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Endpoints Met for RECORD1 and RECORD2 Trials in Total Hip Replacement Surgery
Berlin, November 9, 2007 - 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
- Rivaroxaban?an Oral, Direct Factor Xa Inhibitor?for 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 world's 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.
