GWP.L Regulatory News (GWP)

3 Dec 2007 07:00

GW Pharmaceuticals PLC03 December 2007 GW Commences Sativex(R) Phase III Clinical Trial in MS Spasticity Trial Designed to Secure European Regulatory Approval in MS Spasticity Indication Porton Down, UK; 3 December 2007: GW Pharmaceuticals plc (AIM: GWP) todayannounces that it has started a new Phase III trial of Sativex(R) in MultipleSclerosis (MS) Spasticity. This trial is designed to resolve the outstandingissue arising from the recent European regulatory submission and to provide thebasis for regulatory approval of Sativex in the indication of MS Spasticity. Thestudy aims to report headline results towards the end of 2008. The protocol design of this study follows clear guidance provided by theregulators in both their recent regulatory assessment and additional scientificadvice meetings. The objective of the study is to satisfy the regulator's outstanding requirementfor clarification related to the magnitude of the treatment effect of Sativex in"responders" (those patients that respond to treatment). In previous MSSpasticity clinical trials, the benefit obtained by responders has to someextent been masked by looking at the mean improvement across the whole studiedpatient population, which comprises both responders and non-responders. GW's existing clinical data in MS Spasticity, analysed on a "post-hoc" basis,has shown that responders can be reliably identified after four weeks treatmentand that, after 12 weeks, the difference from placebo is clinically importantand highly statistically significant (p=0.015). The regulators have requiredthat this analysis be replicated in a prospectively planned study. The new study therefore follows an "enriched design" which first identifiesresponders over a four week period (Phase A), and then focuses on analysing theeffect of Sativex vs placebo on those responders over a further period of 12weeks (Phase B). The study aims to recruit a total of 244 patients into Phase B.The primary endpoint of the study is the difference between the Sativex andplacebo groups in Phase B of the study in MS Spasticity as measured on a NumericRating Scale. This study will include hospital centres across five Europeancountries. Dr Stephen Wright, R&D Director, said, "This new study is an explicitrequirement of the regulatory authorities and provides a route to approval forSativex in the relief of MS-related spasticity. This study is designed toprovide compelling evidence of clinically relevant benefit for Sativex in thispopulation of people with MS and we look forward to reporting results towardsthe end of 2008." Sativex Resubmission There are now two potential short term opportunities to re-submit Sativex forregulatory approval in Europe. In the indication of MS Neuropathic Pain, asecond pivotal Phase III trial has already completed patient recruitment and isdue to report headline results in the first quarter of 2008. This could lead toa regulatory filing in this indication in the first half of 2008. In the eventthat GW does not submit the MS Neuropathic Pain indication, the secondopportunity is to resubmit for MS Spasticity following completion of the newstudy which has commenced today. In addition to the MS indications, future European regulatory submissions areplanned for Sativex in cancer pain and in peripheral neuropathic pain. Thecancer pain clinical development programme is being conducted in the UnitedStates and funded under the collaboration with Otsuka Pharmaceutical Co. Ltd. Enquiries: GW Pharmaceuticals plc Today: +44 20 7831 3113Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000Justin Gover, Managing DirectorMark Rogerson, Press and PR Tel: + 44 7885 638810 Financial Dynamics Tel: +44 20 7831 3113David Yates, Ben Atwell Notes to Editors About Sativex Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC(delta 9 tetrahydrocannabinol). Sativex is administered as a metered doseoro-mucosal spray; each 100uL spray contains 2.7mg THC and 2.5mg CBD. TheSativex formulation is standardized by both composition and dose and is suppliedin small spray vials. The components of Sativex have been shown to bind tocannabinoid receptors that are distributed throughout the central nervous systemand in immune cells. Sativex is already approved and marketed in Canada as adjunctive treatment forthe symptomatic relief of neuropathic pain in MS, and for the relief of cancerpain. Health Canada has approved Sativex under its Notice of Compliance withconditions (NOC/c) policy. In the US, the lead indication for Sativex is cancer pain. On 26 November, GWand its US licensing partner, Otsuka, announced that the first US Phase II/IIIcancer pain trial had been initiated. GW has to date entered into three Sativex license agreements - with Otsuka inthe US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe(ex-UK). 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 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 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(R) and other products byconsumer and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange