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| |  Photofrin Photodynamic Therapy Promising For Treating Barrett’s Esophagus MONT SAINT-HILAIRE, QC -- September 5, 2000 -- Axcan Pharma Inc. announced that the data from its phase III clinical trial on Photofrin® in the treatment of high grade dysplasia associated with Barrett's esophagus, is excellent. Barrett's esophagus is a relatively common condition that results from prolonged acid reflux (heartburn). Results were presented at the 6th World Congress of the International Organization for Statistical Studies on Diseases of the Esophagus (O.E.S.O.) held in Paris, France from September 1 to September 6, under the patronage of UNESCO. This Phase III trial using Photofrin in Photodynamic Therapy ("PDT") in the treatment of Barrett's esophagus was conducted in the United States, Canada, and Europe. This partially blinded, controlled, randomized, parallel group, multicenter phase III study enrolled 208 patients with biopsy-proven high-grade dysplasia ("HGD"). The main purpose of this study was to assess the efficacy of PDT with Photofrin in conjunction with omeprazole in producing complete ablation of HGD as compared to a control group of patients receiving omeprazole alone. The results at six months showed that HGD was eliminated in 72 percent of the patients who received Photofrin and PDT, but only in 31 percent of the patients who received omeprazole alone. Moreover, this PDT Photofrin therapeutic effect is sustained up to two years in 70 percent of responders, whilst no therapeutic effect is observed after three months in the omeprazole responders. More importantly, only 10 percent of patients treated with Photofrin progressed from HGD to esophageal cancer, compared to 19 percent of patients who received omeprazole alone. The incidence of progression to cancer is thus reduced by 47 percent by the Photofrin and PDT treatment modality. "Axcan is extremely happy with these excellent results since it is now clear that Photofrin has the potential to help many patients with this insidious condition. We clearly demonstrated that Photofrin can be used as a means of prevention of esophageal cancer, once dysplasia or metaplasia is diagnosed in patients suffering from gastroesophageal reflux disease. Not only is it likely to substantially improve upon the risks and costs of eventual esophagectomy, but it could also allow effective treatment for early as well as later stages of disease progression," stated Dr. François Martin, Senior Vice President, Scientific Affairs of Axcan. "We will endeavour to file a supplementary new drug submission in the first half of fiscal 2001, once our study results have been completely analysed," he concluded. Barrett's esophagus is a condition that results from prolonged acid reflux (heartburn). Frequent exposure to bile flowing back from the stomach causes the lining of the esophagus to be converted into tissue similar to that lining the stomach. This transformation makes the esophageal tissue more susceptible to cancer. Scientific studies indicate that patients with Barrett's esophagus have 30 to 40 times more chance of developing esophageal cancer than people who do not have Barrett's esophagus. There is currently no approved treatment to reverse the condition and decrease the risk of developing cancer. Symptoms of gastroesophageal reflux, when present, can be relieved by a variety of acid suppressants, but surgical removal of the esophagus, called an esophagectomy, is currently the only curative treatment for patients with high-grade dysplasia or early cancer, even if it is believed that esophagectomy patients have a relatively high risk of mortality (5 percent), and that their hospitalization has a relatively high cost (approximately US$50,000 in the United States). Studies carried out to date have also indicated that the incidence of Barrett's esophagus is increasing steadily, particularly among middle-aged males with stressful lifestyles and a mid to high socio-economic status. In Western countries, Barrett's esophagus is primarily associated with white males, aged 55-65. It is estimated that approximately 20 million Americans suffer from chronic heartburn and that approximately 12 to 15 percent of them are likely to develop Barrett's esophagus. Of these, approximately 90 percent are likely to have metaplasia, an early-stage abnormal transformation of tissue, and 10 percent are likely to have dysplasia. Barrett's esophagus high-grade dysplasia is estimated to have an incidence of approximately 5,000 to 7,000 patients per year in the United Sates, with a patient prevalence between 25,000 to 35,000 patients. Patient prevalence and incidence of the disease is similar in Europe, resulting in between 50,000 to 70,000 patients who require treatment. Related Links: Photofrin and Axcan Pharma Inc.
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