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| |  Axcan Files For U.S. Approval And Obtains Orphan Drug Status For Photofrin in The Treatment of High-Grade Dysplasia Associated With Barrett's Esophagus MONT SAINT-HILAIRE, QC -- May 30, 2002 -- Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has filed a supplemental new drug application ("SNDA") with the Food and Drug Administration ("FDA"), for the use of its photodynamic therapy ("PDT"), Photofrin (porfimer sodium), in the treatment of high-grade dysplasia associated with Barrett's Esophagus. Axcan is also pleased to announce that the FDA granted an orphan drug status for this submission, which will provide the Company with seven (7) years of marketing exclusivity for this specific indication, if the product is approved. Photofrin has already been filed fort his indication in both the European Union and Canada. "We are very pleased that the FDA has granted orphan drug status with respect to this important new indication for Photofrin since study results indicated that this product has the potential to treat high-grade dysplasia associated with Barrett's Esophagus," indicated Dr. Francois Martin, Axcan's Senior Vice President, Scientific Affairs. The submission was filed following completion of a Phase III pivotal study evaluating the safety and efficacy of Photofrin PDT in the treatment of high-grade dysplasia associated with Barrett's Esophagus. This study was conducted in 208 patients in North America and Europe, and compared Photofrin PDT (2 mg/kg intravenously followed by laser light-delivery at a wavelength of 630 nm within 48-72 hours up to a maximum of 3 courses followed by oral administration of omeprazole) in combination with omeprazole, to the administration of omeprazole alone. It was demonstrated that Photofrin PDT was significantly more effective than omeprazole alone (p less than 0.0001) since ablation of all areas of high-grade dysplasia was noted in 72% of patients in the Photofrin PDT group versus 31% in the omeprazole group. A strong trend toward reduction of progression to cancer was also observed: only 9.4% of the patients treated with Photofrin PDT experienced a progression to esophageal cancer compared to 18.6% of those patients treated with omeprazole alone. These results were noted after a minimum of 6 months, and a median 11.5 months follow-up period. ABOUT BARRETT'S ESOPHAGUS Studies conducted 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 socioeconomic 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 of which approximately 12-15% are likely to develop Barrett's Esophagus. Of this 12-15%, approximately 90% are likely to have metaplasia, an early-stage abnormal transformation of tissue, and 10% are likely to have dysplasia. Barrett's Esophagus high-grade dysplasia is estimated to have an incidence of approximately 5,000-7,000 patients per year in the United Sates, with a patient prevalence between 25,000 and 35,000. Current data suggests that Photofrin-based PDT not only successfully ablates high-grade dysplasia related to Barrett's Esophagus but offers wide potential either on its own or as part of combination therapy. Axcan is supporting several studies evaluating Photofrin PDT in cholangocarcinoma, colorectal cancer and various other cancers. Axcan Pharma is a specialty pharmaceutical company involved in there search, development, production and marketing of innovative products, in the field of gastroenterology. The company markets a broad range of prescription products sold for the treatment of symptoms in a number of gastrointestinal diseases and disorders such as inflammatory bowel disease, irritable bowel syndrome, cholestatic liver diseases and complications related to cystic fibrosis. Its products are marketed in Canada, the United States, France and Poland. Its common shares are listed on the Toronto Stock Exchange under the symbol "AXP" and on the NASDAQ National Market under the symbol "AXCA". Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. The name Photofrin appearing in this press release is a trademark of Axcan Pharma Inc. SOURCE: Axcan Pharma Inc.
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