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Monday, December 2, 2013

GW Pharma's Sativex Gets Swiss Nod for Spasticity releif

GW Pharmaceuticals’ (GWPH) sole marketed drug Sativex is currently approved in 23 countries across the globe for the treatment of spasticity due to multiple sclerosis (MS). The 23rdcountry where drug received approval is Switzerland.
GW Pharma gained Swiss approval for Sativex for the treatment of moderate-to-severe spasticity in MS patients non-responsive to other anti-spasticity therapies.
The drug will be launched in Switzerland by GW Pharma’s commercial partner Almirall S.A. We note that GW Pharma has a licensing agreement with Almirall S.A. for Sativex. As per the agreement, Almirall has exclusive rights to market the drug in the EU (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. Almirall also has the rights to market the drug in Mexico.
GW Pharma also filed a phase III Investigational New Drug (IND) application with the U.S. Food and Drug Administration (:FDA) in Aug 2013 to evaluate Sativex for MS spasticity. The company expects to start phase III study in 2014
Meanwhile, GW Pharma is also conducting two phase III studies on Sativex in the U.S. for treating pain in cancer patients. The company expects top-line results from one of these studies to come out by the end of next year. Results from another study will be out shortly thereafter following which approval will be sought for Sativex in the U.S.
As per World Health Organization (:WHO), 1.3 million people suffer from MS globally, of whom 80% suffer from spasticity.
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