Healthcare Industry News:  hemophilia A 

Biopharmaceuticals

 News Release - January 19, 2006

Bayer HealthCare Introduces Kogenate(R) FS with BIO-SET(R) in the United States

First and Only Self-Contained Needleless Reconstitution System Will Set New Standard in hemophilia A Treatment

BERKELEY, Calif.--(HSMN NewsFeed)--Jan. 19, 2006--Bayer HealthCare, LLC., announced today that Kogenate® FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose), its recombinant factor VIII hemophilia A treatment, is now available with BIO-SET® needleless reconstitution system in the United States. Approved by the United States Food and Drug Administration (FDA), BIO-SET® is the first and only integrated reconstitution system for recombinant factor VIII that reduces the risk of accidental needle-stick injuries during reconstitution.

With its simplicity, safety, and convenience, Kogenate® FS with BIO-SET® represents a new standard for the reconstitution and delivery of factor VIII. Compared to currently available systems, Kogenate® FS with BIO-SET® involves fewer components for reconstitution and offers a compact size for easy portability. It 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. It was designed to satisfy the expressed needs of today's hemophilia A community who seek an easy and fast way to reconstitute and administer recombinant factor VIII.

Jeremy Short is a twenty-five-year-old graduate student at the University of Arizona College of Pharmacy living with hemophilia A, but having the condition has not stopped him from living the life he chooses. "Treatment advances have helped fit hemophilia into my life rather than the other way around," said Jeremy. "Attending graduate school and working full-time doesn't leave me with much free time, so I want treatment options that offer more convenience. By offering fewer preparation steps, fewer exposed needles, and better portability, I feel Kogenate® FS with BIO-SET® will be a treatment option that fits well into my active life."

Jeremy's comments mirror the results from a recently published study in the Journal of Outcomes Research(1) that compared recombinant factor VIII reconstitution systems. The study showed 74 percent of respondents -- including patients, caregivers, and healthcare professionals -- preferred Kogenate® FS with BIO-SET® over standard reconstitution methods. In fact, Kogenate® FS with BIO-SET® ranked as "favorite device overall" compared to other reconstitution systems.(a)

"At the core of Bayer HealthCare's research and development process is an ongoing dialogue with the community about current and emerging needs," said Terry Tenbrunsel, Vice President, Sales and Marketing, Bayer HealthCare. "BIO-SET® was developed to satisfy the community's expressed need for innovative products that simplify the reconstitution and administration of recombinant factor VIII. We are excited to offer Kogenate® FS with BIO-SET® to our customers in the United States."

As part of its launch efforts, Bayer will be hosting a series of demonstration and training sessions across the country to educate customers about the new reconstitution system. Healthcare professionals and patients interested in arranging a training session should contact Clinical Communications at 1-800-288-8371 or their local account executive. Alternatively, additional information about Kogenate® FS with BIO-SET® can be found at www.KogenateFS.com.

(a) When compared to the standard reconstitution method and the plastic double-spike stopcock reconstitution device.

(1) Butler, et al. Evaluation of user preference for a needleless factor VIII delivery device for hemophilia patients, Journal of Outcomes Research 2004; 8:63-78.

About Kogenate® FS

Kogenate® FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose), is a recombinant factor VIII treatment for hemophilia A that offers a more convenient administration by utilizing a 2.5 mL volume diluent, one of the smallest among available factor VIII products. Kogenate® FS does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation step. Kogenate® FS is manufactured at Bayer HealthCare's state-of-the-art biotechnology facility in Berkeley, Calif. The most frequently reported adverse event was local injection site reactions. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate® FS. For additional details, see full prescribing information. Visit www.KogenateFS.com for additional information about Kogenate® FS and its programs.

About Hemophilia

Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. About 17,000 Americans have hemophilia. The disease is caused by deficient or defective blood coagulation proteins, known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.

About Bayer HealthCare AG

Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics, and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.

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

Information about Bayer HealthCare can be found at www.bayerhealthcare.com.

Forward-looking statements

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.


Source: Bayer HealthCare

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