Irish pharmaceuticals group Elan said yesterday a key EU regulatory body had given its NeuroBloc muscle spasm treatment the go-ahead.
NeuroBloc, for the treatment of muscle spasm condition cervical dystonia, has been cleared by the Committee for Proprietary Medicinal Products and now passes to the European Commission for marketing authorisation. The process can take several months to complete.
Elan, which plans to market NeuroBloc in the US under the trade name Myobloc, said in October it expected the US Food and Drug Administration to approve the drug shortly. Industry sources said yesterday this was likely before the end of this month.
Elan said clinical studies had shown NeuroBloc to be safe and effective for patients with cervical dystonia, a painful condition affecting neck and shoulder muscles.
"NeuroBloc represents the first advance in the treatment of cervical dystonia in over a decade and addresses a number of problems associated with existing medications," said Elan's chief executive and chairman, Mr Donal Geaney.
Elan planned to market NeuroBloc in several European countries in the first quarter of 2001, he added.
"Of course this is good news but the approval everyone wants to see is for the US," said Ms Joan Garahy, analyst at Good body Stockbrokers in Dublin.
Analysts said there was evidence in the US that there was significant revenue potential from so-called "off-label" use of botulinim toxin products for cosmetic applications, specifically in alleviating facial wrinkles.
Analysts see Elan's medication as competition for Botox, a neurotoxin produced by US company Allergan, which has had considerable success as an antiwrinkle agent in a market estimated to be heading for $1 billion (€1.2 billion).
Elan shares were up 68 3/4 US cents at $52.0625 in New York by the close last night.
