Biotie: Selincro receives European marketing authorization
Turku based Biotie has announced that its partner H.Lundbeck A/S has received European marketing authorization from the European Commission for Selincro (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with alcohol dependence.
The marketing authorization applies to all 27 European Union member states.
Timo Veromaa, President and CEO: "This is very good news to the patients suffering from alcohol dependence and a most significant milestone for Biotie as a drug development company."
Lundbeck will provide Selincro as part of a new treatment concept that includes continuous psychosocial support focused on the reduction of alcohol consumption and treatment adherence. Subject to the completion of pricing and reimbursement discussions, Lundbeck expects to launch Selincro in its first markets in mid-2013.