GW Pharmaceuticals Receives FDA Fast Track and EMA Orphan Designations for Intravenous Cannabidiol in the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)

London, UK, 6 August 2015: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for a proprietary intravenous form of cannabidiol (CBD) to treat Neonatal Hypoxic-Ischemic Encephalopathy, or NHIE. In addition, the European Medicines Agency (EMA) has granted orphan designation for the same product to treat perinatal asphyxia, an alternate term that describes the same condition as NHIE, for which GW has already received Orphan Drug Designation from the FDA. There are currently no approved medicines in Europe or the U.S. specifically indicated for NHIE or perinatal asphyxia.

“GW believes that cannabinoids may have a potentially important role in the treatment of high need pediatric neurologic conditions. As a result, we have developed a proprietary...

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