GWP.L Regulatory News (GWP)

6 Jun 2005 18:19

GW Pharmaceuticals PLC06 June 2005 For Immediate Release 6 June 2005 GW Pharmaceuticals plc ("GW" or "the Company") Statement Re: Media Comment GW notes recent media comment. 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 aproduct licence for Sativex. GW elected to appeal against the CSM's decision tothe Medicines Commission, the senior advisory body to the MHRA. The Company confirms that this appeal was considered by the Medicines Commissionat its meeting in mid May. GW has yet to be informed of any recommendations made by the Commission to theMHRA, nor has it received any communication from the MHRA since the meeting. Prior to the meeting, GW was informed that it may take a number of weeks for theMHRA to formally notify the outcome of the meeting to the Company. The Companywill issue a further statement as soon it has received notification of thedecision by the MHRA. - Ends - GW Pharmaceuticals plc + 44 (0)1980 557000Justin Gover, Managing Director Weber Shandwick Square Mile + 44 (0)20 7067 0700Kevin Smith 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