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Canada Approves Helcide, Single Capsule Triple Therapy For Eradication Of Helicobacter Pylori

MONT SAINT-HILAIRE, QC -- March 17, 2003 -- Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it received approval from the Therapeutic Products Directorate of Health Canada for Helcide, a patented single capsule triple therapy, for the eradication of Helicobacter pylori which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers. Each Helcide capsule contains the equivalent of 40 mg of bismuth biskalcitrate (bismuth), 125 mg of metronidazole and 125 mg of tetracycline hydrochloride (tetracycline), and is administered in combination with a proton pump inhibitor.

"We are very pleased with this approval since our studies confirmed that Helcide is not only as effective as the most widely prescribed therapeutic regimen for the eradication of Helicobacter pylori, but it can be administered successfully in patients who are resistant to existing therapies," indicated Dr. François Martin, Axcan's Senior Vice President, Scientific Affairs. " Axcan has indeed been able to demonstrate that Helcide is highly effective in eradicating metronidazole-resistant strains of Helicobacter pylori whereas the omeprazole, amoxycillin and clarithromycin ("OAC") combination, the most widely prescribed therapeutic regimen for Helicobacter pylori eradication, is not as effective against clarithromycin-resistant strains of Helicobacter pylori. As a consequence, Helcide, unlike clarithromycin-based therapies, may be successfully administered not only to patients who are infected by metronidazole-resistant strains but also to those who are resistant to clarithromycin-resistant Helicobacter pylori strains," Dr. Martin added.

The commercial launch plans of Helcide for the Canadian market will be announced at a later date. Axcan expects to receive approval for the U.S. market in 2003. The entire North American market for pre-packaged Helicobacter pylori eradication regimens is valued at more than US $100 million annually.

ABOUT HELICOBACTER PYLORI
Helicobacter pylori is now recognized as the primary cause of gastric and duodenal ulcers, which affect at least 10% of the North American population at some point. Existing ulcer treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers respectively recur in approximately 40% and 80% of patients within a year if they receive short-term treatment with acid suppression therapy, but without Helicobacter pylori eradication.

Helicobacter pylori infects half of the world population, including at least 25% of the North American population. The presence of this bacterium in the stomach of patients can be diagnosed by several methods, some of which require tissue specimens and culture. Other, less invasive tests include C13 or C14urea tests (Breath Tests). Once a diagnosis of Helicobacter pylori infection has been established, current treatment consensus suggests that eradication therapy be prescribed for all patients with a history of peptic ulcer disease, since the eradication of Helicobacter pylori reduces the rate of ulcer recurrence. Studies have shown that the recurrence rate of peptic ulcer after one year is only 2% in patients in whom the organism has been eradicated.

STUDY RESULTS
The Phase III North American trials conducted on 275 patients compared Axcan's Helcide regimen (3 single-triple capsules given 4-times a day, plus omeprazole 20 mg twice a day) to the widely used OAC combination. On a per-protocol basis (results in full accordance with the protocol established for the study), the eradication rates observed were 92% for the group treated with Helcide versus 87% for the group treated with OAC. On an intent-to-treat basis (results including all data associated with the correct or incorrect use of the drug), the eradication rates were 88% and 83%, for Helcide and OAC, respectively. In addition, although in all study patients at baseline, 40% had a metronidazole-resistant strain, and 11% had a clarithromycin-resistant strain, metronidazole resistance was overcome and Helicobacter pylori eradication was achieved in 86% of metronidazole-resistant patients treated with Helcide on a per-protocol basis, and in 80% on an intent-to-treat basis. On the other hand, only 23% of clarithromycin-resistant patients were successfully treated with OAC on a per-protocol basis and 21% on an intent-to-treat basis. These results confirm that Helcide is statistically and clinically comparable to OAC and that Helcide has the potential to be used as a first-line therapy for the eradication of Helicobacter pylori.

Axcan is a leading specialty pharmaceutical company involved in the field of gastroenterology. The Company markets a broad line of prescription products sold for the treatment of symptoms in a number of gastrointestinal diseases and disorders such as inflammatory bowel disease, irritable bowel syndrome, cholestatic liver diseases and complications related to cystic fibrosis. Axcan's products are marketed by its own sales force in North America and Europe. Its common shares are listed on the Toronto Stock Exchange under the symbol "AXP" and on the Nasdaq National Market under the symbol "AXCA".

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.

To the extent any statements made in this release contain information that is not historical, including statements related to the expected benefits to Axcan of the co-development agreement with Nordmark, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.

The name Helcide appearing in this press release is a trademark of Axcan Pharma Inc. and its subsidiaries.


SOURCE: Axcan Pharma Inc.

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