Interim Results For The Six Months Ended 31 March 2005

31 March 2005

GW Pharmaceuticals plc, the company which develops and manufactures a range of new medicines based on cannabis and other controlled drugs, announces its interim results for the six months ended 31 March 2005.

Sativex ® launched in Canada, the first launch of a cannabis-derived medicine anywhere in the world (announced separately today)
Medicines Commission confirms further efficacy data required prior to UK approval. No quality or safety issues to prevent grant of a product licence.
Clear and well defined programme of new Phase III trials in place to meet European regulatory requirements
Preparations for discussions with US regulator at an advanced stage
Two further Phase III trials fully recruited and due to report results in coming months
Advanced Dispensing System undergoing regulatory device approval testing prior to start of methadone clinical trial
Amendment signed to Bayer marketing agreement, yielding an extra £1m cash payment in period since half-year end
Founder US investors increase equity position through £2.5m investment
Net loss for the six months to 31 March 2005 of £5.1m (2004: £6.9m), in line with budget
Cash and short term deposits at 31 March 2005 of £14.0m. Inflows since the period end have increased cash and short term deposits to £16.2m at 31 May 2005.

Dr Geoffrey Guy, Executive Chairman of GW, said: “Today marks the Canadian launch of Sativex, GW’s first ever product launch. GW was responsible for obtaining Canadian regulatory approval for this product in less than one year from the time of its submission. This approval was also granted just over six years from the start of GW’s development programme, a significant achievement. Although the recent UK regulatory setback is disappointing, GW can from this point onwards look forward to generating product sales revenues from Canada. Sativex is an important new medicine which has been widely anticipated by patients and the medical community. Whilst delighted at the Canadian launch, we recognise and share the profound frustration of MS patients in the UK who will need to wait longer before Sativex may be licensed for prescription in the UK.

“GW’s prospects remain strong. GW has now satisfied both the UK and Canadian regulators with respect to its quality and safety data relating to Sativex. In respect of efficacy, we have, over recent years, produced a wealth of positive clinical trials data, which include seven Phase III trials. In parallel with the UK Medicines Commission appeal, we had already put in place a clear and well defined programme of additional clinical trials to address any outstanding efficacy questions and which have been the subject of formal guidance to meet European regulatory requirements. We believe that this is a highly attractive programme for pharmaceutical companies and over the coming months we will be pursuing product licensing discussions with a view to establishing marketing arrangements for Sativex in various countries.”

A presentation for analysts is taking place today at 09.30 at Weber Shandwick Square Mile, Fox Court, 14 Gray’s Inn Road, London WC1. An audio webcast of the presentation will be available on GW’s website at www.gwpharm.com from 15.00 today.

Enquiries:

GW Pharmaceuticals plc   (20/06/05) + 44 20 7067 0700
Dr Geoffrey Guy, Executive Chairman    (Thereafter) + 44 1980 557000
Justin Gover, Managing Director

Weber Shandwick Square Mile   + 44 20 7067 0700
Kevin Smith/Rachel Taylor/Yvonne Alexander

View the webcast of the analyst presentation

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