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| |  FDA Approves Canasa Mesalamine (5-ASA) Rectal Suppositories For Ulcerative Proctitis MONT-SAINT-HILAIRE, QC -- January 8, 2001 -- Axcan Pharma Inc. announced that the United States Food and Drug Administration has issued an approval letter for Canasa® 500 mg mesalamine (5-ASA) rectal suppositories for the treatment of active ulcerative proctitis. This announcement was made during a presentation made at the J.P. Morgan Chase & Co's 19th Annual Healthcare Conference in San Francisco. In August 1999, the Food and Drug Administration requested that Axcan sell these suppositories in the United States under a temporary, emergency measure due to the lack of any other source of supply. Subsequently, Axcan performed preclinical and clinical studies and then filed an NDA on April 28, 2000. This NDA was filed pursuant to regulation 505(b)(2), which expressly permits the FDA to rely, for approval of an NDA, on data not developed by the applicant, but on its own findings of safety and effectiveness for an approved drug. In conjunction with the approval, Axcan will perform a clinical study in children aged 12-18 years with active or quiescent disease, since in many cases, inflammatory bowel disease is also diagnosed at a young age. "This approval is great news not only for Axcan, but also for patients suffering from active ulcerative proctitis, a chronic inflammatory disease affecting the inner colonic mucosa, patients for whom these suppositories could induce a rapid remission of their disease and an improved quality of life," commented Leon F. Gosselin, Axcan's President and CEO. "We are looking forward to meeting the needs of these patients and we should be able to launch the product at the end of March 2001. Until this official launch patients will still be able to buy this product," he added. In the United States, the total market for mesalamine suppositories was approximately US$22 million prior to the beginning of the emergency measure. Sales of FIV-ASA, the legacy product that will be replaced by Canasa, were approximately US$9.5 million since the beginning of the emergency measure. Axcan believes that it will be able to serve a larger portion of patients treated with mesalamine once Canasa is launched and actively marketed, since this product fits perfectly into Axcan's gastroenterology niche. Related Link: Axcan Pharma Inc.
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