GW Pharmaceuticals plc, the company which develops and manufactures a range of new medicines based on cannabis and other controlled drugs, announces its preliminary results for the year ended 30 September 2005.
Sativex approved and launched in Canada. In-market sales in first six months of C$1.1m (£540,000), in line with expectations
European (ex-UK) marketing agreement for Sativex signed with Almirall, including £12m signature fee
US FDA accepts IND for Sativex, allowing direct entry into pivotal Phase III trials in cancer pain
Contract to supply Sativex to 600 patients in Spain under compassionate access programme – first patient now enrolled
UK Home Office permits import of Sativex from Canada to UK as an unlicensed medicine. Hundreds of enquiries received to date
Medicines Commission confirms further efficacy data required prior to UK regulatory approval. No quality or safety issues to prevent grant of a product licence
Pivotal MS spasticity Phase III trial completed patient recruitment and due to report results in the second quarter of 2006
Two pivotal neuropathic pain Phase III trials ongoing and due to report results by the end of 2006
Phase III trial shows that Sativex improves symptoms of bladder dysfunction in Multiple Sclerosis
Progress in earlier stage research programmes, notably rheumatoid arthritis and the study of THCV
Net loss for the year of £7.5m (2004: £13.7m), in line with budget
Cash and short term deposits at 30 Sept 2005 of £13.0m (2004: £17.8m)
Balance sheet significantly strengthened since the year end following the £12m signature fee from Almirall and £8.1m US share placing
Dr Geoffrey Guy, Executive Chairman, commented: “During the last twelve months, GW has made significant advances, including its first product approval and launch, first sales revenues, completion of its most sizeable commercial agreement to date, and, latterly, the grant of a Phase III IND in the United States, the world’s largest pharmaceutical market. As a result, we start 2006 in a strong position from a commercial, financial, and scientific perspective.
“We are encouraged by the initial performance of Sativex since its launch in Canada at the end of June. We are pleased that the product is now also generating revenues on a named patient basis in Europe. The smooth commercial introduction of Sativex bodes well for the long term potential of the Sativex franchise.
“With the Canadian launch, Phase III IND in the US, and a comprehensive late stage clinical programme in Europe, GW now has a truly international strategic outlook. Whilst UK regulatory progress has been slower than hoped, the ongoing Phase III trials programme now provides a number of independent routes to European regulatory approvals for Sativex. In the indication of Multiple Sclerosis spasticity, the pivotal Phase III trial will report results in the second quarter of 2006. In the indication of peripheral neuropathic pain, two pivotal Phase III trials are on track to conclude towards the end of the year.
“In building upon the achievements of 2005, the Company can look forward with confidence to 2006, a year in which we expect to see revenue growth, results from three pivotal clinical trials, a regulatory submission in Europe, the start of pivotal Phase III trials in the US, and a renewed focus on earlier stage research.”
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.
GW Pharmaceuticals plc (19/01/06) 020 7067 0700
Dr Geoffrey Guy, Chairman (Thereafter) 01980 557000
Justin Gover, Managing Director
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith / Yvonne Alexander
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