UK-based GW Pharmaceuticals (AIM: GWP) says that it has received commercialization approval for its cannabinoid-based prescription medicine Sativex from 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 the drug 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 (ALM: MC), Spain’s largest drugmaker. The reimbursed price of the medicine granted by the authorities in Italy is consistent with the reimbursed Sativex price in Spain. The publication triggers a 250,000-euro ($268,250) 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 of GW
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