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2007-05-23 17:48:04 CEST 2007-05-23 17:48:04 CEST REGLAMENTUOJAMA INFORMACIJA Biotie Therapies - Company AnnouncementBIOTIE-LUNDBECK NALMEFENE LICENSE ENTERS INTO FORCEBIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 23 May 2007 - Partners to maximise nalmefene's potential by seeking EU-wide marketing authorisation via the centralised procedure. - Lundbeck to conduct additional clinical studies to further strengthen MAA dossier. - License terms amended to reflect new EU-wide regulatory and marketing strategy Biotie Therapies Corp. announced today that the licensing agreement has entered into force on H. Lundbeck A/S worldwide rights for nalmefene, excluding North America, Mexico, UK, Ireland, Turkey, and South-Korea. To maximise nalmefene's potential in the treatment of alcoholism the partners have jointly decided to seek marketing authorisation 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. The studies are expected to start in 2008. The license agreement terms have been amended to reflect the planned additional Lundbeck investment to strengthen the registration dossier for the centralized procedure. Under the terms of the amended agreement, BioTie will receive an execution fee of EUR 12 million, of which EUR 10 million was paid on signing in November 2006. In total, BioTie is eligible for up to EUR 80 million in upfront and milestone payments plus royalty on sales. BioTie will participate in financing some of the clinical development costs. BioTie submitted a national marketing authorisation application regarding nalmefene in the treatment of alcoholism to the UK Medicines and Healthcare Regulatory Authority (the "MHRA") in November 2006. However, the change in regulatory strategy to seek an EU-wide marketing authorisation simultaneously in all 27 member states may involve BioTie withdrawing the UK national application to enable the centralised EU-wide registration process in due course. Timo Veromaa, President and CEO of BioTie, said: "We are pleased to see Lundbeck's commitment to the new treatment paradigm in alcoholism that we have introduced. Seeking a centralised approval will significantly bolster the potential of nalmefene in the EU compared to the mutual recognition route initially planned by Biotie. We remain confident that nalmefene will generate significant revenues to the company in the long term." 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. Turku, May 23, 2007 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: Helsinki Stock Exchange Main Media Biotie Therapies Corp. BioTie is a Finnish biotech company with focus on dependence disorders, inflammatory diseases and thrombosis. The Company started operations in 1996 and as a pioneer in dependence disorders has been developing nalmefene for the treatment of alcoholism and pathological gambling since 1999. (www.biotie.com) |
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