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Pylera

Generic name: bismuth subcitrate potassium, metronidazole and tetracycline
Treatment for: Helicobacter Pylori Infection

Axcan submits FDA amendment to its new drug application for Helizide

MONT-SAINT-HILAIRE, QC, March 29, 2006 -- Axcan Pharma Inc. announced today that it has submitted an amendment to its New Drug Application ("NDA") for Helizide, its patented capsule therapy for the eradication of Helicobacter pylori. Each Helizide capsule contains biskalcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline hydrochloride (125 mg). This amendment addresses earlier FDA questions related to manufacturing issues and is the final step before potential approval of the drug. Phase III clinical data have already been submitted to the FDA, and no safety or efficacy issues were raised.

"We are very pleased to be at this stage, as results of our Phase III studies indicate that Helizide is effective in eradicating Helicobacter pylori. Furthermore, it is well known that resistance is an increasing issue, so it is extremely positive to have some excellent data confirming that Helizide is also successful in patients who are resistant to some of the drugs used in current therapies," said Frank Verwiel, M.D., President and Chief Executive Officer of Axcan. "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. 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. In parallel, we are currently working on filing in the European Union," he concluded.

Helizide Phase III Clinical Studies

The Phase III North American trials conducted on 275 patients with a history of duodenal ulcer compared Axcan's Helizide regimen (3 capsules given 4 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 rates were 88% and 83%, respectively, in favor of Helizide.

In the group of patients with a metronidazole-resistant strain of Helicobacter pylori (41% of patients at the start of the study), Helicobacter pylori eradication was achieved in 80% of patients treated with Helizide. In the group of clarithromycin-resistant patients (12% of patients at the beginning of the study), only 21% were successfully treated with OAC. These results confirm that Helizide has the potential to be used as a first-line therapy for the eradication of Helicobacter pylori, the main cause of duodenal ulcers, as it is also successful in eradicating Helicobacter pylori even in patients who have a metronidazole-resistant strain of Helicobacter pylori.

About Helicobacter Pylori

The discovery in 1983 of the Helicobacter pylori organism was one of the major advances in gastroenterology in recent decades, as it revolutionized the approach to many upper gastrointestinal disorders. Helicobacter pylori is now recognized as one of the most important causes of gastric and duodenal ulcers, which affect at least 10% of the North American population at one point in their lives. It is believed to cause a spectrum of diseases in humans, including gastritis, ulcer disease (gastric and duodenal), gastric cancer, and gastric lymphoma. Existing ulcer treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers recur respectively in approximately 40% to 80% of patients within a year after having received short-term treatment with acid suppression therapy. Studies have shown that the recurrence rate of peptic ulcers after one year is only 2% in patients in whom the organism has been eradicated.

Posted: March 2006

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