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FDA Approves 1-Gram Mesalamine Suppository for the Treatment of Ulcerative Proctitis MONT SAINT-HILAIRE, QC -- November 9, 2004 -- Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has received approval from the U.S. Food and Drug Administration for the use of a 1-gram mesalamine suppository dosage form, to be administered once-per-day, for the treatment of ulcerative proctitis. "We believe this new, stronger, one-a-day mesalamine dosage form will strengthen our competitive position in the U.S. rectal mesalamine market," stated Leon F. Gosselin, President and Chief Executive Officer of Axcan. "Also, this should greatly enhance compliance in patients using rectal mesalamine therapy since they will now have the convenience of using only one suppository per day," he concluded. In the United States alone, the rectal mesalamine market is valued at approximately U.S. $80 million annually. According to IMS Health data published in August, 2004, approximately 55% of all U.S. gastrointestinal prescriptions for rectal mesalamine were written for Canasa 500 mg, making Axcan's Canasa 500 mg the most prescribed brand of rectal mesalamine in the U.S. Axcan already markets a 1-gram rectal suppository in Canada under the brand name Salofalk. This new product will be marketed in the U.S.A. under the brand name Canasa. Ulcerative proctitis is a subgroup of ulcerative colitis, one of the most common inflammatory bowel diseases. For approximately 30% of patients with ulcerative colitis, the illness begins as ulcerative proctitis where bowel inflammation is limited to the rectum. Currently, it is estimated that there are 1,000,000 cases of inflammatory bowel disease in the U.S. with approximately 400,000 new cases every year. The names Canasa and Salofalk appearing in this press release are trademarks of Axcan Pharma Inc. and its subsidiaries. SOURCE: AXCAN PHARMA INC. E-mail this page to a friend or colleague! To print, use this version