It was good news for GW Pharmaceuticals and Spanish partner Almirall this morning after regulators in the UK and Spain agreed that, under the decentralisation procedure, Sativex is approvable in Europe.

Regulatory agencies in both countries agreed that all issues relating to the application to market Sativex (delta-9-tetrahydrocannabinol and cannabidiol) for multiple sclerosis spasticity have been resolved, which means the process has now entered the final stage, which, on completion, will allow national marketing approvals to be issued.

A green light for the drug in the UK (expected in the second quarter) will see GW’s books boosted by a £10-million milestone payment from Bayer Schering Pharma, which will market Sativex in the country, while approval in Spain, expected in the second half of this year, will see a further £2.5 million from Almirall, which holds marketing rights in the rest of Europe.

Shares in GW had, however, dipped this morning on the London Stock Exchange after the group’s interim results showed a swing into the red, posting a net loss before tax of £2.7 million compared to profit of £4.0 million in the year-ago period.

On the upside, the firm saw revenues (excluding milestones) jump to £11.4 million from £8.1 million in the first half of 2009, with growth driven by sales from its alliance with Otsuka and Sativex, it said.

In addition, GW closed the period with significantly more cash in its back pocket, with £20.4 million at March 31 compared to £11.8 million a year ago, and all-in-all the firm is certainly very upbeat about its future prospects.

“GW is transitioning from a late stage development company to a commercial pharmaceutical business with excellent growth prospects,” said the company’s chairman Geoffrey Guy, and added that the first half of 2010 has proven to be “the most important in GW’s history in which we have made material progress towards Sativex’s launch in Europe and generated positive cancer pain data in the US”.

“With the first major approvals and launches for Sativex now imminent, the US cancer pain Phase III trial preparation well underway, partners for Sativex secured in key markets, a highly promising earlier stage pipeline and a strong financial position, we remain confident in the future prospects for GW,” the company said.