Catalan Government Reports Positive Outcome of Sativex Access Programme

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Apr 04, 2008


GW Pharmaceuticals plc:(Today) + 44 20 7831 3113

Dr Geoffrey Guy, Executive Chairma: (Thereafter) + 44 1980 557000

Justin Gover, Managing Director

Financial Dynamics:+ 44 20 7831 3113

David Yates / Ben Atwell

GW Pharmaceuticals plc (GWP:AIM) announces that the Government of Catalonia in Spain is today publishing positive results of its pilot programme to evaluate Sativex® as a treatment for high need patients suffering from a range of medical conditions.

Dr Stephen Wright, R&D Director, said, “This programme has shown that Sativex provides important improvements in approximately half of high need patients who have otherwise failed to gain benefit from currently available medicines. This is entirely consistent with our experience of Sativex prescription use in Canada and the UK as well as in controlled clinical trials. We are pleased to have been able to assist the Catalan government in conducting this important research.”

The results are being presented at a press conference being held today in Barcelona. 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

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.

Almost half of the patients who received Sativex responded well by reporting improvement of their symptoms.

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 the pilot programme on the therapeutic use of cannabis, which completed last December.

The primary goal of this pilot programme was to respond to demand for the availability of a legitimate pharmaceutical formulation of cannabis. The programme resulted from an initiative of the associationl’Associació Agatain breast cancer patients which led the Catalan Parliament to approve two proposals authorising the government to take necessary steps to source a therapeutic preparation of cannabis on the one hand and to promote a research project about the therapeutic use of cannabis derivatives on the other.

The pilot programme commenced in January 2006 by order of the Head of the Catalan Health Department, under the direction of a committee presided by Direcció General de Recursos Sanitaris (the Catalan Directorate of Health Resources). The Col·legi de Metges de Barcelona (the Medical Association of Barcelona), the Col·legi de Farmacèutics de Barcelona (Pharmacists’ Association), the Fundació Institut Català de Farmacologia (Catalan Institute for Pharmacology Foundation) and the Institut Municipal d’Investigació Mèdica (City Institute for Medical Investigation) also participated.

The cannabis derivative employed in this programme is a standardized extract administered as an oro-mucosal spray authorized in Canada under the brand name Sativex® as a co-adjuvant in the treatment of neuropathic pain in people with multiple sclerosis (MS).

This project, promoted by the Catalan Health Department, has involved the participation of over 40 doctors in 6 hospitals in the Barcelona Area (Hospital Universitari Vall d’Hebron; Hospital de Bellvitge; Hospital Germans Trias i Pujol de Badalona; Hospital Clínic; Hospital del Mar, i Hospital de la Santa Creu i Sant Pau), 15 pharmacists of the different hospitals, 75 retail pharmacies and 8 nurses, who were in charge of the control and follow up of the study patients. This study is unique in Europe in respect of its coordination between the various types of health professionals.

A total of 207 patients were included with the following therapeutic indications:

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 term chronic diseases, were taking multiple medications to which they exhibited a poor response, and suffered from a poor quality of life. It has been shown that Sativex could be an alternative therapy in a considerable number of such cases.

Patients with anorexia-cachexia syndrome received Sativex as monotherapy for the treatment of their symptoms. Almost all the other patients received Sativex on top of their other symptomatic treatments. The study was restricted to patients who were unable to respond to, or unable to tolerate, currently available treatments and whose medical condition and quality of life were considered to be poor.

The published results show that half of the patients who received Sativex responded well by reporting improvement of their symptoms. Patients with MS reported an improvement of their pain and/or their spasticity. Patients with neuropathic pain from other causes also experienced improvement of their pain. The majority of patients with anorexia–cachexia syndrome showed improved appetite and patients undergoing chemotherapy reported an improvement of their nausea and vomiting.

It should be noted that this initiative was implemented in response to demand for the availability of a therapeutic form of cannabis. The results of the study contribute data that show patients reporting an improvement in their condition. Nevertheless it is necessary to continue to conduct research to evaluate its therapeutic potential. These results allow for the continued use of Sativex in patients who do not respond to current treatment.

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