BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 28 June, 2007 Based on its new regulatory strategy in the EU BioTie has withdrawn the UK national marketing authorisation application on nalmefene in its alcoholism indication to enable a centralised EU-wide registration procedure in due course. Biotie announced on 23 May 2007 that to maximise nalmefene's potential in the treatment of alcoholism Biotie and Lundbeck 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. 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. A centralised EU-wide registration procedure is not feasible if the product already has a granted or pending national marketing authorisation in the EU. The new regulatory strategy in the EU ensures exploitation in full of the expected 10-year market exclusivity for nalmefene in the EU. The market exclusivity period starts from the first granted marketing authorisation in the EU. Turku, June 28, 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 WITHDRAWS NALMEFENE NATIONAL MARKETING AUTHORISATION APPLICATION IN THE UK TO ENABLE A CENTRALISED EU-WIDE REGISTRATION PROCEDURE
| Source: Biotie Therapies