Insys Therapeutics Receives FDA Orphan Drug Designation for Its Liposomal Encapsulated Paclitaxel

Insys Therapeutics, Inc.

, a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. "We are pleased to have received orphan drug designation for LEP-ETU to treat ovarian cancer, a devastating and difficult-to-treat disease," said Michael L. Babich, President and Chief Executive Officer. "By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate." Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.