The European Commission has granged EU marketing authorization for H.Lundbeck's 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 said, "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.
Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (>60 g/day for men, >40 g/day for women) without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and the reduction of alcohol consumption. Treatment should be initiated only in patients who continue to have a high drinking risk level two weeks after an initial assessment. Selincro is to be taken as-needed; that is, on each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking.
Biotie has licensed global rights to Selincro to Lundbeck. Under the terms of the agreement, Biotie is eligible for up to EUR 89 million in upfront and milestone payments plus royalties on sales of Selincro. Biotie has previously received EUR 12 million of such milestone payments from Lundbeck. Further milestone payments are expected on commercial launch of Selincro and on the product potentially reaching certain predetermined sales. Lundbeck is responsible for the registration, manufacturing and marketing of the product.
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence (addiction) and post-traumatic stress disorder), and inflammatory and fibrotic liver disease.