URSO 500 mg Tablets Approved in Canada for the Treatment of Cholestatic Liver Diseases
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URSO 500 mg Tablets Approved in Canada for the Treatment of Cholestatic Liver Diseases

MONT SAINT-HILAIRE, QC -- May 29, 2002 -- Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has received approval from the Therapeutic Products Directorate of Health Canada for the use of 500mg tablets of URSO (ursodiol) in the treatment of cholestatic liver diseases. This new dosage will complement the 250 mg URSO tablets Axcan already market in Canada for this indication. Axcan plans to submit, by the end of fiscal 2002, a similar U.S. application for the treatment of primary biliary cirrhosis.

"We are very pleased with the approval of this new stronger dosage form for ursodiol," stated Mr. Leon F. Gosselin, Axcan's President & CEO. "It will allow patients to take fewer tablets per day on a lifetime basis and should improve compliance," he concluded.

Cholestatic diseases of the liver are conditions in which bile flow within the liver is impaired. They include affections such as primary biliary cirrhosis and primary sclerosing cholangitis. The Company is currently investigating the use of ursodiol to treat various other diseases, such as primary sclerosing cholangitis, non-alcoholic steatohepatitis and the prevention of the recurrence of adenomateous colorectal polyps.

Axcan Pharma is a specialty pharmaceutical company involved in the research, development, production and marketing of innovative products, in the field of gastroenterology. The company markets a broad range 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. Its products are marketed in Canada, the United States, France and Poland. 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 name URSO appearing in this press release is a trademark of Axcan Pharma Inc.

SOURCE: Axcan Pharma Inc.

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