Executive Summary

Axcan supplemental NDA for Photofrin (porfimer photodynamic therapy) for treatment of high-grade dysplasia associated with Barrett's esophagus is granted orphan drug status. The filing is based on a 208-patient Phase III study showing ablation of dysplasia in 72% of patients using Photofrin plus oral omeprazole (AstraZeneca's Prilosec) vs. 31% for omeprazole alone (p<0.0001). A trend toward reduction of progression to esophageal cancer was also seen, with a 9.4% progression rate for Photofrin plus omeprazole vs. 18.6% for omeprazole. Photofrin is currently approved for use in esophageal, lung and bladder cancer