[420 Girl]

GW Pharmaceuticals has turned in a healthy set of results for the year ended September 30, 2009, with a hefty increase in revenues helping to push the balance sheet into the black for the first time.

The Porton-Down, UK-based company said sales for 2009 rocketed to £24.1 million from £11.8 million posted for the previous year, propelled by turnover of the group’s cannabis-based drug Sativex (delta-9-tetrahydrocannabinol and cannabidiol) and a sizeable milestone payment banked during the 12 months.

Turnover of Sativex jumped 32% to £1.7 million, driven by named-patient sales which soared 44% to £1.3 million following particularly strong growth in Spain, while the group said it also received a milestone payment of $8 million on the back of positive results from a Phase III trial assessing the drug in multiple sclerosis spasticity.

These factors helped GW generate its first maiden yearly profit (after tax) of £1.5 million, a far cry from the £8.2 million loss booked in 2008 and, according to the firm, a reflection of its business model “which provides for sustained investment in its product pipeline whilst at the same time maintaining a strong cash position as well as a focus towards profitability”.

The company closed the year with cash and short-term deposits of £20.6 million in its back pocket, leaving its reserves nicely stocked to fund the further development of its R&D pipeline. Moreover, in 2010 the firm stands to receive a milestone payment of £10 million from Bayer if Sativex gains regulatory approval in the UK, while an additional £2.5 million will come from Almirall on regulatory and pricing approval in Spain, adding further ballast to the group’s coffers.

Positive outlook
Commenting on the group’s outlook for the coming year, Dr Geoffrey Guy, GW’s Chairman, said the firm is currently working with its marketing partners to prepare for the first major commercial launch of Sativex in Europe if the regulatory go-ahead is given, and “with this landmark event and further material clinical data due next year, I believe that 2010 will see GW complete the transition into a commercial stage pharmaceutical business with excellent growth prospects”.

Meanwhile, the company announced alongside its results that patient recruitment into a Phase II/III trial assessing Sativex in cancer pain is now complete.

The study, which is being carried out in collaboration with Otsuka Pharmaceutical as part of the US development programme for Sativex, has enrolled 360 patients across 14 countries in North America, Europe, Latin America and South Africa, and results are expected in the Spring of next year.

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