GWP.L Regulatory News (GWP)

7 Aug 2007 07:00

GW Pharmaceuticals PLC07 August 2007 Health Canada Approves Sativex(R) For Cancer Pain Innovative Treatment Option for Cancer Pain Now Available in Canada Porton Down, UK; Toronto, Canada - August 7, 2007- GW Pharmaceuticals plc (AIM:GWP) and Bayer Inc., a subsidiary of Bayer AG, today announce that Health Canadahas approved Sativex(R), a cannabis derived pharmaceutical treatment, asadjunctive analgesic treatment in adult patients with advanced cancer whoexperience moderate to severe pain during the highest tolerated dose of strongopioid therapy for persistent background pain. Sativex, the only pharmaceuticalproduct derived from components of the cannabis plant, is administered through aspray into the patient's 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. In 2005, Health Canada approved Sativex for the treatment of neuropathic pain inadults with multiple sclerosis (MS) under the NOC/c policy. Sativex is a buccal spray composed primarily of delta-9-tetrahydrocannabinol(THC) and cannabidiol (CBD), a non-psychoactive cannabinoid. The product isstandardized by both composition and dose. Sativex is thought to act viacannabinoid receptors that are distributed throughout the central nervous systemand in immune cells (1). These receptors are distributed throughout the painpathways of the nervous system, and their activation is known to reduce pain inrelevant pain models. Dr. Geoffrey Guy, GW's Chairman, commented: "GW is delighted to receive HealthCanada's regulatory approval for Sativex in the relief of cancer pain. Sativexhas been shown to provide important pain relief to the most high need patientswith advanced cancer. We are pleased to be able to offer the prospect of animproved quality of life for people who previously had little such opportunity." "Bayer HealthCare is committed to putting the needs of patients first and isvery pleased that Sativex can now be used to manage cancer pain in Canada," saidPhilip Blake, president and CEO, Bayer Inc. "Health Canada's approval ofSativex is further recognition of the important role this medicine can play ineffective pain treatment." "Cancer pain is not managed as well as it could be and the resources availableto manage cancer pain effectively are still somewhat limited. Cannabinoids havean important role in treating complex cancer pain particularly neuropathic painand demonstrate a positive effect with current treatment options," said Dr.Lawrence Librach, Director of the Temmy Latner Centre for Palliative Care atMount Sinai Hospital and Vice President of the Canadian Hospice Palliative CareAssociation. Cancer Statistics in Canada According to the Canadian Cancer Society, an estimated 159,900 new cases ofcancer and 72,700 deaths will occur in Canada this year alone. On average, eachweek 3,075 Canadians will be diagnosed and 1,398 will die of cancer. Based oncurrent incidence rates, 39 per cent of Canadian women and 44 per cent of menwill develop cancer during their lifetimes. Cancer is the leading cause ofpremature death - or early death - in Canada: 1,006,000 potential years werelost in 2003 as a result of cancer. This represents 32 per cent of thepotential years of life lost resulting from all causes of death (2). Advanced Cancer in Canada Advanced cancer is one that may have spread to other places in the body beyondits origin and usually cannot be cured or controlled with treatment. Sixty to90 per cent of patients with advanced cancer will experience moderate to severepain, regardless of age, gender and whether or not they are hospitalized(3,4,5). For these patients, pain will interfere with their sleep, dailyactivities, enjoyment of life, work capacity, and social relations (6). Data Demonstrates Promising Efficacy The efficacy of Sativex has been demonstrated in a double-blind placebocontrolled parallel group study in patients with cancer pain. Patients in thestudy had advanced cancer and were experiencing pain that was not respondingadequately to strong opioid medication (e.g. morphine). In addition to studymedication, all patients remained on their existing opioid and other analgesicmedication during the trial. In this study, Sativex achieved a statistically significant improvement in painrelief, in comparison with placebo. The study further showed that in patientswith advanced cancer who were already taking the strongest available paintreatments, more than four of ten patients taking Sativex were able to achieve afurther clinically important reduction in pain (7). Principal Components A product resulting from the pioneering research efforts of UK-based GWPharmaceuticals plc and marketed in Canada by Bayer HealthCare Pharmaceuticals,Sativex was first indicated in Canada in 2005 as adjunctive treatment for thesymptomatic relief of neuropathic pain in MS. Sativex contains Tetranabinex(R)and Nabidiolex(R), extracts of chemically and genetically characterised Cannabissativa L. plants (hemp plants). Its principal active cannabinoid components areTHC and CBD.8 The ratio of THC to CBD in Sativex is 2.7mg:2.5mg per spray,ensuring a standardized dose is delivered each time it is used (8). How Sativex Works Sativex 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. Sativex and Side-Effects In 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 (9). About Bayer Inc. Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an internationalresearch-based group with core businesses in health care, crop science, andinnovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group'sHealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc.,headquartered in Calgary, Alberta operates as a separate legal entity in Canada.Together, the companies play a vital role in improving the quality of life forCanadians - producing products that fight diseases, protecting crops andanimals, and developing high-performance materials for applications in numerousareas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Ottawaand Calgary. Bayer Inc. has approximately 1,000 employees across Canada and hadsales of over $910 million CDN in 2006. Globally, the Bayer Group had sales ofover 28 billion Euro in 2006. Bayer Inc. invested approximately $47 million CDN in research and development in2006. Worldwide, the Bayer Group spends the equivalent of over 2 billion Euroin 2006 in R&D. About GW Pharmaceuticals GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under license from the UK Home Office, thecompany researches and develops cannabinoid pharmaceutical products thatalleviate pain and other neurological symptoms in patients who suffer fromserious ailments. GW has assembled a team of over 100 scientists with extensiveexperience in developing both plant-based prescription pharmaceutical productsand medicines containing controlled substances. GW occupies a world leadingposition in cannabinoids and has developed an extensive international network ofthe most prominent scientists in the field. For further information, pleasevisit www.gwpharm.com Footnotes: (1) Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Last accessed December 16 2005. Available at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/ Sativex_factsheet_e.html (2) Canadian Cancer Society. General Cancer Stats for 2007 http://www.cancer.ca/ ccs/internet/standard/0,2283,3172_14423__langId-en,00.html (3) Cleeland CS, et al. Multidimensional measurement of cancer pain: comparisons of US and Vietnamese patients. J Pain Symptom Manage 1988;3:23-7 (4) Cleeland CS, et al. Dimensions of the impact of cancer pain in a four country sample: new information from multidimensional scaling. Pain 1996;67: 267-73. (5) Stjernsward, J Clark, D. Palliative medicine: a global perspective. In: D Doyle, GWC Hanks N Cherny, KC Calman (eds) Oxford Textbook of Palliative Medicine Third ed. Oxford: Oxford University Press. 2003. (6) Maunsell E, et al. A brief pain diary for ambulatory patients with advanced cancer: acceptability and validity. Cancer 2000;88:2387-97. (7) Sativex Product Monograph - June 2007. (8) Sativex Product Monograph - June 2007. (9) Sativex Product Monograph - June 2007. 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. Enquiries:GW Pharmaceuticals plc Today: +44 20 7831 3113Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000Justin Gover, Managing DirectorMark Rogerson, Press and PR Tel: + 44 7885 638810 Financial Dynamics Tel: +44 20 7831 3113David Yates, Ben Atwell Bayer Inc.Emily Hanft Tel: +1 416 240 5252 This information is provided by RNS The company news service from the London Stock Exchange