GWP.L Regulatory News (GWP)

9 Apr 2008 07:00

GW Pharmaceuticals PLC09 April 2008 Catalan Government Reports Positive Outcome of Sativex Access Programme Porton Down, UK, 9 April 2008: GW Pharmaceuticals plc (GWP:AIM) announces thatthe Government of Catalonia in Spain is today publishing positive results of itspilot programme to evaluate Sativex(R) as a treatment for high need patientssuffering from a range of medical conditions. Dr Stephen Wright, R&D Director, said, "This programme has shown that Sativexprovides important improvements in approximately half of high need patients whohave otherwise failed to gain benefit from currently available medicines. Thisis entirely consistent with our experience of Sativex prescription use in Canadaand the UK as well as in controlled clinical trials. We are pleased to have beenable to assist the Catalan government in conducting this important research." The results are being presented at a press conference being held today inBarcelona. The accompanying press release being issued by the Catalan Government(translated from Catalan) is provided below: Pilot programme on the therapeutic use of cannabis promoted by the Health Department of the Catalan Government complete O This study was implemented in response to demand for the availability of a pharmaceutical formulation of cannabis for use in severe patients suffering from a number of long term chronic diseases. O Almost half of the patients who received Sativex responded well by reporting improvement of their symptoms. O This research project, promoted by the Catalan administration, is groundbreaking in its coordination of doctors, hospital and retail pharmacies and other health professionals such as nurses in the therapeutic follow-up of patients. The Health Department of the Catalan Government has published results of thepilot programme on the therapeutic use of cannabis, which completed lastDecember. The primary goal of this pilot programme was to respond to demand for theavailability of a legitimate pharmaceutical formulation of cannabis. Theprogramme resulted from an initiative of the association l'Associacio Agata inbreast cancer patients which led the Catalan Parliament to approve two proposalsauthorising the government to take necessary steps to source a therapeuticpreparation of cannabis on the one hand and to promote a research project aboutthe therapeutic use of cannabis derivatives on the other. The pilot programme commenced in January 2006 by order of the Head of theCatalan Health Department, under the direction of a committee presided byDireccio General de Recursos Sanitaris (the Catalan Directorate of HealthResources). The Col•legi de Metges de Barcelona (the Medical Association ofBarcelona), the Col•legi de Farmaceutics de Barcelona (Pharmacists'Association), the Fundacio Institut Catala de Farmacologia (Catalan Institutefor Pharmacology Foundation) and the Institut Municipal d'Investigacio Medica(City Institute for Medical Investigation) also participated. The cannabis derivative employed in this programme is a standardized extractadministered as an oro-mucosal spray authorized in Canada under the brand nameSativex(R) as a co-adjuvant in the treatment of neuropathic pain in people withmultiple sclerosis (MS). This project, promoted by the Catalan Health Department, has involved theparticipation of over 40 doctors in 6 hospitals in the Barcelona Area (HospitalUniversitari Vall d'Hebron; Hospital de Bellvitge; Hospital Germans Trias iPujol de Badalona; Hospital Clinic; Hospital del Mar, i Hospital de la SantaCreu i Sant Pau), 15 pharmacists of the different hospitals, 75 retailpharmacies and 8 nurses, who were in charge of the control and follow up of thestudy patients. This study is unique in Europe in respect of its coordinationbetween the various types of health professionals. A total of 207 patients were included with the following therapeuticindications: - 32 with neuropathic pain due to MS,- 54 with spasticity due to MS,- 47 with neuropathic pain due to different medical conditions (other than MS),- 41 with diagnosed anorexia-cachexia syndrome due to cancer or AIDS, and- 33 with nausea and secondary vomiting due to chemotherapy treatment. Patients enrolled in the programme had severe symptoms, suffered from long termchronic diseases, were taking multiple medications to which they exhibited apoor response, and suffered from a poor quality of life. It has been shown thatSativex could be an alternative therapy in a considerable number of such cases. Patients with anorexia-cachexia syndrome received Sativex as monotherapy for thetreatment of their symptoms. Almost all the other patients received Sativex ontop of their other symptomatic treatments. The study was restricted to patientswho were unable to respond to, or unable to tolerate, currently availabletreatments and whose medical condition and quality of life were considered to bepoor. The published results show that half of the patients who received Sativexresponded well by reporting improvement of their symptoms. Patients with MSreported an improvement of their pain and/or their spasticity. Patients withneuropathic pain from other causes also experienced improvement of their pain.The majority of patients with anorexia-cachexia syndrome showed improvedappetite and patients undergoing chemotherapy reported an improvement of theirnausea and vomiting. It should be noted that this initiative was implemented in response to demandfor the availability of a therapeutic form of cannabis. The results of the studycontribute data that show patients reporting an improvement in their condition.Nevertheless it is necessary to continue to conduct research to evaluate itstherapeutic potential. These results allow for the continued use of Sativex inpatients who do not respond to current treatment. Enquiries: GW Pharmaceuticals plc (Today) + 44 20 7831 3113 Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000 Justin Gover, Managing Director Financial Dynamics + 44 20 7831 3113 David Yates / Ben Atwell Notes to Editors 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 for patientswho suffer from a range of serious ailments, in particular pain and otherneurological symptoms. GW has assembled a team of over 100 scientists withextensive experience in developing both plant-based prescription pharmaceuticalproducts and medicines containing controlled substances. GW occupies a worldleading position in cannabinoids and has developed an extensive internationalnetwork of the most prominent scientists in the field. This information is provided by RNS The company news service from the London Stock Exchange