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| |  New Drug Application For Colazide Accepted For Review By The U.S. FDA PALO ALTO, CA -- August 29, 1997 - Salix Holdings, Ltd. an international pharmaceutical company specializing in the treatment of gastrointestinal diseases, announced today that the United States Food and Drug Administration has accepted for filing the Company's New Drug Application (NDA) for the use of Colazide(R) (balsalazide disodium) for the treatment of acute ulcerative colitis. The FDA filing means that the FDA has determined that the NDA is sufficiently complete to permit a substantive review. The Company submitted the NDA in June 1997. In July 1997, the Company received its first product approval from the United Kingdom Medicines Control Agency for the use of Colazide to treat acute ulcerative colitis. The United Kingdom Colazide launch is scheduled for the fourth quarter of 1997. "The FDA's filing of the Colazide NDA represents the Company's first filing with the FDA and marks an additional major product development milestone for 1997," said Randy W. Hamilton, President and Chief Executive Officer of Salix Holdings, Ltd. "This filing further demonstrates the Company's ability to execute our business strategy of in-licensing late stage drugs and completing clinical development and regulatory filings." Colazide is an orally-administered anti-inflammatory drug designed to act in the gastrointestinal tract and specifically in the colon. Because very little of the drug is absorbed into the bloodstream, most of the side effects experienced with other products are avoided. Ulcerative colitis is a chronic disease which causes ulceration of the inner lining of the colon and rectum. Symptoms include diarrhea, abdominal pain, rectal bleeding and fever. Decreased appetite and weight loss are also common. As with many chronic illnesses, ulcerative colitis also can have serious emotional side effects, including depression, anxiety and reduced self-esteem, typically resulting from the painful and embarrassing symptoms caused by the disease. Ulcerative colitis is a form of inflammatory bowel disease (IBD) a condition which includes ulcerative colitis and Crohn's disease. It is estimated that there are approximately 2 million people afflicted with IBD in the United States. Salix Holdings, Ltd., develops and markets prescription pharmaceutical products for the treatment of gastrointestinal disease. The Company's strategy is to in-license, complete development, and market proprietary therapeutic drugs with an existing data base of positive, late-stage clinical data in humans. Salix has strategic alliances with several leading pharmaceutical companies including Astra AB and Menarini Pharmaceutical Industries.
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