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Venous Blood Clot Prevention after Elective Hip or Knee Replacement Surgery:
Bayer will start marketing the new oral, once-daily anticoagulant very soon / First-in-class product to demonstrate superior efficacy to current standard of care
Leverkusen, October 1, 2008 - The Bayer Group has achieved a major success in
its product development: The European Commission has granted marketing approval
for Xarelto® (rivaroxaban), a novel anticoagulant taken as one tablet,
once-daily, for the prevention of venous blood clots in adult patients
undergoing elective (planned) hip or knee replacement surgery. Bayer HealthCare
will start launching the product in the EU member states very soon.
"The successful development program of Xarelto underpins Bayer's innovative
strength," said Werner Wenning, CEO of Bayer AG. "Xarelto could prove to be a
significant medical breakthrough, bringing hope to millions of patients
worldwide. As Xarelto has the potential to become a blockbuster, its launch is
an important milestone for Bayer."
EU marketing approval for Xarelto was received following a review of data from
the extensive RECORD clinical program that included three Phase III trials of
Xarelto involving nearly 10,000 patients undergoing elective hip or knee
replacement surgery (RECORD1, 2 and 3 trials). Results from these three studies
demonstrated the superior efficacy of Xarelto, both in head-to-head comparisons
with enoxaparin (RECORD1 and 3) as well as when comparing extended-duration (5
weeks) Xarelto with short-duration (2 weeks) enoxaparin (RECORD2). In all three
trials, Xarelto and enoxaparin had comparable safety profiles including low
rates of major bleeding.
"Venous blood clots kill more than half a million people a year in the EU,"
commented Dr. Bengt Eriksson, Orthopedic Surgeon at the Sahlgrenska University
Hospital/Östra, Gothenburg, Sweden, and a leading investigator in the Xarelto
clinical development program. "Existing treatments have limitations in terms of
efficacy and ease of administration. The development of Xarelto, an effective
oral, once-daily anticoagulant, which does not need routine coagulation
monitoring, is a huge step forward in blood clot prevention, and will save
lives."
On September 15, 2008, Health Canada granted Bayer HealthCare marketing
authorization for the novel anticoagulant Xarelto. Taken as one tablet,
once-daily, it was approved for the prevention of venous thromboembolic events
(VTE) in adult patients who have undergone elective total hip or total knee
replacement surgery. This decision marked the first approval for Xarelto
worldwide. Bayer started marketing the product in Canada immediately.
Xarelto was submitted in July 2008 for approval to the U.S. Food and Drug
Administration (FDA). On approval, Ortho-McNeil, a Division of
Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the United
States. In addition to the FDA submission, filings are under review with
regulatory agencies in more than 10 other countries.
Almost 50,000 patients are expected to be enrolled into the extensive
development program with Xarelto worldwide. The clinical trial program will
evaluate the product in the prevention and treatment of a broad range of acute
and chronic blood-clotting disorders including VTE treatment, stroke prevention
in patients with atrial fibrillation, VTE prevention in hospitalized, medically
ill patients, and secondary prevention of acute coronary syndrome.
Xarelto was invented in Bayer's Wuppertal laboratories in Germany, and is being
jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical
Research & Development, L.L.C.
About Venous Thromboembolism
Venous thromboembolism (VTE) is a serious life-threatening condition. In the
EU, there are in excess of 1.5 million blood clot events annually and these are
responsible for killing some 544,000 people each year - more than breast
cancer, prostate cancer, HIV/AIDS and road traffic accidents combined.
During hip or knee replacement procedures, the large veins of the leg that
carry blood back to the heart are damaged, which significantly increases the
risk of VTE for patients undergoing such major orthopedic surgery. In fact,
venous blood clots occur in 40-60% of patients undergoing major orthopedic
surgery who do not receive preventative care.
In the five largest EU-member states, approximately 450,000 total hip - and
approximately 300,000 total knee replacement surgeries are being conducted
annually.
To learn more about VTE please visit www.thrombosisadviser.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, 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. 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, General Medicine, Specialty Medicine 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.
