Biotie's partner Lundbeck submits European Marketing Authorization Application for Selincro(TM) (nalmefene)
Turku, Finland, Dec 21, 2011 (Thomson Reuters ONE via COMTEX) -- BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 21 December 2011 at 9.30 a.m.
Biotie's partner Lundbeck submits European Marketing Authorization Application for Selincro(TM) (nalmefene)
Biotie Therapies announced today that its partner Lundbeck has submitted a marketing authorization application (MAA) through the centralized procedure to the European Medicines Agency (EMA) for Selincro(TM) (nalmefene), a novel opioid receptor ligand intended for the treatment of alcohol dependence. The dossier has been accepted for review by the EMA.
Timo Veromaa, Chief Executive Officer of Biotie said, "Filing of Selincro(TM) in Europe is an important step in bringing this novel treatment to patients. Existing drugs for alcohol dependence require abstinence, which is a very high treatment hurdle. Selincro(TM) provides a solution for patients by allowing them to take the drug on an as needed basis, leading to a reduction in their alcohol consumption and number of heavy drinking days."
Lundbeck plans to present efficacy and safety data from its Phase 3 program at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic, 3-6 March 2012.
In Turku, 21 December 2011
Biotie Therapies Corp.
Timo Veromaa
President and CEO
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8911, e-mail: [email protected]
Media contact:
Pete Chan, Tudor Reilly
Mobile +44 (0) 7725 554 632.
Office: +44 (0) 20 7034 7608
DISTRIBUTION
NASDAQ OMX Helsinki Ltd