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)

By Bayer Healthcare, PRNE
Wednesday, January 5, 2011

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

NEWBURY, England, January 6, 2011 - 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
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

Bayer: Science for a Better Life

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

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

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.

Forward-Looking Statements

This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup 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 Bayer's public reports which are available
on the Bayer website at The company assumes no
liability whatsoever to update these forward-looking statements or to conform
them to future events or developments.


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

Contacts for further information: Craig Haslop, Fleishman Hillard, Tel: +44(0)20 7395 7089, Mobile : +44(0)7584-304-914, Email: craig.haslop at; Stefanie de Borba, Fleishman Hillard, Tel: +44(0)20-7395-7184, Mobile: +44(0)7765-609-725, Email: stefanie.deborba at

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