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Second attempt for Sativex

GW Pharmaceuticals files cannabis-based drug for regulatory approval in four European companies

GW Pharmaceuticals has filed its cannabis-based medicine, Sativex, for regulatory approval in four European countries, including the UK.

The filing, for the symptomatic relief of spasticity in patients with multiple sclerosis (MS), is the UK company's second attempt to get its flagship product on the market. It has been made under the 'decentralised procedure' in the UK, Spain, Denmark and the Netherlands.

Under this system, the UK will act as a reference member state, which will consult with the other three countries. If the drug it approved, it will be approved simultaneously in all four countries and marketed in the UK by Bayer Heathcare and in the rest of Europe by Spanish firm, Almirall.

GW tried to get Sativex approved last year, but was knocked back when it lost an appeal against a regulatory decision requiring it to conduct further clinical trials.

Dr Stephen Wright, GW's R&D director, said the firm now had ìa sizeable body of positive clinical data to support the efficacy and safety of Sativex in MS spasticityî.

ìThis is a complex data package and we have therefore reviewed the complete dossier with our marketing partners and discussed it in detail with a number of European regulators,î he said. ìThese meetings have provided constructive and positive feedback.î

He added that GW and its marketing partners had come to the conclusion that the data ìwarrants serious regulatory attentionî.

Karl Keegan, pharmaceutical analyst at Canaccord Capital, told PMLive that GW had reached a stage where it had to decide either to drop the compound for the spasticity indication or take it forward.

ìThe company has decided to pursue the latter strategy so it must believe it has a good chance of getting Sativex approved,î he said.

He explained that if the drug suffers from any delays and is not launched by the end of 2007, GW will be running out of cash as it goes into 2008: ìSo what GW needs is the milestones associated with approval to offset its cashburn. The overwhelming sense of the valuation is tied up in this compound - I can't see a lot of value in GW outside of Sativex.î

Sativex is approved in Canada for the relief of neuropathic pain in MS. There are around 500,000 MS sufferers in Europe on top of the four million experiencing neuropathic pain.

30th September 2008

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