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| |  Helicide (Bismuth/Metronidazole/Tetracycline) Equally or More Effective Than Standard H. Pylori Treatment MONT SAINT-HILAIRE, QC -- March 23, 2000 -- Axcan Pharma Inc. announced encouraging interim results for the phase III North American pivotal clinical trial on Helicide(TM). 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. Axcan also signed a licensing agreement covering Canada, the United States, Europe and Japan, to acquire a series of patents covering the triple and quadruple therapies for Helicobacter pylori eradication. The transaction includes a cash payment of approximately US $136,000 (CAN $200,000) plus royalties to be paid as a percentage of sales, once the product is launched. The phase III study, initiated in September, 1999, and conducted in 62 centers in the US and Canada, compares Helicide's 10-day treatment combination with omeprazole (OBMT), to the most widely-prescribed eradication therapy in North America, a combination of omeprazole, clarithromycin and amoxicillin (OAC). "This study is extremely important for Axcan. Four pilot phase II trials previously conducted in Europe and Australia have demonstrated eradication rates of up to 96 percent when the single capsule was combined with a proton pump inhibitor in a seven-day course of therapy. This trial should confirm that Helicide is at least as, if not, more effective than the OAC combination,'' indicated François Martin, Vice President, Scientific Affairs of Axcan. " Helicide's advantage is that it overcomes an important compliance problem for patients having to take multiple drugs at different times of the day. Its high efficacy combined with its affordable cost should make it the treatment of choice for many patients,'' he added. In an article published in the January, 2000, issue of "Aliment Pharmacol'' (Aliment Pharmacol Ther 200;14:85-89), Dr. W.A. de Boer, gastroenterologist at the Saint Anna Hospital in the Netherlands, stated, "It (the new "all-in-one'' capsule) is the greatest advance in Helicobacter pylori therapy of the last year and the initial results show that the separate drugs are delivered to their site of action. This new patient friendly formulation of bismuth-based triple therapy should greatly improve acceptance as a result of the decrease in the number of different pills.'' The principal investigators in this Phase III study are Dr. Loren A. Laine, from the University of Southern California in Los Angeles and Dr. Richard Hunt from McMaster University in Hamilton, Ontario. The Company also announced that it initiated enrolment of a similar supportive study in Europe and Australia. The interim analysis, involving 155 patients of the 260-patient study target, suggests that this 10-day treatment is at least as efficacious as the active control OAC in North America. Helicide also appears to overcome metronidazole resistance while, in the reference group, clarithromycin resistance seems to greatly limit efficacy. Helicobacter pylori eradication rates in the North American study are as follows: On a per protocol basis (results in patients compliant with study requirements), the eradication rates observed were 94.2 percent for the group treated with Helicide (OBMT combination) versus 85.3 percent for the group treated with OAC. On an intent-to-treat basis (results in patients who started the treatment, regardless of the compliance with study requirements), the respective eradication rates were 85.5 percent and 73.4 percent in favour of Helicide. Metronidazole resistance was observed in 26 percent of patients at baseline, and resistance to clarithromycin was observed in 7 percent of patients. Metronidazole resistance was overcome and Helicobacter pylori eradication of patients treated with Helicide achieved in 100 percent of patients on a per protocol basis and 92.9 percent on an intent-to-treat basis. No clarithromycin-resistant patient (0 percent) was successfully treated with OAC, the most prescribed eradication therapy in North America. Bismuth based regimens are the oldest recognized therapy for eradication of Helicobacter pylori. They are very effective in eradicating Hp strains sensitive to metronidazole but, until now, treatments of 10 days or less showed reduced efficacy in Hp metronidazole-resistant strains. Among Helicobacter pylori eradication regimens, Helicide is indeed one of the most effective treatments, having consistently reproducible results while at the same time representing a less expensive therapy. Axcan believes that this is a real breakthrough treatment for the eradication of Helicobacter pylori. Axcan foresees its entry into the US market by the year 2002 and is currently discussing the potential licensing of this product with different strategic partners in several countries. Helicobacter pylori is now recognized as the cause of gastric and duodenal ulcers, affecting at least 10 percent of the North American population at one point in their lives. Existing treatment regimens lead to high recurrence rates. Gastric and duodenal ulcers recur in approximately 40 to 80 percent of patients after a one-year treatment. 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 Hp infection has been established, eradication therapy should be prescribed for all patients with a history of ulcer disease. Eradication of Hp reduces the rate of ulcer recurrence. Studies have shown that the recurrence rate of gastric ulcer after one year is only 2 percent in patients in whom the organism is eradicated. Axcan has just signed a licensing agreement covering Canada, the United States, Europe and Japan with EXOMED, an Australian Company, for a series of the patents covering the triple and quadruple therapies for Helicobacter pylori eradication. The claims of these patents cover the treatment of duodenal ulcer disease (and in some countries reflux oesophagitis and gastric ulcer) via the eradication of Helicobacter pylori using a bismuth compound together with two or more antibiotics. In March 1999, Axcan purchased Pirri's 50 percent interest in a technology for which Axcan has filed or obtained a series of patents covering a bismuth-based, single capsule therapy for the eradication of Helicobacter pylori. Axcan already owned the other 50 percent interest. The object of this patent is the dosage form for the administration of active principles in multiple therapies featured by the presence of two capsules, one placed inside the other and respectively containing one or more active ingredients. Related Link: Axcan Pharma Inc.
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