MONT-SAINT-HILAIRE, QC, Dec. 15 /PRNewswire-FirstCall/ - Axcan Pharma Inc. (NASDAQ: AXCA - TSX: AXP) announced today that clinical sites participating in the North American ITAX (itopride) Phase III trial have exceeded the goal of randomizing 500 patients. Additional patients are still in the screening process, and Axcan intends to continue randomization until the end of December 2005, consistent with previously announced study timelines. As disclosed on November 10, 2005, all patients required for completion of the international study have already been randomized.
The goal of this clinical development program, consisting of two pivotal Phase III trials, a North American and an international clinical study, is to assess the safety and efficacy of Itopride in the treatment of Functional Dyspepsia, a gastrointestinal disorder.
“This is a significant accomplishment for Axcan, and we are extremely pleased to have achieved this important milestone in the development of Itopride. We have been successful in implementing an action plan designed to meet our randomization goal, which involved an increase of 50% in the number of sites in the North American trial. We continue to be committed to filing a New Drug Application with the U.S. Food and Drug Administration in the summer of 2006,” said Frank Verwiel, M.D., President and Chief Executive Officer of Axcan. “This achievement was further made possible by the dedication and hard work of the clinical investigators, the study site personnel and our own research and development team,” concluded Dr. Verwiel.
Axcan expects to release the overall outcome of the international Phase III clinical trial during the first half of calendar 2006, followed shortly afterwards by that of the North American Phase III trial. Detailed results of the studies will most likely be subsequently presented at a major gastroenterology scientific conference.
About Functional Dyspepsia
Functional Dyspepsia, a disorder of the upper gastrointestinal tract, affects up to 25 percent of the North American population annually and accounts for up to 5 percent of all visits to primary care physicians. Dyspepsia can be defined as pain or discomfort centered in the upper abdomen, characterized by abdominal fullness, early satiety, bloating, or nausea, without evidence of organic disease to explain the symptoms.
Currently, there is no product approved in North America for the treatment of Functional Dyspepsia. To date, patients living with these distressing symptoms have no satisfying therapeutic option available to them.
Itopride is a gastroprokinetic drug effective through a dual action mechanism of action. Firstly, it acts as a dopamine antagonist on D2-receptors thereby increasing the secretion of acetylcholine; and secondly, it prevents hydrolysis of the released acetylcholine by the acetylcholinesterase enzyme in the smooth muscles. Acetylcholine is an important endogenous substance involved in the motor activity of the gastrointestinal tract. Itopride has also been shown to have anti-emetic properties. In addition, a cardiac safety study to examine Itopride in doses of up to four times the proposed therapeutic dose was completed, and the results showed no cardiac adverse drug reaction.
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”.
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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 Multijurisdictional Disclosure System.
Source: AXCAN PHARMA INC.
