GWP.L Regulatory News (GWP)

8 Nov 2005 07:02

GW Pharmaceuticals PLC08 November 2005 For Immediate Release 8 November 2005 GW Pharmaceuticals plc ("GW" or "the Company") Sativex(R) to be supplied by Catalonian Government to 600 patients in Spain GW Pharmaceuticals is today pleased to announce that it has reached agreementwith the Health Department of The Regional Government of Catalonia in Spain tosupply Sativex(R) oromucosal spray, its cannabis-based medicine, to 600 patientssuffering from Multiple Sclerosis and a number of other conditions under acompassionate access programme. This will be the first ever use of Sativex in Spain, and the first time thatpatients in Europe have had access to Sativex outside a clinical trial. TheCatalan Health Department has approved a specific budget to pay for GW to supplythe medicine. An initial batch is due to be shipped to Spain in the next fewweeks and further batches will be sent next year. 130 of the patients will be people with Multiple Sclerosis, a further 130 willbe patients suffering from neuropathic pain arising from a range of medicalconditions, 40 will be suffering from anorexia and malnutrition caused by AIDS,and the remaining 300 will be cancer patients undergoing chemotherapy andsuffering from nausea and vomiting. Those undergoing chemotherapy will beginsix months later than the others. The compassionate access programme has been approved by the Spanish Ministry ofHealth. It is governed by an agreed protocol, which provides for objectives suchas evaluating safety and tolerability and assessing impact on quality of life. The move follows an initiative of the Department of Health in Catalonia, aftercalls by patients for access to an appropriate cannabis-based medicine. TheDepartment determined that the best response was to set up a formal controlledprogramme for patients who may benefit from Sativex where currently availablemedicines have failed to provide adequate relief. Sativex is a pharmaceutical product standardised in composition, formulation,and dose. It is administered as a spray under the tongue or on the inside of thecheek. Its principal active components are the cannabinoidsdelta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Sativex ismanufactured in the UK and was approved as a prescription medicine in Canadaearlier this year and launched in that country in late June. Dr. Rafael Manzanera, General director of Health Resources of the Catalan HealthDepartment, said, "This is a direct response to the wishes of patients with asignificant unmet medical need. The Catalan administration believes that anon-smoked prescription cannabis derived medicine, such as Sativex, representsthe optimum solution for these patients, without in any way promoting the use ofherbal cannabis." Dr Geoffrey Guy, Executive Chairman of GW, said, "We are very pleased to be ableto respond to this request from the Spanish authorities. This initiativerepresents a pragmatic and compassionate approach for seriously ill patientswith little alternative therapy. At the same time, it will provide a usefuladditional source of revenue for GW as we continue to invest in developingSativex to bring it to the UK and other international markets through regulatoryapproval processes." - Ends - Enquiries: GW Pharmaceuticals plc Today: 020 7067 0700Dr Geoffrey Guy, Chairman Thereafter:01980 557000Justin Gover, Managing DirectorMark Rogerson, Press and PR 07885 638810 Weber Shandwick Square Mile 020 7067 0700Kevin Smith / Yvonne Alexander This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Company's products. Forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including (inter alia), the success of the Company's research strategies, theapplicability of the discoveries made therein, the successful and timelycompletion of clinical studies, including with respect to Sativex and theCompany's other products, the uncertainties related to the regulatory process,and the acceptance of Sativex and other products by consumers and medicalprofessionals. This information is provided by RNS The company news service from the London Stock Exchange