GW Pharmaceuticals reacquires full rights of develop Sativex in US

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.