TURKU, Finland, Oct. 31, 2013 (GLOBE NEWSWIRE) -- Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has expanded its existing alliance with Otsuka Pharmaceutical Co. Ltd. (Otsuka) to include development and commercialization of nalmefene (sold under the brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by the European Medicines Agency as the first treatment for the reduction of alcohol consumption. Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan, and it is expected that the first clinical phase III study will be initiated during 2014.
Biotie has licensed global rights to nalmefene to Lundbeck. In September 2012, in connection with Lundbeck making a EUR 10 million equity investment in Biotie, the worldwide license agreement regarding nalmefene was amended whereby the royalties on the sales on markets outside the European Union, the European Free Trade Area and the United States were decreased in order to support the possible launching of the product for these markets, and Biotie is to receive an additional sales milestone payment in the amount of EUR 5 million in Japan. Today's announcement will have no immediate financial impact on Biotie.
Timo Veromaa, President and Chief Executive Officer of Biotie commented: "We are delighted that Lundbeck together with Otsuka are committed to launching nalmefene in Japan. Alcohol dependence is a worldwide problem and nalmefene with its as-needed administration of therapy can reshape the treatment for patients who cannot or do not want to completely stop drinking."
Turku, 31 October 2013
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ABOUT NALMEFENE (sold under the brand name Selincro in Europe)
In Europe, nalmefene 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. Nalmefene 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. Nalmefene 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 nalmefene 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 nalmefene. To date, Biotie has received EUR 16 million in 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.
Source:Biotie Therapies Oyj