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

PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--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.

“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”

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.

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.

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