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1-Gram Mesalamine Suppository Approved in the U.S. for the Treatment of Ulcerative Proctitis

Nov 09, 2004 - 12:00 ET

MONT SAINT-HILAIRE, Nov. 9 / - 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
    "We believe this new, stronger, one-a-day mesalamine dosage form will
strengthen our competitive position in the U.S. rectal mesalamine market,"
stated Léon 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
    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.


    Axcan is a leading specialty pharmaceutical company involved in the field
of gastroenterology. Axcan markets a broad line of prescription products sold
for the treatment of symptoms in 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.

    This press release contains forward-looking statements, which reflect the
    Company's current expectations regarding future events. To the extent any
    statements made in this release contain information that is not
    historical, these statements are essentially forward looking and are
    often identified by words such as "anticipate," "expect," "estimate,"
    "intend," "project," "plan," and "believe." Forward-looking statements
    are subject to risks and uncertainties, which may include the difficulty
    of predicting FDA and other regulatory approvals. Actual results could
    differ materially from those projected herein and depend on a number of
    factors including but not limited to the commercialization of a drug or
    therapy after regulatory approval is received, the 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
    and the Canadian Securities Commissions. The Company disclaims any
    obligation to update these forward-looking statements.

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

David W. Mims, Executive Vice President and 
Chief Operating Officer,  Axcan Pharma Inc., (205) 991-8085 ext. 223 or  Julie 
M. Thibodeau, Manager, Investor Relations, Axcan Pharma Inc., (450) 467-5138 
ext. 2062, Web: