The treatment of cancer pain, Sativex, and Cannabinoids

Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals plc, will make the following comments at Annual General Meeting:

“In 2008, we have started to build on the achievements of 2007, a year of important progress for GW. The licence agreement signed in 2007 with Otsuka secured the future of our lead product, Sativex®, in the United States, the world’s largest pharmaceutical market, by providing funding for the US development plan aimed at securing regulatory approval from the FDA. Separately, the global cannabinoid research collaboration signed with Otsuka later in 2007, enabled us to accelerate the development of our pipeline of new cannabinoid medicines. During 2007, we also secured a further approval for Sativex in Canada for the treatment of cancer pain and achieved clarity from the European regulators as to their requirements to gain approval.

“2008 is a pivotal year in GW’s development with the results expected from three separate late stage trials for Sativex in Europe and the US. The first of these is the MS neuropathic pain Phase III trial in Europe which includes a total of 339 patients. This study is complete and on track for database lock shortly with headline results due in the coming weeks. Separately, the Phase III MS spasticity trial requested last year by the UK regulatory authority commenced on time and is recruiting on schedule. These two trials provide us with separate regulatory filing opportunities for Sativex in Europe over the coming year.

“Progress is also being made under both elements of the Otsuka collaboration. The Sativex US Phase IIb/III cancer pain study commenced towards the end of 2007 as planned. Other aspects of the Sativex US development plan agreed with the FDA are also progressing well. Under the cannabinoid research agreement, promising pre-clinical data is already starting to emerge on a range of novel cannabinoids within the CNS and oncology fields.

“Separately, our in-house research programme in the field of type 2 diabetes and related metabolic disorders is also making progress. We recently announced highly promising results in both pre-clinical pharmacology studies and a Phase I trial of a new potential cannabinoid treatment, delta-9-tetrahydrocannabivarin (THCV). Following on from this first study, GW is now preparing to start a Phase IIa multiple dose study in type 2 diabetic patients in 2008.

“With Sativex now in the regulatory endgame in Europe and in late stage development in the US, and the wider field of cannabinoid medicines continuing to grow, we look forward to reporting news of our progress during 2008.

“As announced in the preliminary results, Dr Brian Whittle, Scientific Director and co-founder, at the age of 75, has chosen not to seek re-election at the AGM and therefore retires today. Although Brian has gradually decreased his working time over the last few years, he played an instrumental role in the development of GW and will be greatly missed. I would like to express on behalf of the Board my sincere gratitude for his contribution to the company.”

Source: GW Pharmaceutical