Bayer's Rivaroxaban Submitted for EU Marketing Authorisation in Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation as well as for the Treatment of Deep Vein Thrombosis (DVT) and Prevention of Recurrent DVT and Pulmonary Embolism (PE)

NEWBURY, England, January 6, 2011 /PRNewswire/ --

- Submission in Stroke Prevention in Patients With Non-valvular Atrial Fibrillation (AF) Based on Positive Results of ROCKET AF Trial in More Than 14,000 Patients

- Submission in Treatment of DVT and Prevention of Recurrent DVT and PE Based on Positive Results of EINSTEIN-DVT and EINSTEIN-Extension Clinical Studies in More Than 4,500 Patients

Bayer has submitted an application for marketing authorisation to the European Medicines Agency (EMA) for the oral anticoagulant rivaroxaban in stroke prevention in patients with non-valvular atrial fibrillation, as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE). Rivaroxaban is an oral direct Factor Xa inhibitor, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD).

The submission for stroke prevention in patients with non-valvular AF is supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010.

Submission for the treatment of DVT, and prevention of recurrent DVT and PE, is based on data from the Phase III EINSTEIN-DVT trial that was presented at the European Society of Cardiology (ESC) Congress in August 2010, and data from the Phase III EINSTEIN-Extension trial that was presented in December 2009 at the 51st Annual Meeting of the American Society of Haematology (ASH). The EINSTEIN-DVT and EINSTEIN-Extension data have recently been published in the New England Journal of Medicine (NEJM)[1].

ROCKET AF, EINSTEIN-DVT and EINSTEIN-Extension are part of the global development programme that has demonstrated the safety and efficacy of rivaroxaban in the seven Phase III studies completed to date.

Bayer also confirmed that J&JPRD filed its complete response with the U.S. Food & Drug Administration (FDA) seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery. The filing includes specific information requested by the FDA in a Complete Response Letter on May 28, 2009, and is primarily supported by data from the pivotal, global Phase III RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial programme.

Rivaroxaban is approved in the European Union for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

Note to Editors

About rivaroxaban

Rivaroxaban was invented in Bayer's Wuppertal laboratories in Germany and is marketed in Europe by Bayer HealthCare.

To date, rivaroxaban has been launched in more than 75 countries around the world by Bayer HealthCare. More than 65,000 patients are expected to be enrolled into the rivaroxaban clinical development programme, which will evaluate the product in a broad range of acute and chronic blood clotting conditions.

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Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. The company's products and services are designed to benefit people and improve their quality of life. At the same time Bayer creates value through innovation, growth and high earning power. The Group is committed to the principles of sustainable development and to its role as a socially and ethically responsible corporate citizen. Economy, ecology and social responsibility are corporate policy objectives of equal rank. In fiscal 2009, Bayer employed 108,400 people and had sales of EUR31.2 billion. Capital expenditures amounted to EUR1.7 billion, R&D expenses to EUR2.7 billion. For more information, go to http://www.bayer.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 with annual sales of more than EUR 15.9 billion (2009), 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, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53,400 employees and is represented in more than 100 countries. Find more information at http://www.bayerhealthcare.com

The pharmaceutical disvision of Bayer HealthCare focuses its research and business activities on the following areas: Diagnostic Imaging, General Medicine, Haematology & Neurology, Oncology and Women's Healthcare. Using innovative ideas, Bayer aims to make a contribution to medical progress and strives to improve the quality of patients' lives.

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References:

[1]. The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N Engl J Med 2010; 363:2499-2510