GWP.L Regulatory News (GWP)

9 Aug 2006 07:00

GW Pharmaceuticals PLC09 August 2006 GW PHARMACEUTICALS PLC ("GW" or "the Company") Start of Second Phase III Trial in MS Neuropathic Pain Porton Down, UK, 9 August 2006 - GW Pharmaceuticals plc (AIM: GWP) announces thestart of a second pivotal Phase III trial in people with multiple sclerosis (MS)suffering from central neuropathic pain. The first patient has now been enrolledin the study. This Phase III study is a double-blind randomised placebo-controlled study ofSativex in 218 patients with central neuropathic pain due to MS, who haveachieved inadequate pain relief with existing therapies. This study thereforeaims to address a currently unmet medical need and will be recruiting patientsin the UK, Canada, France, Spain and the Czech Republic. The primary outcomemeasure in the study is the 0-10 Numeric Rating Scale pain score, as recommendedby regulatory authorities in both Europe and North America. The study isexpected to report headline results in about one year. 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). It is regulatory convention for two pivotal Phase III trials in the same patientpopulation to be required to support a product approval for a particularindication. This second pivotal Phase III study in MS Neuropathic Pain has anumber of important roles in the regulatory strategy for Sativex, as follows: • In Europe, this second pivotal study will complete a clinical datapackage to support a regulatory submission for Sativex in the indication of "MSNeuropathic Pain" • In Europe, this study is intended to enhance the data package arisingfrom GW's two ongoing peripheral neuropathic pain studies, to support a broadindication of "General Neuropathic Pain" as identified in recent EU guidelines • In Canada, this study is intended to meet the conditions associatedwith the approval of Sativex in order to obtain a full Notice of Compliance. Sativex is already approved in Canada as adjunctive treatment for thesymptomatic relief of neuropathic pain in MS. Canada was the first country inthe world to approve Sativex. Health Canada approved Sativex under the Notice ofCompliance with Conditions policy. Dr Stephen Wright, R&D Director, said, "GW has in place a broad regulatorystrategy to support the global approval of Sativex across multiple relatedindications including neuropathic pain and spasticity in multiple sclerosis,peripheral neuropathic pain and cancer pain. One of the principal purposes ofthis study is to complete the regulatory package required for the approval inEurope of Sativex in the indication of neuropathic pain in MS. "Neuropathic pain is a debilitating symptom of MS and is often under treated andinadequately controlled. Our data show that Sativex has a valuable role to playin treating this significant unmet medical need." Enquiries:GW Pharmaceuticals plc Today: +44 (0)20 7831 3113Justin Gover, Managing Director Financial Dynamics Tel: +44 (0)20 7831 3113David YatesSarah MacLeod Notes to Editors Sativex Sativex is derived from whole plant extracts of two specifically bred cannabisplant varieties. The extracts are combined to produce a standardisedformulation containing two major components of cannabis, the cannabinoidsD9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Sativex is formulated into a pump action oromucosal (mouth) spray designed forself-administration by the patient. Each spray of Sativex delivers a fixed doseof 2.7mg THC and 2.5mg CBD. Sativex Phase III Trials Programme GW's ongoing Phase III trials programme has been the subject of formalregulatory advice in Europe and North America and is designed to obtainapprovals for Sativex across global markets in the following indications. Thisprogramme is summarized below: - Peripheral neuropathic pain o Two Phase III studies in the peripheral neuropathic pain indication are due to complete before the end of this year. These studies meet formal pan-European regulatory guidelines in the indication of peripheral neuropathic pain and would support a filing in this indication in Europe. - Neuropathic pain in MS o This indication is approved in Canada. The Phase III MS neuropathic pain trial started today complements the positive Phase III study already completed, and will provide data for a filing in this indication in Europe. - General neuropathic pain o The three studies listed above will together provide a regulatory package in Europe for the broad indication of general neuropathic pain. - Spasticity in MS o GW has previously reported two pivotal Phase III in MS spasticity, Regulatory advice meetings being held to consider possibility of MS spasticity submission in Europe. Decision to be taken in second half of 2006. - Cancer pain o The FDA has accepted an IND for Sativex to commence Phase III trials in the US for this indication. The first trial is due to commence around the end of this year. US development will also contribute to a future European filing in this indication. 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 at least 2.4% of the world's population suffers fromneuropathic pain (2), including over 1.4 million patients in UK. It is estimated that central neuropathic pain (pain initiated or caused bydamage to the central nervous system, i.e. brain or spinal cord) occurs in up to52% of people with multiple sclerosis (3). Up to 32% of patients with MS regardpain among their most severe symptoms (4) describing it as frequent, disablingand 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 is developing cannabis-derived pharmaceutical products for patients withmultiple sclerosis, neuropathic pain, cancer pain, spinal cord injury,rheumatoid arthritis, and other severe medical conditions. GW has assembled a team of over 100 scientists with extensive experience indeveloping both plant-based prescription pharmaceutical products and medicinescontaining controlled substances. GW is dedicated to developing treatmentoptions that alleviate pain symptoms in patients who suffer from seriousailments. For further information, please visit the Company's website: www.gwpharm.com 1. D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlledtrial 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 inmultiple sclerosis. Acta Neurol Scand 1991;84:197-200 5. Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr OpinNeurol 1998;11(4):III05-III09 This information is provided by RNS The company news service from the London Stock Exchange