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Urso (Ursodiol) 500 mg Tablets Approved in the U.S. for the Treatment of Primary Biliary Cirrhosis
MONT SAINT-HILAIRE, QC -- July 26, 2004 -- 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 Urso in a 500 mg tablet dosage form, to be administered two to four times daily, for the treatment of Primary Biliary Cirrhosis ("PBC").
"We expect this new stronger dosage form for ursodiol to contribute to our continued penetration of the U.S. ursodiol market," stated Leon F. Gosselin, President and Chief Executive Officer of Axcan. "In addition, the new dosage form will allow patients the convenience of taking fewer tablets per day, with expected improved compliance," he concluded.
In North America the ursodiol market exceeds U.S.$100 million annually. Axcan's North American sales of ursodiol products amounted to U.S.$47 million for fiscal 2003. During the twelve-month period ended May 31, 2004, 38.3% of all gastrointestinal prescriptions for ursodiol in the United States were for URSO 250, making 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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