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2008-01-02 13:30:00 CET 2008-01-02 13:30:28 CET REGULATED INFORMATION Biotie Therapies - Company AnnouncementNalmefene United Kingdom and Ireland rights acquired by LundbeckBIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE January 2, 2008 NALMEFENE UNITED KINGDOM AND IRELAND RIGHTS ACQUIRED BY LUNDBECK Lundbeck has acquired the United Kingdom and Ireland rights for nalmefene from Britannia Pharmaceuticals (now part of STADA Group, headquartered in Germany). Following the new agreement Lundbeck has worldwide rights for nalmefene, excluding North America, Mexico, Turkey, and South-Korea. Biotie-Lundbeck license agreement terms have been amended due to Lundbeck acquiring the United Kingdom and Ireland rights. Under the terms of the amended agreement, Biotie is now eligible for up to EUR 82 million in upfront and milestone payments (previously up to EUR 80 million) plus royalty on sales. Of the EUR 82 million, Biotie has already received an execution fee of EUR 12 million from Lundbeck. The intention is to seek marketing authorisation for nalmefene in the treatment of alcoholism simultaneously in all 27 EU member states via the centralized procedure. To this end, Lundbeck plans to further strengthen the existing nalmefene registration dossier in its alcoholism indication with additional phase III clinical studies before submitting the marketing authorisation application. The studies are expected to start in 2008. Timo Veromaa, President and CEO of Biotie, said: "Lundbeck now owning all of nalmefene rights in the EU is very positive development indeed for Biotie. This significantly facilitates EU-wide regulatory and marketing activities. We remain confident that nalmefene will generate significant revenues to the company in the long term." Turku, 2 January, 2008 Biotie Therapies Corp. Timo Veromaa President and CEO For further information, please contact: Timo Veromaa, President and CEO, Biotie Therapies Corp. tel. +358 2 274 8901, e-mail: timo.veromaa@biotie.com www.biotie.com Distribution: OMX Nordic Exchange Helsinki Main Media Biotie Therapies Corp. Biotie is a Finnish biotech company with focus on dependence disorders, inflammatory diseases and thrombosis. www.biotie.com About nalmefene Nalmefene is a specific opioid receptor antagonist. Biotie has studied the safety and efficacy of nalmefene in a total of 1,200 patients, including two phase III studies in the UK and Finland in patients suffering from alcoholism and alcohol dependence. Nalmefene is the first oral drug showing efficacy in reducing heavy drinking in multicenter, controlled studies. The treatment of alcoholism represents a significant unmet medical need. More than 30 million people in the US, Europe and Japan suffer from alcohol abuse (Datamonitor 04/2002). Every year, in the UK alone, there are 150,000 hospital admissions and 20,000 premature deaths directly due to alcohol, 1.2 million alcohol related violent incidents, and National Health Service estimates the annual costs of alcohol abuse to range between GBP 1.4 billion and GBP 1.7 billion. |
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