GWP.L Regulatory News (GWP)

19 Oct 2006 07:00

GW Pharmaceuticals PLC19 October 2006 GW Files Sativex(R) Regulatory Submission in Canada for Cancer Pain Porton Down, UK, 19 October 2006 - GW Pharmaceuticals plc (AIM: GWP) ("GW" or "the Company") and Bayer HealthCare, Pharmaceuticals Division - Canada ("Bayer")announce that GW has submitted a regulatory application in Canada for Sativex(R)to seek approval for a new indication for the treatment of pain in patients withadvanced cancer that has not been adequately relieved by opioid medications. This submission follows a formal pre-submission meeting recently held withHealth Canada outlining the evidence of effectiveness of Sativex in this veryseriously ill patient population. Following this meeting, Health Canada advisedthat, on the basis of the clinical data presented, that a submission forconsideration under the Notice of Compliance with Conditions (NOC/c) policycould be made. Dr Geoffrey Guy, GW's Chairman, said, "This regulatory submission represents afurther step in our broad-based regulatory strategy for Sativex, which isdesigned to secure approvals for this important new medicine across a range ofseparate therapeutic indications in countries across the world over the comingyears." GW has completed a positive Phase III study in Europe in 177 patients withcancer pain. The trial was a multi-center double-blind, randomized, placebo-controlled parallel group study. Patients in the study had advanced cancer andwere experiencing pain that was not responding adequately to strong opioidmedication (e.g. morphine). In addition to study medication, all patientsremained on their existing opioid and other analgesic medication during thetrial. In this study, Sativex achieved a statistically significant improvementin comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that 43per cent of patients on Sativex showed a greater than 30 per cent improvement intheir pain (p=0.024). Cancer-related pain can be defined as pain caused by cancer, by cancer treatmentsuch as surgery, radiation therapy or chemotherapy, or by the side effects oftreatment. Severe pain is experienced by at least two thirds of patients withadvanced disease. It is estimated that between 14 per cent and 47 per cent ofthese patients will achieve inadequate pain relief from opioid based approachesand will continue to suffer pain.(i) Dr Jeremy Johnson, Principal Investigator for GW's completed cancer pain studyand Medical Director, Severn Hospice, UK, said, "Pain remains a significantunmet medical need for many patients with cancer, who may be unable to gainadequate pain relief from even the best use of existing strong opioid medicines.Furthermore, a proportion of patients are simply unable to tolerate opioids indoses that may be required to relieve their pain. In short, there is a clearneed for effective new analgesics. The results with Sativex show that it canprovide additional pain relief to this group of patients and may represent animportant new option in the treatment of cancer pain." Philip Blake, President and CEO of Bayer Inc., said "Pain is one of the mostdebilitating and feared symptoms of advanced cancer and once Sativex is approvedfor this indication, we look forward to making it available to these patients." Sativex is a buccal spray composed primarily of tetrahydrocannabinol (THC) andcannabidiol (CBD), a non-psychoactive cannabinoid. The product is standardizedby both composition and dose. Sativex is thought to act via cannabinoidreceptors that are distributed throughout the central nervous system and inimmune cells.(ii) These receptors are distributed throughout the pain pathwaysof the nervous system, and their activation is known to reduce pain in relevantpain models. In 2005, Health Canada approved Sativex for the symptomatic relief ofneuropathic pain in adults with Multiple Sclerosis. Canada became the firstcountry in the world to approve Sativex, a novel prescription pharmaceuticalproduct derived from components of the cannabis plant shown to have therapeuticproperties. This approval was granted under the NOC/c policy. This authorizationreflects the promising nature of the clinical evidence which will be confirmedwith further studies. Products approved under Health Canada's NOC/c policy,have demonstrated promising benefit, are of high quality and possess anacceptable safety profile based on a benefit/risk assessment for the approveduse. Earlier this year, the United States Food and Drug Administration (FDA) acceptedan Investigational New Drug (IND) Application for Sativex to enter directly intoPhase III clinical trials in the U.S. for the treatment of cancer pain. Sativex has been developed by UK-based GW Pharmaceuticals plc and is exclusivelymarketed in Canada by Bayer HealthCare, Pharmaceuticals Division. - ends - Enquiries: GW Pharmaceuticals plc Today: +44 (0)20 7831 3113Dr Geoffrey Guy, ChairmanJustin Gover, Managing Director Financial Dynamics Tel: +44 (0)20 7831 3113David Yates / Ben Atwell Bayer Inc.Lori Ann Horrigan Tel: 001 416 240 5252 Notes to editors: Notice of Compliance with Conditions (NOC/c) policy The NOC/c policy applies to drug submissions intended for the treatment,prevention or diagnosis of a serious, life-threatening or severely debilitatingillness or condition for which there is no existing therapy available on theCanadian market which possesses a similar therapeutic profile or for which thenew submission demonstrates a significant improvement in the benefit/riskprofile over alternate available products. 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. The promising nature ofthe clinical evidence is to be confirmed with further studies. About GW Pharmaceuticals GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under licence from the UK Home Office, theCompany is developing cannabis-derived pharmaceutical products for patients withmultiple sclerosis, neuropathic pain, cancer pain, spinal cord injury,rheumatoid arthritis, and other severe medical conditions. GW has assembled a team of over 100 scientists with extensive experience indeveloping both plant-based prescription pharmaceutical products and medicinescontaining controlled substances. GW is dedicated to developing treatmentoptions that alleviate pain and other neurological symptoms in patients whosuffer from serious ailments. For further information, please visit the Company's website: www.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. 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, offices in Ottawaand Calgary, as well as a manufacturing facility in Sarnia, Ontario. Bayer Inc.has approximately 930 employees across Canada and had sales of $981 millionCanadian in 2005. Globally, the Bayer Group had sales of about 27.4 billionEuro in 2005. Bayer Inc. invested approximately $38.1 million Canadian in research anddevelopment in 2005. Worldwide, the Bayer Group spends the equivalent of 1.9billion Euro in 2005 in R&D. 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. i Zech DF, Grond S, Lynch J et al. Validation of WHO guidelines for cancer pain relief - a 10 year prospective study. Pain 1995; 63: 65-76. ii Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Last accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp-mps/ prodpharma/notices-avis/conditions/sativex_factsheet_e.html. This information is provided by RNS The company news service from the London Stock Exchange