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GW Pharmaceuticals 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.
Newhawk: DankCloset - 420Times.com
Source: Reuters (UK)
Published: June 20, 2006
Copyright: 2006 Reuters
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.
Newhawk: DankCloset - 420Times.com
Source: Reuters (UK)
Published: June 20, 2006
Copyright: 2006 Reuters