Canada Approves GW Pharma Drug in Cannabis First

  Canada Approves GW Pharma Drug in Cannabis First

Posted by CN Staff on April 19, 2005 at 06:45:24 PT
By Ben Hirschler 
Source: Reuters 

London -- Canada became the first country in the world to approve a cannabis-derived medicine on Tuesday when it gave a green light to a mouth spray developed by Britain's GW Pharmaceuticals Plc.The go-ahead had been expected after Canadian regulators said last December that Sativex, which is sprayed under the tongue, qualified to be considered for approval.
But the news still boosted GW shares as much as 14 percent, reflecting the importance of the product to the small biotechnology firm.Sativex, which is designed to help patients with multiple sclerosis (MS), will be marketed in Canada by Germany's Bayer AG and is likely to launched in May, according to GW Pharma Executive Chairman Geoffrey Guy.Guy has long championed the benefits of certain chemicals in cannabis for countering the neuropathic, or nerve, pain suffered by many MS patients.But his company's product has suffered a series of delays and setbacks in development, which have sent its shares on a rollercoaster ride.The company had originally hoped to win British approval for Sativex in 2003 but UK officials said in December they wanted more evidence about the benefits of the medicine. It is not expected to be approved in its home market until later this year or possibly 2006.GLOBAL AMBITIONSNevertheless, Guy said he was confident the drug would win approval in major markets around the world, underpinning its "significant" sales potential."Canada is the first approval of a global regulatory strategy which will probably take us about five years, after which we should be in virtually all major countries, except perhaps Japan," he told Reuters.He declined to forecast sales for the product and said the price would only be announced by Bayer shortly before launch.GW Pharma 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.Cannabis has a long history of medicinal use, dating back to ancient Chinese times. Queen Victoria, whose physician described it as "one of the most valuable medicines we possess", is said to have taken cannabis tincture for her menstrual pains.But it fell out of favour in the 20th century because of a lack of standardised preparations and the development of more potent synthetic painkillers.GW Pharma believes it has got round those standardisation problems with its spray-based product, which also avoids the damaging effects of smoking the drug.Its approval was welcomed by the MS Society of Canada, whose national medical adviser Dr William McIlroy said sufferers needed new options to address their pain.Shares in GW Pharma -- which were floated at 182 pence each in 2001 -- jumped to a four-month high of 138-1/2p following the Canadian green light before paring some of the gain to trade up 11 percent at 134-1/2p by 1215 GMT. Source: Reuters (Wire)Author: Ben HirschlerPublished: April 19, 2005Copyright: 2005 Reuters Related Articles & Web Site:GW Pharmaceuticals Plans U.S. Future for Cannabis Drug Approves Cannabis Drug Canada To Approve UK Cannabis Drug 

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Comment #2 posted by FoM on April 19, 2005 at 12:27:52 PT

ASA: Natural Marijuana Extract Coming to US Soon?
 For Immediate ReleaseMedia contacts: Hilary McQuie 510-333-8554; Steph Sherer 510-872-7822Natural Marijuana Extract Coming to U.S. Soon? Canada Approves World’s First Whole Cannabis Plant-Derived PharmaceuticalApril 19, 2005Canada today approved Sativex, the world’s first natural marijuana extract pharmaceutical, for pain related to multiple sclerosis. England-based GW Pharmaceuticals and its marketing partner, Bayer, has said it will ask the US Food and Drug Administration (FDA) for permission to start the regulatory approval process in the US later his year. In order for the FDA to commence the approval process in the US for Sativex, they would have to concede that the whole cannabis plant does have medical value.Americans for Safe Access, the largest soley medical marijuana patient advocacy organization nationally, is delighted with the release of Sativex. “Now Canadian patients have an additional option in terms of delivery systems for medical cannabis. Approval in the US appears inevitable, now that the medical marijuana movement has successfully convinced our opponents of its efficacy. It is just so unfortunate that so many have had suffer during the process,” said Steph Sherer, director of Americans for Safe Access.With over 350,000 diagnosed cases of MS in the United States and only 11 states with laws that allow for medical use of marijuana, a number of MS patients have been arrested, and even convicted, for their personal marijuana use for medical reasons.John Pastuovic, now the public relations contact in the US for GW Pharmaceuticals, is a former anti-medical marijuana campaigner. He worked as recently as February 2005 to oppose the passage of state legislation allowing for compassionate use of medical marijuana. His high profile coworker was Dr. Andrea Barthwell, former Deputy Director of the Office of National Drug Control Policy, where her primary role was to oppose medical marijuana. For more information, see: Dr. Barthwell is reported to have accepted an advisory board role for GW Pharmaceuticals.Phillippe Lucas,of ASA affiliate Canadians for Safe Access also notes, “Since Sativex is a whole-plant cannabis medicine, if we submitted Sativex and regular marijuana to a lab for chemical profiling, it would be very hard for a judge to tell the difference between the two based solely on cannabinoids profiles. Outlawing cannabis while approving Sativex as a medicine makes about as much sense as outlawing oranges while selling Vitamin C through pharmacies.”This decision comes immediately after the promised decision date by Health and Human Services, which oversees the FDA, on the Americans for Safe Access ’ Data Quality Act petition. The petition is a challenge to HHS’s finding that marijuana has no recognized medical value. The decision was due on Friday, April 15, but has been inexplicably delayed and is promised delivery today.For more information on the FDA and medical marijuana and background on the Data Quality Act please visit: Geoffrey Guy, GW Chairman (44) 1980 557000 John Pastuovic, Press and PR (US) 312 925 9092 HHS Barbara Greenberg 202-401-8279
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Comment #1 posted by goneposthole on April 19, 2005 at 07:42:10 PT

It would seem to me...
that GW Pharmaceuticals has a fair and balanced approach with their work in developing cannabis-based medicine.They took a bath when their Total Brain Injury cannabis-based drug didn't live up to its purported efficacy.However, even if they are being sued to the hilt, they are playing fair and square.It gives them credence. It would also seem that the British government is playing fair and square. It's a win-win situation; it appears as such, anyway.When you play fair and square, don't expect to win, but you have no regrets when you lose. You're not going to win them all.One thing is for sure, if you don't play fair and square, you always lose.If you won't play fair and square, how can you be fair and balanced?
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