GW Pharmaceuticals Plc ADS (GWPH)

[SymphonicDelight]

Sativex Receives FastTrack Designation From FDA (CancerPain)

GW Pharmaceuticals Announces That Sativex Receives Fast Track Designation From FDA in Cancer Pain

LONDON, April 28, 2014 (GLOBE NEWSWIRE) -- 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, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Sativex(R) for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. Sativex is currently in Phase 3 clinical trials for this indication.

FDA's Fast Track program facilitates the development of drugs intended to treat serious or life--threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.

"The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain," stated Justin Gover, GW's Chief Executive Officer. "Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications. We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn."