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Axcan Submits 1 g Mesalamine Suppositories for Approval in the U.S. for the Treatment of Ulcerative Proctitis; TSX SYMBOL (Toronto Stock Exchange): AXP NASDAQ SYMBOL (NASDAQ National Market): AXCA.

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 Leon 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.

Axcan is a leading specialty pharmaceutical company involved in the field of gastroenterology. The Company markets a broad line of prescription products sold for the treatment of symptoms for a number of gastrointestinal diseases and disorders such as inflammatory bowel disease, irritable bowel syndrome, cholestatic liver diseases and complications related to cystic fibrosis. Axcan's products are marketed by its own sales force in North America and Europe. Its common shares are listed on the Toronto Stock Exchange under the symbol "AXP" and on the NASDAQ National Market under the symbol "AXCA".
 "Safe Harbor" statement under the Private Securities Litigation Reform
 Act of 1995.
 ----------------------------------------------------------------------
 To the extent any statements made in this release contain information
 that is not historical, these statements are essentially forward looking
 and are subject to risks and uncertainties, including the difficulty of
 predicting FDA approvals, acceptance and demand for new pharmaceutical
 products, the impact of competitive products and pricing, new product
 development and launch, reliance on key strategic alliances, availability
 of raw materials, the regulatory environment, fluctuations in operating
 results and other risks detailed from time to time in the Company's
 filings with the Securities and Exchange Commission.

 The names CANASA and SALOFALK appearing in this press release are
 trademarks of Axcan Pharma Inc. and its subsidiaries.



CONTACT: David W. Mims, Executive Vice President and Chief Operating Officer, Axcan Pharma Inc., (205) 991-8085 ext. 223 or Isabelle Adjahi, Director, Investor Relations , Axcan Pharma Inc., (450) 467-2600 ext. 2000; SOURCE: Axcan Pharma Inc.; http://www.axcan.com/
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Publication:PR Newswire
Geographic Code:1CANA
Date:Jan 14, 2004
Words:512
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