Axcan submits FDA amendment to its New Drug Application for Helizide

By Lisa Kerner

Erie, Pa., March 29 - Axcan Pharma Inc. said it has submitted an amendment to its New Drug Application for Helizide, its patented capsule therapy for the eradication of the Helicobacter pylori organism, a recognized cause of gastric and duodenal ulcers.

The amendment addresses earlier Food and Drug Administration questions related to manufacturing issues, according to a company news release.

Phase 3 clinical data has been submitted to the FDA, and no safety or efficacy issues were raised, the company said.

"Based on the review time needed by the FDA, we could launch Helizide in the United States as early as the first half of calendar 2007," president and chief executive officer Frank Verwiel said in the release.

"The U.S. patent on the use of a double capsule for the administration of the Helizide triple therapy will expire in December 2018, which gives us ample time to penetrate the $150 million U.S. market."

The phase 3 North American trials conducted on 275 patients with a history of duodenal ulcer compared Axcan's Helizide regimen (three capsules given four times a day) given in combination with two daily doses of 20 mg of omeprazole, to the widely used OAC combination (20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, all given twice a day).

On an intent-to-treat basis, the eradication rate of Helizide was 88%, compared to the OAC rate of 83%, the company said.

Similar results were found in the group of patients with a metronidazole-resistant strain of Helicobacter pylori, where 80% eradication was achieved using Helizide.

Axcan is a specialty pharmaceutical company focused on the field of gastroenterology. The company is based in Mont-Saint-Hilaire, Quebec.

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