17.12. 2012 BioTurku®

Biotie’s Selincro (nalmefene) receives positive opinion for approval in the European Union

Biotie has announced that its partner H.Lundbeck A/S has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization of Selincro (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. Once approved, 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.

The European Commission usually delivers its final decision on approval within 2-3 months of the CHMP recommendation. The decision will be applicable to all 27 European Union member states plus Iceland and Norway. Subject to the Commission's final approval and completion of pricing and reimbursement discussions, Lundbeck expects to launch Selincro in a number of European markets by mid-2013.

"This is a historic occasion for Biotie. We are extremely pleased that the CHMP has recommended Selincro for approval and we look forward to the final decision from the European Commission in the coming months." said Timo Veromaa, President & CEO of Biotie. He continued, "There are limited options available for patients who need to reduce their harmful levels of alcohol intake and, for many, stopping drinking is not an acceptable or achievable treatment goal. Selincro will be the first product specifically developed to reduce alcohol consumption without the need to completely abstain from drinking.  In Europe alone, over 10% of all deaths in adults are attributable to alcohol - this represents a huge medical burden and one we hope Selincro will help to address by providing physicians and patients with a fresh approach to treatment".

The CHMP opinion was based on the results from three pivotal, randomized, double-blind, placebo controlled clinical trials studying the effects of 18 mg Selincro in adult patients with alcohol dependence.  These studies included approximately 2,000 patients diagnosed with alcohol dependence; two-thirds of these patients had never before received treatment for their disease.