Press Release
Venous Blood Clot Prevention after Elective Total Knee and Hip Replacement Surgery:
Bayer’s Xarelto® Approved in Canada
- First approval for Bayer's new oral, once-daily anticoagulant
- Marketing to start immediately
- First-in-class product to demonstrate superior efficacy to standard of care
- Most studied oral, direct Factor Xa inhibitor in the world today
Sep 16th, 2008 - Health Canada has granted Bayer HealthCare marketing authorization for the anticoagulant Xarelto (rivaroxaban), taken as one tablet, once-daily, for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. This decision marks the first approval for Xarelto worldwide. Bayer will start marketing the product immediately.
“Xarelto, discovered in Bayer’s Wuppertal laboratories in Germany, is a first-in-class product and the only oral anticoagulant to demonstrate superior efficacy over the standard of care, enoxaparin,” said Arthur Higgins, CEO of Bayer HealthCare. “The approval in Canada marks an important milestone for the most extensively studied product of its class and Bayer HealthCare has achieved a major step forward in establishing a new era in antithrombosis therapy.”
“Xarelto has the potential to revolutionize how we prevent dangerous blood clots after elective total hip or knee replacement surgery in Canada,” said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada, and Principal Investigator for the RECORD program. “The existing treatment standards have limitations, so new therapies such as Xarelto can help doctors to prevent the potentially lethal effects of venous blood clots.”
The approval from Health Canada was based on 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), and when comparing extended-duration (5 weeks) Xarelto with short-duration (2 weeks) enoxaparin (RECORD2). In all three trials, Xarelto and enoxaparin had similar safety profiles including low rates of major bleeding.
Xarelto has also been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) and Bayer expects the marketing authorization across all EU-member states very soon.
About Venous Thromboembolism
Venous thromboembolism (VTE) is a serious life-threatening condition which kills more people each year than breast cancer, AIDS, prostate cancer and traffic accidents combined. Overall, it is estimated that there are 15,000 to 20,000 VTE cases in Canada annually.
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 2005-2006, there were nearly 69,000 hospitalizations for hip and knee replacements in Canada alone.
To learn more about VTE please visit www.thrombosisadviser.com.
About Xarelto (rivaroxaban)
The extensive clinical trial program supporting Xarelto makes it the most studied oral, direct Factor Xa inhibitor in the world today. Almost 50,000 patients are expected to be enrolled into the Xarelto clinical development program which 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 recently submitted 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. 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 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.
Contact:
Dr. Jost Reinhard, Phone: +49 30-468-15062
E-mail: jost.reinhard@bayerhealthcare.com
Contact (US and Canada media):
Doug Grant, Phone: +1 416 246 5001
E-mail: doug.grant.b@bayer.com
Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
- Efficacy
- The ability of a drug to produce the desired effect.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Acute coronary syndrome
- An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
- Atrial fibrillation
- A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
- Factor Xa
- Pivotal component of blood clotting cascade. Stimulates the production of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots.
