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.
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.
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