GWP.L Regulatory News (GWP)

18 Mar 2008 07:00

GW Pharmaceuticals PLC18 March 2008 GW Pharmaceuticals plc AGM Statement Porton Down, UK, 18 March 2008: Dr. Geoffrey Guy, Chairman of GW Pharmaceuticalsplc, will make the following comments at today's Annual General Meeting: "In 2008, we have started to build on the achievements of 2007, a year ofimportant progress for GW. The licence agreement signed in 2007 with Otsukasecured the future of our lead product, Sativex(R), in the United States, theworld's largest pharmaceutical market, by providing funding for the USdevelopment plan aimed at securing regulatory approval from the Food & DrugAdministration (FDA). Separately, the global cannabinoid research collaborationsigned with Otsuka later in 2007, enabled us to accelerate the development ofour pipeline of new cannabinoid medicines. During 2007, we also secured afurther approval for Sativex in Canada for the treatment of cancer pain andachieved clarity from the European regulators as to their requirements to gainapproval. "2008 is a pivotal year in GW's development with the results expected from threeseparate late stage trials for Sativex in Europe and the US. The first of theseis the MS neuropathic pain Phase III trial in Europe which includes a total of339 patients. This study is complete and on track for database lock shortly withheadline results due in the coming weeks. Separately, the Phase III MSspasticity trial requested last year by the UK regulatory authority commenced ontime and is recruiting on schedule. These two trials provide us with separateregulatory 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 2007as planned. Other aspects of the Sativex US development plan agreed with the FDAare also progressing well. Under the cannabinoid research agreement, promisingpre-clinical data is already starting to emerge on a range of novel cannabinoidswithin the Central Nervous System (CNS) and oncology fields. "Separately, our in-house research programme in the field of type 2 diabetes andrelated metabolic disorders is also making progress. We recently announcedhighly promising results in both pre-clinical pharmacology studies and a Phase Itrial of a new potential cannabinoid treatment, delta-9-tetrahydrocannabivarin(THCV). Following on from this first study, GW is now preparing to start a PhaseIIa multiple dose study in type 2 diabetic patients in 2008. "With Sativex now in the regulatory endgame in Europe and in late stagedevelopment in the US, and the wider field of cannabinoid medicines continuingto grow, we look forward to reporting news of our progress during 2008. "As announced in the preliminary results, Dr Brian Whittle, Scientific Directorand co-founder, at the age of 75, has chosen not to seek re-election at the AGMand therefore retires today. Although Brian has gradually decreased his workingtime over the last few years, he played an instrumental role in the developmentof GW and will be greatly missed. I would like to express on behalf of theBoard my sincere gratitude for his contribution to the company." Enquiries: GW Pharmaceuticals plc (Today) + 44 20 7831 3113Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000Justin Gover, Managing Director Financial Dynamics + 44 20 7831 3113David Yates / Ben Atwell Notes to Editors About GW GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under license from the UK Home Office, thecompany researches and develops cannabinoid pharmaceutical products for patientswho suffer from a range of serious ailments, in particular pain and otherneurological symptoms. GW has assembled a team of over 100 scientists withextensive experience in developing both plant-based prescription pharmaceuticalproducts and medicines containing controlled substances. GW occupies a worldleading position in cannabinoids and has developed an extensive internationalnetwork of the most prominent scientists in the field. This information is provided by RNS The company news service from the London Stock Exchange