GW signs up Novartis to sell Sativex in certain markets

Sativex is a cannabis-based treatment for spasticity due to multiple sclerosis

GW Pharmaceuticals, a UK company that makes medicines from cannabis, has signed up Novartis Pharma of Switzerland to sell Sativex, its treatment for spasticity due to multiple sclerosis, in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), Middle East (excluding Israel/Palestine) and Africa.

Under the agreement, GW will receive an upfront payment of US$5m and a further $28.75m dependent on the achievement of certain approvals and commercial milestones. In addition, GW will receive royalties on net sales of Sativex.

Novartis will have exclusive rights to sell Sativex in the above regions. Regulatory filings for the treatment will begin in some of these countries during 2011, GW said.

GW will be responsible for the manufacture and supply of Sativex to Novartis.

Savitex, an endocannabinoid modulator made of two actives – THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol), is approved in the UK, Spain, Canada and New Zealand for the treatment of spasticity due to MS.

In addition, a further five European countries (Germany, Italy, Sweden, Denmark and Austria) have recently recommended Sativex for approval and are expected to grant national licences in June. Sativex was approved in the Czech Republic this month as a treatment for spasticity due to MS and is expected to be launched in 2012. It is licensed to Otsuka Pharmaceutical Co in the US, to Almirall in Europe (excluding the UK), to Bayer HealthCare in the UK and Canada, and to Neopharm Group in Israel/Palestine.

Sativex is also in Phase III clinical trials with Otsuka Pharmaceutical Co for the treatment of cancer pain.

Justin Gover, GW’s managing director, said: ‘Novartis represents an excellent commercial partner for Sativex in these important and growing international markets.’

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