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. -- The Biological Products Division of Bayer HealthCare, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control ., (Bayer BP) announced today that Kogenate(R) FS (Antihemophilic Factor an·ti·he·mo·phil·ic factor n. Abbr. AHF See factor VIII. antihemophilic factor (AHF, factor VIII) Alphanate, Hemofil M, Koate-DVI, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, ReFacto (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 United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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within specified limits through the expiration date Expiration Date The day on which an options or futures contract is no longer valid and, therefore, ceases to exist. Notes: The expiration date for all listed stock options in the U.S. of the product. The room temperature storage option is expected to be a significant convenience for Kogenate(R) 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 hemophilia A n. Hemophilia due to deficiency of factor VIII, characterized by prolonged clotting time, decreased formation of thromboplastin, and diminished conversion of prothrombin. . "Storage convenience is important for us, especially when we head out on extended vacations. I feel this is a significant development for Kogenate(R) FS users." Starting in November 2005, each package of Kogenate(R) 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) Kogenate(R) FS whenever possible. It also is important to note that product stored at room temperature should not be returned to refrigeration refrigeration, process for drawing heat from substances to lower their temperature, often for purposes of preservation. Refrigeration in its modern, portable form also depends on insulating materials that are thin yet effective. . Kogenate(R) 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 Kogenate(R) FS product offering. Along with other product features such as the 2.5 mL low volume diluent diluent /dil·u·ent/ (dil´oo-int) 1. causing dilution. 2. an agent that dilutes or renders less potent or irritant. dil·u·ent adj. Serving to dilute. n. 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 Kogenate(R) FS Kogenate(R) FS (Antihemophilic Factor (Recombinant), Formulated with Sucrose), is a recombinant factor VIII factor VIII n. A factor in the clotting of blood, a deficiency of which is associated with hemophilia A. Also called antihemophilic factor, antihemophilic globulin, antihemophilic globulin A, 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(R) FS does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent. step. Kogenate(R) 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 hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to mouse or hamster protein may be a contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable. con·tra·in·di·ca·tion n. to the use of Kogenate(R) FS. For additional details, see full prescribing information. Visit www.KogenateFS.com for additional information on Kogenate(R) 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 Frankfurt Stock Exchange The largest of Germany's eight securities exchanges, operated by Deutsche Borse AS. 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. |
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