San Diego Business Journal

MEI Pharma’s Leukemia Drug Receives Orphan Status From FDA

By SDBJ Staff Monday, March 3, 2014

MEI Pharma Inc.’s investigational drug Pracinostat for treating acute myeloid leukemia has been granted orphan drug designation by the U.S. Food and Drug Administration, the company announced.

San Diego-based MEI Pharma (Nasdaq: MEIP) focuses on the clinical development of novel therapies for cancer.

Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

Daniel Gold, president and CEO of MEI Pharma, expressed the company’s satisfaction with the FDA’s designation.

Acute myeloid leukemia “is a particularly devastating cancer for which there are currently few broadly effective treatments,” Gold said. “Through development of Pracinostat, we hope to address this significant unmet medical need.”