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More than 1000 patients enrolled in Axcan's ITAX Phase III functional dyspepsia studies
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TSX Symbol (Toronto Stock Exchange): AXP NASDAQ Symbol (NASDAQ National Market): AXCA
MONT SAINT-HILAIRE, QC, June 9 /CNW Telbec/ - Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has enrolled more than 1000 patients in the Company's two Phase III studies on ITAX (Itopride hydrochloride) for the treatment of functional dyspepsia. Recruitment activities will continue for a few weeks. The Company has also enrolled more than 300 patients who will receive active medication for six months in accordance with the International Conference on Harmonisation ("ICH") guidelines. Axcan expects to complete its Functional Dyspepsia Phase III program in the fourth quarter of 2005. Work has begun on preparing the ITAX New Drug Application ("NDA") to be filed during the first half of 2006, most likely at the end of the first quarter. Other regulatory filings in Canada and selected Western European countries will follow in the second quarter of 2006. "We are very pleased to have reached this important milestone in our ITAX development program," said LDeon F. Gosselin, Chairman and outgoing President and Chief Executive Officer of Axcan. "The approval and launch of ITAX, expected in early calendar 2007, will allow Frank Verwiel and the Axcan team to take the Company to the next level." ITAX is a patented oral gastroprokinetic drug containing itopride hydrochloride, which increases upper gastrointestinal motility and possesses antiemetic properties. In addition to functional dyspepsia Axcan plans to investigate the use of ITAX for the treatment of diabetic gastroparesis & gastropathy.
ABOUT FUNCTIONAL DYSPEPSIA
Functional dyspepsia, a disorder of the upper gastrointestinal system, affects up to 25% of the US population annually and accounts for up to 5% of all visits to primary care physicians in the USA (Talley et al Gastroenterology 1992:102;1259-1268). Currently, there are no known approved drugs for this indication in the United States.
ABOUT AXCAN PHARMA
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 Western 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.
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 regulatory authorities.
ITAX is a trademark of Axcan or its affiliates.