Porton Down, UK, 22 November 2011: GW Pharmaceuticals plc (AIM: GWP, “GW” or “the Group”), the specialty pharmaceutical company focused on cannabinoid science, announces its preliminary results for the year ended 30 September 2011.
- Sativex®successfully launched in UK, Germany, Spain and Denmark – strong initial uptake in key German market recently reported by marketing partner, Almirall
- Licence agreement signed with Novartis to commercialise Sativex in Australasia, Asia (excluding Japan/China), Middle East (excluding Israel) and Africa. $5m upfront payment received. Regulatory submission filed in Australia.
- Sativex approved in Czech Republic and further approvals in Italy, Sweden, and Austria expected in the coming months. Launches in these countries expected in 2012
- Second European Mutual Recognition Procedure submission procedure now underway with aim to expand approvals to up to ten additional European countries in 2012 (see separate release today)
- Expansion of facilities and staff to support sales growth and R&D activity
- Two Sativex Phase III cancer pain trials recruiting on track. Third Phase III cancer pain trial in advanced stage of planning and due to commence H1 2012. All trials fully funded by US partner, Otsuka
- Two important new patents granted to protect Sativex’s formulation and its use in cancer pain
- Three Phase IIa clinical trials of novel cannabinoid medicines (GWP42003 and GWP42004) in diabetes/metabolic disease now underway. First trial fully recruited.
- Phase IIa clinical trial of novel cannabinoid medicine (GWP42003) in ulcerative colitis expected to commence Q1 2012
- Positive pre-clinical data in epilepsy and cancer continue to be generated as part of Otsuka research collaboration
- Sativex sales up by 59% to £4.4m (2010: £2.8m) and milestone income of £5.3m (2010: £11.2m). Total revenue of £29.6m (2010: £30.7m). 95% of revenue generated from overseas customers.
- Net profit before tax of £2.5m (2010: £4.6m)
- Cash and short term deposits at 30 September 2011 increased to £28.3m (2010: £25.2m)
Dr Geoffrey Guy, GW’s Chairman, said, “GW has delivered a better than expected profit as a result of higher than anticipated Sativex sales and licence fee income from the recent Novartis agreement. The recent launch of Sativex in the key German market has been particularly encouraging and with the international commercial roll-out of Sativex gathering pace, we look forward to continued sales growth and further approvals and launches in Europe in the year ahead. Beyond Europe, we look forward to working with Novartis to commercialise Sativex in a number of key emerging markets.
“We remain confident that our ongoing research programme provides a wealth of opportunity for further growth and value creation. A substantial Phase III programme for Sativex in cancer pain is underway with the aim of addressing a major global market opportunity. In addition, we have multiple Phase II trials now underway and further trials planned across several areas of the pipeline with a view to signing new out-licensing agreements in due course. We look forward to building on these achievements during the year ahead.”An analyst presentation is being held today at 9.30am at FTI Consulting, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB. Please contact Mo Noonan at FTI Consulting on +44 20 7269 7116 for details. An audio webcast of the presentation will be available on GW’s website at www.gwpharm.com later this afternoon.
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
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