TURKU, FINLAND--(Marketwired - April 22, 2013) - BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 22 April 2013 at 9:00 a.m.
Biotie: Selincro launched in first European markets
Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has started launching Selincro™ in the first European markets, making the new treatment available to alcohol dependent patients in Norway, Finland, Poland and the Baltic countries. The launch marks the first introduction of a new treatment for alcohol dependence in Europe for more than a decade. Lundbeck will continue the rollout of Selincro in Europe through 2013 and into 2014.
According to the terms of the license agreement between Biotie and Lundbeck for Selincro, Biotie is eligible for milestone payments upon commercial launch of Selincro in France, Germany, Italy, Spain, and the United Kingdom, some of which may occur in 2013; royalties on sales in all launched markets, which are not expected to give rise to significant revenue in 2013; and a potential contribution to Lundbeck towards any required post approval commitments studies, which are not expected to be significant in 2013.
Turku, 22 April 2013
Biotie Therapies Corp.
President and CEO
NASDAQ OMX Helsinki Ltd
ABOUT SELINCRO (nalmefene):
Selincro 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. Selincro 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. Selincro 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 Selincroto 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 Selincro. Biotie has previously received EUR 12 million of such milestone payments from Lundbeck. Further milestone payments are expected on commercial launch of Selincro in France, Germany, Italy, Spain, and the United Kingdom and on the product potentially reaching certain predetermined sales. Lundbeck is responsible for the registration, manufacturing and marketing of the product.
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease, Alzheimer's disease and other cognitive disorders, alcohol and drug dependence (addiction) and post-traumatic stress disorder), and inflammatory and fibrotic liver disease. The company has a strong and balanced development portfolio with several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Biotie's most advanced product, Selincro (nalmefene), licensed to H. Lundbeck A/S, has on 28 February 2013 received European marketing authorization for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption. In addition, Biotie has a strategic collaboration with UCB Pharma S.A. covering tozadenant which is transitioning into Phase 3 development for Parkinson's disease. Biotie shares are listed on NASDAQ OMX Helsinki Ltd.