GW Pharmaceuticals Reacquires Full Rights to Develop and Commercialize Sativex® in U.S.
“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
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.
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
This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of Sativex® (nabiximols) and the safety profile and commercial potential of Sativex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the
|GW Pharmaceuticals plc|
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Source: GW Pharmaceuticals plc