Remicade Works in Colitis Trials

Two-thirds of patients experienced reduced symptoms and one-third achieved remission.
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Results from two late-stage clinical trials show the multipurpose drug Remicade provides "significant improvement" in treating symptoms of ulcerative colitis, a digestive tract disease that can lead to surgical removal of the colon.

Remicade was developed by the Centocor unit of

Johnson & Johnson

(JNJ) - Get Report

, and the drug is co-marketed with

Schering-Plough

(SGP)

.

Test results announced Monday showed two-thirds of patients experienced reduced symptoms and one-third achieved remission. The tests reached the primary goals of clinical response such as diminished rectal bleeding and improvement in healing of damaged intestinal lining. The results were announced at a digestive diseases conference in Chicago.

Ulcerative colitis causes inflammation and ulceration of the colon mucosa, or innermost lining of the colon. There are several traditional treatments, including anti-inflammatory drugs and corticosteroids. But when they don't work, Schering-Plough says 40% of most undergo colon-removal surgery.

Remicade is approved by the Food and Drug Administration for treating a related inflammation of the gastrointestinal tract, Crohn's disease, as well as for rheumatoid arthritis and for ankylosing spondylitis, a chronic inflammation of the spine and certain joints. Although federal law allows doctors to prescribe a drug for any condition once the FDA approves the drug for a single disease, companies can only market a drug for FDA-approved uses. These results could help the companies seek formal marketing approval from the FDA for ulcerative colitis.

Shares of J&J rose 29 cents to $67.43. Shares of Schering-Plough rose 10 cents to $20.35. J&J has exclusive marketing rights for Remicade in the U.S. Schering-Plough has exclusive rights in the rest of the world except for Japan, China, Taiwan and Indonesia, where Japan's

Tanabe Seiyaku

sells the drug.