GWP.L Regulatory News (GWP)

30 Aug 2007 07:00

GW Pharmaceuticals PLC30 August 2007 Sativex(R) Phase III Trial in MS Neuropathic Pain Completes Patient Recruitment Porton Down, UK, 30 August 2007 - GW Pharmaceuticals plc (AIM: GWP) announcesthat patient recruitment is now complete in its pivotal Phase III trial inpeople with multiple sclerosis (MS) suffering from central neuropathic pain. This Phase III study is a double-blind randomised placebo-controlled study ofSativex(R) in patients with central neuropathic pain due to MS, who haveachieved inadequate pain relief with existing therapies. The study hasrecruited 339 patients in the UK, Canada, France, Spain and the Czech Republicand is GW's largest clinical trial to date. The duration of treatment in the study is 14 weeks. The last patient will exitthe study at the end of 2007 with headline results expected in H1 2008. GW has previously carried out a similar pivotal Phase III study with positiveresults. This study, which was published in the peer-reviewed journal,Neurology, showed that Sativex was significantly superior to placebo in reducingpain (p=0.005) and sleep disturbance (p=0.003) (1). This second pivotal Phase III study in MS Neuropathic Pain has two potentialroles in the regulatory strategy for Sativex, as follows: • In Europe, this study may provide a clinical data package to support a regulatory submission for Sativex in the indication of "MS Neuropathic Pain" • In Canada, this study is intended to meet the condition associated with the approval of Sativex in order to obtain a full Notice of Compliance Dr Stephen Wright, R&D Director, said, "Neuropathic pain is a debilitatingsymptom of MS and is often under treated and inadequately controlled. Previousclinical trials and post-marketing experience in Canada show that Sativex has avaluable role to play in treating this significant unmet medical need. We lookforward to the results of this confirmatory Phase III study." Sativex is already approved in Canada as adjunctive treatment for thesymptomatic relief of neuropathic pain in MS and in cancer pain. Health Canadaapproved Sativex under the Notice of Compliance with conditions (NOC/c) policy. Enquiries:GW Pharmaceuticals plc Today: +44 (0)20 7831 3113Dr Geoffrey Guy, Chairman Justin Gover, Managing Director Financial Dynamics Tel: +44 (0)20 7831 3113David Yates, Ben Atwell Notes to Editors Central Neuropathic Pain Neuropathic pain is caused by damage to or dysfunction of the nervous system. Itis usually chronic and accompanied by unpleasant burning or shooting sensations,or extreme sensitivity to touch. It is estimated that central neuropathic pain(pain initiated or caused by damage to the central nervous system, i.e. brain orspinal cord) occurs in up to 52% of people with multiple sclerosis (3). Up to32% of patients with MS regard pain among their most severe symptoms (4)describing it as frequent, disabling and inadequately managed (5). About GW Pharmaceuticals plc 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 thatalleviate pain and other neurological symptoms in patients who suffer fromserious ailments. GW has assembled a team of over 100 scientists with extensiveexperience in developing both plant-based prescription pharmaceutical productsand medicines containing controlled substances. GW occupies a world leadingposition in cannabinoids and has developed an extensive international network ofthe most prominent scientists in the field. For further information, pleasevisit the Company's website: www.gwpharm.com This news release may contain forward-looking statements that reflect GWscurrent expectations regarding future events, including development andregulatory clearance of the GW's products. Forward-looking statements involverisks and uncertainties. Actual events could differ materially from thoseprojected herein and depend on a number of factors, including (inter alia), thesuccess of the GW's research strategies, the applicability of the discoveriesmade therein, the successful and timely completion of uncertainties related tothe regulatory process, and the acceptance of Sativex and other products byconsumer and medical professionals. Footnotes: (1) D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812 (2) Neuropathy Trust 2005. www.neurocentre.com (Source September 2005) (3) Biovie J. Central Pain. In: Wall PD, Melzack R, eds. Textbook of pain, 4th ed. Hong Kong: Harcourt Publishers Ltd, 1999:879-914 (4) Stenager E, Knudsen L, Jensen K. Acute and chronic pain syndromes in multiple sclerosis. Acta Neurol Scand 1991;84:197-200 (5) Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr Opin Neurol 1998;11(4):III05-III09 This information is provided by RNS The company news service from the London Stock Exchange