GW Pharmaceuticals is today pleased to announce that it has reached agreement with the Health Department of The Regional Government of Catalonia in Spain to supply Sativex® oromucosal spray, its cannabis-based medicine, to 600 patients suffering from Multiple Sclerosis and a number of other conditions under a compassionate access programme.
GW Pharmaceuticals is today pleased to announce that it has reached agreement with the Health Department of The Regional Government of Catalonia in Spain to supply Sativex ® oromucosal spray, its cannabis-based medicine, to 600 patients suffering from Multiple Sclerosis and a number of other conditions under a compassionate access programme.
This will be the first ever use of Sativex in Spain, and the first time that patients in Europe have had access to Sativex outside a clinical trial. The Catalan Health Department has approved a specific budget to pay for GW to supply the medicine. An initial batch is due to be shipped to Spain in the next few weeks and further batches will be sent next year.
130 of the patients will be people with Multiple Sclerosis, a further 130 will be patients suffering from neuropathic pain arising from a range of medical conditions, 40 will be suffering from anorexia and malnutrition caused by AIDS, and the remaining 300 will be cancer patients undergoing chemotherapy and suffering from nausea and vomiting. Those undergoing chemotherapy will begin six months later than the others.
The compassionate access programme has been approved by the Spanish Ministry of Health. It is governed by an agreed protocol, which provides for objectives such as evaluating safety and tolerability and assessing impact on quality of life.
The move follows an initiative of the Department of Health in Catalonia , after calls by patients for access to an appropriate cannabis-based medicine. The Department determined that the best response was to set up a formal controlled programme for patients who may benefit from Sativex where currently available medicines 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 the cheek. Its principal active components are the cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Sativex is manufactured in the UK and was approved as a prescription medicine in Canada earlier this year and launched in that country in late June.
Dr. Rafael Manzanera, General director of Health Resources of the Catalan Health Department, said, “This is a direct response to the wishes of patients with a significant unmet medical need. The Catalan administration believes that a non-smoked prescription cannabis derived medicine, such as Sativex, represents the optimum solution for these patients, without in any way promoting the use of herbal cannabis.”
Dr Geoffrey Guy, Executive Chairman of GW, said, “We are very pleased to be able to respond to this request from the Spanish authorities. This initiative represents a pragmatic and compassionate approach for seriously ill patients with little alternative therapy. At the same time, it will provide a useful additional source of revenue for GW as we continue to invest in developing Sativex to bring it to the UK and other international markets through regulatory approval processes.”
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This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical development and regulatory clearance of the Company's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and the Company's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.