New regulatory submissions for MS drug is expected during 2011.
Novartis Pharma is paying GW Pharmaceuticals $5 million up front and potentially $28.75 million in milestone payments as part of an exclusive licensing deal for commercialization of the latter’s cannabinoid drug Sativex® in Australia, New Zealand, Asia (excluding Japan, China, and Hong Kong), Africa, and the Middle East (excluding Israel/Palestine). Sativex has already been approved in the U.K., Canada, New Zealand, and Spain as an add-on treatment for improving the symptoms of spasticity in multiple sclerosis patients who have not responded adequately to other antispasticity medications. A further six European approvals are expected by mid-2011. Sativex is separately undergoing Phase III development for the treatment of cancer pain.
Under terms of the agreement Novartis gains exclusive commercialization rights to Sativex in its designated territories, and will have the responsibility for regulatory filings. GW Pharm says it anticipates Novartis will submit Sativex applications for the MS indication in some of its territories during 2011. GW Pharm’s other Sativex licensees include Otsuka Pharmaceutical for the U.S., Almirall for Europe (excluding the U.K.), Bayer HealthCare in the U.K. and Canada, and Neopharm in Israel/Palestine.
In September 2010 Novartis’ own drug Gilenya(TM) (fingolimod) was approved by FDA as first-line therapy for relapsing forms of MS. The sphingosine 1-phosphate receptor (S1PR) modulator is the first oral disease-modifying MS drug approved in the U.S. Gilenya is now approved in more than 35 countries.