2013-02-28 11:11:24 -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 28 February 2013 at 12:00
Biotie: Selincro (nalmefene) receives European marketing authorization
Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has received
European marketing authorization from the European Commission for Selincro
(nalmefene; an opioid system modulator) for the reduction of alcohol consumption
in adult patients with alcohol dependence. The marketing authorization applies
to all 27 European Union member states.
Timo Veromaa, President and CEO: "This is very good news to the patients
suffering from alcohol dependence and a most significant milestone for Biotie as
a drug development company."
Lundbeck will provide Selincro as part of a new treatment concept that includes
continuous psychosocial support focused on the reduction of alcohol consumption
and treatment adherence. Subject to the completion of pricing and
discussions, Lundbeck expects to launch Selincro in its first markets in mid-
Turku, 28 February 2013
Biotie Therapies Corp.
President and CEO
For further information, please contact:
Timo Veromaa President and CEO
tel. +358 2274 8900, email: firstname.lastname@example.org
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: email@example.com
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 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 has successfully
completed a Phase 2b study in 420 patients with advanced Parkinson's disease.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.
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Source: Biotie Therapies Oyj via Thomson Reuters ONE