Business
Axcan announces outcome of ITAX International Phase III clinical trial
Axcan announces outcome of ITAX International Phase III clinical trial.
About this update from Trailbreaker Resources Ltd
[{"type":"text","content":"\n\n\n\n\nTSX SYMBOL (Toronto Stock Exchange): AXP\nNASDAQ SYMBOL (NASDAQ National Market): AXCA\n\nMONT-SAINT-HILAIRE, QC, Feb. 22 /CNW Telbec/ - Axcan Pharma Inc. (NASDAQ:\nAXCA - TSX: AXP) announced today that results of the ITAX (Itopride)\nInternational Phase III clinical trial showed that Itopride, a drug developed\nfor the treatment of Functional Dyspepsia, did not meet its primary endpoint\nand, as such, the results did not confirm the efficacy observed in other\nstudies, including the Phase II clinical trial. The Company will continue to\nanalyze the efficacy data from this Phase III trial, and this analysis,\ntogether with the results of the North American Phase III study, should\nprovide a better understanding of the outcome. These findings will enable the\nCompany to decide on the continuation of the ITAX Functional Dyspepsia\nprogram. The Company will continue the development of this compound in other\nareas such as Diabetic Gastropathy.\n\"We are obviously surprised with the results of the Itopride\nInternational Phase III trial, particularly in view of the positive results\nseen in the soon-to-be published Phase II trial and in the preclinical data\nthat provided strong mechanistic support for Itopride. The results of the\nstudy did, however, confirm the safety profile of the product candidate. While\nefficacy results are disappointing for all stakeholders, we intend to examine\nall potential factors relating to this outcome and are therefore conducting\nadditional analyses including by subgroup populations, with a view to\nunderstanding the discrepancy between the results of the Phase II trial and\nthe International Phase III trial. Another important element of information\nwill be the results of the North American Phase III trial expected to be\nannounced by the end of the first half of calendar 2006,\" said Frank A.G.M.\nVerwiel, M.D., president and chief executive officer of Axcan. \"While we\ncomplete our assessment of the Itopride program's future, we will focus on\nother opportunities to accelerate growth of the Company by leveraging our\nsolid business base and executing on our growth strategy,\" he concluded.\nThe unique focus on gastroenterology has led to constant revenue growth,\nwhich was highlighted by the two most recent quarters in which record sales\nwere obtained. Axcan is a solid, Company with m...