Healthcare Industry News:  hemophilia A 


 News Release - July 17, 2006

Bayer HealthCare Introduces Free Product Trial Program For Kogenate(R) FS with BIO-SET(R)

Individuals Living with hemophilia A in the United States Can Now Experience the Safety, Simplicity, and Convenience of Treatment with the First Needleless Reconstitution Device for rFVIII Treatment

BERKELEY, Calif.--(HSMN NewsFeed)--July 17, 2006--Bayer HealthCare today announced the launch of the Kogenate® FS with BIO-SET® Free Trial Program. The Program gives individuals with hemophilia A in the United States a one-time opportunity to experience treatment with Kogenate FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose) with BIO-SET, a needleless reconstitution system, as well as the accompanying support programs and services available through Bayer. Kogenate FS with BIO-SET is the first integrated reconstitution system for recombinant factor VIII that avoids the risk of accidental needle-stick injuries during reconstitution.

"The Kogenate FS with BIO-SET Free Trial Program is another example of our commitment to advancing the state of hemophilia care," said Terry Tenbrunsel, Vice President, U.S. Sales and Marketing for Kogenate, Bayer HealthCare. "We are pleased to offer the hemophilia A community the opportunity to experience first hand the benefits of treatment with Kogenate FS with BIO-SET."

The Kogenate FS with BIO-SET Free Trial Program is a special one-time offer for individuals living with hemophilia A in the United States. Program enrollees will receive up to six free infusions of Kogenate FS with BIO-SET (not to exceed a program maximum of 20,000 IU) delivered to their home or location of choice within the U.S.

The Kogenate FS with BIO-SET Free Trial Program also includes access to the following programs and services:

  • A Kogenate FS with BIO-SET Practice Kit to teach patients and caregivers how to use the innovative reconstitution system. Contents include demonstration vials, training DVD, and a user's guide.
  • A Kogenate FS with BIO-SET Experience Kit, which introduces the support programs and services available with Kogenate FS with BIO-SET treatment.
  • An optional EZ-Log electronic patient diary, a hand-held computer that can simplify record-keeping.

Kogenate FS with BIO-SET represents an advance in the reconstitution of rFVIII. Kogenate FS with BIO-SET offers many important features, such as the 2.5 mL diluent for fast infusions, no exposure to needles during the reconstitution process, and fewer than half the steps to prepare an infusion as compared conventional vial-to-vial reconstitution.

People living with hemophilia A who are interested in learning more about the Kogenate FS with BIO-SET Free Trial Program are encouraged to visit Enrolling in the program is simple -- persons who wish to enroll can download an enrollment form online at and bring it to their physician. Or, they can call 800-288-8374, Monday through Friday, 8:30 a.m. to 5:30 p.m. Eastern Time. Your doctor or healthcare provider is the single best source of information regarding your health and hemophilia treatment. Please consult with your healthcare provider to see if Kogenate FS with BIO-SET is appropriate for you.

Please note that patients who have previously received product through the Kogenate FS Free Trial Program or who are currently receiving Kogenate FS or Kogenate FS with BIO-SET therapy, or patients covered in whole or in part by federal or state health care programs, such as Medicare or Medicaid, are not eligible for the Kogenate FS with BIO-SET Free Trial Program.

About Kogenate® FS

Kogenate® FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose) is a recombinant factor VIII treatment indicated for the treatment of hemophilia A. The most frequently reported adverse event was local site injection site reactions. Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Kogenate® FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate® FS. For important safety and use information, please see the attached full prescribing information.

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, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33,800 people worldwide in 2005.

The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Pharmaceuticals now has 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.

Information about Bayer HealthCare can be found at

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

Issuer of this News Release is solely responsible for its content.
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