Insys Reports FDA Orphan Drug Status For Its Liposomal Encapsulated Paclitaxel

(RTTNews) - Specialty pharmaceutical company Insys Therapeutics, Inc. (INSY) Monday said the U.S. Food and Drug Administration has granted orphan drug designation to its Liposomal Encapsulated Paclitaxel candidate for the treatment of ovarian cancer.

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 less than 200,000 patients in the U.S.

The status 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.

Michael Babich, President and CEO, said, "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."