Bureaucracy, Hemp -Marijuana

UPDATE 3-GW Pharma files cannabis drug for MS in Europe (Reuters)

Ben Hirschler
Wed May 20, 2009 7:39am EDT

* Multiple sclerosis drug Sativex filed for European OK

* Firm posts maiden first-half profit of 4 mln pounds

* Plans to test new cannabinoid medicine for dyslipidaemia

* Shares up 8 percent

(Adds comments from R&D head, analyst, latest shares)

By Ben Deighton and Ben Hirschler

LONDON, May 20 (Reuters) – A pioneering cannabis-based medicine for multiple sclerosis from GW Pharmaceuticals (GWP.L) has been filed for approval in Europe, paving the way for its potential approval at the end of 2009 or early in 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 ($6.2 million) in the six months to March 31 from a 4.2 million loss a year ago.

Shares in the company rose 7.6 percent to 85 pence by midday after touching a high of 89.5p.

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 (BAYG.DE) and in the rest of Europe by Spain’s Almirall (ALM.MC).

Following the filings in Britain and Spain, submissions for approval will made in other European countries during 2010.

Further clinical trials need to be completed before the medicine is ready for submission for approval in the United States, where GW’s partner is Otsuka.

Sativex became the world’s first cannabis medicine to win regulatory approval when it was approved in Canada in 2005.

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.

Despite past disappointments, analysts are hopeful that this time GW will win a green light.

“Since the pivotal trial was designed largely by the regulators we feel there is relatively low risk of a rejection,” said KBC analyst Paul Cuddon.

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 trial with a new cannabinoid medicine for the treatment of dyslipidaemia, or raised levels of fat in the blood, in type II diabetes patients.

Other potential use for cannabinoid medicines could include treatments for cancer and schizophrenia.

“We’re looking at developing other products from the plant which are not psychoactive … The plant has 60 or 70 of them, many of which have a very interesting pharmacology,” R&D Director Stephen Wright told Reuters.

(Editing by John Stonestreet)

($1 = 0.6465 pound)

(ben.hirschler@thomsonreuters.com; Tel: +44 20 7542 5082; Reuters Messaging: ben.hirschler.reuters.com@reuters.net; blogs.reuters.com/ben-hirschler/))

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