UPDATE 1-Spain approves GW, Almirall cannabis drug for MS

Wed Jul 28, 2010 2:36am EDT

Related Topics

* 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 (Reuters) - 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 (ALM.MC).

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 in Britain. (Reporting by Ben Hirschler; editing by Karen Foster)

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