GWP.L Regulatory News (GWP)

10 Jun 2005 07:00

GW Pharmaceuticals PLC10 June 2005 For Immediate Release 10 June 2005 GW Pharmaceuticals plc ("GW" or "the Company") UK Regulatory Update Medicines Commission Confirms Further Clinical Efficacy Data Required In December 2004, GW announced that the Committee on Safety of Medicines (CSM),an advisory body to the UK regulatory authority, the Medicines and Healthcareproducts Regulatory Agency (MHRA), had advised that a further clinical study inMultiple Sclerosis (MS) Spasticity would be required prior to the grant of a UKproduct licence for Sativex(R). At that time, the CSM confirmed that there wereno quality or safety issues that would prevent the grant of a product licence. GW elected to appeal against the CSM's decision to request a further study tothe Medicines Commission, the senior advisory body to the MHRA. The MedicinesCommission met in mid May and received a presentation supporting the approval ofSativex by a number of the UK's leading experts in the field. The appeal wasalso attended by MS patient representative organisations. At a meeting with senior officials at the MHRA yesterday afternoon, GW wasinformed that the Medicines Commission has declined GW's appeal. The Commissionhas determined that the evidence of efficacy of Sativex in MS Spasticity is notyet sufficiently compelling. In December 2004, GW announced its intention to start an additional MSSpasticity study in parallel to the Medicines Commission process. This 280patient study has now commenced and is due to report results in Spring 2006. Meanwhile, Sativex has received regulatory approval in Canada in the treatmentof Neuropathic Pain in MS. The product is due for Canadian launch imminently. Professor Mike Barnes, President of the World Federation ofNeuro-rehabilitation, Chairman of the Royal College of Physicians RehabilitationCommittee and Professor of Neurological Rehabilitation at the University ofNewcastle-upon-tyne, said, "It is my view that there is excellent clinicalevidence to support the regulatory approval of Sativex in the UK. I am verydisappointed that the Medicines Commission did not follow the recommendation ofmyself and other leading experts in the treatment of MS. People with MS haveconsiderable unmet medical needs and I am deeply saddened that the regulators donot yet feel in a position to licence this important product." The MHRA's position relates solely to the indication of MS Spasticity. GW willcontinue to progress its research programme for the use of Sativex in a range ofindications. In addition to its MS programme, GW has reported positive Phase IIIdata in Neuropathic Pain and two further neuropathic pain trials are commencingin support of a future regulatory filing in this indication. In addition, havingreported a positive Phase III Cancer Pain trial earlier this year, the Companyis now planning an additional trial which will provide a registration packagefor this indication also. GW remains in a strong financial position, with net cash balances of £16.2m atend of May 2005. Dr Geoffrey Guy, Executive Chairman, said, "We are disappointed that the UKregulators consider that the efficacy data is not yet sufficiently compelling tomake Sativex available to UK patients for the relief of MS Spasticity. Our view,which is shared by prominent experts in the field, is that the existing clinicaldata shows that Sativex provides an important new treatment option for patientswith MS. We know that UK patients will share our disappointment at the decisionof the regulators to delay its introduction. "It is clear from our discussions with the regulatory authority that theyrecognise the promising results seen to date and they have expressed a desire toprovide constructive advice to GW as to how the regulatory requirements may bestbe met. "Whilst today's news is disappointing, the fundamentals for the company remainstrong. Sativex will be available on prescription to MS patients in Canadaimminently. Furthermore, we have produced a wealth of positive clinical trialsdata, including seven Phase III trials and have a range of further trialsunderway. GW also retains its world leading position in cannabinoid science.Today's setback will only serve to reinforce our determination to bring thisimportant and innovative new medicine to the UK market." GW Pharmaceuticals will provide a further update when it announces interimresults on 20 June, 2005. - Ends - GW Pharmaceuticals plc (10/6/05) + 44 (0)20 7067 0700Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 (0)1980 557000Justin Gover, Managing Director Weber Shandwick Square Mile + 44 (0)20 7067 0700Kevin Smith/Rachel Taylor/Yvonne Alexander This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Company's products. Forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including (inter alia), the success of the Company's research strategies, theapplicability of the discoveries made therein, the successful and timelycompletion of clinical studies, including with respect to Sativex and theCompany's other products, the uncertainties related to the regulatory process,and the acceptance of Sativex and other products by consumers and medicalprofessionals. This information is provided by RNS The company news service from the London Stock Exchange