Almirall, S.A. presented full results from three Phase III studies with Sativex®, in a satellite symposium at the 27th ECTRIMS congress,which took place in Amsterdam from 19th to 22nd October 2011.

These Phase III studies provide evidence of the long term efficacy of Sativex® (2.7 mg delta-9-tetrahydrocannabinol and 2.5 mg cannabidiol per puff) in symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis 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.

These data have led to the approval of this first-in-class medication in the UK, Spain, Denmark, Germany and Czech Republic, with additional countries expected to grant approvals in the near future. (1, 2, 3)

Professor H.P. Hartung, Chair of Neurology at Heinrich-Heine University, Dusseldorf, Germany and Chairman of the satellite symposium, commented:"Sativex® has proven to reduce the severity of symptoms and improve patients' quality of life and functional status, in patients with spasticity in multiple sclerosis, meaning that they can undertake everyday tasks more easily. Also, importantly, clinical experience to date has demonstrated that the tolerability profile of this medicine is favourable, with limited relevant adverse effects and - particularly reassuring - the drug does not appear to lead to withdrawal effects if patients suddenly stop using it."

"The Sativex® data show this is a unique opportunity to help patients with MS spasticity, a clearly underserved indication. We believe Sativex® will offer a new way to help the patients with MS spasticity", said Bertil Lindmark, Chief Scientific Officer at Almirall.

Professor Xavier Montalbán, Director of the Multiple Sclerosis Center of Catalunya and the Unit of Clinical Neuroimmunology, Vall d´Hebron University Hospital, Barcelona, also announced the award of 2 post-graduate clinical research grants by Almirall, aimed at fostering clinical research in multiple sclerosis spasticity across Europe. The project selection board is comprised of Professor Montalbán, who will provide guidance on the development of project proposals, Professor Hartung and Almirall's global Medical Affairs Department. The resulting projects will be developed in 2012, and results will be published by authors in Q2 2013.

Sativex® has been developed by the UK-based company GW Pharmaceuticals plc and is marketed in Europe (except the UK) by Almirall, S.A.

SOURCE: GW Pharmaceuticals plc (24/10/11)