October 15, 2004

KOGENATE® Bayer with BIO-SET® Approved by European Union Commission, Sets New Standard in Patient Safety and Convenience


Research Triangle Park, N.C. / Leverkusen ? Bayer Biological Products (BP) announced today regulatory approval for KOGENATE® Bayer (Antihemophilic Factor [Recombinant], Formulated with Sucrose) with BIO-SET® from the European Union Commission. Representing the most advanced technology available for recombinant factor VIII product reconstitution and use, KOGENATE® Bayer with BIO-SET® becomes the first and only EU-approved self-contained, fully assembled, needleless reconstitution system that virtually eliminates the risk of accidental needle stick injuries during reconstitution. BIO-SET® will be exclusively available with KOGENATE® Bayer for hemophilia A treatment and is expected to be available in Europe starting early in 2005.

With its simplicity, safety and convenience, KOGENATE® Bayer with BIO-SET® represents a new standard for the reconstitution and delivery of factor VIII. Compared to currently available systems, KOGENATE® Bayer with BIO-SET® involves fewer than half the components for reconstitution and offers a compact size for easy portability. It is the first and only EU-approved system to provide a prefilled syringe with 2.5 ml diluent, as small as any diluent volume currently available among recombinant factor VIII products. KOGENATE® Bayer with BIO-SET® will advance patient safety as there is no exposure to needles during the reconstitution process; no latex utilized in the system; and minimal risk of contamination during reconstitution because of the special vacuum seal and fewer component parts. Finally, disposal is easier and safer because no needles are exposed.

The European Commission also recently approved labeling amendments allowing room temperature storage for KOGENATE® Bayer. KOGENATE® Bayer (Antihemophilic Factor [Recombinant], Formulated with Sucrose) with BIO-SET® can be stored at up to 250C for up to two months.

"By offering patient simplicity, improved safety and proven efficacy, KOGENATE® Bayer with BIO-SET® is a major advance in hemophilia care" said Martin Dawkins, vice president, Bayer BP Europe. "This is a significant milestone for us at Bayer BP, as it represents the next step in our quest to advance care by providing products, technologies, and services that improves patient convenience and quality of life."

The addition of a needleless reconstitution device further strengthens the excellent record of clinical safety and efficacy of Kogenate® products, represented by more than 16 years of clinical experience and more than five billion units infused with no confirmed viral transmissions. The European Commission approval follows the recent approval of Kogenate® FS with BIO-SET® by Health Canada.

BIO-SET® is a registered trademark of Biodome.

About Bayer HealthCare AG Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics Professional Testing Systems and Diagnostics Self Testing Systems, and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing, and treating disease.

Information about Bayer Biological Products Division can be found at www.bayerbiologicals.com.


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 filed with the Frankfurt Stock Exchange and 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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