Sativex® regulatory approval received in Austria

 

Sativex® regulatory approval received in Austria

7  February  2012

Porton Down, UK; 7 February 2012: GW Pharmaceuticals plc (AIM: GWP) today announces a regulatory update for Sativex® (Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) oromucosal spray.

Sativex®has received regulatory approval in Austria as a treatment of spasticity due to Multiple Sclerosis (MS). The launch of Sativex® in Austria is expected to take place during 2012 following completion of the national pricing and reimbursement process. Sativex®will be marketed in Austria by GW's marketing partner, Almirall S.A.

In addition, further to the November 2011 announcement of the filing of a new regulatory application, under the European Mutual Recognition Procedure (MRP), to expand Sativex®approvals to additional European countries, the dossier has been validated and is now under technical review by regulatory authorities in the following countries: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. It is expected that this new MRP process should complete around mid 2012.

Sativex®is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic.

Sativex®has been developed by GW Pharmaceuticals and is marketed in Europe (except the UK) by Almirall. The product is also in Phase III clinical development as a treatment for cancer pain.

Enquiries:

GW Pharmaceuticals pl:(Today)+ 44 20 7831 3113

Dr Geoffrey Guy, Executive Chairman: (Thereafter) + 44 1980 557000

Justin Gover, Managing Director

Financial Dynamics:+ 44 20 7831 3113

Ben Atwell / John Dineen

GW Nominated Adviser: Peel Hunt LLP:+44 (0)20 7418 8900

James Steel / Vijay Barathan

 

Notes to Editors

About GW

GW was founded in 1998 and listed on the AIM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. For further information, please visit www.gwpharm.com

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’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 GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®and other products by consumer and medical professionals.