GWP.L Regulatory News (GWP)

22 Mar 2007 07:00

GW Pharmaceuticals PLC22 March 2007 GW and Otsuka Receive Hart-Scott-Rodino Clearance for Sativex(R) US License Agreement 22 March 2007: GW Pharmaceuticals plc and Otsuka Pharmaceutical Co. Ltd todayannounce that they have each received early termination by the United StatesFederal Trade Commission and the Antitrust Division of the United StatesDepartment of Justice of the required waiting period under the Hart-Scott-RodinoAntitrust Improvements Act of 1976 with respect to the development and licenseagreement announced on 14 February 2007 granting Otsuka exclusive rights todevelop and market Sativex(R), GW's lead product, in the United States. Withthe grant of HSR clearance, GW and Otsuka have now received the approval of theU.S. antitrust authorities necessary to close the transaction. On 14 February 2007, GW and Otsuka announced that they had entered into a majorlong term strategic cannabinoid alliance. The relationship has commenced withthe grant to Otsuka of an exclusive license to develop and market Sativex in theU.S. The companies are also in detailed discussions with a view to enteringinto a cannabinoid research collaboration in the field of Central Nervous System(CNS) disorders and cancer treatment in order to research, develop andcommercialize a range of other early stage cannabinoid product opportunities. Enquiries:For GW: GW Pharmaceuticals plc Tel: + 44 1980 557000 Dr Geoffrey Guy, Chairman Justin Gover, Managing Director Financial Dynamics Tel: +44 20 7831 3113 David Yates, Nicola DaleyFor Otsuka: US Enquiries Debbie Kaufmann Tel: +1 240 683 3568 Europe Enquiries Alison Ross Tel: +44 1895 207 7122 Japan Enquiries Hideki Shirai Tel: +81 3 3292 0021 Notes to Editors About Otsuka Pharmaceutical Co., Ltd Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company withthe mission statement: "Otsuka - people creating new products for better healthworldwide." Otsuka researches, develops, manufactures and markets innovative,original products, focusing its core businesses on pharmaceutical products forthe treatment of disease and consumer products for the maintenance of everydayhealth. The Otsuka Pharmaceutical Group comprises 87 companies and employsapproximately 27,000 people in 17 countries and regions worldwide. Otsuka andits consolidated subsidiaries earned US $6.8 billion in consolidated annualrevenues in fiscal 2005. The Group has R&D facilities in Japan (Osaka andTokushima), EU (Frankfurt) and US (Rockville, MD). Its commercial operations areheadquartered in US (Rockville, MD and Princeton, NJ), EU (UK) and Japan(Tokyo). 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. GW has to date entered into twoadditional Sativex license agreements - with Bayer HealthCare in the UK andCanada, and with Almirall in Europe (ex-UK). These agreements together providepayments to GW totaling up to £79m ($156m) as well as significant long termsupply price provisions. For further information, please visit www.gwpharm.com This information is provided by RNS The company news service from the London Stock Exchange