GWP.L Regulatory News (GWP)

20 Jun 2005 07:02

GW Pharmaceuticals PLC20 June 2005 For Immediate Release 20 June 2005 GW Pharmaceuticals plc ("GW" or "the Company") Sativex(R) Launched in Canadian Market by Bayer HealthCare GW is pleased to announce that, following the receipt of regulatory approvalfrom Health Canada, Sativex is now available by prescription through Canadianpharmacies as an adjunctive treatment for symptomatic relief of neuropathic painin adults with Multiple Sclerosis (MS). In April 2005, Canada became the firstcountry in the world to approve Sativex, an effective and safe cannabis derivedprescription medicine. Sativex is manufactured in the UK by GW and its contract manufacturing partners.The product is being marketed in Canada by Bayer HealthCare, PharmaceuticalsDivision, GW's marketing partner. Sativex is administered through a spray pump under the tongue or on the insideof the cheek, providing reliable, self-administered pain relief. Its principalactive cannabinoid components are delta-9-tetrahydrocannabinol (THC) andcannabidiol (CBD). Sativex is a pharmaceutical product standardised incomposition, formulation, and dose. While there is no complete cure for MS orneuropathic pain, a double-blind placebo controlled parallel group studydemonstrated that Sativex provided significantly greater pain relief thanplacebo. Sativex also significantly reduced pain-related sleep disturbance. MS is a disease of the central nervous system and is the most commonneurological disease affecting young adults in Canada. It is estimated that 50per cent of people with MS suffer from chronic neuropathic pain(1),(2),(3).Approximately 50,000 Canadian men and women have the disease(4). "Effective pain control and management are extremely important in a disease likeMS," said Dr. Allan Gordon, Neurologist and Director of the Wasser PainManagement Centre, and of the Edward Bronfman Family Foundation MS ResearchClinic at Mount Sinai Hospital, Toronto, Ontario. "The availability of Sativexaddresses the great demand for an effective treatment option in the field ofneuropathic pain in MS. Many patients, including some in my own practice, reportusing cannabis for relief of their pain." "Sativex will be welcomed by the Canadian MS community," said Dr. William J.McIlroy, National Medical Advisor, Multiple Sclerosis Society of Canada."Neuropathic pain associated with MS is often under treated and undercontrolled. The availability of Sativex will now allow people living with MS andneuropathic pain a new treatment option to address one of the more debilitatingsymptoms associated with the disease." Dr Geoffrey Guy, Executive Chairman of GW, commented: "Market launch of Sativexin Canada is a major milestone in GW's development and marks not only our firstsuccessful product launch but the first launch of a cannabis derivedprescription medicine anywhere in the world. GW has not only been responsiblefor securing regulatory approval in Canada but has also established commercialmanufacturing capability so that it can supply Sativex to the Canadian market.We can now look forward to receiving our first sales revenues through supply ofproduct to Canada." - 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/Rachel Taylor/Yvonne Alexander Bayer Inc. 001 416 240 5252Lori Ann Horrigan 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 clinical trials programme can be found atwww.gwpharm.com. GW's clinical research programme is being carried out by a teamof pharmaceutical professionals experienced in drug development and, inparticular, the development of plant-based medicines and drug delivery systems. 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.--------------------------(1) Archibald CJ, et al. Pain 1994; 58:89-93.(2) Sketris IS, et al. Clinical Therapeutics 1996; 18(2):303-318.(3) Moulin DE, et al. Neurology 1988;38:1830-1834.(4) www.mssociety.ca This information is provided by RNS The company news service from the London Stock Exchange