Cannabis based drug filed for approval

Published: 7:46PM Wednesday May 20, 2009 Source: Reuters

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A pioneering cannabis-based medicine for multiple sclerosis from GW Pharmaceuticals has been filed for approval in Europe, paving the way for its potential approval at the end of 2009 or early 2010.
   
Following numerous delays, the submission to regulators in Britain and Spain is a landmark for the British drugmaker, which also announced on Wednesday it had made a maiden net profit of 4.0 million pounds ($10.3 million) in the six months to March 31 from a 4.2 million loss a year ago.
   
Shares in the company rose nine percent in early trade.
   
Clinical trials have shown GW's drug Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies.
   
If it is approved, Sativex will be marketed in Britain by Germany's Bayer and in the rest of Europe by Spain's Almirall.
   
Following the filings in Britain and Spain, submissions for approval will made in other European countries during 2010.
   
Sativex became the world's first cannabis medicine to win regulatory approval when it was approved in Canada in 2005.
   
But the drug - extracted from marijuana plants, grown at secret locations in the English countryside - has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.
   
The spray contains two active cannabinoids, CBD and THC. The latter substance is responsible for the euphoria associated with smoking cannabis.
   
GW also said it was planning a mid-stage Phase II clinical with a new cannabinoid medicine for the treatment of dyslipidaemia, or raised levels of fat in the blood, in Type II diabetes patients.

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