GWP.L Regulatory News (GWP)

15 Nov 2005 07:02

GW Pharmaceuticals PLC15 November 2005 Embargoed until 0700 15 November 2005 GW Pharmaceuticals plc ("GW" or "the Company") UK Named Patient Prescribing for Sativex(R) GW announces that it has been informed by the Home Office that the DrugsMinister, Paul Goggins, has confirmed that Sativex(R) oromucosal spray, itscannabis-based medicine, may be imported from Canada to satisfy its prescriptionto individual patients in the UK as an unlicensed medicine. This development isin response to enquiries from a number of UK doctors and individual patients whohave been in contact with the Home Office to request access to Sativex. In accordance with the Medicines Act, a medicine which has yet to be licensed inthe UK may be prescribed and supplied in response to an unsolicited request tofulfil the special needs of an individual patient under a physician's directpersonal responsibility. The basis on which Sativex may be imported, therefore,is the clinical judgement of doctors in relation to specific nominated patients. This development follows the approval of Sativex by Health Canada in April 2005.The medicine has been available on prescription in Canada since late June. More recently, the Medicines and Healthcare products Regulatory Agency (MHRA)has issued to GW a Wholesale Dealer's (Importation from non-EU countries)Licence, and has not objected to the importation of Sativex under theregulations for importation of medicines unlicensed in the UK. Sativex will remain a Schedule 1 controlled drug in the UK in line with statedgovernment policy. This means that the prescribing of Sativex can only bepermitted under Home Office licence. The Home Office will therefore bedeveloping a licensing regime to fit these circumstances. GW expects to discussthe implementation practicalities with the Home Office over the coming weeks. Clearance for supply on an unlicensed basis does not affect GW's plans to seekfull regulatory approval from the MHRA for Sativex in the UK. The Company iscurrently conducting a number of further Phase III trials and is still planningto submit an application for Marketing Authorisation to the MHRA during 2006.Only after such an approval is granted can the product be promoted in the UK. - Ends- GW Pharmaceuticals plc + 44 (0)1980 557000Dr Geoffrey Guy, ChairmanJustin Gover, Managing DirectorMark Rogerson, Press and PR + 44 (0)7885 638810 Weber Shandwick Square Mile + 44 (0)20 7067 0700Kevin Smith/Yvonne Alexander About GW Pharmaceuticals plcGW Pharmaceuticals plc is licensed by the UK Home Office to undertake apharmaceutical research and development program to develop non-smokedcannabis-based prescription medicines. GW's shares are publicly traded on AiM, amarket on the London Stock Exchange. Full details of GW and the company's research programme can be found atwww.gwpharm.com. This news release may contain forward-looking statements that reflect GW'scurrent expectations regarding future events, including the clinical developmentand regulatory clearance of its 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 GW's research strategies, the applicability of the discoveries madetherein, the successful and timely completion of clinical studies, includingwith respect to Sativex and GW's other products, the uncertainties related tothe regulatory process, and the acceptance of Sativex and other products byconsumers and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange