BIOTIE: UK'S NICE ISSUES POSITIVE FINAL GUIDANCE FOR SELINCRO(r)
TURKU, Finland, Nov. 26, 2014 (GLOBE NEWSWIRE) -- 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
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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.
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.