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| |  Remicade Now Available In U.S. For Crohn's Disease MALVERN, PA -- Oct. 13, 1998 -- Centocor, Inc.’s Remicade(TM) (infliximab) is now available in the United States for the treatment of Crohn's disease. Remicade was cleared for marketing by the U.S. Food and Drug Administration Aug. 24, 1998, for the treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapy. It is also indicated as a treatment for patients with fistulizing Crohn's disease for reduction in the number of draining enterocutaneous fistula(s). Remicade is the first new product in 30 years indicated for this serious condition. Remicade is the first of a revolutionary new class of agents that blocks activity of a key inflammatory mediator called tumour necrosis factor alpha (TNF-alpha). Overproduction of TNF-alpha leads to inflammation in conditions such as Crohn's, rheumatoid arthritis and other autoimmune diseases. It is believed that Remicade reduces intestinal inflammation in patients with Crohn's disease by binding to and neutralising TNF-alpha on the cell membrane and in the blood. In a clinical study, patients with moderate to severe Crohn's disease who did not respond to conventional therapy were treated with Remicade (5 mg/kg). Eighty-two percent of Remicade-treated patients achieved a clinical response after four weeks compared to 16 percent of patients who received placebo. In addition, 48 percent of patients achieved clinical remission. Remicade is the first product documented to reduce the number of open fistulas -- openings that burrow through the bowel wall, into nearby organs or through the surface of the skin -- in a controlled clinical trial. In one Phase III clinical study of 94 patients with fistulizing Crohn's disease, 68 percent of patients treated with Remicade (5 mg/kg) experienced closure of at least 50 percent of fistula(s) for four weeks or more compared with 26 percent of placebo-treated patients. Over half (55 percent) experienced closure of all their fistula(s). Approximately five percent of Crohn's disease patients studied discontinued Remicade treatment. The most common reasons for discontinuation were infusion reactions and infections. On rare occasions, these reactions were serious but resolved with standard treatment for hypersensitivity reactions or discontinuation of Remicade therapy. The most common adverse reactions occurring more frequently with Remicade than with placebo include nausea, upper respiratory tract infections and abdominal pain. Remicade therapy may result in the development of autoantibodies. However, development of such autoantibodies rarely leads to clinical symptoms or discontinuation of therapy.
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