BIOTIE: UK'S NICE ISSUES POSITIVE FINAL GUIDANCE FOR SELINCRO®
(Thomson Reuters ONE) -
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 26 November,
2014 at 1.30 p.m.
BIOTIE: UK'S NICE ISSUES POSITIVE FINAL GUIDANCE FOR SELINCRO®
Biotie Therapies (Biotie) announces that the National Institute for Health and
Care Excellence (NICE), the United Kingdom's health technology assessment
authority, has issued its final guidance for Selincro (nalmefene), recommending
its use within the conditions of its marketing authorization in the National
Health Service (NHS) in England and Wales as an option for reducing alcohol
consumption for people with alcohol dependence. Upon issuance of the final
guidance, the NHS has three months to implement the recommendation and make the
necessary funding available. It is expected that up to 600,000 alcohol dependent
individuals in England and Wales may be eligible for the treatment.
Selincro (nalmefene) is a dual-acting opioid system modulator and the first
therapy approved in Europe for the reduction of alcohol consumption in alcohol
dependent individuals. Biotie has licensed global rights to Selincro to
H.Lundbeck A/S (Lundbeck). Lundbeck received European marketing authorization
for Selincro in February 2013 and has to date introduced the product in well
over 20 European markets.
Timo Veromaa, President and CEO of Biotie commented, "We are pleased that
Selincro will now be available through the NHS to appropriate alcohol dependent
patients in England and Wales. Positive reimbursement decisions have also been
granted in a number of additional EU countries, including France and Spain, and
our partner Lundbeck is continuing with its negotiations in order to provide
access to this exciting new treatment option for patients."
Turku, 26 November 2014
Biotie Therapies Corp.
Timo Veromaa
President and CEO
Further information:
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900, e-mail: virve.nurmi(at)biotie.com
Distribution:
NASDAQ OMX Helsinki Ltd
Main media
www.biotie.com
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 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 22 million in milestone payments from Lundbeck. Further potential
milestone payments are expected on launches in certain ex-EU 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 post approval commitments studies. Lundbeck is responsible for
the registration, manufacturing and marketing of the product.
ABOUT BIOTIE
Biotie is a specialized drug development company focused on products for
neurodegenerative and psychiatric disorders. Biotie's development has delivered
Selincro (nalmefene) for alcohol dependence, which received European marketing
authorization in 2013 and is currently being rolled out across Europe by partner
Lundbeck. The current development products include tozadenant for Parkinson's
disease, which is transitioning into Phase 3 development, and three additional
compounds which are in Phase 2 development for cognitive disorders including
Parkinson's disease dementia, cocaine dependence, and primary sclerosing
cholangitis (PSC), a rare fibrotic disease of the liver.
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biotie Therapies Oyj via GlobeNewswire
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Datum: 26.11.2014 - 12:31 Uhr
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