GW Pharmaceuticals plc announces that it has entered into an exclusive licence agreement for Novartis Pharma AG to commercialise Sativex in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), Middle East (excluding Israel/Palestine) and Africa.

Under the terms of the agreement, Novartis will have exclusive commercialisation rights to Sativex and will also be responsible for regulatory filings and act as Marketing Authorisation holder for Sativex. GW will be responsible for the manufacture and supply of Sativex to Novartis.

Sativex has been developed as a treatment for spasticity due to Multiple Sclerosis (MS). It is anticipated that regulatory filings for Sativex in MS will begin in some of the countries in the above region during 2011. Sativex is also in phase III clinical development for the treatment of cancer pain.

Under the agreement, GW will receive an upfront payment of $5 million and will be eligible for additional payments totalling $28.75 million upon the achievement of certain approval and commercial milestones. In addition, GW will receive royalties on net sales of Sativex.

Justin Gover, GW’s managing director, said, “We are delighted to have entered into this agreement with Novartis. As one of the world's leading pharmaceutical companies with a strategic focus in both MS and oncology, Novartis represents an excellent commercial partner for Sativex in these important and growing international markets."

Sativex is licensed to Otsuka Pharmaceutical Co. Ltd in the United States, to Almirall SA in Europe (excluding the United Kingdom), to Bayer HealthCare AG in the UK and Canada, and to Neopharm Group in Israel/Palestine.
 
Sativex is an endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) - which was developed and is manufactured by GW.

Sativex is indicated as an add-on treatment for patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not adequately responded to other anti-spasticity medications and who have demonstrated a clinically significant improvement in symptoms related to spasticity during an initial treatment testing period.

Sativex contains active ingredients known as ‘cannabinoids’ which are extracted from the plant Cannabis Sativa grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that exist naturally throughout our body, including the brain. A receptor is a site located in a brain cell in which certain substances can stick or “bind” for a while. If this happens, this binding has an effect on the cell and the nerve impulses it produces, causing a ‘dimming-down’ of the spasticity symptom. In patients who respond to Sativex, this is the effect that improves their spasticity symptoms and helps them cope with their daily activities.

Sativex is approved in the UK, Spain, Canada and New Zealand in the treatment of spasticity due to MS. In addition, a further six European countries (Germany, Italy, Sweden, Denmark, Austria and the Czech Republic) have recently recommended Sativex for approval and are expected to grant national licences in mid-2011.

Spasticity is a symptom defined by patients and carers as muscle spasms, seizing-up, stiffness and/or difficulty in moving muscles and it is one of the most common symptoms of MS, occurring in up to 75% of MS sufferers in the course of the disease. Spasticity can affect many aspects of the daily lives of patients with MS and is one of the main factors contributing to their distress and disability.

GW Pharmaceuticals plc (AIM:GWP) was founded in 1998 and is listed on the AIM, a market of the London Stock Exchange. Operating under licence from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular MS and cancer pain.