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
, and the drug is co-marketed with
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
sells the drug.