GW Pharma loss widens

[Midnight toker]

Cannabis drug firm GW Pharma loss widens

Reuters UK
Tue Jun 20, 2006 11:04 AM BST

<img class=postimg src=bin/sativex.jpg align=right title="Picture shows Sativex. GW Pharmaceuticals (GWP.L), which has developed a pain relief drug from cannabis, posted a wider first-half net loss on Tuesday on an expected rise in spending on clinical trials.">LONDON (Reuters) - GW Pharmaceuticals (GWP.L: Quote, Profile, Research), which has developed a pain relief drug from cannabis, posted a wider first-half net loss on Tuesday on an expected rise in spending on clinical trials.

The firm also said it had spoken to about five regulators in continental Europe about potentially filing its flagship drug, Sativex, with them rather than in Britain.

Sativex, which is sprayed under the tongue, was initially expected to be approved in Britain by the end of 2003, but has suffered numerous delays with regulators requesting more data to prove its benefits.

Its prospects were further muddied in March, when GW reported mixed results from a clinical trial in multiple sclerosis patients with spasticity.


GW told Reuters earlier this month it was talking to an unspecified number of regulators in continental Europe.

"I think we've seen about five so far and we have further discussions with them which will take us through the summer," Chief Executive Geoffrey Guy said in a telephone interview.

If these talks do not give GW enough confidence of success, the firm will wait for the results of two clinical trials of Sativex in neuropathic pain due later this year, he added.

Canada became the first country to approve Sativex for sale in April 2005 as a treatment for neuropathic pain.

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.

The firm said it made a net loss of 6.2 million pounds in the six months ended March 31, up from a loss of 5.1 million in the same period last year.

Revenues totalled 730,000 pounds, including 501,000 pounds from sales of Sativex in Canada, as well as severely restricted sales in Spain and the UK.

Research and development spending rose to 6.5 million pounds from 5 million, as GW works towards starting clinical trials for Sativex in the United States towards the end of this year.

Guy said the firm was in talks with a number of potential partners for Sativex in the United States, but did not expect a deal until next year.

At 10:40 a.m., GW shares were down 5.1 percent at 74 pence, reversing some of the gains it has made in the past week.

GW said it had 25.4 million pounds of cash at March 31, which Investec Securities analysts said would take it well into 2008, not accounting for the potential U.S. partnering deal.

[palmspringsbum]

GW Pharma files cannabis drug for approval

The Scotsman
Tuesday, September 5, 2006

<table class=posttable align=right width=215><tr><td class=postcell><img src=bin/marijuana_leaf_hand_closeup.jpg></td></tr></table>LONDON (Reuters) - 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.

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Last updated: 05-Sep-06 14:50 BST