FDA Advisory Committee Strongly Endorses Use of Trasylol® in CABG Surgery Patients

Leverkusen, Germany and West Haven, CT, USA, September 21, 2006 – Bayer was glad to participate in today’s advisory committee meeting held by the Cardiovascular and Renal Drugs Division of the U.S. Food and Drug Administration (FDA). This session provided an open forum in which to discuss the complex scientific issues surrounding the risk/benefit profile of Trasylol® (aprotinin injection) in detail.

At the end of the session, the committee overwhelmingly affirmed (18 yes votes and one abstention) that the totality of clinical data presented in today’s meeting supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients. Additionally, as noted in today’s meeting, Bayer has begun discussions with the FDA regarding possible updates to the U.S. Trasylol label. Under consideration are: additional detail to the indication to specify that Trasylol should be used in patients at increased risk for blood loss and blood transfusion and revised guidance with regard to elevations in serum creatinine levels and hypersensitivity reactions in association with Trasylol. Also discussed were additional measures that Bayer could implement to further increase safety around hypersensitivity reactions. These included: additional instructions to physicians concerning administration of the test dose and possible development of a serological (blood) test to determine previous exposure to aprotinin.

Bayer considers the discussion today and the valuable feedback provided by the committee as important guidance and input that will help the company, and the FDA, in clarifying and addressing these critical issues. Bayer will continue to work closely with the FDA and other regulatory authorities regarding changes to the Trasylol label.

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.