Turku, 26 September 2013 -Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has brought Selincro on the market in Italy. According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for a milestone payment of EUR 2 million related to the market entry. Lundbeck will continue the rollout of Selincro in additional European markets through 2013 and into 2014.
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ABOUT SELINCRO (nalmefene):
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 Turku, 26 September 2013taken 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. Upon payment of the milestone for market entry in Italy, Biotie will have received EUR 16 million of such milestone payments from Lundbeck. Further payments of EUR 2 million are expected on commercial launch of Selincro in each of France, Germany and Spain, and further potential milestone payments on launches in certain other markets and if the product reaches certain predetermined sales. In addition, Biotie will continue to receive royalties on sales in all launched markets and make a contribution to Lundbeck towards any required post approval commitments studies, neither of which are expected to have a significant financial impact in 2013. Lundbeck is responsible for the registration, manufacturing and marketing of the product.
Biotie is a specialized drug development company focused primarily on products for neurodegenerative and psychiatric disorders. For the past years, Biotie has successfully operated a strategy built around search, profile and partner. This has delivered Selincro (nalmefene) for alcohol dependency, which received European marketing authorization in February 2013 and is currently being rolled out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a antagonist which is transitioning into Phase 3 development for Parkinson's disease in collaboration with UCB Pharma S.A.. Biotie also has exclusive rights through an option to acquire Neurelis Inc., which includes NRL-1, an intranasal formulation of diazepam for epileptic seizure management. Biotie plans to seek further opportunities of this kind to generate a strong portfolio of products. Biotie's shares are listed on NASDAQ OMX Helsinki.