* Spain approves Sativex as add-on therapy for MS spasticity
* Pricing and reimbursement approval expected in Q4
* Sativex also being submitted in France, Germany, Italy
(Adds details on Sativex, background)
LONDON, July 28 GW Pharmaceuticals Plc's GWP.L
cannabis-derived medicine Sativex has been approved in its
second European market, Spain, as an add-on therapy for treating
spasticity in patients with multiple sclerosis (MS).
The news, which follows a green light last month in Britain,
is a boost for British-based GW and its Spanish partner Almirall
Following the regulatory clearance, Sativex is expected to
get pricing and reimbursement approval from the Spanish Ministry
of Health in the fourth quarter of 2010.
GW said on Wednesday it had also filed to get the medicine
approved under the Europe Union's mutual recognition procedure
in other selected markets, including France, Germany and Italy.
Clinical trials have shown Sativex, which is sprayed under
the tongue, reduces spasticity in MS in patients who do not
respond adequately to existing therapies.
It became the world's first cannabis medicine to win
regulatory clearance when it was approved in Canada in 2005 for
neuropathic pain but its roll-out in Europe for MS is a larger
sales opportunity. Germany's Bayer (BAYGn.DE) sells the product
(Reporting by Ben Hirschler; editing by Karen Foster)