* Lundbeck says submits Europe application for Selincro
* Says drug is first of its kind aimed at approval in Europe
* Says drug cuts heavy drinking days, total consumption
* Shares rise 1.3 pct, outperforming wider market
COPENHAGEN, Dec 21 Danish pharmaceutical
group Lundbeck said on Wednesday it had submitted a
European marketing authorization application for its alcohol
dependence treatment Selincro as the company works to replace
revenue from key drugs when patents expire.
A reduction in heavy drinking days and total alcohol
consumption had been seen within the first month of treatment in
three studies and was maintained throughout a 12-month safety
study, Lundbeck said in a statement.
The drug had also shown to be well tolerated, it said.
"Selincro is the first medicine aimed at regulatory approval
in Europe for the reduction of alcohol consumption in patients
with alcohol dependence," Lundbeck said in the statement.
Shares in Lundbeck rose 1.3 percent at 0928 GMT,
outperforming a nearly flat STOXX Europe 600 healthcare index
and a 0.5 percent rise in the Copenhagen stock
exchange's benchmark index.
Lundbeck has licensed the rights to Selincro, which reduces
the urge to continue drinking when alcohol is consumed, from
Finnish pharmaceuticals company Biotie Therapeutics Corp.
Under the deal, Biotie received an execution fee of 12
million euro and is eligible for up to 84 million euro in
upfront and milestone payments plus royalty on sales.
Lundbeck will be responsible for manufacturing and
registration of the product and holds the global rights to the
compound, it said.
The Danish company generates most of its revenue from
antidepressant Cipralex, sold as Lexapro in the United States by
Forest Laboratories and is working to find replacements
as patents expire.
The key antidepressant's patents expire between 2012 and
2014 and Lundbeck has warned it stands to lose about 90 percent
of U.S. sales of Lexapro due to generic competition.
Lundbeck said it would present efficacy and safety data from
its clinical phase III programme for Selincro at the 20th
European Congress of Psychiatry in Prague on March 3-6 next