Search form

 

Press Releases


URSO 500 mg Tablets Approved in the U.S. for the Treatment of Primary Biliary Cirrhosis


Jul 26, 2004 - 12:00 ET

URSO 500 mg Tablets Approved in the U.S. for the Treatment of Primary Biliary Cirrhosis

MONT SAINT-HILAIRE, Quebec, July 26 - 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
Léon 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.

ABOUT AXCAN PHARMA

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 irritable bowel disorder, 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, which may include the
difficulty of predicting FDA and other regulatory 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 and the Canadian Multijurisdictional Disclosure
System.

URSO is a trademark 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; 
Julie M. Thibodeau
Manager, Investor Relations
Axcan Pharma Inc.
(450) 467-5138, ext. 2062
Web: www.axcan.com