Results were announced today from two clinical trials presented at the International Society of Thrombosis and Hemostasis annual meeting, evaluating the safety and efficacy of Bayer's Kogenate product line. The first study showed Kogenate, Bayer's first generation recombinant factor VIII treatment, did not increase the incidence of factor VIII antibodies in this study's patient population with severe Hemophilia A. The second trial showed that patients treated with the second generation of Kogenate (Recombinant Factor VIII Formulated With Sucrose) achieved hemostasis (blood clotting) in all episodes of bleeding or surgery. Kogenate and the Incidence of FVIII Inhibitors This study, presented by Alan R. Giles, of Queen's University and Kingston General Hospital, is a three-year follow-up surveillance study designed to assess the occurrence of side effects, including the incidence of factor VIII inhibitors, in 562 previously treated patients whose therapy was converted from plasma derived factor VIII (pdF.VIII) to recombinant factor VIII (rF.VIII). The results of this study showed that over three years, only 4.5% of patients (n=446) developed inhibitors to FVIII. Additionally, of the 25 patients who tested positive for factor VIII inhibitors prior to study initiation, 84% subsequently tested negative for FVIII inhibitors after conversion to Kogenate. Study investigators concluded that recombinant factor VIII products did not increase the incidence of inhibitors in these patients who were previously treated with plasma derived factor VIII. According to the National Hemophilia Foundation, 6-21% of patients with Hemophilia A develop antibodies to factor VIII (inhibitors) after they have received factor VIII treatment of any kind. These inhibitors can prevent patients from responding to treatment with infused factor VIII protein and, in some cases, worsen a patient's bleeding pattern. Most inhibitors to FVIII in patients with Hemophilia can be suppressed, however, some patients will respond poorly to treatment with factor VIII protein during the period of time required for antibody suppression, thus leaving them more vulnerable to bleeding episodes induced by trivial injuries. "Historically, there has been a concern over the possibility that using recombinant factor VIII products may be associated with an increase in the incidence of FVIII inhibitors. This study is exciting because it shows that Kogenate did not increase the occurrence of inhibitors in this population of previously transfused hemophiliacs and suggests that these concerns appear to be unfounded," said Alan R. Giles, lead investigator of the study. A Second Generation of Kogenate Results from a multicenter, international clinical trial were also presented at the conference by Dr. Hans-Hermann Brackmann of the Institute for Experimental Hematology and Transfusion Medicine at the University of Bonn. This study evaluated the safety and efficacy of Recombinant Factor VIII Formulated With Sucrose in 72 patients (34 in Europe, 38 in North America) with Hemophilia A. This study showed that hemostasis (blood coagulation) was achieved in all cases of bleeding episodes and surgery. Overall, of 2585 bleeding episodes during the study, 79.9% (2066) were effectively treated with one infusion of Recombinant FVIII Formulated With Sucrose, while 93.3% (2413) were effectively treated with 1-2 infusions. Additionally, 22 minor and major surgical procedures were successfully performed in 15 patients with no occurrence of bleeding complications, and no patients required treatment with another type of factor VIII concentrate. In 12,548 infusions with Recombinant FVIII Formulated With Sucrose, adverse events were reported in only 2% (249) with 0.2% (24) of these reported as possibly being drug-related. Study investigators concluded that all adverse events in this study were mild to moderate except one where the patient suffered intermittent chest pain with palpitations ending after treatment with analgesics. "As a Company committed to the advancement of hemophilia treatment, Bayer's goal is to offer patients a product with the efficacy of Kogenate coupled with improvements afforded by the removal of human plasma proteins in its purification and formulation," said Peter Larson, M.D., Kogenate Clinical Project Director from Bayer. Kogenate and the second generation of Kogenate Formulated With Sucrose are genetically engineered versions of the naturally occurring coagulation protein that is missing or deficient in Hemophilia A patients. Kogenate was approved by the U.S. Food and Drug Administration in 1993. Since its introduction, over 2 billion units of Kogenate have been infused. A licensing application for the second generation of Kogenate, formulated with sucrose, is currently under review by the FDA. Hemophilia A is an inherited blood clotting disorder affecting more 50,000 individuals worldwide and characterized by prolonged blood clotting time. Patients with Hemophilia A have deficient or defective coagulation factor VIII, a naturally occurring protein involved in coagulation, the process that normally controls bleeding by changing blood from a liquid to a solid state. During the clotting process, factor VIII is required for the production of fibrin, which in turn creates a "plug" at the injury site. The fibrin "plug" helps to seal the wound and stop the flow of blood. The majority of patients with Hemophilia A must be treated regularly by intravenous infusion of factor VIII to stop or prevent bleeding. Bayer Corporation is a research-based company with major businesses in health care and life sciences, chemicals and imaging technologies. The company had 1997 sales of $9.3 billion and employs more than 26,000 people. Bayer Corporation is investing $9 billion in capital expenditures and research and development from 1995 through the year 2000. 1998 capital investment and R&D expenditures are projected to total $1.7 billion. Bayer Corporation, with headquarters in Pittsburgh, PA., is a member of the worldwide Bayer Group, a $32 billion chemical and pharmaceutical company based in Leverkusen, Germany. ots Original Text Service: Bayer Corporation Internet: http://www.newsaktuell.de Contact: Nancy Wright of Bayer Corporation, (USA) 203-812-6436; or Miriam Weber or Lisa Fern, Media, (USA) 212-213-0006, or Mike Sinclaire, European Media, +44-171-665-6643, all of Burns McClellan, for Bayer Corporation