London, UK, 7 May 2013: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW” or the “Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces that it has received commercialization approval for its prescription medicine Sativex® in Italy. A full marketing authorization has been granted by the authorities in Italy for the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. This license to market Sativex® in Italy comes by way of the publication of Sativex® in the Italian Official Journal (Gazzetta Ufficiale) and reflects that regulatory, pricing and reimbursement approvals are now in place for an expected commercial launch in September by GW’s partner, Almirall S.A. The reimbursed price of the medicine granted by the authorities in Italy is consistent with the reimbursed Sativex® price in Spain.
The publication of Sativex® in the Italian Official Journal triggers a €250,000 milestone payment from Almirall to GW.
“The approval in Italy brings the total to 21 countries that have approved Sativex® for use in the treatment of MS spasticity,” stated Justin Gover, Chief Executive Officer of GW. “In granting reimbursement approval for Sativex®, we appreciate the foresight of the Italian authorities in recognizing the value of a medicine that treats a particularly debilitating symptom of MS that is not adequately treated with currently available medications. We now look forward to working with our partners Almirall towards commercial launch in this important market in a few months’ time.”