Company Seeks European Approval for Alcohol Treatment Drug

COPENHAGEN, Dec 21 (Reuters) – 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 year.

Read more…

This entry was posted in Uncategorized. Bookmark the permalink.