GWP.L Regulatory News (GWP)

19 Jun 2007 07:01

GW Pharmaceuticals PLC19 June 2007 Sativex(R) receives Qualifying Notice for approval in Canada for the relief of Cancer Pain Porton Down, UK; Toronto, Canada; 19 June 2007: GW Pharmaceuticals plc (AIM:GWP) and Bayer HealthCare Pharmaceuticals announce that Health Canada, theCanadian regulatory agency, has issued a Qualifying Notice for the approval ofSativex(R) in the relief of cancer pain. Sativex is already approved andmarketed in Canada as adjunctive treatment for the symptomatic relief ofneuropathic pain in Multiple Sclerosis ("MS") in adults. This approval wasgranted under the NOC/c policy. GW filed the application in October 2006 with Health Canada under the Notice ofCompliance with conditions (NOC/c) policy. The approved indication will be "adjunctive 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". Health Canada has completed itsregulatory review in line with its 200 day review target. Sativex has been developed by UK-based GW Pharmaceuticals and is exclusivelymarketed in Canada by Bayer. Under the NOC/c process, the issue of a Qualifying Notice confirms that Sativexqualifies to be considered for approval in cancer pain and sets out theconditions and post-approval undertakings upon which the marketing authorizationfor Sativex in this indication can be granted. The conditions for the approvalof Sativex in cancer pain are in accordance with standard guidance provided bythe regulator for NOC/c approvals and include a commitment to ongoing clinicalresearch. This process is identical to that under which Sativex is alreadyapproved in the MS neuropathic pain indication. GW is required to respond and accept the conditions within 30 days. Followingthis, Health Canada will review this response, subject to a 30 day reviewtarget. Should the response be acceptable, Health Canada can then be expected toproceed to finalise the marketing authorisation. Dr Geoffrey Guy, GW's Chairman, said, "We are delighted to receive thisQualifying Notice from Health Canada and look forward to receiving regulatoryapproval for Sativex in the relief of cancer pain in the next few months. Thisadditional regulatory approval represents a further step in our broad-basedregulatory strategy for Sativex, which is designed to secure approvals for thisimportant new medicine across a range of separate therapeutic indications incountries across the world over the coming years." Philip Blake, President and CEO of Bayer Inc., said, "Pain is one of the mostdebilitating and feared symptoms of advanced cancer. The approval of Sativex forthe treatment of these high need patients is further recognition of the value ofthis important medicine and we shall now actively commence our launch plans forthis indication." Sativex in Cancer Pain 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 advancedcancer and were experiencing pain that was not responding adequately to strongopioid medication (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 43 percent 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 (1). Dr Paul Daeninck, Director, Symptom Management Group for Cancer Care Manitobaand Assistant Professor, Depts of Internal Medicine and Family Medicine,University of Manitoba, said, "Pain remains a significant unmet medical need formany patients with cancer, who may be unable to gain adequate pain relief fromeven the best use of existing strong opioid medicines. Furthermore, a proportionof patients are simply unable to tolerate opioids in doses that may be requiredto relieve their pain. In short, there is a clear need for effective newanalgesics. The results with Sativex show that it can provide additional painrelief to this group of patients and may represent an important new option inthe treatment of cancer pain." In 2006, the United States Food and Drug Administration (FDA) accepted anInvestigational New Drug (IND) Application for Sativex to enter into Phase IIIclinical trials in the U.S. for the treatment of cancer pain. The first U.Strial is due to commence in the next few months. 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.Alison Bing Tel: 001 416 240 5298 Notes to editors: Sativex 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 (2). 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. This approval was grantedunder the NOC/c policy. 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 About Bayer HealthCare Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading,innovative companies in the healthcare and medical products industry. Thecompany combines the global activities of the Animal Health, Consumer Care,Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticalscomprises the following business units: Women's Healthcare, Diagnostic Imaging,Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aimis to discover and manufacture products that will improve human health worldwideby diagnosing, preventing and treating diseases. 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. Footnotes: (1) Zech DF, Grond S, Lynch J et al. Validation of WHO guidelines for cancerpain relief - a 10 year prospective study. Pain 1995; 63: 65-76.). (2) Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Lastaccessed 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