HTTP/1.0 200 OK Content-Type: text/html 011 Canada Approves GW's Cannabis Drug for Multiple Sclerosis
Pubdate: Wed, 20 Apr 2005
Source: Independent  (UK)
Copyright: 2005 Independent Newspapers (UK) Ltd.
Author: Stephen Foley
Cited: GW Pharmaceuticals
Bookmark: (GW Pharmaceuticals)
Bookmark: (Cannabis - Medicinal)
Bookmark: (Chronic Pain)


GW Pharmaceuticals has become the first drug company to gain approval to 
launch a cannabis-based medicine for multiple sclerosis sufferers.

The approval in Canada comes after six years of work for the company, which 
grows cannabis at a secret farm in southern England and turns it into an 
under-the-tongue spray, Sativex. And it marks a breakthrough for MS 
sufferers, who have long argued that cannabis relieves its symptoms, 
including pain and spasticity.

The Canadian authorities will allow GW - through its marketing partner, the 
German drug giant Bayer - to sell Sativex as a prescription painkiller, 
provided the company does additional clinical trials of the medicine over 
the next five years. GW must confirm the results of the studies to date, 
which have been promising, Health Canada said. The drug has so far been 
turned down by regulators in the UK, who say GW has not proven to their 
satisfaction that Sativex is effective.

Bayer will pay GW a UKP2m milestone as a result of Health Canada's 
approval. Launch batches of Sativex are already in the country, and the 
drug will be available within weeks. Analysts disagree on the likely sales 
potential in Canada, which has 50,000 MS sufferers, half of whom suffer 
from the neuropathic pain Sativex has been approved to treat. Smoked 
cannabis is also available in Canada for medicinal use, and proposals for 
its decriminalisation are being debated.

Karl Keegan, an analyst at Canaccord, said: "I think initially there will 
be a lot of hype over Sativex, but I suspect that people will want to smoke 
cannabis rather than use a mouth spray."

How Sativex Is Seen

. Canada: Health Canada has become the first regulator to approve a 
prescription medicine based on cannabis. Because so few MS sufferers say 
their pain can be treated effectively with existing medicines, it 
accelerated the approval process.

. UK: GW has faced several setbacks in its dealings with the UK, despite 
the Home Office's backing for its plans to develop a cannabis-based MS 
treatment. The independent medicines regulator argued there was not enough 
data to support its launch as a painkiller. GW is appealing the ruling at a 
hearing this summer.

. Europe: European regulators will take their cue from the UK, so analysts 
believe that Sativex's full commercial potential can only be unlocked when 
GW has satisfied the regulator in its home country.

. US: Originally thought opposed to cannabis-based medicines because it 
would represent weakness in its war on drugs. Now, though, GW believes 
regulators might be won round and will open talks this summer on how it 
might be allowed to trial Sativex in the US.
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