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| |  Helicide (Bismuth Subcitrate, Metronidazole, Tetracycline) Promising For First-Line Helicobactor Pylori Therapy MONT SAINT-HILAIRE, QC -- October 16, 2000 -- Axcan Pharma Inc. announced final results of the Phase III North American pivotal clinical trial on Helicide™. Helicide is a bismuth-based single triple capsule containing colloidal bismuth subcitrate (40 mg), metronidazole (125 mg) and tetracycline (125 mg), for the eradication of Helicobacter pylori. Results were presented at the "2000 European Helicobacter Study Group" held in Rome, Italy, from October 11 to October 14. These results confirmed that Helicide has the potential to be used as a first-line therapy for the eradication of Helicobacter pylori, the main cause of gastric and duodenal ulcers. The Phase III study, initiated in September, 1999, and conducted in 62 centers in the US and Canada, compared Helicide's 10-day treatment combination with 20 mg of omeprazole (OBMT), to the most widely-prescribed eradication therapy in North America, a daily combination of omeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (2 x 500 mg), (OAC). "One of the most important outcomes of this study is that it confirmed that not only is Helicide as effective as OAC in eradicating Helicobacter pylori but more importantly, it can be used successfully in patients who are infected by metronidazole resistant Helicobacter pylori strains. This feature confirms Helicide's potential to be used as first-line therapy for the eradication of Helicobacter pylori," indicated Dr. Francois Martin, Axcan's Senior Vice President, Scientific Affairs. This trial, involving 282 patients with a history of duodenal ulcer, confirmed that this 10-day treatment is at least as efficacious as the active control OAC in North America. It also confirmed that unlike OAC, which is not efficient in treating clarithromycin resistant patients, Helicide overcomes metronidazole resistance. Bismuth-based regimens are the oldest recognized therapy for eradication of Helicobacter pylori. They are very effective in eradicating Helicobacter pylori strains sensitive to metronidazole but, until now, treatments of 10 days or less showed reduced efficacy in Helicobacter pylori metronidazole- resistant strains. Helicobacter pylori eradication rates in this North American study are as follows: - On a per protocol basis (results in patients compliant with study requirements), the eradication rates observed were 91 percent for the group treated with Helicide (OBMT combination) versus 88 percent for the group treated with OAC. On an intent-to-treat basis (patients who met all study's inclusion/exclusion criteria and took at least one dose of treatment), the respective eradication rates were 82 percent and 80 percent, respectively, in favour of Helicide. - Metronidazole resistance was observed in 39 percent of all study patients at baseline, and resistance to clarithromycin was observed in 11 percent of these patients. Metronidazole resistance was overcome and Helicobacter pylori eradication in patients treated with Helicide was achieved in 86 percent of patients on a per protocol basis and 78 percent on an intent-to-treat basis. On the other end, only 25 percent of clarithromycin-resistant patients were successfully treated with OAC on a per protocol basis and 23 percent in the intent-to-treat analysis.OAC currently is the most prescribed eradication therapy in North America. Among Helicobacter pylori eradication regimens, Helicide has the potential to be one of the most effective treatments, demonstrating consistently reproducible Helicobacter pylori eradication results at a very competitive cost. Axcan believes that this is a real breakthrough treatment for the eradication of Helicobacter pylori as well as patient compliance. Axcan intends to file an NDA application with the FDA at the beginning of calendar 2001 and foresees its entry into the US market by the year 2002. Axcan is currently discussing the potential licensing of this product with a number of strategic partners in several countries. Helicobacter pylori is now recognized as the most important cause of gastric and duodenal ulcers, which affect at least 10 percent of the North American population at one point in their lives. Existing ulcer treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers recur respectively in approximately 40 to 80 percent of patients after a one-year treatment with acid suppression therapy. Helicobacter pylori infects half of the world population, including at least 25 percent of people in North America. The presence of this bacterium can be diagnosed by several methods, some of which require biopsy and culture. Other, less invasive tests include C13 or C14 tests (Breath Tests). Once a diagnosis of Helicobacter pylori infection has been established, current treatment norms suggest that eradication therapy be prescribed for all patients with a history of peptic ulcer disease, given that 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 percent in patients in whom the organism is eradicated. Related Link: Axcan Pharma Inc.
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