London, UK, 13 Dec 2017: GW Pharmaceuticals plc (Nasdaq: GWPH, “GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announces the termination of its previous license agreement with Otsuka Pharmaceutical Co., Ltd. in relation to Sativex®(nabiximols) in the U.S. As a result, GW has now reacquired full ownership of the development and commercialization rights to the product in the U.S. market without making any upfront payment to Otsuka. GW has agreed to make contingent milestone payments to Otsuka, the first of which would become due upon FDA approval of Sativex and thereafter additional payments would become due upon the achievement of certain annual sales thresholds of Sativex in the United States.
“We are pleased to have amicably reached this agreement with Otsuka, which enables GW to develop, seek approval for, and commercialize Sativex in the United States,” stated Justin Gover, GW’s CEO. “We have previously conducted several positive Phase 2 and 3 trials for Sativex and believe that this product represents an important new late-stage pipeline opportunity for GW in the U.S. market.”
Sativex is an oromucosal spray of a formulated extract that contains the principal cannabinoids cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) in a 1:1 ratio. Sativex is currently approved in 29 countries outside the U.S. for the treatment of spasticity in patients with multiple sclerosis. GW and Otsuka originally signed a licensing agreement in 2007 under which GW granted Otsuka an exclusive license to develop and market Sativex in the U.S. The two companies conducted a clinical trials program in the treatment of cancer pain, in which the trials did not meet the primary endpoint.
About GW Pharmaceuticals plc and Greenwich Biosciences
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted an NDA to the FDA for the adjunctive treatment of LGS and Dravet syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioblastoma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.