Concordia International Corp. ("Concordia" or the "Company"), an international pharmaceutical company focused on legacy pharmaceutical products and orphan drugs, today announced that the U.S. Food and Drug Administration has approved the Company's premarket approval application (PMA) for its new Photofrin® 630 PDT Laser.
Photodynamic therapy (PDT) with Photofrin® is Concordia's light-based cancer treatment that combines a photosensitizing drug called Photofrin® (porfimer sodium) with a specific type of light administered by a laser to attack cancer cells.
The newly approved laser, which is designed for use with Photofrin® to treat esophageal cancer, Barrett's Esophagus and non-small cell lung cancer, has been re-engineered with technological advancements in laser design. These advancements include new controls and peripheral systems while maintaining the same specifications with minimal changes to the treatment procedures.
"We anticipate that these improvements could support greater adoption of PDT with Photofrin® within the oncology community," said Mark Thompson, Chairman and CEO of Concordia. "In addition, PMA approval for this new laser represents an important milestone in our global growth plans for this asset."
The Company is also evaluating Photofrin® as a rare disease product candidate through a Phase 3 clinical trial. The ongoing Phase 3 trial is evaluating the product's safety and efficacy as a potential treatment for cholangiocarcinoma, or bile duct cancer, which is a rare disease affecting approximately 2,000-3,000 patients annually in the United States.