Bayer Receives FDA Approval for Room Temperature
Storage of Kogenate(R) FS
Extended Storage Labeling Provides Greater Flexibility for Individuals Living with Hemophilia A BERKELEY, Calif.--(BUSINESS WIRE)--Oct. 6, 2005--The Biological Products Division of Bayer HealthCare, LLC., (Bayer BP) announced today that KogenateŽ FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose) received approval to be stored at room temperature (77 degrees F, 25 degrees C) for up to three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options.
The United States Food and Drug Administration (FDA) approved the storage labeling change based on data from testing to assure the labeled potency (number of recombinant FVIII units contained in a vial) remains within specified limits through the expiration date of the product. The room temperature storage option is expected to be a significant convenience for KogenateŽ FS users. "As a busy mom, the new room temperature storage feature will make managing my son's treatment easier," said Chris Barnes, mother of a three-year-old boy with hemophilia A. "Storage convenience is important for us, especially when we head out on extended vacations. I feel this is a significant development for KogenateŽ FS users." Starting in November 2005, each package of KogenateŽ FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, Bayer recommends refrigerating (36 degrees - 46 degrees F, 2 degrees - 8 degrees C) KogenateŽ FS whenever possible. It also is important to note that product stored at room temperature should not be returned to refrigeration. KogenateŽ FS users who may have additional questions about storage requirements for their existing product inventory should call Bayer Clinical Communications at 800-288-8371 (option 3). "We are pleased with the approval and the opportunity to provide our customers with this convenience," said Terry Tenbrunsel, Vice President, Sales and Marketing, Bayer BP. "Room temperature storage will be a great addition to our overall KogenateŽ FS product offering. Along with other product features such as the 2.5 mL low volume diluent and the EZ-Log handheld electronic patient diary, this new labeling will provide greater freedom and allow individuals with hemophilia A to lead full, active, and productive lives." About KogenateŽ FS KogenateŽ 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. KogenateŽ FS does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation step. KogenateŽ FS is manufactured at Bayer BPs 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 KogenateŽ FS. For additional details, see full prescribing information. Visit www.KogenateFS.com for additional information on KogenateŽ 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 health care 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 Biological Products Division can be found at www.bayerbiologicals.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
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.
Contact: Bayer Biological Products
Clelia Baur, 510-705-7880
Fax: 510-705-7878 clelia.baur.b@bayer.com Source: Bayer Biological Products
Dennis Penning - Clinical Services
Coordinator
Hemophilia Foundation of Illinois
|
| ||||||||||||||||