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NDA Submitted for Mesalamine Suppositories for the Treatment of Ulcerative Proctitis

MONT SAINT-HILAIRE, Quebec, Jan. 14 /CNW Telbec/ - Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has submitted to the U.S. Food and Drug Administration a supplemental New Drug Application for a 1-gram mesalamine suppository dosage form for the treatment of ulcerative proctitis.

Axcan already markets a 1-gram rectal suppository in Canada under the brand name of SALOFALK.

"We are very pleased with the submission of this new, stronger, once-per-day mesalamine dosage form. If approved, we expect to accelerate our position in the U.S. rectal mesalamine market," stated Léon F. Gosselin, President and Chief Executive Officer of Axcan. "In addition, patients using mesalamine will be able to use only one suppository per day, most likely improving acceptability," he concluded.

In the United States alone, the rectal mesalamine market is valued at approximately U.S. $65 million annually. Axcan's fiscal 2003 U.S. sales of CANASA, its 500 mg form of rectal mesalamine, amounted to U.S. $16.2 million.

According to IMS data at September 30, 2003, approximately 54% of all U.S. gastrointestinal prescriptions for rectal mesalamine were written for CANASA 500 mg, making CANASA 500 mg the most prescribed brand of rectal mesalamine in the U.S.

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.

Source: Axcan Pharma Inc.

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