Axcan Takes Third Stab At FDA Approval For Helizide
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm said it could launch the H. pylori bacteria agent in the first half of 2007.
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Axcan's Helicobacter pylori bacteria agent Helizide (biskalcitrate potassium/metronidazole/tetracycline) could gain FDA approval by late September following a arduous regulatory history. The firm announced March 29 that it had submitted an amendment to its NDA for Helizide (formerly Helicide ). Axcan said it could launch the product in the first half of 2007. The company first submitted the Helizide NDA in 2001, but received two "not approvable" letters from FDA, in August 2002 and in October 2003. The letters cited agency concerns related to the manufacture of bismuth salt, a key ingredient in Helizide's subcitrate component. Before Axcan could resolve the issue, the bismuth manufacturer declared bankruptcy. Axcan has since found a new source for bismuth salt with adequate stability test results, the company said. FDA has not raised any efficacy or safety concerns associated with Helizide. The drug is designed to fight strains of H. pylori that resist traditional therapies, such as metronidazole and clarithromycin, and is administered in combination with omeprazole. The firm is currently preparing an EU marketing authorization application for Helizide; it is approved in Canada. Axcan's R&D pipeline recently suffered another setback when international Phase III trials for stomach pain drug Itax (itopride) failed to meet their primary and secondary endpoints (1 (Also see "Axcan To Ax Itax?: Phase III Data Put Functional Dyspepsia Program In Jeopardy" - Pink Sheet, 22 Feb, 2006.)). The company is awaiting results from its North American Phase III trial before it decides whether to continue work on that drug. -Todd Leeuwenburgh |