GWP.L Regulatory News (GWP)

9 Jul 2007 07:00

GW Pharmaceuticals PLC09 July 2007 GW and Otsuka Enter Into Global Cannabinoid Research Collaboration London, UK; Tokyo, Japan; 9 July 2007: GW Pharmaceuticals plc (AIM: GWP) andOtsuka Pharmaceutical Co., Ltd. today announce that they have signed a globalcannabinoid research collaboration in the field of Central Nervous System (CNS)and oncology in order to research, develop and commercialize a range ofcandidate cannabinoid products. The research collaboration agreement follows the signature in February 2007 ofan exclusive license and development agreement between GW and Otsuka to developand market Sativex(R), GW's lead product, in the United States. The cannabinoid research collaboration has an initial term of three years,during which Otsuka will make available a research fund of $9 million, which maybe increased from time to time by Otsuka, to cover research activities carriedout by GW and its scientific collaborators under this agreement. The GW-Otsuka collaboration research team, which incorporates senior scientistsfrom both companies, will evaluate a range of GW cannabinoids as drug candidateswithin the field of CNS and oncology, with a view to selecting the mostpromising candidates for full clinical development, regulatory approval andglobal commercialization. Products selected for full development will be thesubject of a license from GW. Under the terms of each product license, Otsukawill fund the global development and commercialization of such products, and GWwill receive license fees, milestone payments and a long term commercial supplyprice and royalty. The financial terms of each license are to be agreed at thetime of selection of each product for global development. Dr Geoffrey Guy, GW's Chairman, said, "Otsuka is a world leader in the field ofCNS and we are delighted to be working with such a prestigious company toenhance and develop our product pipeline. The relationship between GW and Otsukacommenced earlier this year with the signature of the Sativex US licenseagreement, and this new research collaboration will serve to enhance further theclose relationship between our two companies. "Over the last few years, GW has been undertaking a primary cannabinoid researchprogramme addressing a range of therapeutic areas under the direction ofProfessor Roger Pertwee and in collaboration with a number of other worldleading cannabinoid scientists. This collaboration with Otsuka will enable GW toaccelerate and expand this programme in order to develop and commercialise novelcannabinoid medicines in the exciting areas of CNS and oncology." Mr. Tatsuo Higuchi, President of Otsuka Pharmaceutical Co., Ltd. said, "Otsukastrives to contribute to the health of people around the world through thecreation of innovative products in an effort to address unmet medical needs. Weare delighted to be embarking on this great opportunity with GW Pharmaceuticalsto further investigate cannabinoids, which are considered to be a significantpotential source of new medicines in the field of CNS and oncology. At the sametime, we anticipate that our further contribution to global well being will besignificant as a result of this research collaboration." 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 AtwellFor Otsuka: Hideki Shirai Tel: +81 3 6717 1400 siraih@otsuka.jp Notes to Editors About Cannabinoids The cannabinoid (CB) receptor system is a complex and far-reaching system whichhas only started to become understood in the last decade or so. To date, CB1 andCB2 receptors have been identified and cloned. Initially, the chemicals whichaffect these receptors ("cannabinoids") were identified only within the cannabisplant, but extensive scientific investigation has now elaborated a series ofendogenous chemicals which maintain this 'endocannabinoid system'. Theseendogenous cannabinoids are produced in human tissues, exert their actionswithin those tissues and are then destroyed locally. This allows the system tofunction in a fine-tuning, modulatory role, and abnormalities of theendocannabinoid system have now been found in several important diseases.Originally, it was believed that these receptors acted largely within the brain,but it is becoming increasingly clear that they are present at many differentsites, in many different body systems. The importance of the integrity of this system of receptors in maintainingseveral critical areas of mental and physical well-being is becoming clearerbecause of the type of research that GW and its collaborators are performing.Equally, this research work has identified several important disease areas wherethe administration of cannabinoids as medicines may lead to desirabletherapeutic consequences. Cannabinoid modulators are showing promise in chronicpainful conditions, in movement disorders, and in disorders of cellproliferation such as cancer. Furthermore, the role of cannabinoids in the brainmay offer therapeutic promise in disorders of behaviour and mood. This is anarea of active scientific discovery and therapeutic research which may deliver arange of new treatments to meet unmet medical needs. About Sativex US License Agreement On February 14 2007, GW and Otsuka entered into an exclusive license agreementto develop and market Sativex, GW's lead product, in the US. In 2006, the Food & Drug Administration (FDA) permitted Sativex to enterdirectly into Phase III clinical trials in the US for the treatment of pain inpatients with advanced cancer that has not been adequately relieved by opioidmedications. GW and Otsuka currently plan for the first US pivotal efficacyclinical trial to be a Phase II/III cancer pain dose ranging study, to commencein the near future. 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 and other products byconsumer and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange