OPERATIONAL HIGHLIGHTS
• Positive results in Sativex Phase III MS spasticity trial
• Sativex European regulatory submission filed (announced separately today) with outcome expected towards end of 2009 / early 2010
• Sativex European launch preparations underway
• Positive results in Sativex MS Spasticity randomised withdrawal study provide evidence of long term efficacy
• Sativex Phase IIb/III cancer pain trial, funded by Otsuka as part of the US development programme, ongoing and due to report results in Spring 2010
• Sativex named patient prescription use ongoing – product exported to 21 countries
• Otsuka cannabinoid research collaboration yielding promising new psychiatric, neurological and oncology drug candidates
• In-house metabolic research programme due to expand. Phase II trial in planning on novel cannabinoid medicine for the treatment of dyslipidaemia in Type II diabetes patients
FINANCIAL HIGHLIGHTS
• Net profit for the period of £4.0m (H1 2008: £4.2m loss)
• Turnover increased to £16.1m (H1 2008: £5.7m) reflecting revenue growth from milestone income, Otsuka alliance and Sativex sales
• Cash and short term deposits at 31 March 2009 of £11.8m. A further £8m, in the form of a milestone payment from Almirall, was received in early April 2009.
Dr Geoffrey Guy, GW’s Chairman, said: “We are pleased to report our maiden profit, significantly increased turnover and a robust cash position. Following the outstanding data in our recently reported Sativex Phase III trial and the regulatory submission announced today, GW is now making the transition from a late stage development company to an emerging pharmaceutical business with excellent growth prospects.
“Our focus for the remainder of 2009 will be on securing the first major regulatory approvals for Sativex in Europe, preparing for launch, and completing the Sativex cancer pain study in the United States. We will also continue to build on the promising data being generated in our cannabinoid pipeline. I am confident that GW has now entered its most exciting time since its foundation.”
An analyst presentation of the interim results is being held today at 09.30 at Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Please contact Juliet Edwards at Financial Dynamics on +44 20 7269 7125 for details. An audio webcast of the presentation will be available on GW’s website at www.gwpharm.com later this afternoon.