Porton Down, UK, 20 June 2006: GW Pharmaceuticals plc (AIM: GWP), the developer and manufacturer of a range of new medicines based on cannabis and other controlled drugs, announces its interim results for the six months ended 31 March 2006. GW today is also hosting a research and development (R&D) day for analysts and investors.
FDA permits Sativex to enter directly into US Phase III trials in cancer pain. First Phase III trial to commence around the end of 2006. US licensing discussions for Sativex have commenced
Licence agreement signed in December 2005 with Almirall to market Sativex in Europe (excluding the UK)
Results announced of a third Phase III MS spasticity study showing significant positive results in the per protocol analysis. Regulatory advice meetings being held to consider possibility of MS spasticity submission in Europe. Decision to be taken in second half of 2006
Programme of Phase III trials continues. Two further Phase III peripheral neuropathic pain trials fully recruited and due to report results by end of 2006. Phase III MS neuropathic pain trial to commence Q3 2006
Revenues for six months to 31 March 2006 of £0.73m, including £0.5m relating to commercial sales of Sativex in Canada, Spain and the UK
Net loss for the period of £6.2m (2005: £5.1m), in line with expectation
Cash and short term deposits at 31 March 2006 of £25.4m
Dr Geoffrey Guy, Executive Chairman of GW, said:
"GW is now generating product sales revenues in Canada, Spain and the UK. In addition, we are increasingly excited by the prospects for Sativex in the US following the FDA’s permission to enter directly into Phase III trials. GW has a broad development and regulatory strategy for Sativex which provides multiple opportunities over the next few years to continue to obtain product approvals in various indications across Europe, North America and beyond. In the nearer term, we will continue our regulatory discussions in Europe to determine the initial target indication for our next regulatory filing , report results of two further European Phase III studies and start our first pivotal study in the US. With these important value drivers to come, we believe the prospects for GW are extremely encouraging."
An analyst presentation of the interim results and an R&D day are being held today from 09.30 at Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Please contact Gemma Cross Brown 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.comlater this afternoon.
GW Pharmaceuticals plc Today: +44 (0)20 7831 3113
Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates / Sarah Macleod
View the complete document[PDF, 144KB, opens in a new window].
To view this document you will need Adobe Acrobat Reader. Download this software.