GW Pharmaceuticals plc, a biopharmaceutical company, has successfully closed the European Mutual Recognition Procedure (MRP) in France for Sativex oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS) and a resulting recommendation for approval by the French authorities.

The next step in the regulatory process is to work with the French National Agency of Medicine and Health Products Safety (ANSM) to finalize any country-specific requirements. Following completion of this next step, it is then expected that France will issue a national marketing authorisation. Launch timing in France is dependent on completion of subsequent national pricing and reimbursement procedures. Sativex will be commercialized in France by GW’s European partner, Almirall SA.

“The successful completion of this regulatory process for Sativex in France maintains our positive regulatory track record for Sativex, which is already approved in 22 countries, and provides further endorsement of the important role Sativex can play in meeting a substantial unmet need of people with Multiple Sclerosis,” stated Justin Gover, chief executive Officer of GW Pharmaceuticals. “We look forward to working with our partners, Almirall, towards the launch of Sativex in this important European country.”

Sativex is approved as a treatment for MS spasticity in 22 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further eight European countries, as well as Australia, New Zealand and Kuwait.

In the United States, GW announced in August 2013 that it had opened a phase III Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical programme to evaluate Sativex for the treatment of MS spasticity. GW expects the US phase III trial to commence in 2014.

Sativex is also currently in phase III clinical trials as a treatment for cancer pain. This represents the lead target indication for the product in the United States.

GW is focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.