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Ursodiol New Drug Application Undergoing FDA Review, Treatment for Biliary Cirrhosis

MONT SAINT-HILAIRE, Quebec - MONT SAINT-HILAIRE, Quebec - 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 URSO in a 500 mg tablet dosage form ("URSO DS") for the treatment of Primary Biliary Cirrhosis ("PBC"). If approved, this new dosage form will complement the 250 mg URSO tablets Axcan currently markets in the U.S. for the treatment of PBC. Axcan launched URSO DS in Canada earlier this year for the treatment of cholestatic liver diseases.

"We are very pleased with the submission of this new stronger dosage form for ursodiol. If approved, we expect URSO DS to accelerate our penetration of the US ursodiol market," stated Léon F. Gosselin, President and Chief Executive Officer of Axcan. "In addition, URSO DS patients will be able to take fewer tablets per day on a lifetime basis and compliance should improve," he concluded.

In the United States alone, the ursodiol market is valued at approximately U.S. $90 million annually. Sales of URSO 250 in the U.S. amounted to U.S. $25.8 million for fiscal 2002. During the nine-month period ended June 30, 2003, 37.5% of all gastrointestinal prescriptions for ursodiol in the United States were for URSO 250, which makes URSO 250 the most prescribed brand of ursodiol in the U.S.

PBC is a chronic liver disease that slowly destroys the bile ducts in the liver and eventually leads to cirrhosis. Cirrhosis results in severe liver scarring (fibrosis) that diminishes liver function. The cause of PBC is unknown. Studies show that women are affected 10 times more commonly than men. PBC is usually diagnosed in patients between the ages of 35 and 60. The illness is chronic and can lead to liver failure and other life-threatening complications.

Source: Axcan Pharma Inc.

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