Almirall, S.A. (ALM:MC) and GW Pharmaceuticals plc (AIM:GWP) today announced that the health authorities in Denmark have granted regulatory approval for Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other anti-spasticity medication Sativex® Summary of Product Characteristics, 2011. .

Regulatory approval for Sativex® has been granted after the recent change in the local laws. Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS, currently available in the UK and Spain.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance. By relieving the symptoms of MS, Sativex® can improve patients' quality of life and allow them greater independence in performing their daily activities. Multiple Sclerosis Trust. A-Z of MS - Spasticity. Available here (Last accessed: 26/07/10).

Approval in Denmark follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all countries involved recommending approval. Approval for Sativex® was granted in Germany on 26th May 2011 and the product is expected to be launched there in July. In addition to Germany and Denmark, launch is also expected in Sweden before the end of 2011. Launches in Italy, Czech Republic and Austria are expected in 2012.

A further MRP is planned for later 2011 involving other European countries, in order to make this medicine available to more patients suffering from MS.

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Notes

Sativex®


Sativex® was developed by UK-based GW Pharmaceuticals plc in specific response to the MS population's unmet need for a prescription cannabis-based medicine. Manufactured under Home Office licence at an undisclosed location in the UK it will be marketed in Europe (except the UK) by Almirall.

Sativex® is indicated as add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Sativex® is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and multiple sclerosis from patient to patient.

Sativex® contains active ingredients called 'cannabinoids', which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brains. GW Pharmaceuticals. Cannabinoid Science: Mechanism of action. Available here (Last accessed: 01/07/10). A receptor is a site on a brain cell where certain substances can stick or "bind" for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a 'dimming down' of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activities. GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available here. (Last accessed: 01/07/10).

Spasticity

There are almost 500,000 people suffering of MS in the top five EU countries 2010 EMSP, MSIF, 16/06/2010. Top five EU countries include: France, Germany, Italy, Spain and UK., and 10,000 Danish Sclerosis Association of them are reported to live with the condition in Denmark. Spasticity (otherwise known as muscle stiffness) is one of the most common symptoms of MS, occurring in as many as 75% of people with MS and has a negative impact on patients' daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleep. Prevalence and treatment of spasticity reported by multiple sclerosis patients - MA Rizzo et al - Multiple Sclerosis 2004; 10:589-595.

This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments

Source:
Almirall
GW Pharmaceuticals