GWP.L Regulatory News (GWP)

26 Nov 2007 07:00

GW Pharmaceuticals PLC26 November 2007 Sativex(R) Commences US Phase II/III Clinical Trial in Cancer Pain London, UK; Tokyo, Japan; 26 November 2007: GW Pharmaceuticals plc (AIM: GWP)and Otsuka Pharmaceutical Co., Ltd. today announced that the first US Phase II/III dose-ranging trial has been initiated to evaluate the efficacy and safety ofSativex(R) in the treatment of pain in patients with advanced cancer, whoexperience inadequate analgesia during optimized chronic opioid therapy. The principal investigator of this study is Dr. Russell K. Portenoy, Chairman ofthe Department of Pain Medicine and Palliative Care at Beth Israel MedicalCenter in New York City. This five-week, placebo-controlled study will includeapproximately 40 centers primarily in the US and recruit a total of 336patients. Patients enrolled in this study must have advanced cancer for whichthere is no known curative therapy and have a clinical diagnosis ofcancer-related pain, which is not wholly alleviated with their current opioidtreatment. The primary objective of the study is to evaluate the potential roleand dose range of Sativex in these patients as an adjunct to their pre-existingpain medications. The primary endpoint of the study will be the response ratefor patients at the end of 5 weeks of therapy, as defined by a 30% or greaterreduction in the 11-point, Numeric Rating Scale (NRS). Commenting on the importance of this study, Dr. Portenoy, said, "Studies suggestthat more than one-third of patients with cancer, and more than three-quartersof those with advanced disease, have chronic pain. Large surveys indicate thatoptimal opioid therapy does not yield sufficient relief in a substantialproportion of these patients. There is a clear need for new treatments toimprove these outcomes and it is our hope that cannabinoid formulations mayrepresent an important option in the future. This US-based study is a welcomestep in assessing the role of Sativex(R) as a potential new treatment for cancerpain." Dr Geoffrey Guy, GW's Chairman, said, "GW has spent many years preparing for theUS development of Sativex(R) and has established open and positive interactionswith relevant federal agencies. The start of the first large scale US clinicaltrial is a major milestone for the company and for the future prospects forSativex(R). We are delighted to be working in close collaboration with ourpartner, Otsuka, in advancing Sativex(R) toward the goal of obtaining USregulatory approval. Dr. Taro Iwamoto, President of Otsuka Pharmaceutical Development andCommercialization, Inc., likewise noted that "Otsuka is very excited to beworking with GW Pharmaceuticals for the development of this potentialalternative approach to the treatment of advanced cancer pain. The initiationof this US clinical trial for Sativex is consistent with our mission to developproducts for better health." Sativex(R) is an investigational new product composed primarily of twocannabinoids: CBD (cannabidiol,) and THC (delta 9 tetrahydrocannabinol). Sativex(R) will be administered as a metered dose oro-mucosal spray each 100(micro)Lspray contains 2.7mg THC and 2.5mg CBD. The Sativex(R) formulation isstandardized by both composition and dose and is supplied in small spray vials.The components of Sativex have been shown to bind to cannabinoid receptors thatare distributed throughout the central nervous system and in immune cells. This Phase II/III dose ranging study will attempt to replicate and extend datafrom a previous, two-week clinical trial in 177 patients conducted in Europe. Inthis European study, Sativex(R) was administered to patients with terminalcancer and persistent pain that was not fully relieved by current strong opioidtherapy. The primary endpoint of this study was the change from baseline toendpoint in the NRS pain score. Sativex, as adjunctive treatment to strongopioid therapy, was associated with a larger decrease in NRS score than wasplacebo and strong opiods (p=0.014). In addition, 43% of patients who receivedSativex(R), while remaining on opioids, exhibited at least a 30% decrease intheir pain score compared to 21% of patients receiving placebo and opioids (p=0.024) Treatment related adverse events in this study were reported by 85% of patientsreceiving Sativex and by 75% of patients receiving placebo. The most commonadverse events (> 10%) reported by patients in this study were somnolence (15%Sativex(R) vs. 13% placebo); nausea (12% Sativex(R) vs. 11% placebo) anddizziness (12% Sativex(R) vs. 5% placebo). Serious adverse events reported bymore than one patient receiving Sativex were urinary retention (n=2) andprogression of the underlying cancer (n=6). Enquiries:For GW: GW Pharmaceuticals plc Today: +44 20 7831 3113 Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000 Justin Gover, Managing Director Mark Rogerson, Press and PR Tel: + 44 7885 638810 Financial Dynamics Tel: +44 20 7831 3113 David Yates, Ben Atwell For Otsuka: US Inquiry Debbie Kaufmann Tel: +1 240 683 3568 Japan Inquiry Hideki Shirai siraih@otsuka.jp Notes to Editors About GW-Otsuka On 14 February 2007, GW and Otsuka entered into a major long term strategicalliance. The relationship commenced with the signing of an exclusive licenseagreement to develop and market Sativex(R) GW's lead product, in the US. Underthis agreement, GW and Otsuka jointly oversee US clinical development andregulatory activities as well as the commercialization strategy. GW isresponsible for carrying out the US clinical development program, the costs ofwhich are borne by Otsuka. Otsuka will be responsible for the marketing andsales activities in the US. On 9 July 2007, GW and Otsuka signed a global research collaboration for thestudy of cannabinoids in the field of Central Nervous System (CNS) and oncologyto research, develop and commercialize a range of candidate cannabinoidproducts. About Otsuka Pharmaceutical Co., Ltd Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare companywith the corporate philosophy: 'Otsuka - people creating new products for betterhealth worldwide.' Otsuka researches, develops, manufactures and marketsinnovative and original products, with a focus on pharmaceutical products forthe treatment of diseases and consumer products for the maintenance of everydayhealth. Otsuka is committed to being a corporation that creates global value,adhering to the high ethical standards required of a company involved in humanhealth and life, maintaining a dynamic corporate culture, and working in harmonywith local communities and the natural environment. The Otsuka Pharmaceutical Group comprises 99 companies and employs approximately31,000 people in 17 countries and regions worldwide. Otsuka and its consolidatedsubsidiaries earned US$7.2 billion in annual revenues in fiscal 2006. Focusing on the central nervous system, the circulatory, respiratory, anddigestive systems, ophthalmology and dermatology, Otsuka's pharmaceuticalproduct business engages in the research and development, manufacture and saleof pharmaceuticals, aiming to maximize the assets of a global network to addressunmet medical meets. For additional information, visit www.otsuka-global.com About GW 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 This news release may contain forward-looking statements that reflect GWscurrent expectations regarding future events, including development andregulatory clearance of the GW's 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 the GW's research strategies, the applicability of the discoveriesmade therein, the successful and timely completion of uncertainties related tothe regulatory process, and the acceptance of Sativex(R) and other products byconsumer and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange