Lord Mong
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Britain's GW Pharmaceuticals Plc (GWP.L: Quote, Profile , Research) announced a new delay for its pioneering cannabis-based medicine on Friday, saying European drug regulators had requested a further clinical study as a condition for approval.
Shares in GW, which has dispensation from the British government to use cannabis for medical research, plunged around a third in value as Chief Executive Justin Gover said the new study was likely to set back approval by 12 to 18 months.
But he also told Reuters he was more confident that Sativex would win approval following the detailed talks with regulators.
"It's slightly regrettable that this produces something of a delay in the approval. But on the other hand, it makes us comfortable that the approval is even more certain than it was three or four months ago," he said in a telephone interview.
Cannabis has a history of medicinal use dating back to ancient Chinese times, and Queen Victoria's personal physician, J. R. Reynolds, declared it "by far the most useful of drugs" in treating "painful maladies".
Sativex, which is sprayed under the tongue, became the first cannabis-derived medicine to win regulatory approval when it was approved in Canada in 2005 as a treatment for neuropathic, or nerve, pain in multiple sclerosis (MS) patients.
But the drug has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.
MARIJUANA
GW, which is seeking approval in Europe for Sativex as a treatment for spasticity in MS patients, said regulators wanted to be able to identify patients who responded in the first four weeks of treatment and confirm that improvements gained over a further 12 weeks were statistically greater than placebo.
The firm, which grows thousands of marijuana plants at a secret location in the English countryside, said it had provided statistical proof based on existing data, but that regulators wanted a new study specifically designed to meet their goals.
Gover said GW was confident of producing favourable results.
"We feel that the analyses that we've done are very robust. They don't leave us with room for doubt that we can reproduce these because the results we've had are very impressive."
GW said it expected to complete the new study in the second half of 2008, but that it might be able to resubmit Sativex to European regulators before then as a treatment for neuropathic pain in MS patients if separate trial results in this therapeutic area, due early next year, are favourable.
The new study in MS spasticity would be funded from the firm's existing budget for 2008, GW said in a statement.
At 0755 GMT, its shares were down 28 percent at 66 pence, valuing the business at about 81 million pounds ($166 million).
News Hawk- Lord Mong 420 MAGAZINE ® - Medical Marijuana Publication & Social Networking
Source: Reuters UK
Contact: contact@reuters.co.uk
Copyright: 2007 Reuters
Website: https://investing.reuters.co.uk/new...d=&cap=&sz=13&WTModLoc=InvArt-C1-ArticlePage1
Shares in GW, which has dispensation from the British government to use cannabis for medical research, plunged around a third in value as Chief Executive Justin Gover said the new study was likely to set back approval by 12 to 18 months.
But he also told Reuters he was more confident that Sativex would win approval following the detailed talks with regulators.
"It's slightly regrettable that this produces something of a delay in the approval. But on the other hand, it makes us comfortable that the approval is even more certain than it was three or four months ago," he said in a telephone interview.
Cannabis has a history of medicinal use dating back to ancient Chinese times, and Queen Victoria's personal physician, J. R. Reynolds, declared it "by far the most useful of drugs" in treating "painful maladies".
Sativex, which is sprayed under the tongue, became the first cannabis-derived medicine to win regulatory approval when it was approved in Canada in 2005 as a treatment for neuropathic, or nerve, pain in multiple sclerosis (MS) patients.
But the drug has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.
MARIJUANA
GW, which is seeking approval in Europe for Sativex as a treatment for spasticity in MS patients, said regulators wanted to be able to identify patients who responded in the first four weeks of treatment and confirm that improvements gained over a further 12 weeks were statistically greater than placebo.
The firm, which grows thousands of marijuana plants at a secret location in the English countryside, said it had provided statistical proof based on existing data, but that regulators wanted a new study specifically designed to meet their goals.
Gover said GW was confident of producing favourable results.
"We feel that the analyses that we've done are very robust. They don't leave us with room for doubt that we can reproduce these because the results we've had are very impressive."
GW said it expected to complete the new study in the second half of 2008, but that it might be able to resubmit Sativex to European regulators before then as a treatment for neuropathic pain in MS patients if separate trial results in this therapeutic area, due early next year, are favourable.
The new study in MS spasticity would be funded from the firm's existing budget for 2008, GW said in a statement.
At 0755 GMT, its shares were down 28 percent at 66 pence, valuing the business at about 81 million pounds ($166 million).
News Hawk- Lord Mong 420 MAGAZINE ® - Medical Marijuana Publication & Social Networking
Source: Reuters UK
Contact: contact@reuters.co.uk
Copyright: 2007 Reuters
Website: https://investing.reuters.co.uk/new...d=&cap=&sz=13&WTModLoc=InvArt-C1-ArticlePage1
