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Biotie: Lundbeck and Otsuka announce partnership to develop and commercialize nalmefene in Japan

Biotie: Lundbeck and Otsuka announce partnership to develop and commercialize
nalmefene in Japan

TURKU, Finland, Oct. 31, 2013 (GLOBE NEWSWIRE) -- Biotie today announced that
its partner H.Lundbeck A/S (Lundbeck) has expanded its existing alliance with
Otsuka Pharmaceutical Co. Ltd. (Otsuka) to include development and
commercialization of nalmefene (sold under the brand name Selincro in Europe)
in Japan. Earlier this year, nalmefene was approved by the European Medicines
Agency as the first treatment for the reduction of alcohol consumption.
Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene
in Japan, and it is expected that the first clinical phase III study will be
initiated during 2014.

Biotie has licensed global rights to nalmefene to Lundbeck. In September 2012,
in connection with Lundbeck making a EUR 10 million equity investment in
Biotie, the worldwide license agreement regarding nalmefene was amended
whereby the royalties on the sales on markets outside the European Union, the
European Free Trade Area and the United States were decreased in order to
support the possible launching of the product for these markets, and Biotie is
to receive an additional sales milestone payment in the amount of EUR 5
million in Japan. Today's announcement will have no immediate financial impact
on Biotie.

Timo Veromaa, President and Chief Executive Officer of Biotie commented: "We
are delighted that Lundbeck together with Otsuka are committed to launching
nalmefene in Japan. Alcohol dependence is a worldwide problem and nalmefene
with its as-needed administration of therapy can reshape the treatment for
patients who cannot or do not want to completely stop drinking."

Turku, 31 October 2013

Biotie Therapies Corp.

Timo Veromaa
President and CEO

For further information, please contact:

Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail:

NASDAQ OMX Helsinki Ltd
Main Media

ABOUT NALMEFENE (sold under the brand name Selincro in Europe)

In Europe, nalmefene 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. Nalmefene 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. Nalmefene 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

Biotie has licensed global rights to nalmefene 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 nalmefene. To date, Biotie has
received EUR 16 million in 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 product.


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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