Bayer Successfully Completes Largest License-Relevant Trials Ever Conducted On Intravenous Immune Globulin (IGIV) for Primary Immunodeficiency Diseases (PID) And Idiopathic Thrombocytopenic Purpura (ITP)

Largest body of data on IGIV intervention in these diseases documenting patient outcomes -- investigators optimistic trials will point to increased information and confident treatment for anti-infective and autoimmune categories SAN FRANCISCO, Dec. 4 /PRNewswire/ -- Investigators from around the globe met to mark the close of two large trials today at the American Society of Hematology (ASH) meeting in San Francisco. ITP investigators from the U.S., Canada, and Israel met in San Francisco. PID investigators met at a preview meeting in Dallas earlier this fall. The trials were the most extensive of their kind, representing 97 ITP patients at 26 centers, and 160 PID patients at 25 sites -- the largest powered, randomized, controlled trials with IGIV in these populations to date. Robust clinical endpoints were introduced for the first time in such a trial, which included validated infections and duration of elevated platelet levels. Investigators marking the completion of the trials were responsible for conducting pharmacokinetic and efficacy trials for a new chromatography-purified, double-virus inactivated IGIV product. The Bayer Corporation has introduced a Caprylate inactivation for this new IGIV. Bayer has been a worldwide market leader in IGIV for 20 years. The company introduced the first IGIV preparation to the U.S. market in 1981. In 1986, Bayer introduced Gamimune(R) N, 5%, Immune Globulin Intravenous (Human), the first liquid, "ready to use" formulation. Another milestone was the launch of Gamimune(R) N, 10%, Immune Globulin Intravenous (Human), the first high-concentrated, 10% "ready to use" formulation in 1992. Building on extensive clinical experience with Gamimune(R) N, Bayer has now designed a patented manufacturing process and has built a new dedicated facility in Clayton, North Carolina for manufacture of this new IGIV product. This will be the first facility worldwide exclusively designed for and dedicated to the production of IGIV. Bayer expects to file a Biologic License Application (BLA) for this IGIV with the FDA in 2001. At the two meetings, investigators representing 51 centers, conducting trials with 257 patients, were the first to inspect the aggregate data. "The studies did a great job of describing the health status of these patients ... health care utilization, illness patterns, frequency of antibody use," said Dr. Harry Schroeder, of the University of Alabama, Birmingham Medical Center. "These studies are groundbreaking because they show broad patient data collected in well designed, comparative trials ... something never done before in these disease categories. The data from these trials will go a long way to describing the medical course and expected functional status of patients with PID and ITP who rely upon IGIV." "These studies were the first large, well-designed trials which may not only demonstrate the use of a new IGIV, but help us better characterize the disease and help us identify factors which may predict patient response," said James Bussel, M.D., lead investigator from Cornell Medical Center in New York. "This study is powerful because it represents the first systematic approach to get information of treatment response, as well as duration of response in all ITP subsets." Tom Moran, president of the Immune Deficiency Foundation (IDF), said, "The patients who suffer from these diseases and the doctors who treat them commend Bayer's commitment to research and provision of high quality, valid outcomes for people whose disease requires intravenous immune globulin." Data from these trials is expected to be published by the end of 2001. Bayer Corporation is a research-based company with major businesses in health care, life sciences, and chemicals. It had 1999 sales of $8.9 billion and employs about 22,200 people. Bayer Corporation is investing $9 billion in capital expenditures and research and development from 2000 through 2004. In 2000 alone, capital investment and R&D expenditures are projected to total $1.6 billion. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $29 billion international life sciences, polymers, and specialty chemicals group based in Leverkusen, Germany. The Bayer Biological Products Business Unit, headquartered in Research Triangle Park, N.C., is responsible for the global development and marketing of Bayer Biological products. CONTACT: Douglas Bell, Director, Public Affairs, 919-316-6316, or Melanie Tolley, 816-512-2246, both for Bayer.