Findings from three phase III clinical trials will be presented in the plenary session and during oral presentations at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia, from December 8 to 11, 2007. The studies evaluated rivaroxaban in head-to-head comparison with enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. The presentations will highlight results from the recently-completed RECORD1 and RECORD2 studies in total hip replacement surgery as well as additional data from the RECORD3 trial, which evaluated
rivaroxaban in total knee replacement surgery.
Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Copies of abstracts are available and can be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm
Information that goes beyond what is contained in the abstract is embargoed until the start time of the official annual meeting presentation.
Data from the RECORD (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) phase III clinical trial program will be presented during the ASH meeting as follows:
- Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial Abstract# 6. Plenary presentation: Sunday, December 9, 3:10 p.m., Hall A1, Georgia World Congress Center
- Extended Thromboprophylaxis with Rivaroxaban Compared with Short-Term Thromboprophylaxis with Enoxaparin After Total Hip Arthroplasty: The RECORD2 Trial Abstract# 307. Oral presentation: Monday, December 10, 11:00 a.m., Rooms B312-B313a
- Rivaroxabanâan Oral, Direct Factor Xa Inhibitorâfor Thromboprophylaxis After Total Knee Arthroplasty: The RECORD3 Trial Abstract# 308. Oral presentation: Monday, December 10, 11:15 a.m., Rooms B312-B313a
Four additional abstracts will be presented as poster presentations on Saturday, December 8 and Sunday, December 9, 2007.
Upon regulatory approval for the prevention of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. The companies plan to file rivaroxaban for a similar indication in the United States in 2008, where if approved, it will be commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are Johnson & Johnson companies.
The trade name of rivaroxaban is expected to be Xarelto®, pending health authority approval.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the worldâs leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will
improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.