GWP.L Regulatory News (GWP)

20 Jul 2007 07:00

GW Pharmaceuticals PLC20 July 2007 Regulatory Update Porton Down, UK, 20 July 2007: GW Pharmaceuticals plc (AIM: GWP) announces thatit has chosen to withdraw its current regulatory application for Sativex inEurope and that it expects to resubmit an application for approval in 2008. Thisfollows constructive and detailed discussions with regulatory authorities inwhich they have provided a clear path to approval for Sativex in the treatmentof MS Spasticity. MS Spasticity Application In September 2006, GW filed an application for Sativex under the decentralisedprocedure in four European countries (UK, Spain, Denmark, Netherlands) for therelief of MS Spasticity. GW has been able to resolve successfully all the majorquestions raised by the regulators during this process except one, and at ameeting with the UK assessors this week, it became clear that this outstandingissue requires the generation of additional data. As European regulatory rulesdo not permit the introduction of new data as part of the current process, GWhas elected to withdraw and resubmit its application. The current regulatory application process has confirmed that quality and safetydata are already sufficient to support a marketing authorisation of Sativex. Theregulators have also confirmed that existing efficacy data provide statisticallysignificant evidence and "could in principle lead to a positive risk benefitconclusion". In addition, regulators have recognised that a large proportion ofotherwise treatment-resistant patients respond to Sativex by obtainingclinically meaningful improvements in spasticity. Sativex provides benefit to the most high need MS patients who have no furthertherapeutic options available. The regulator's outstanding clarification relatesto the fact that in a clinical trial context, the benefit obtained by "responders" can be masked by looking at the mean improvement across the wholestudied patient population, which comprises both responders and non-responders.The regulators therefore wish to be able to identify Sativex responders in thefirst 4 weeks of treatment and to confirm that the improvements gained by suchresponders over a further 12 week period is significantly greater than placebo. As part of the current regulatory process, GW performed analyses of existingdata showing that responders can be reliably identified after 4 weeks and that,after 12 weeks, the difference from placebo is clinically important and highlystatistically significant (p=0.015). The regulators view this as acceptableevidence of efficacy in principle but consider these analyses technically to be"post-hoc" since they were performed at the regulator's request followingcompletion of the trials. They require such data to be produced as part of aprospectively planned analysis and hence GW will undertake an additional studyto re-confirm this result prior to resubmitting its regulatory application. The regulators have given GW clear guidance as to the design of the furtherstudy required, which differs from a conventional Phase III design. The study isexpected to start recruiting patients in the next few months, with the resultsdue in the second half of 2008. The regulators have specified a novel "enricheddesign" which first identifies responders over a 4 week period, and then focuseson analysing the effect of Sativex vs placebo on those responders over a furtherperiod of time. GW's clinical plans for the next twelve months have for some time included afurther MS Spasticity trial and the regulator's specific design requirementswill therefore be incorporated into the planned study. This study is alreadywithin GW's budget for 2008, will not result in any increase in rate of R&Dexpenditure above current levels and will be financed from existing cashresources, which today stand at £19.5m. Sativex Resubmission There are two potential opportunities for early re-submission in Europe nextyear. In the indication of MS Neuropathic Pain, a second pivotal Phase III trialcompletes in early 2008 which could lead to a regulatory filing in thisindication at that time. Since this is a distinct indication from MS Spasticity,the outstanding issue identified as part of this recent application would not berelevant. In the event that GW does not submit for this indication, the secondopportunity is to resubmit for MS Spasticity later in 2008 following completionof the new study outlined above. Dr Stephen Wright, R&D Director, said, "We are encouraged that the regulatorssee Sativex as providing useful efficacy and that they accept our quality andsafety data as sufficient for approval. This regulatory application has providedus with a clear route to approval for Sativex in the relief of MS Spasticity. Wehave received detailed and constructive guidance from the regulators on how tosatisfy their single outstanding requirement and are confident that we canaddress this. "We expect to re-submit our application to the regulators in Europe in 2008,either in the indication of MS Neuropathic Pain or MS Spasticity. Elsewhere, welook forward to receiving final regulatory approval in Canada for the CancerPain indication in the coming weeks and our first large scale clinical trials inthe US are scheduled to commence in the late summer." Professor Mike Barnes, President of the World Federation ofNeuro-rehabilitation, Professor of Neurological Rehabilitation and ConsultantNeurologist, University of Newcastle, said, "The data clearly show that Sativexprovides valuable and much needed relief of MS Spasticity. Indeed, this medicineis able to treat some of the highest need MS patients, who currently have nofurther treatment options available. It is regrettable and unnecessary in myview, and in the view of other prominent members of the MS treatment community,that the regulators require GW to generate further data to show what we alreadyknow - that Sativex is a safe and efficacious treatment for people with MS." Dr Geoffrey Guy, GW Chairman, said, "We recognise that it is taking longer thanwe had hoped for Sativex to obtain approval in Europe. Each step, however, hasbeen one of progress towards achieving this goal. Whilst we complete these finalsteps, we will continue to respond to the needs of people with MS by ensuringSativex remains available under our named patient prescription programme." There will be a conference call for analysts today at 8.30am BST. Analystsshould contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113for details. There will be a live audio web cast of this call, which will beaccessible on the press releases page in the investor relations section of theGW website (www.gwpharm.com). A recording of this call will be available on theGW website later today. Enquiries:GW Pharmaceuticals plc Today: +44 20 7831 3113Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000Justin Gover, Managing Director Mark Rogerson, Press and PR Tel: + 44 7885 638810 Financial Dynamics Tel: +44 20 7831 3113David Yates, Ben Atwell About Sativex Sativex is being developed for approval in four target indications (MSSpasticity, MS Neuropathic Pain, Cancer Pain and Peripheral Neuropathic Pain).Each of these indications provides a distinct regulatory opportunity and issupported by a specific clinical development programme. In Canada, Sativex is approved for the relief of MS Neuropathic Pain and hasalso received a Qualifying Notice from the Canadian regulators for a furtherapproval in the relief of Cancer Pain. Final approval of the Cancer Painindication is expected shortly. In the United States, the lead indication for Sativex is Cancer Pain and,following a series of positive meetings with the Food & Drug Administration(FDA), late stage trials in that country are about to commence. 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). These agreements together have yielded financial terms to GW totaling$51m of signature fees, up to $376m of milestone payments as well as significantlong term supply price provisions. 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 and other products byconsumer and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange