GW SUBMITS APPLICATION IN UK FOR MS SPASTICITY DRUG

GW Pharmaceuticals has filed a regulatory submission in selected European countries for Sativex, its cannabinoid spray medicine. The filing is for the symptomatic relief of spasticity in people with multiple sclerosis (MS).

The filing has been made under the decentralised procedure in the UK, Spain, Denmark and the Netherlands. Under this procedure, the UK is acting as reference member state and will consult with the three other countries. If successful, approval would lead to the simultaneous approval of Sativex in the other countries. Upon approval, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe by Almirall.

The submission is supported by a body of clinical data from approximately 700 patients with MS spasticity and includes results of two Phase III trials as well as two supportive trials. Results from the first pivotal trial, which showed positive results across all primary analyses, was announced in June 2004 and reviewed by the UK regulatory authority. The UK regulators subsequently advised that this trial would need to be supplemented by an additional study. The second trial in MS spasticity, the results of which were reported in March, showed a consistent positive treatment effect to the first trial.