Porton Down, UK; 22 November 2011: GW Pharmaceuticals plc (AIM: GWP) today announces that it has submitted an application under the European Mutual Recognition Procedure (MRP) to seek to expand the marketing authorization for Sativex®to a number of additional European member states.
The new MRP follows successful completion of a previous MRP earlier this year in which recommendation for approval of Sativex®was obtained from regulatory authorities in Germany, Italy, Denmark, Sweden, Austria and the Czech Republic. Prior to this, Sativex®received approval in 2010 in the UK and Spain.
The complete list of countries to which the MRP application is being made is currently being finalized. The list is expected to include approximately ten new countries and will mean that if this MRP process is successful, approaching twenty European countries will have recommended approval of Sativex.
It is expected that this new MRP process should complete around mid 2012.
As with the previous MRP, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as Reference Member State for the purposes of this new MRP procedure.
Dr Stephen Wright, GW’s R&D Director, said,“This new regulatory filing seeks to build on our regulatory successes to date by expanding the approval of Sativex®to several additional European markets. We look forward to progressing this application during the first half of next year.”
Sativex®oromucosal spray is a first in class endocannabinoid system modulator for the treatment of spasticity in MS. Sativex®has been developed by UK-based GW Pharmaceuticals and is marketed in Europe (except the UK) by Almirall, S.A. Sativex®is approved in the UK, Spain, Germany, Denmark, Czech Republic, Canada and New Zealand as a treatment of MS spasticity. The product is also in Phase III clinical development as a treatment for cancer pain.
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
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.