Clinical Trial Investigates Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) with Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified Largest-Ever Trial Will Evaluate the Efficacy and Safety of IGIV for People With CIDP RESEARCH TRIANGLE PARK, N.C., May 18 /PRNewswire/ -- Bayer HealthCare LLC, Biological Products Division (Bayer BP), has initiated an international multi-center clinical trial to investigate the use of its new and advanced immunoglobulin intravenous (IGIV) product, Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, to treat people with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is an acquired immune-mediated disease affecting the peripheral nervous system. Recovery without treatment is uncommon for people with CIDP, and the condition significantly impacts quality of life and causes considerable disability. Therapeutic options for people with CIDP include plasma exchange, corticosteroids, cytotoxic drugs, IGIV, or combinations of these treatments. The Gamunex trial has been designed to provide regulatory agencies throughout the world, including the U.S. Food and Drug Administration (FDA), with clinical efficacy and safety data from the largest clinical trial conducted to date in CIDP. Bayer BP's trial will enroll more than 100 patients in 15 countries in North America, Europe, Central and South America, and Israel. "The current therapeutic options for this chronic condition are either invasive, such as plasmapheresis, or carry potential long-term risks, such as the use of steroids," said trial lead investigator Norman Latov, professor of neurology and neuroscience and director of the Peripheral Neuropathy Center at the Weill Medical College of Cornell University. "In several smaller trials, IGIV therapy has consistently demonstrated the potential to be a standard of care for CIDP patients." CIDP is a neurological disorder in which there is inflammation of nerve roots and destruction of the myelin sheath, the fatty protective covering of the nerves. This disorder causes weakness, paralysis, and/or impairment in motor function, especially of the arms and legs. Sensory loss also may be present, causing loss of coordination in addition to numbness, tingling, or prickling sensations. CIDP does not resolve quickly, but produces a chronic immune reaction that may become progressively more severe. The disease affects people of all ages and gender. It is similar to Guillain-Barre Syndrome (GBS) and sometimes referred to as a chronic version of GBS. This current multi-national Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, study is a randomized, double-blind, placebo-controlled prospective trial, powered for proof of efficacy as its endpoint. The study is enrolling newly or previously diagnosed CIDP patients, age 18 or older, for a one-year period and will evaluate the efficacy of treatment with Gamunex, compared with placebo, on the effect of functional disability. Results of the Gamunex study are expected by mid-2006. Each vial of Gamunex contains purified antibodies from the donated blood plasma of thousands of people and can be a lifesaving anti- infective or immunomodulatory therapy to treat people with compromised or malfunctioning immune systems. Gamunex is indicated for the treatment of patients with primary humoral immune deficiency (PI)*, a group of diseases caused by genetic defects in the immune system. Gamunex also is indicated for the acute and chronic treatment of idiopathic thrombocytopenia purpura (ITP), an autoimmune condition characterized by a low platelet count, leading to occasional life-threatening bleeding episodes. The most common side effects noted during clinical trials for PI and ITP included headache, vomiting, fever, nausea, rash, and back pain. In addition to the CIDP trials, Bayer BP also has invested in development of clinical studies in other neurological disorders, including relapsing-remitting multiple sclerosis (RRMS). For additional information about the ongoing trials using Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, or for full prescribing information, visit http://www.gamunex.com/. * Primary immunodeficiency diseases also are known as PI diseases, PIDD, and PID. About Bayer HealthCare AG Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.3 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics, and Pharmaceuticals. More than 34,000 people are employed by Bayer HealthCare worldwide. Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing, and treating disease. Information about Bayer Biological Products Division can be found at http://www.bayerbiologicals.com/. For additional information on Gamunex, visit http://www.gamunex.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. DATASOURCE: Bayer HealthCare AG CONTACT: Tricia McKernan of Bayer HealthCare AG, +1-919-316-6316, fax, +1-919-316-6673, Web site: http://www.bayerbiologicals.com/ http://www.gamunex.com/

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