GWP.L Regulatory News (GWP)

16 Jul 2009 07:00



GW RECEIVES COMMERCIAL MANUFACTURING LICENCE FOR SATIVEX®

Porton Down, UK, 16 July 2009: GW Pharmaceuticals plc (GWP:AIM) today announces that it has passed a Good Manufacturing Practice (GMP) inspection by the UK regulatory authority of its new in-house commercial manufacturing facility for Sativex®, enabling the facility to act as the primary manufacturing site for the anticipated European commercial launch of Sativex. 

Prior to now, GW has sub-contracted the final step in the bulk GMP manufacture of Sativex to a contract manufacturing partner. GW has previously announced that it had decided to upgrade its in-house facility with a view to taking over responsibility for GMP commercial finished product manufacture from its sub-contracting partner in time for European commercial launch. This upgrade has been completed on time and on budget. This means that GW now controls each step in the manufacturing supply chain for Sativex.

GW's new in-house facility was recently inspected by the Medicines and Healthcare products Regulatory Agency (MHRA) and a GMP Certificate and Manufacturer's/Importer's Licence has now been issued to allow for commercial manufacture. This commercial licence adds to GW's previous licences to manufacture clinical trials materials and to manufacture product for named patient supply. 

The new GW facility is initially able to produce quantities of Sativex sufficient to treat 25,000 patients per year. In addition, GW has put in place arrangements at its manufacturing site to expand this capacity in order to respond to increased demand in the coming years. 

In May, GW filed a regulatory submission for Sativex for the treatment of spasticity due to Multiple Sclerosis in the UK and Spain under the European decentralised procedure. It is expected that an outcome of the regulatory submission will be known towards the end of 2009 / early 2010. Upon approval, Sativex will be marketed in the UK by Bayer HealthCare, and in the rest of the European Union by Laboratorios Almirall S.A.

Mr Justin Gover, GW's Managing Director, said, "We are pleased to have passed this important step in preparation for the anticipated European commercial launch of Sativex. We now have full control of the manufacturing supply chain for Sativex, which will benefit the company strategically as well as in terms of our gross margin."

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Notes to Editors

Sativex MS Spasticity Regulatory Submission

In May 2009, GW announced that it had filed a regulatory submission for Sativex for the treatment of spasticity due to Multiple Sclerosis. This submission followed the announcement in March 2009 of a positive Phase III trial in this indication. The regulatory submission has been filed in the UK and Spain under the European decentralised procedure. The UK regulatory authority, the MHRA, is acting as Reference Member State and has validated the application. It is expected that an outcome of the regulatory submission will be known towards the end of 2009 / early 2010. 

Following approval in the UK and Spain, submissions for approval will made in additional European countries during 2010 under the mutual recognition procedure.

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.