GW Pharmaceuticals plc confirms that following its announcement on 23 November 2010 that the phase III clinical trials programme of Sativex in cancer pain had been initiated, the first patient was randomized in Europe as anticipated in December 2010. As a result, and in accordance with the terms of GW’s licence agreement with Otsuka Pharmaceutical Co. Ltd, GW has received a milestone payment from Otsuka of $4 million.

Sativex in Cancer Pain: Cancer pain represents the initial target indication for Sativex in the United States. Sativex is approved in the UK, Spain, Canada and New Zealand as a treatment for Multiple Sclerosis spasticity.

The phase III cancer pain programme is being performed in conjunction with GW’s licensing partner for Sativex in the US, Otsuka Pharmaceutical Co. Ltd. The programme, which is fully funded by Otsuka, includes two phase III randomised placebo-controlled multi-centre multinational trials as well as a long term extension study. Each phase III trial will include approximately 370 patients and will evaluate the efficacy and safety of Sativex versus placebo over a 5 week treatment period.

Studies suggest that more than one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain.  Large surveys indicate that optimal opioid therapy does not yield sufficient relief in a substantial proportion of these patients.

In February 2007, GW and Otsuka entered into a major long term strategic alliance. The relationship commenced with the signing of an exclusive license agreement to develop and market Sativex, GW’s lead product, in the US. In July 2007, GW and Otsuka signed a global research collaboration for the study of cannabinoids in the field of Central Nervous System (CNS) and oncology to research, develop and commercialize a range of candidate cannabinoid products.

Founded in 1964, Otsuka Pharmaceutical Co.,Ltd. is a global healthcare company with the corporate philosophy 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases, and consumer products for the maintenance of everyday health.Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide.

GW was founded in 1998 and listed on the AIM, a market of the London Stock Exchange, in June 2001. Operating under license 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 multiple sclerosis and cancer pain.