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GW Pharmaceuticals plc Reports 2013 Q4 and Full Year Financial Results
Date:11/19/2013

LONDON, Nov. 19, 2013 /PRNewswire/ -- 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 announces its preliminary results for the fourth quarter and the year ended 30 September 2013.  

2013 HIGHLIGHTS:

  • Initial public offering on the NASDAQ Global Market completed in May 2013 raising total net proceeds before expenses of $30.7m (£19.8m)
  • Two U.S.-targeted Sativex® Phase 3 pivotal programs advanced in 2013
  • Cancer Pain: two pivotal Sativex Phase 3 trials in recruitment
  • First Phase 3 top-line results expected in H2 2014
  • Data intended to lead to a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA)
  • Multiple Sclerosis (MS): Phase 3 Investigational New Drug (IND) application opened with the FDA for Sativex in the treatment of MS spasticity
  • Special Protocol Assessment (SPA) to be requested prior to anticipated start of Phase 3 trial in 2014
  • All Sativex Phase 3 clinical trials targeted at FDA approval are fully funded by U.S. partner, Otsuka
  • Sativex U.S. patent position further strengthened through two additional U.S. Notices of Allowance
  • Sativex now approved in 22 countries (ex-U.S) as a treatment for MS spasticity
  • In-market sales by partners increased by 25%
  • Commercial launch in Italy in July 2013
  • Germany pricing agreement reached in September 2013
  • Recommendation for approval in France in October 2013
  • On-going commercial launches in planning over next 12 months
  • New Sativex data presented at ECTRIMS in October 2013
  • Expansion of epilepsy research program through commencement of a new orphan pediatric epilepsy program for Epidiolex® (
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  • SOURCE GW Pharmaceuticals plc
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