cannabisnews.com: GW Says Cannabis Drug Helps MS Patients





GW Says Cannabis Drug Helps MS Patients
Posted by CN Staff on June 21, 2004 at 06:29:36 PT
By Reuters
Source: Reuters 
London -- GW Pharmaceuticals says its pioneering cannabis-based medicine has shown positive preliminary results in a final-stage clinical trial to treat spasms and stiffness in multiple sclerosis sufferers.The biotechnology firm also said on Monday it had made a net first-half loss of 6.9 million pounds in the six months to end-March, compared with 6.7 million the year before.
"The financial results are absolutely bang in line with expectation and exactly within our budget," Executive Chairman Geoffrey Guy told Reuters."We have adequate funding for our purposes at present. The bulk of the research programme is now behind us."In a study of MS sufferers, cannabis-based Sativex achieved statistically significant improvement compared with a placebo based on the main numerical measure of spasms and stiffness -- not on another scale based on patients' subjective response.Shares in GW GWP.L , which grows over 40,000 marijuana plants a year at a secret location in the English countryside, were up 2.3 percent at 133-1/2 pence by 9:26 a.m., valuing the company around 150 million pounds.GW had initially hoped the Medicines Control Agency would approve Sativex, which is administered as an oral spray, last year. At the end of April its shares fell to a 16-month low after GW said it did not expect approval before the end of June."We are not giving a timetable at present," Guy said, but added: "We are very confident that approval will follow. One rarely gets this far into regulatory programmes without there being any light at the end of the tunnel." FRONTIER IN PAIN TREATMENT The average time for British approval is 16 months from validation, Guy said, and the Sativex dossier had only had 13 months."This drug is a plant extract rather than a single chemical entity, and a drug of that nature has not been put before regulators in modern times."Guy said analysts have predicted a market of 200-250 million pounds in Europe and Canada for Sativex and have also estimated that GW would get 35-40 percent of the revenue from its marketing partnership with Germany's Bayer.GW is not making its own forecasts, but Guy pointed out the scarcity of drugs for symptoms of multiple sclerosis, particularly neuropathic pain, which is from damaged or dysfunctional nerves -- for which Sativex has had positive final-stage trials."Neuropathic pain is one of the last big frontiers in terms of pain control -- the doctors have very little to use. And about one percent of the Western population has it," he said.Guy said GW would seek European approval when Sativex is cleared in the UK. Across the Atlantic, GW has filed with Canadian regulators, but Guy was less optimistic about the United States."We first had visits from the Canadian regulators in 1999. They came at their own instigation to see our programme," he said. "But the U.S. is a much greater mountain to climb. There is a polarised debate relating to cannabis over there."Newshawk: Ganda Source: Reuters (UK)Published: June 21, 2004Copyright: 2004 Reuters Related Articles & Web Site:GW Pharmaceuticalshttp://www.gwpharm.com/Cannabis Drug Cuts Arthritis Painhttp://cannabisnews.com/news/thread18984.shtmlThe Cannabis Conundrumhttp://cannabisnews.com/news/thread18285.shtmlBritish Firm Holds Hope for Users of Medical Pothttp://cannabisnews.com/news/thread18277.shtmlBritain To Approve Medicine Derived From MJhttp://cannabisnews.com/news/thread18224.shtml 
Home Comment Email Register Recent Comments Help




Comment #2 posted by FoM on June 21, 2004 at 10:34:29 PT
Related Article from The Financial Times UK
GW Pharma Cannabis Drug Nears Approval By David Firn, Pharmaceuticals and Chemicals Correspondent Published: June 21 2004 
GW Pharmaceuticals on Monday reported more clinical trial data showing that its cannabis-based treatment helps control symptoms of multiple sclerosis. 
Sativex, an oral spray, reduced spasticity, the spasms and stiffness that afflict as many as three-quarters of people with MS. The trials were Phase III, the last stage before a drug is approved for marketing.But British doctors are unlikely to prescribe the purified mixture of cannabis extracts for some time, because the Medicines and Healthcare Products Regulation Agency has asked for further data on its safety and effectiveness.Geoffrey Guy, chief executive, admitted approval was taking longer than expected, but said the process was on track.The trial data was released alongside GW's results for the six months to March 31, which showed pre-tax losses of £7.95m (£7.34m). Mr Guy said cash reserves of £24.2m were enough to see the company through to commercialisation of Sativex.Julie Simmonds, analyst at Evolution Beeson Gregory, said the latest data meant GW had a better chance of getting Sativex approved, although it would probably be restricted to spasticity, not the broader pain indication the company had previously been seeking.Comment
Geoffrey Guy has committed one of the most heinous crimes in biotechnology and it is not possession of cannabis with the intent to supply. He has overpromised and underdelivered, and investors have punished the stock accordingly. GW's shares have lost almost half their value since last summer, when investors expected Sativex to be approved by December. Now the company has admitted it won't meet its June target either. Today's spasticity data are good news and the market now has a more realistic view of the Sativex timetable, but that is somewhat undermined by a headcount reduction and "reprioritisation" of the early-stage pipeline that hint at lean times ahead. Don't expect a more significant recovery in the share price until there is a date fixed for the commercial launch. 
http://news.ft.com/servlet/ContentServer?pagename=FT.com/StoryFT/FullStory&c=StoryFT&cid=1087373153176
[ Post Comment ]


Comment #1 posted by Ganda on June 21, 2004 at 07:14:44 PT
Spanner in the works for Walters and co.....
The myth 'there's absolutely no medicinal benefits with cannabis' is being totally blown out the water!Another headache for the poor feds!
[ Post Comment ]


Post Comment