November 08, 2006
Patient Recruitment for Phase III Clinical Trial to Start in Studies of Oral Anticoagulant in Chronic Indications

Bayer and Ortho-McNeil, Inc. Outline Phase III Study Program of Oral Factor Xa Inhibitor Rivaroxaban in Chronic Indications

Phase III studies in chronic indications to involve more than 20,000 patients / Phase III trials to study stroke prevention in atrial fibrillation will begin patient recruitment during the coming weeks; phase III trials for the treatment of venous thromboembolism (VTE) will start recruiting in early 2007 / Based on the finalization of the study design, the companies are targeting a regulatory filing of rivaroxaban in these indications in 2010

Leverkusen - After extensive discussions with the regulatory authorities in the U.S. and Europe, Bayer and Ortho-McNeil, Inc. have determined the final design of the phase III study program for the oral anticoagulant rivaroxaban in two chronic indications:

• Stroke prevention in atrial fibrillation (SPAF) • Treatment and long-term secondary prevention of venous thromboembolism (VTE)

Stroke prevention in atrial fibrillation represents the largest potential indication, for which there exists substantial unmet medical need. The phase III program consists of one large, double-blind trial, which is designed to demonstrate non-inferiority of rivaroxaban against the current standard treatment of dose-adjusted warfarin. The principle investigator will be Robert Califf, M.D., director of the Duke Clinical Research Institute at the Duke University Medical Center, in Durham, North Carolina. The trial will include an estimated 14,000 patients, across 1,100 centres in more than 40 countries. This will be an event-driven study, meaning it will depend upon the occurrence of a statistically required number of strokes or systemic embolisms. After extensive dose-finding studies, the standard dose for rivaroxaban has been set at 20 mg once daily.

The VTE treatment program consists of two open label trials in patients with deep vein thromboembolism (DVT) and pulmonary embolism (PE) with a variable length of treatment up to 12 months against current standard treatment of low molecular weight heparin followed by dose-adjusted Vitamin-K antagonist. A third double-blind, placebo-controlled trial will analyze the value of prolonged treatment in this indication. The principle investigator for these trials is Harry Bueller, M.D., PhD, of the Academic Medical Center in Amsterdam. These event-driven studies will recruit about 7,500 patients, in about 300 centers in more than 20 countries. The study will use oral rivaroxaban for both the initial, intensified treatment phase as well as for the following period. The main dose of rivaroxaban will be 20mg once daily.

Currently, most anticoagulants are available only in injectable form, and as such are not suitable for use in long-term treatment. The only oral anticoagulant is warfarin, which requires frequent monitoring and interacts with numerous foods and other drugs.

``There currently exists significant medical need for an oral anticoagulant that does not require extensive and costly monitoring, " said Kemal Malik, MD, Head of Global Development and Chief Medical Officer at Bayer HealthCare. ``In studies conducted to date, rivaroxaban has demonstrated safety and efficacy across a wide range of doses and we look forward to the results of these studies."

Rivaroxaban is also currently in phase III trials in the prevention of venous thromboembolism, which are recruiting well. A first submission for marketing approval in this indication is planned for late 2007 in the EU and 2008 in the U.S. The global market for anticoagulants is currently estimated to be worth $5.7 billion (USD) and is forecast to grow at a double-digit percentage rate each year.

About Rivaroxaban
Rivaroxaban is a novel, oral, direct Factor Xa inhibitor that could potentially reduce the risk of life-threatening thromboembolic events. Factor Xa, the target enzyme, is a protease that acts to hinder blood clotting at the pivotal point in the coagulation cascade, the process that leads to clot formation.

Published results show that rivaroxaban offers predictable anticoagulation across a wide range of parameters, which strongly suggests that routine coagulation monitoring will not be required. In addition, data also show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.

Phase III trials with rivaroxaban in the prevention of venous thromboembolism (VTE) following major orthopedic surgery are already ongoing. The RECORD trial program (REgulation of Coagulation in ORthopedic surgery to prevent DVT and PE) began in December 2005.

Bayer HealthCare is developing this antithrombotic compound jointly with Ortho-McNeil Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.

Bayer HealthCare Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry based in Leverkusen/Germany. In 2005, the Bayer HealthCare subgroup generated sales amounting to some 9.4 billion Euro. Bayer HealthCare employed 33.800 people worldwide in 2005.

The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006, the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology, Oncology and Primary Care.

Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.


Forward-looking statements<br/>
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 public reports file with the Frankfurt Stock Exchange and 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.

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