GW PHARMA CANNABIS DRUG NEARS APPROVAL

[Alfa]

GW PHARMA CANNABIS DRUG NEARS APPROVAL

GW Pharmaceuticals on Monday reported more clinical trial data showing
that its cannabis-based treatment helps control symptoms of multiple
sclerosis.

Sativex, an oral spray, reduced spasticity, the spasms and stiffness
that afflict as many as three-quarters of people with MS. The trials
were Phase III, the last stage before a drug is approved for marketing.

But British doctors are unlikely to prescribe the purified mixture of
cannabis extracts for some time, because the Medicines and Healthcare
Products Regulation Agency has asked for further data on its safety
and effectiveness.

Geoffrey Guy, chief executive, admitted approval was taking longer
than expected, but said the process was on track.

The trial data was released alongside GW's results for the six months
to March 31, which showed pre-tax losses of UKP7.95m (UKP7.34m). Mr
Guy said cash reserves of UKP24.2m were enough to see the company
through to commercialisation of Sativex.

Julie Simmonds, analyst at Evolution Beeson Gregory, said the latest
data meant GW had a better chance of getting Sativex approved,
although it would probably be restricted to spasticity, not the


broader pain indication the company had previously been seeking.