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News Release

Not intended for U.S. and UK Media

Bayer Pharma AG 13342 Berlin Germany

Tel. +49 30 468-1111

www.bayerpharma.com



American Society of Hematology (ASH) 57th Annual Meeting:


New Data from Bayer's Portfolio in Thrombosis, Hematology, and Oncology to be Presented at ASH 2015



Berlin, November 30, 2015 - Bayer announced today that new data from its advancing pharmaceutical portfolio in Thrombosis, Hematology and Oncology will be presented at the American Society of Hematology (ASH) 57th Annual Meeting, December 5-8, 2015, in Orlando, FL.


The following studies will be presented at ASH 2015:


Thrombosis:

Xarelto®(rivaroxaban) Studies

An oral presentation on the XALIA study, the first prospective, observational real world study of a NOAC investigating the safety and effectiveness of rivaroxaban in patients with deep vein thrombosis (DVT) compared to standard of care. This will offer physicians insights on how rivaroxaban performs in everyday clinical practice and complements the published Phase III EINSTEIN DVT clinical trial for rivaroxaban.

  • XALIA, a Non-Interventional Study Comparing Rivaroxaban with Standard Anticoagulation for Initial and Long-Term Therapy in Deep Vein Thrombosis

    • Abstract #894, Session: 332. Antithrombotic Therapy II. Oral Presentation

    • Monday, December 7, 2015, 6:15 PM-7:45 PM; Orange County Convention Center, W307


      An oral presentation from an investigator initiated study that is part of the CALLISTO Clinical Research Programme will provide real world evidence on the potential benefits of rivaroxaban in patients with cancer-associated thrombosis.

  • Safe and Effective Use of Rivaroxaban for Treatment of Cancer-Associated Venous Thromboembolic Disease: A Quality Improvement Initiative


    • Abstract #431, Session: 332. Antithrombotic therapy: Therapy in Cancer Patients. Oral Presentation

    • Monday, December 7, 2015, 7:00 AM-8:30 AM; Orange County Convention Center, W311 ABCD


      Hemophilia:

      Data from clinical trials of BAY 81-8973, a new full length unmodified recombinant factor VIII product, which has demonstrated control of bleeds and reduction of bleeding frequency in patients with hemophilia A when used prophylactically two or three times per week, along with other next generation therapies that are part of Bayer's hemophilia pipeline.


      BAY 81-8973 Phase III Studies
  • New Approach in Assessing the Pharmacokinetic/Pharmacodynamic Relationship in Patients With Severe Hemophilia A Using Data From BAY 81-8973 Studies

    • Abstract #1095, Session: 322. Disorders of Coagulation or Fibrinolysis:

      Poster I

    • Saturday, December 5, 2015, 5:30 PM-7:30 PM; Orange County Convention Center, Hall A, Level 2


  • Patterns of prior treatment and bleeds among patients with severe hemophilia A:

    Impact on frequency of dosing with Bay 81-8973 in the LEOPOLD I trial

    • Abstract #1103, Session: 322. Disorders of Coagulation or Fibrinolysis:

      Poster I

    • Saturday, December 5, 2015, 5:30 PM-7:30 PM; Orange County Convention Center, Hall A, Level 2


  • BAY 81-8973, a Full-Length Recombinant Factor VIII: Results From Assay Field Study

    • Abstract #3539, Session: 322. Disorders of Coagulation or Fibrinolysis:

      Poster III

    • Monday, December 7, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


      BAY 1093884 Studies
  • Acute Efficacy of a Novel Anti-Tissue Factor Pathway Inhibitor Antibody BAY 1093884 in Hemophilia A Mouse Severe Tail Bleeding

    • Abstract #3500, Session: 321. Blood Coagulation and Fibrinolytic Factors:

      Poster III

    • Monday, December 7, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


  • Antibody Engineering of Anti-TFPI Bypass Therapeutic BAY 1093884: Isotype Selection and Sequence Optimization

    • Abstract #3496, Session: 321. Blood Coagulation and Fibrinolytic Factors:

      Poster III

    • Monday, December 7, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


      Other Studies
  • A Factor VIII with Site-Specific Pegylation Attenuates the Binding with Inhibitors Results in the Retention of Hemostatic Effect

    • Abstract #1076, Session: 321. Blood Coagulation and Fibrinolytic Factors: Poster I (61 abstracts)

    • Saturday, December 5, 2015, 5:30 PM-7:30 PM; Orange County Convention Center, Hall A, Level 2


  • Renal Status and Hematuria in Older Patients with Hemophilia

    • Abstract #2290, Session: 322. Disorders of Coagulation or Fibrinolysis:

      Poster II

    • Sunday, December 6, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


  • Mapping T-Cell Peptide Epitopes on Activated Recombinant Factor VII (rFVIIa)

    Contributing to Inhibitor Antibody Response

    • Abstract #2295, Session: 322. Disorders of Coagulation or Fibrinolysis:

      Poster II

    • Sunday, December 6, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


  • Characterization of a High-Affinity Fully Human IgG2 Antibody Against Tissue Factor Pathway Inhibitor As a Bypass Agent for the Treatment of Hemophilia

    • Abstract #3513, Session: 322. Disorders of Coagulation or Fibrinolysis:

      Poster III

    • Monday, December 7, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


  • Protection of Microvascular Liver Perfusion With 5-Hydroxymethylfurfural in Sickle Cell Disease Mice Following Hypoxia-Induced Vasoocclusion

    • Abstract #3382, Session: 113. Hemoglobinopathies, Excluding Thalassemia

      - Basic and Translational Science: Poster III

    • Monday, December 7, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


      Oncology:

      One abstract on copanlisib in a subset of patients from the completed Part A of a Phase II Study will be presented. Part B, an extension of this Phase II Study in relapsed, refractory indolent non-Hodgkin's lymphoma (NHL), is currently ongoing (CHRONOS-1). The

      Phase III trials CHRONOS-2 and CHRONOS-3 in NHL are open for enrollment. Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against both PI3K-α and PI3K-δ isoforms.


      Copanlisib Phase IIa Study Subset
  • Results of the Mantle Cell Lymphoma Subset from a Phase 2a Study of Copanlisib, a Novel PI3K Inhibitor, in Patients with Indolent and Aggressive Lymphoma

    • Abstract #3935, Session: 623. Lymphoma: Chemotherapy, excluding Pre-

      Clinical Models: Poster III

    • Monday, December 7, 2015, 6:00 PM-8:00 PM; Orange County Convention Center, Hall A, Level 2


Thrombosis, Hematology, and Oncology are core areas of Bayer's pharmaceutical portfolio and pipeline. Bayer offers a product for both the treatment and prevention of venous and arterial thromboembolism and is investigating the further use of this product as well as new potential therapeutic approaches in the Thrombosis field. Hematology at Bayer includes an approved treatment for hemophilia A and numerous compounds in various stages of development for hemophilia, sickle cell anemia, and other blood and

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