Almirall, S.A. (ALM) and GW Pharmaceuticals plc (AIM:GWP) today announce that the health authorities in Germany 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 Multiple Sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication. Sativex® is expected to be launched in Germany in July 2011.
Sativex® is a first in class endocannabinoid system modulator for the treatment of spasticity in MS and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). The medicine is already available for MS patients in the UK and Spain.
Spasticity (otherwise known as muscle stiffness) 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. 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.
Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder and sleep disturbance.
Approval in Germany follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all six countries involved recommending approval. These countries were Germany, Denmark, Sweden, Italy, Czech Republic and Austria. In addition to Germany, launch is also expected before the end of 2011 in Denmark and Sweden. Launches in Italy, Czech Republic and Austria are expected in 2012.
A further MRP submission is expected to be made later in 2011 with a view to expanding the approval of Sativex® to additional European countries.
Justin Gover, Managing Director of GW, said: “Having recently successfully launched Sativex® in Spain, we are very pleased to have now received regulatory approval in Germany. Germany has the largest MS population in Europe and we look forward to offering people with MS in Germany the opportunity to benefit from Sativex® as a new first in class treatment to treat their spasticity.”
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).