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UPDATE 1-Lundbeck moves to Phase III with alcoholism drug

Mon Dec 15, 2008 4:21am EST

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COPENHAGEN, Dec 15 (Reuters) - Danish pharmaceutical group Lundbeck (LUN.CO) said on Monday it would start Phase III clinical trials for its alcohol dependence drug candidate nalmefene, with data expected by 2011.

Lundbeck said previous studies had documented nalmefene's safety and ability to "significantly limit both the patient's average alcohol intake and the number of days with an intake above five units of alcohol."

Nalmefene was originally developed by BioTie Therapies Corp. (BTH1V.HE). Lundbeck now holds the rights to the compound in all regions except North America, Turkey and South Korea.

The Danish firm said it would launch three Phase III trials with more than 1,800 patients. The first data from the trials are expected in the first half of 2011.

Valby-based Lundbeck's biggest drug is antidepressant Cipralex, sold in the United States as Lexapro. It faces generic competition for the drug in major markets starting in 2012 as patents run out, and the firm is seeking to develop or acquire drugs to replace the blockbuster's revenue stream.

Nalmefene is a opioid receptor antagonist, which acts by blocking the mechanism in the brain that can cause a continuing and uncontrolled intake of alcohol.

(Reporting by Kim McLaughlin; editing by John Stonestreet)



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