Blow For Gw Pharma Cannabis Remedy

GW Pharmaceuticals, the company developing a painkilling spray from
cannabis, is braced to miss its end-of-year deadline for gaining approval
to launch the drug.

The company is also growing less confident that the Government's medicines
regulator will approve the drug, to be called Sativex, for all the uses it
originally requested. At briefings with City analysts, GW has been saying
it expects approval "from the end of the year", while its broker, Collins
Stewart, has warned its clients that a decision could take until next autumn.

In an investment note, Collins Stewart analyst Jonathan Kwok wrote: "We
expect to hear the final decision from the end of 2003 onwards."

With barely a month to go, sources at the MHRA believe it is unlikely an
announcement would now be ready this year. Multiple sclerosis patient
groups have long campaigned to be allowed to use a cannabis drug to relieve
their symptoms, and GW believes it has trial data which shows Sativex is an
effective treatment for muscle stiffness and bladder problems.

It has also requested that it be approved for use to relieve neuropathic
pain, pain caused by a diseased or damaged nervous system. This would be a
breakthrough treatment since neuropathic pain is viewed as difficult or
impossible to treat.

People close to the company now believe the regulator, the MHRA, could
reject the application to launch Sativex for neuropathic pain until more
trial results are available later next year.

The likely delays will dismay investors who bought into a fund raising by
the company after its interim results in June. At the time, the company
said it was confident Sativex would be available on prescription in the UK
by the end of 2003. Geoffrey Guy, the founder and chairman, sold ?5m of
shares at 200p at that time.

The company itself yesterday insisted nothing had changed since the start
of the year. A spokesman said: "The process is continuing as expected.
There is a month to go and we are confident of getting approval. We have
always said the timing was going to be in the hands of the regulator".

The launch of Sativex will require a change in the law to reschedule
cannabis, which the Government has promised on MHRA approval. GW shares
were off 5p at 189.5p yesterday on fading hopes that the drug can be made
available this year.


Pubdate: Fri, 28 Nov 2003
Source: Independent (UK)
Copyright: 2003 Independent Newspapers (UK) Ltd.
Contact: letters@independent.co.uk
Website: http://www.independent.co.uk/