MONT-SAINT-HILAIRE, QC, Feb. 13 /PRNewswire-FirstCall/ - Axcan Pharma Inc. announced today that based on clear interest in obtaining additional insight into the statistical methods that will be used to analyze the results of its ITAX (Itopride) Phase III pivotal trials, the Company will host a conference call on February 13, 2006 at 9:00 A.M. E.S.T.
The telephone numbers to access the conference call are (800) 796-7558 (Canada and United States) or (416) 644-3425 (international). A replay of the call will be available until February 20, 2006. The telephone number to access the replay of the call is (416) 640-1917 code: 21177134. Interested parties may also access the conference call by web cast at www.axcan.com. The web cast will be archived for 90 days.
The main topic of the conference call will be the statistical approach that will be used to analyze the results of the Itopride Phase III pivotal trials.
Axcan also wishes to reiterate the Company is on track to meet the timeline that was announced on August 11, 2005 with the planned filing of a New Drug Application for Itopride with the U.S. Food and Drug Administration in the summer of 2006. As also announced in August of 2005, overall results of the International Phase III clinical trial will be disclosed during the first half of calendar 2006, followed shortly by the North American Phase III trial. Details from the International study will be submitted to a major gastroenterology and scientific conference following the announcement of the International study results. A similar approach will be taken for the North American Study.
ABOUT AXCAN PHARMA
Axcan is a leading specialty pharmaceutical company specialized 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 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 the European Union. 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.
This release contains forward-looking statements, which reflect the Company's current expectations regarding future events. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are often identified by words such as "anticipate," "expect," "estimate," "intend," "project," "plan" and "believe." Forward-looking statements are subject to risks and uncertainties, including 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, the protection of our intellectual property and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Canadian Securities Regulators, including under the Canadian Multijurisdictional Disclosure System.
The name ITAX appearing in this press release is a trademark of Axcan Pharma Inc. and its subsidiaries.
AXCAN PHARMA INC.CONTACT: Isabelle Adjahi, Director, Investor Relations, Axcan Pharma Inc.,(450) 467-2600 ext. 2000, www.axcan.com; Source: Axcan Pharma inc. Torequest a free copy of this organization's annual report, please go tohttp://www.newswire.ca and click on reports@cnw.