Sativex regulatory update

GW Pharma said Italy granted marketing approval for Sativex to treat moderate to severe spasticity in multiple sclerosis patients with inadequate response to other anti-spasticity medications. The company said partner Almirall S.A. (Madrid:ALM, Barcelona, Spain) is expected to launch it in the country in September. The Italian approval triggered a €250,000 ($328,150) milestone payment to GW from Almirall. Sativex is approved to treat spasticity due to MS in 20 other countries, including Canada, Spain, New Zealand, Denmark and the U.K. Last May, the product was recommended for approval under the EU Mutual Recognition Procedure (see BioCentury, May 14, 2012). The sublingual cannabis extract spray containing tetrahydrocannabinol (THC) and cannabidiol (CBD) is also in Phase III testing for cancer pain, with data expected next year. ...