2013-09-26 08:10:03 -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 26 September 2013 at 9.00
Biotie: Selincro enters the market in Italy
Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has brought
Selincro on the market in Italy. 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 through 2013 and into 2014.
Turku, 26 September 2013
Biotie Therapies Corp.
President and CEO
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: firstname.lastname@example.org
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 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 Italy, Biotie will have received EUR 16 million of
such milestone payments from Lundbeck. Further payments of EUR 2 million are
expected on commercial launch of Selincro in each of France, Germany and Spain,
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 make a
contribution to Lundbeck towards any required post approval commitments studies,
neither of which are expected to have a significant financial impact in 2013.
Lundbeck is responsible for the registration, manufacturing and marketing of the
Biotie is a specialized drug development company focused primarily 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 dependency, 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 in collaboration with UCB Pharma S.A.. Biotie also has exclusive rights
through an option to acquire Neurelis Inc., which includes NRL-1, an intranasal
formulation of diazepam for epileptic seizure management. Biotie plans to seek
further opportunities of this kind to generate a strong portfolio of products.
Biotie's shares are listed on NASDAQ OMX Helsinki.
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Source: Biotie Therapies Oyj via Thomson Reuters ONE