Turku, 29 August 2014 -Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has brought Selincro on the market in Germany. 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 during 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 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.
Selincro received European marketing authorization in February 2013 and has to date been introduced in over 20 European markets. 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 Germany, Biotie will have received EUR 20 million of such milestone payments from Lundbeck. A further payment of EUR 2 million is expected on commercial launch of Selincro in France with 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 will make a contribution to Lundbeck towards post approval commitments studies. Lundbeck is responsible for the registration, manufacturing and marketing of the product.
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. Biotie's development has delivered Selincro (nalmefene) for alcohol dependence, which received European marketing authorization in 2013 and is currently being rolled out across Europe by partner Lundbeck. The current development products include tozadenant for Parkinson's disease, which is transitioning into Phase 3 development, and three additional compounds which are in Phase 2 development for cognitive disorders including Parkinson's disease dementia, cocaine dependence, and primary sclerosing cholangitis (PSC), a rare fibrotic disease of the liver.