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GW Pharma Files Cannabis Drug For Approval
Reuters | Scotsman | 09/05/2006

GW Pharmaceuticals has submitted a pioneering cannabis-based medicine for assessment by several European regulators as a potential treatment for spasticity in patients with multiple sclerosis.

GW said on Tuesday it had filed its Sativex treatment in the UK, Denmark, Spain and the Netherlands. The UK will be the main assessor, consulting with the other three countries, with a positive decision triggering approval in all four countries.

Sativex is GW's flagship product, and was first approved in Canada in April 2005 for neuropathic pain.

Its progress in the UK, however, has been much delayed.

GW initially hoped for approval by the end of 2003, but regulators asked for more data. Its prospects were further muddied in March, when GW reported mixed results from a clinical trial in multiple sclerosis (MS) patients with spasticity.

GW said after those results that it would talk to regulators about whether to file Sativex to treat this condition, or whether to wait for the results for two more trials in neuropathic pain later this year.

GW said its decision to file now was backed by Germany's Bayer , its marketing partner in the UK, and Spain's Almirall, its partner in the rest of Europe. Analysts said it was a sign that all three were optimistic of success.

"GW would not have made this submission without very careful consideration and support from partners and the regulators," Investec Securities analyst Ibraheem Mahmood said in a research note, estimating the European market for spasticity in MS patients at about 500 million pounds.

But Charles Stanley's Jeremy Batstone said there was no certainty that Sativex, an under-the-tongue spray, would be approved.

"Given past experience and the regulator's apparent desire to move the goalposts from time to time, the strategy should be regarded as high risk," he wrote in a research note.

GW shares, which have risen almost a third over the past month, were down 1 percent at 97-1/2 pence by 1 p.m., valuing the business at about 117 million pounds.

GW grows thousands of marijuana plants at a secret location in the English countryside, having been granted a dispensation by the government to use the plant for medical research.