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| |  Health Canada Approves Photofrin Treatment of High-Grade Dysplasia Associated with Barrett's Esophagus MONT SAINT-HILAIRE, QC -- March 20, 2003 -- Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it received approval from the Therapeutic Products Directorate of Health Canada for Photofrin in the treatment of High-Grade Dysplasia ("HGD") associated with Barrett's Esopaghus. "This is a very important milestone for the Company since HGD associated with Barrett's Esophagus is a condition for which there has been no treatment," commented Dr. François Martin, Senior Vice President, Scientific Affairs of Axcan. "In addition, long-term study results confirm that Photofrin photodynamic therapy ("PDT") significantly reduces the probability for patients suffering from HGD associated with Barrett's Esophagus to experience a progression to cancer, and that Photofrin PDT can potentially prevent esophageal cancer. The absolute risk reduction of progression to cancer of 14% outlined in our study would suggest that the number of patients needed to be treated to prevent 1 progression to esophageal cancer is only 7," concluded Dr. Martin. Photofrin in the treatment of HGD associated with Barrett's Esophagus will be launched in Canada by the end of the third quarter of fiscal 2003. In 2003, Axcan also expects to receive approval for the U.S. and European markets, where Orphan Drug designation has been granted. The entire North American market for Photofrin for the treatment of this indication is estimated to be U.S. $30-50 million annually. This market is estimated to be of a similar size in Europe. ABOUT BARRETT'S ESOPHAGUS It is estimated, in North America, that 25,000 to 35,000 people suffer from High-Grade Dysplasia associated with Barrett's Esophagus, and approximately 5,000 to 7,000 new patients in North America are diagnosed with this condition each year. STUDY RESULTS Axcan is a leading specialty pharmaceutical company involved in the field of gastroenterology. The Company 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. 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 Photofrin appearing in this press release is a trademark of Axcan Pharma Inc. and its subsidiaries.
SOURCE: AXCAN PHARMA INC.
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