Firms aim for global development of drugs for CNS and oncology indications.
Otsuka Pharmaceuticals has pledged another $12 million in research funding as part of a three-year extension to its global cannabinoid research collaboration with GW Pharmaceuticals. The firms say the extended agreement will allow further evaluation of a range of GW’s cannabinoid candidates as potential new drugs for central nervous system disorders and oncology.
Licensing agreements will be set in place to cover compounds selected for clinical development and commercialization. Under the terms of each product-specific license Otsuka will fund global product development and commercialization and pay GW license fees, milestone payments, commercial supply costs, and product royalties.
GW and Otsuka have been working together since 2007 on the cannabinoid drug collaboration. The firms are in addition progressing clinical development of GW’s lead cannabis plant-derived product, Sativex®, for the U.S. market. The initial indication for Sativex in the U.S. is for the amelioration of pain in advanced cancer patients who experience inadequate analgesic responses to optimized opioid therapy.
Sativex oromucosal spray was just last week launched in the U.K. as a treatment for spasticity associated with multiple sclerosis (MS). GW points out that the U.K. is the first country in the world to grant a full regulatory authorization for the product. Sativex is marketed in the U.K. by GW’s licensee, Bayer Schering Pharma. The drug is manufactured at an undisclosed location in the U.K. under a government license.
Sativex is also expected to be approved and launched in Spain during the second half of this year, and regulatory applications in other European countries are planned for submission later this year via the mutual recognition procedure, GW points out.
Sativex is continuing to undergo Phase II and III trials in relevant markets for the MS spasticity and cancer pain indications and for the treatment of neuropathic pain. GW’s licensee for the European market (excluding the U.K.) is Almirall. Bayer has U.K. and Canadian rights to the drug. In Canada Sativex is approved under the Notice of Compliance with Conditions (NOC/c) policy for symptomatic relief of neuropathic pain in MS and as adjunctive analgesic treatment in patients with advanced cancer who experience moderate-to-severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain.
GW’s cannabinoid pipeline includes additional candidates in early clinical development for diabetes/metabolic syndrome and inflammation. Cannabinoid-based compounds are also in preclinical development for the treatment of cancer, epilepsy, and psychiatric disorders.