The deal will see UK-based GW receive milestone payments of up to $273 million, including a signature fee of $18 million from Otsuka. In addition, Otsuka will bear the costs of all US development activities for Sativex. Otsuka will have an exclusive license to develop and market Sativex in the US.
Sativex is in late stage development in the US for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications, and is already approved in Canada for pain relief in multiple sclerosis. GW and Otsuka currently plan for the first US pivotal efficacy clinical trial to be a phase II/III cancer pain dose ranging study, to commence this year.
The companies are also in discussions to start a cannabinoid research collaboration in central nervous system disorders and cancer treatment.
Russell Portenoy, principal investigator of the first planned US Sativex study, said: “Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role.”