GW PHARMA SHARES TAKE A HIT ON CANNABIS TRIAL DELAY

GW Pharmaceuticals, the company developing a painkilling spray from
cannabis, has warned that regulatory concerns will delay the launch of
the drug for a second time.

The UK authorities have demanded more information on how the drug is
formulated and on how safe and effective it might be to treat the
symptoms of multiple sclerosis and the pain caused by nerve damage.

GW's shares lost 25 per cent of their value on the latest delay, ending at
133.5p.

Geoffrey Guy, GW's founder and chairman, said there was no prospect of
the product, to be called Sativex, being approved by the end of June
as promised at the start of this year. At the time of a fund raising
and directors' share sales last June, GW was promising the drug would
be available on the National Health Service by the end of 2003.

Dr Guy said: "We haven't changed our view that the product is
approvable, but clearly we got the timing wrong - as have all the
people involved."

The Medicines and Healthcare Products Regulatory Authority (MHRA) has
had a dossier of scientific information on Sativex, including the
results of several human trials, for more than a year but has
repeatedly expressed dissatisfaction with the data. GW first admitted
the authority had demanded extra information in January.

"Their questions covered all parts of the dossier," said Dr Guy. "In
January we had just submitted responses and large numbers of those
original issues have been resolved, but they will keep asking
questions until they are fully comfortable with this new style of dossier."

The Government has been keen to promote a medicinal alternative to
smoked cannabis and GW believes it has overcome problems of how to
ensure a plant-based drug contains the same amount of active
ingredient in each dose, and of ensuring that patients take the right
dose.

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. Dr Guy promised an update on
progress next month, which could reveal whether results from the
latest human trials, due to complete over the summer, will be needed
to satisfy the MHRA.