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Axcan submits FDA amendment to its new drug application for HELIZIDE
Axcan submits FDA amendment to its new drug application for HELIZIDE.
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[{"type":"text","content":"\n\n\n\n\nTSE SYMBOL (Toronto Stock Exchange): AXP \nNASDAQ SYMBOL (NASDAQ National Market): AXCA\n\nMONT-SAINT-HILAIRE, QC, March 29 /CNW Telbec/ - Axcan Pharma Inc.\n(NASDAQ: AXCA - TSX: AXP) announced today that it has submitted an amendment\nto its New Drug Application (\"NDA\") for HELIZIDE, its patented capsule therapy\nfor the eradication of Helicobacter pylori. Each HELIZIDE capsule contains\nbiskalcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline\nhydrochloride (125 mg). This amendment addresses earlier FDA questions related\nto manufacturing issues and is the final step before potential approval of the\ndrug. Phase III clinical data have already been submitted to the FDA, and no\nsafety or efficacy issues were raised.\n\"We are very pleased to be at this stage, as results of our Phase III\nstudies indicate that HELIZIDE is effective in eradicating Helicobacter\npylori. Furthermore, it is well known that resistance is an increasing issue,\nso it is extremely positive to have some excellent data confirming that\nHELIZIDE is also successful in patients who are resistant to some of the drugs\nused in current therapies,\" said Frank Verwiel, M.D., President and Chief\nExecutive Officer of Axcan. \"Based on the review time needed by the FDA, we\ncould launch HELIZIDE in the United States as early as the first half of\ncalendar 2007. The U.S. patent on the use of a double capsule for the\nadministration of the HELIZIDE triple therapy will expire in December 2018,\nwhich gives us ample time to penetrate the $150 million U.S. market. In\nparallel, we are currently working on filing in the European Union,\" he\nconcluded.\n\nHELIZIDE PHASE III CLINICAL STUDIES\n\nThe Phase III North American trials conducted on 275 patients with a\nhistory of duodenal ulcer compared Axcan's HELIZIDE regimen (3 capsules given\n4 times a day) given in combination with two daily doses of \n20 mg of omeprazole, to the widely used OAC combination (20 mg of omeprazole,\n1 g of amoxicillin and 500 mg of clarithromycin, all given twice a day). On an\nintent-to-treat basis, the eradication rates were 88% and 83%, respectively,\nin favor of HELIZIDE.\nIn the group of patients with a metronidazole-resistant strain of\nHelicobacter pylori (41% of patients at the start of the study), Helicobacter\npylori eradication was achieved in 80% of p...