Biotie: Lundbeck and Otsuka announce partnership to develop and commercialize nalmefene in Japan
| Source:Biotie Therapies
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 31 October 2013 at 12.10
Biotie: Lundbeck and Otsuka announce partnership to develop and commercialize
nalmefene in Japan
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.
President and CEO
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NASDAQ OMX Helsinki Ltd
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 drinking.
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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