19th Apr 2005 11:38
GW Pharmaceuticals PLC19 April 2005 Embargoed until 1135 19 April 2005 GW Pharmaceuticals plc ("GW" or "the Company") GW Announces Regulatory Approval of Sativex(R) in Canada GW announces that Sativex(R) has been granted regulatory approval in Canada forthe symptomatic relief of neuropathic pain in multiple sclerosis. Dr Geoffrey Guy, Executive Chairman, said, "We are delighted that Sativex hasreceived regulatory approval in Canada. This event marks the world's firstapproval of a cannabis derived medicine. This first regulatory approval has beenobtained by GW in just over six years since the Company's development programmecommenced, a highly significant achievement. We are now working with ourCanadian marketing partner, Bayer, towards the launch of Sativex throughoutCanada in late Spring." The full text of a joint statement released today with Bayer Healthcare, followsbelow: HEALTH CANADA FIRST TO APPROVE A NOVEL CANNABIS DERIVED PHARMACEUTICAL TREATMENT FOR PEOPLE WITH MULTIPLE SCLEROSIS TORONTO, Ontario -- (19 April 2005) - Health Canada has approved Sativex(R)(Cannabis sativa L. extract) a new drug developed as adjunctive treatment forthe symptomatic relief of neuropathic pain in adults with multiple sclerosis(MS). Canada becomes the first country in the world to approve Sativex, a novelprescription pharmaceutical product derived from components of the cannabisplant shown to have therapeutic properties. Sativex is administered via a sprayinto the mouth. Health Canada has approved Sativex with conditions, under the Notice ofCompliance with Conditions (NOC/c) policy. This authorization reflects thepromising nature of the clinical evidence which will be confirmed with furtherstudies. Products approved under Health Canada's NOC/c policy, have demonstratedpromising benefit, are of high quality and possess an acceptable safety profilebased on a benefit/risk assessment for the approved use. "Effective pain control and management are extremely important in a disease likeMS," said Dr. Allan Gordon, Neurologist and Director of the Wasser PainManagement Centre, Mount Sinai Hospital, Toronto, Ontario. "The approval ofSativex in Canada reflects the urgent need for additional treatment options inthe field of neuropathic pain in MS." Neuropathic painPain is a common symptom of MS occurring in up to 86 per cent of people with MS.(1) Neuropathic or nerve pain can occur spontaneously or can be provoked bytouch, temperature or movement. It is estimated that 50 per cent of people withMS suffer from chronic neuropathic pain.(2),(3),(4) The most common descriptionsof neuropathic pain are of freezing, cold or burning sensations usually of thelimbs and most often of the lower extremities.(5) Many individuals withneuopathic pain respond inadequately to current treatment options.(6),(7) "It's hard to explain to someone who has never felt this type of pain. It's likebeing plugged into an electric socket all the time," said Steve Walsh, whosuffers from MS and has lived with neuropathic pain for five years. "At times,putting on clothes or anything touching me can be too much to take," he added. Data demonstrates efficacyWhile there is no complete cure for MS or neuropathic pain, a double-blindplacebo controlled parallel group study demonstrated that Sativex providedsignificantly greater pain relief than placebo. Sativex also significantlyreduced pain-related sleep disturbance. Principal componentsA product resulting from the pioneering research efforts of UK-based GWPharmaceuticals plc and marketed in Canada by Bayer HealthCare, PharmaceuticalsDivision, Sativex is the first product indicated in Canada as adjunctivetreatment for the symptomatic relief of neuropathic pain in MS. Its principal active cannabinoid components are delta-9-tetrahydrocannabinol(THC) and cannabidiol (CBD). The ratio of THC to CBD in Sativex is2.7 mg : 2.5 mg per spray, ensuring a standardized dose is delivered each timeit is used. "The approval of Sativex is good news for the Canadian MS community. Peopleliving with MS and neuropathic pain need new options to address their pain.Sativex will likely be welcomed by the many people with MS, whose quality oflife has been further compromised with neuropathic pain," said Dr. William J.McIlroy, National Medical Advisor, MS Society of Canada. How Sativex worksSativex is administered through a spray pump under the tongue or on the insideof the cheek, providing reliable, self-administered pain relief. The sprayformulation allows for more flexible dosing than an oral tablet, well suited tothe variable nature of neuropathic pain experienced by people with MS. "Because Sativex is designed for self-administration, this allows for flexibledosing and puts the patient in control of their pain," said Dr. Gordon. "This isvery important since pain severity varies between different patients and even inthe same patient at different times." Sativex and side-effectsIn clinical trials, the most frequent side-effects included nausea, fatigue,dizziness and application site reactions. Side-effects were usually mild ormoderate in severity and often resolved with down-titration or interruption oftreatment.(8) Sativex is expected to be available through Canadian pharmacies by late Spring2005. Multiple sclerosis (MS) in Canada(9)MS is a disease of the central nervous system and is the most commonneurological disease affecting young adults in Canada. Approximately 50,000Canadian men and women have the disease and each day approximately three morepeople are diagnosed. MS is most often diagnosed in people between the ages of20 to 40 years of age. - Ends - Enquiries: GW Pharmaceuticals plc Today: (44) 20 7067 0700Dr Geoffrey Guy, Chairman Thereafter: (44) 1980 557000Justin Gover, Managing DirectorMark Rogerson, Press and PR (Europe/Canada) (44) 7885 638810John Pastuovic, Press and PR (US) 001 312 925 9092 Weber Shandwick Square Mile (44) 20 7067 0700Kevin Smith Bayer Inc.Lori Ann Horrigan 001 416 240 5252 About Bayer HealthCare AGBayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading,innovative companies in the health care and medical products industry. In 2004,the Bayer HealthCare subgroup generated sales amounting to some 8.5 billionEuro. The company combines the global activities of the divisions Animal Health,Biological Products, Consumer Care, Diabetes Care, Diagnostics andPharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004. Bayer HealthCare's aim is to discover and manufacture innovative products thatwill improve human and animal health worldwide. The products enhance well-beingand quality of life by diagnosing, preventing and treating disease. This news release contains forward-looking statements based on currentassumptions and forecasts made by Bayer Group Management. Various known andunknown risks, uncertainties and other factors could lead to materialdifferences between the actual future results, financial situation, developmentor performance of the company and the estimates given here. These factorsinclude those discussed in our public reports filed with the Frankfurt StockExchange and with the U.S. Securities and Exchange Commission (including ourForm 20-F). The company assumes no liability whatsoever to update theseforward-looking statements or to conform them to future events or developments. 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 program can be found atwww.gwpharm.com. GW's clinical research program 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. References:--------------------------(1) Ehde DM et al. Multiple Sclerosis 2003; 9; 605-611.(2) Archibald CJ, et al. Pain 1994; 58:89-93.(3) Sketris IS, et al. Clinical Therapeutics 1996; 18(2):303-318.(4) Moulin DE, et al. Neurology 1988;38:1830-1834.(5) Multiple Sclerosis International Federation www.msif.org/print.rm?id=10188(6) Harden N and Cohen M. Journal of Pain Symptom Management 2003; 25 (5 Suppl):S12-S17.(7) New Directions in Neuropathic Pain: Focusing Treatment on Symptoms and Mechanisms. Royal Society of Medicine Press Ltd.: 2000.(8) Sativex Product Monograph - April 2005(9) www.mssociety.ca This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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