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Photofrin PDT Reduces Esophageal Cancer Occurrence in Patients With Barrett's High Grade Dysplasia - Results of a 5-Year Follow-up Study MONT SAINT-HILAIRE, CANADA -- September 21, 2005 -- Coinciding with the World Congress of Gastroenterology 2005 being held in Montreal, Canada, Axcan Pharma Inc. disclosed new data demonstrating that Photofrin photodynamic therapy ("PDT") used in conjunction with omeprazole, a standard acid suppression therapy, reduced occurrence of esophageal cancer. This new clinical information is based on the analysis of the 5-year follow-up observation of patients with High Grade Dysplasia ("HGD") associated with Barrett's esophagus ("BE") who were randomized in the original pivotal 2-year Phase III study conducted by Axcan which led to regulatory approval in 2003. Since HGD and the eventual possibility of developing cancer in BE are inextricably linked, the original 24-month follow-up study was continued over 5 years to confirm the reduction in cancer occurrence. "We are extremely pleased with these results since they confirm that Photofrin PDT has the potential to be used for the prevention of esophageal cancer and that it is a clinically effective endoscopic therapy in reducing the incidence of cancer in patients with Barrett's High Grade Dysplasia," commented Dr. Francois Martin, Senior Vice-President, Scientific Affairs of Axcan. "Results already noted in our initial study are now strengthened by the 5-year follow-up. It has been demonstrated that Photofrin PDT is not only safe and effective but that its effects are prolonged," he concluded. Study Results The study used multiple sites and involved 208 patients randomized (2:1) to Photofrin PDT used in conjunction with omeprazole 20mg twice-a-day, or to omeprazole alone at a dose of 20mg twice-a-day. At the end of the 5-year follow-up, results of the study confirmed that Photofrin PDT used in conjunction with omeprazole was superior to omeprazole alone in preventing the progression to cancer, with about twice the likelihood of cancer occurring in the omeprazole alone group (29%) compared to Photofrin PDT used in conjunction with omeprazole (15%). This reduction of the progression to cancer is highly statistically significant (p (equal sign) 0.0272). The original pivotal 2-year Phase III study had shown successful HGD ablation in 77% of patients using Photofrin PDT in conjunction with omeprazole compared with 39% of patients using omeprazole alone. Detailed results of this original study will be published in the October 2005 issue of "Gastrointestinal Endoscopy "(GIE). About Barrett's Esophagus Barrett's esophagus (BE) is a condition in which the normal lining of the lower part of the esophagus is replaced over time by another type of lining, normally present in the stomach. Usually BE develops during the process of healing after a chronic injury to the esophageal mucosa such as caused by reflux of gastric juice (GERD) in the esophagus. Continued reflux may cause dysplastic changes progressing from Low-Grade to HGD. Such dysplasia may lead to esophageal adenocarcinoma, which is a life-threatening condition. The U.S. National Digestive Diseases Information Clearing House (NDDIC) estimates that the risk of developing adenocarcinoma is 30 to 125 times greater in people who have BE than in people who do not. About Photofrin Photofrin for injection is a photosensitizing agent used in the photodynamic therapy of tumors. It uses a combination of a photoactive drug and light from a laser, allowing the doctor to specifically target and destroy cells with HGD associated with BE while limiting damage to surrounding healthy tissue. Photofrin is marketed by Axcan in North America under the brand Photofrin, and in the European Union under the brand Photobarr. SOURCE: Axcan Pharma Inc. E-mail this page to a friend or colleague! To print, use this version