Axcan Pharma Inc. has been granted a Marketing Authorization in the European Union for its photodynamic therapy (PDT), Photobarr (porfimer sodium). Photobarr PDT is used in the ablation of high-grade dysplasia associated with Barrett's esophagus.
PDT using porfimer sodium as a photosensitizer was approved and recently launched in North America under the brand Photofrin PDT.
Photobarr PDT was also granted an orphan medical product status at the time of its submission. This guarantees Axcan exclusive marketing rights for Photobarr PDT in the European Union for a 10-year period.
|Barrett's esophagus affects 25,000 to 35,000 people in Europe.|
|Axcan Pharma Inc.|
It is estimated that high-grade dysplasia associated with Barrett's esophagus affects 25,000 to 35,000 people in Europe. An additional 5000 to 7000 cases are diagnosed each year.
Léon Gosselin, President and Chief Executive Officer of Axcan stated, "This approval, which is the first one for Axcan in Europe, is very important since it demonstrates our ability to navigate the European regulatory process".
"We expect to launch Photobarr PDT in the second half of fiscal 2004."