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2008-12-15 08:30:00 CET 2008-12-15 09:09:00 CET REGULATED INFORMATION Biotie Therapies - Company AnnouncementLundbeck announces start of new phase III clinical trials with nalmefeneBIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 15 December, 2008 at 9.30 a.m. Lundbeck announces start of new phase III clinical trials with nalmefene Biotie's license partner, H. Lundbeck A/S (Lundbeck), announced today that it is initiating three phase III clinical trials with nalmefene for the treatment of alcohol dependence. Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, the treatment with nalmefene is not aimed at keeping the patients from drinking. Nalmefene instead removes the desire to drink more, thereby controlling and limiting the intake of alcohol. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time. Biotie's previously conducted study in 400 alcoholic patients documented nalmefene's ability to significantly limit both the patient's average alcohol intake and the number of days with an intake above five units of alcohol. This means a sharp reduction in patients' risk of developing diseases such as various cancers, cardiovascular diseases and cirrhosis of the liver. Previous trials have also shown nalmefene to be well-tolerated and safe. Based on the earlier Biotie-sponsored trials, Lundbeck is now launching three phase III trials enrolling more than 1,800 patients randomised into groups receiving nalmefene or placebo. The first two trials, in which patients are treated over a period of six months,primarily aim to demonstrate the efficacy of nalmefene, whilst the objective of the last study, in which patients are treated for 12 months, is particularly to confirm that the compound is well-tolerated. The first data from the trials are expected in the first half of 2011."Nalmefene offers a rare opportunity for us to provide a new and more effective treatment of alcohol dependence, which causes major harm to millions of people worldwide," says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck."We are pleased with Lundbeck's commitment with nalmefene and believe that Lundbeck, with its impressive track record in the CNS space, is an ideal partner for us in the continuing development and ultimately commercialisation of nalmefene. We remain confident that nalmefene will generate significant revenues to the company in the long term," says Timo Veromaa, President and CEO of Biotie Therapies Corp. About nalmefene Nalmefene is an opioid receptor antagonist. The compound acts by blocking the mechanism in the brain that can cause a continuing and uncontrolled intake of alcohol. This helps to control and limit the intake. Nalmefene was originally developed by Biotie. Lundbeck holds the global rights to the compound with the exception of North America, Mexico, Turkey and South Korea. Turku, 15 December 2008 Timo Veromaa President and CEO For further information, please contact: Timo Veromaa, President and CEO, Biotie Therapies Corp. tel. +358 2 274 8900, e-mail: timo.veromaa@biotie.com www.biotie.com DISTRIBUTION NASDAQ OMX Helsinki Ltd Main Media About Biotie Biotie Therapies Corp. is a drug development company with operations in Turku, Finland and Radebeul, Germany. The company focuses in discovery and development of therapeutics for central nervous system (addiction, psychotic disorders) and inflammatory diseases (e.g. rheumatoid arthritis, psoriasis and COPD). Biotie has a broad range of innovative drug candidates at different stages of clinical and pre-clinical development. The product pipeline represents a compelling range of new drugs for diseases with high unmet medical need. For more information, please visit www.biotie.com. About Lundbeck H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2007, the company's revenue was DKK 11 billion (approximately EUR 1.5 billion or USD 2.0 billion). The number of employees is approx. 5,300 globally. For more information, please visit www.lundbeck.com. |
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