisions about their patient’s care.”

Initial findings from a Bristol-Myers Squibb (BMS)- and Pfizer- commissioned global policy research project conducted by The Economist Intelligence Unit (EIU), the research analysis division of The Economist Group, will also be presented at the ESC Congress. These findings bring attention to the global disparity of stroke risk reduction policies, and inadequate detection of risk factors for stroke – including NVAF – in clinical practice. The full report, which will be released by The EIU on September 21, is part of the BMS-Pfizer Alliance’s commitment to collaborating with patient advocacy and research organizations around the world to uncover barriers to atrial fibrillation screening and appropriate treatment to reduce the risk of stroke for patients with NVAF.

Data from the EMANATE trial will be presented during various sessions on August 28:
09:17 – 09:25 CET - Press Conference – Hot Line: Late-Breaking Clinical Trials 2
11:18 – 11:28 CET - Hot Line: Late-Breaking Clinical Trials 2
15:40 – 16:00 CET - Meet the Trialists - EMANATE
15:37 – 18:00 CET - Anticoagulation for cardioversion of atrial fibrillation: exploring areas of uncertainty
One-year follow-up data evaluating the safety and effectiveness of continued oral anticoagulation treatment beyond one year after venous thromboembolism (VTE) in patients at intermediate risk of recurrence will be presented as an oral presentation on August 26, from 14:24 to 14:42 CET.
A real-world data analysis investigating the safety and effectiveness of Eliquis in high-risk patient subgroups will be featured as part of the Stroke Prevention poster session on August 28, from 8:30 to 12:30 CET.
A real-world data analysis evaluating the safety and effectiveness of Eliquis specifically in NVAF patients aged 65 years and older will be presented as an oral presentation during the Anticoagulation in Atrial Fibrillation Rapid Fire Abstract session on August 29 from 15:12 to 15:21 CET.
Top-line findings from The EIU report on stroke risk reduction and screening policies in 12 countries will be presented as a poster on August 28, from 8:30 to 12:30 CET. The full report will be released by The EIU on September 21.
Below is a complete list of BMS and Pfizer Alliance presentations during the ESC Congress. Abstracts can be accessed through the ESC Congress 2017 Scientific Programme.

            
Title   Presenting Author/Type   Date/Time (CET)   Location/Session
Clinical Data
INR prior to bleeding is below 3.0 most of the time in patients with atrial fibrillation using warfarin

Session: Poster Session 3 – Drug Treatment
  Oliveira Guimaraes et al./ Poster   Aug. 27,
14:00-18:00
  Poster Area
Apixaban vs conventional therapy in anticoagulation-naive patients with atrial fibrillation undergoing cardioversion: The EMANATE Trial

Sessions:
Hot Line: Late-Breaking Clinical Trials 2
Meet the Trialists - EMANATE
  Ezekowitz et al./
Hot Line
Meet the Trialists
  Aug. 28,
Hot Line: 11:18-11:28
Meet the Trialists: 15:40 – 16:00   Hot Line:
Main Auditorium
Meet the Trialists:
Dali – The Hub
Serial IL-6 levels and risk of death in anticoagulated patients with atrial fibrillation: Insights from the ARISTOTLE trial

Session: Poster Session 4 – Stroke Prevention
  Aulin et al./
Poster
  Aug. 28,
8:30-12:30
  Poster Area
Clinical outcomes in patients with atrial fibrillation and echocardiographic risk factors for stroke anticoagulated with apixaban or warfarin

Session: Poster Session 4 – Stroke Prevention
  Vinereanu et al./ Poster   Aug. 28,
8:30-12:30
  Poster Area
Low apolipoprotein A1 is significantly associated with decreased risk of cardiovascular events in anticoagulated patients with atrial fibrillation: Insights from the ARISTOTLE trial

Session: Poster Session 4 – Atrial Fibrillation Obesity
  Pol et al./
Poster
  Aug. 28,
8:30-12:30
  Poster Area
A novel biomarker-based risk score to predict death in patients with atrial fibrillation: Insights from the ARISTOTLE and RE-LY trials

Session: Stroke risk prediction in atrial fibrillation
  Hijazi et al./
Poster
  Aug. 29,
14:54-15:12
  Valetta – Village 5
Real-World Data and Other Analyses
Effectiveness and safety of continued oral anticoagulation treatment beyond 1 year after venous thromboembolism in patients at intermediate risk: a nationwide propensity score weighted-cohort study

Session: After pulmonary embolism: optimising treatment and follow up
  Johnsen et al./Oral   Aug. 26,
14:24-14:42
  Rabat – Village 7
Real-world comparison of major bleeding risk associated with direct oral anticoagulants or warfarin in patients with non-valvular atrial fibrillation: a systematic review and network meta-analysis

Session: Poster Session 3 – Drug Treatment
  Deitelzweig et al./Poster   Aug. 27,
14:00-18:00
  Poster Area
Effectiveness and safety of apixaban versus warfarin among high-risk subgroups of non-valvular atrial fibrillation patients: a propensity score matched analysis

Session: Poster Session 4 – Stroke Prevention
  Li et al./
Poster
  Aug. 28,
8:30-12:30
  Poster Area
Predictors of warfarin discontinuation or switching among non-valvular atrial fibrillation patients

Session: Poster Session 4 – Stroke Prevention
  Luo et al./
Poster
  Aug. 28,
8:30-12:30
  Poster Area
Effectiveness and safety of standard and lower dose apixaban compared to warfarin in non-valvular atrial fibrillation patients: a propensity score matched analysis

Session: Poster Session 4 – Stroke Prevention
  Li et al./
Poster
  Aug. 28,
8:30-12:30
  Poster Area
Stroke prevention: From policy to clinical practice in the U.S. and Europe

Session: Poster Session 4 – Cardiovascular risk factors in general population
 
Karnad et al./Poster
  Aug. 28,
8:30-12:30
  Poster Area
A changing landscape: temporal trends in incidence and characteristics of patients hospitalised with venous thromboembolism.

Session: Best Posters – Best Posters in acute pulmonary embolism
  Johnsen et al./Poster   Aug. 28, 14:00-18:00   Poster Area
Risk of major bleeding among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, rivaroxaban or warfarin in the U.S. Medicare population

Session: Poster Session 5 - Bleeding and LAA Occlusion
  Trocio et al./
Poster
  Aug. 28,
14:00-18:00
  Poster Area
Comparison of stroke and major bleeding risk of treatment with apixaban vs. rivaroxaban and dabigatran among elderly non-valvular atrial fibrillation patients in the United States

Session: Anticoagulation in Atrial Fibrillation
  Deitelzweig et al./Rapid Fire Abstract   Aug. 29,
15:12-15:21
  Agora 2
       
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 multiple 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

(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 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, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

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, 2016, 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 18, 2017. 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, 2016 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.

Source: www.pfizer.com