BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 22 July 2014
at 9.00 a.m.
Biotie: Selincro enters the market in Spain
Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has brought
Selincro on the market in Spain. According to the terms of the license agreement
between Biotie and Lundbeck for Selincro, Biotie is eligible for a milestone
payment of EUR 2 million related to the market entry. Lundbeck will continue the
rollout of Selincro in additional European markets during 2014.
Turku, 22 July 2014
Biotie Therapies Corp.
President and CEO
For further information, please contact:
Virve Nurmi, Investor Relations Manager
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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.
Selincro received European marketing authorization in February 2013 and has to
date been introduced in over 20 European markets. Biotie has licensed global
rights to Selincro to 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. Upon payment of the milestone for market entry
in Spain, Biotie will have received EUR 18 million of such milestone payments
from Lundbeck. Further payments of EUR 2 million each are expected on commercial
launch of Selincro in France and Germany, and further potential milestone
payments on launches in certain other markets and if the product reaches certain
predetermined sales. In addition, Biotie will continue to receive royalties on
sales in all launched markets and will make a contribution to Lundbeck towards
post approval commitments studies. Lundbeck is responsible for the registration,
manufacturing and marketing of the product.
Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. For the past years, Biotie has
successfully operated a strategy built around search, profile and partner. This
has delivered Selincro (nalmefene) for alcohol dependence, which received
European marketing authorization in February 2013 and is currently being rolled
out across Europe by partner H. Lundbeck A/S, and tozadenant, a novel A2a
antagonist which is transitioning into Phase 3 development for Parkinson's
disease and for which Biotie holds exclusive, global rights. Biotie is actively
developing its pipeline assets, including SYN120, a unique potent 5-HT6/5-HT2a
dual antagonist for which Biotie initially expects to conduct a Phase 2 study in
Parkinson's disease dementia that is largely funded by the Michael J Fox
Foundation; nepicastat, a selective inhibitor of dopamine beta hydroxylase which
is currently in a Phase 2 study, fully funded by NIDA, for treatment seeking
cocaine addicts; and BTT-1023, a monoclonal antibody targeting Vascular Adhesion
Protein 1 for which Biotie intends to conduct a Phase 2 study in primary
sclerosing cholangitis, a rare fibrotic disease of the liver. Biotie's shares
are listed on NASDAQ OMX Helsinki.
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