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| |  European Committee Grants Orphan Drug Status to Photobarr (Porfimer) for High-Grade Dysplasia Linked to Barrett’s Esophagus MONT SAINT-HILAIRE, QC -- April 11, 2002 -- Axcan Pharma Inc. announced today that it has filed a marketing authorisation application with the European Agency for the Evaluation of Medicinal Products (EMEA), for the use of its photodynamic therapy, Photobarr™ (porfimer sodium), in the treatment of high-grade dysplasia associated with Barrett's Esophagus, and that an orphan medicinal status was granted by the EMEA for this submission. The grant of the orphan medicinal status is based on the following cumulative criteria: (i) the seriousness of the condition; (ii) the existence or not of alternative methods of diagnosis, prevention or treatment and (iii) either the rarity of the condition (considered to be affecting not more than five in ten thousand persons in the European Community) or the insufficient return on development investment. This status introduces incentives including the grant of exclusive marketing rights for a ten-year period. "We are very pleased that the EMEA has granted orphan medicinal status with respect to this important new indication for Photobarr. This underlines the need to treat high-grade dysplasia associated with Barrett's Esophagus and hence reduce the progression to esophageal cancer," commented Dr. Francois Martin, Senior Vice President, Scientific Affairs of Axcan Pharma. "There is currently no approved treatment to reverse the condition and decrease the risk of developing esophageal 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 esophageal cancer, even if it is believed that esophagectomy patients have a relatively high risk of mortality (5 percent), and that their hospitalisation has a relatively high cost. Photobarr PDT (photodynamic therapy) is a minimally invasive therapy that preserves normal tissue, which enables future treatments if required," he concluded. The submission was filed following completion of a Phase III pivotal study evaluating the safety and efficacy of Photobarr PDT in the treatment of high-grade dysplasia associated with Barrett's Esophagus. This study was conducted in 208 patients in both North America and Europe, and compared Photobarr PDT (2 mg/kg intravenously followed by laser light-delivery at a wavelength of 630 nm within 48 to 72 hours up to a maximum of three courses followed by oral administration of omeprazole) to the administration of omeprazole alone. It was demonstrated that Photobarr 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 percent of patients in the Photobarr PDT group versus 31 percent in the omeprazole group. A strong trend toward reduction of progression to cancer was observed: only 9.4 percent of the patients treated with Photobarr PDT experienced a progression to esophageal cancer compared to 18.6 percent of those treated with omeprazole alone. SOURCE: Axcan Pharma Inc.
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