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| |  FDA Approves Colazal (Balsalazide Disodium) For Ulcerative Colitis RALEIGH, NC -- July 24, 2000 -- Salix Pharmaceuticals, Ltd announced that Colazal™ (balsalazide disodium) has been approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States for the treatment of mildly to moderately active ulcerative colitis, a chronic and debilitating inflammatory disease of the gastrointestinal tract. "FDA approval of Colazal is terrific news for patients who suffer from mild to moderate ulcerative colitis as they will have an innovative new product available as a first-line therapy to treat their active disease," said Randy Hamilton, Chairman of the Board and co-founder of Salix. "This is also excellent news for Salix, as it is a major milestone in Salix becoming the leading specialty pharmaceutical company providing solutions to gastroenterologists and their patients. This approval is the culmination of significant contributions made by many parties that make up the Salix team, including employees, investors, board members, consultants, clinical investigators, suppliers and Biorex Laboratories, Ltd. (the original innovator of Colazal)." "Colazal, a sulfa-free prodrug of 5-ASA, is the first new chemical entity approved by the FDA for the treatment of ulcerative colitis in ten years," said Lorin Johnson, Ph.D., Senior Vice President, Development, and a co-founder of Salix. "Colazal offers an excellent choice to sufferers of mild to moderate ulcerative colitis, as it treats the disease by delivering the active anti-inflammatory medication directly to the colon where it appears to work topically." "The Colazal clinical profile shows that it is an important and creative new therapy that should prove very attractive both to patients who have ulcerative colitis and to the physicians who treat them," said Malcolm Robinson, MD, Clinical Professor of Medicine at the University of Oklahoma College of Medicine, and the founder and Medical Director of the Oklahoma Foundation for Digestive Research. "Many of these patients remain terribly demoralized and debilitated by ulcerative colitis despite available treatments, and Colazal will offer physicians a new, safe and effective first-line therapy." Colazal is approved for a course of therapy of up to 12 weeks. During the course of clinical investigations, the most commonly reported side effects were headache and abdominal pain.
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