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Selincro (Nalmefene)

21:05 EDT 21st September 2017 | BioPortfolio

Treatment of alcohol dependence

Selincro (nalmefene) is an orally administered opioid receptor ligand for the treatment of alcohol dependence.

Selincro is approved in Europe in February 2013 for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high level of alcohol consumption.

Selincro is taken on an ‘as needed’ basis to reduce the desire to drink, offering patients a novel treatment option such as total abstinence and intensive psychosocial therapy. Biotie the findish biopharmaceutical company has licensed global development and commercialization rights to nalmefene to H. Lundbeck A/S, a leader in CNS drug development.

Alcohol dependence

Alcohol dependence is a brain disease with a high probability of following a progressive course.  Alcohol is toxic to most organs of the body, and the level of consumption is strongly correlated with the risk for long-term morbidity and mortality.  Alcohol is a causal factor in more than 60 types of disease and injury.  Genetic and environmental factors are important in the development of alcohol dependence; genetic factors account for an estimated 60% of the risk of developing the disease.  A central characteristic of alcohol dependence is the often overpowering desire to consume alcohol. Patients experience difficulties in controlling the consumption of alcohol and continue consuming alcohol despite harmful consequence.

Selincro product profile

Selincro is a small molecule opioid receptor modulator that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances. As a result, Selincro targets a novel principle in the treatment of alcohol dependence by removing a person’s desire to drink.

Selincro builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with Selincro is not aimed at keeping the patients from drinking. Instead, Selincro helps to control and limit the intake of alcohol. Selincro distinguishes itself by being available as a tablet formulation to be taken only according to need, ("as needed"), whereas existing pharmaceuticals must be taken continuously over a longer period of time and are aimed at maintaining abstinence.

Collaboration partner

Biotie has licensed global development and commercialization rights to nalmefene to Danish CNS specialist, H. Lundbeck A/S (Lundbeck).  Lundbeck is an ideal partner for Biotie, as it has significant experience and a substantial track record in depression, a therapeutic area with many parallels to alcohol use disorders.  Lundbeck’s specialist marketing force and its long-established relationships with prescribers in the relevant therapeutic areas will be important in driving a successful launch and maximizing the market potential for nalmefene.

Under the terms of the agreement with Lundbeck, Biotie is eligible for up to EUR 89 million in upfront and milestone payments plus royalties 

Program status

In February 2013 Biotie´s partner Lundbeck received European marketing authorization from the European Commission for Selincro for the reduction of alcohol consumption in adult patients with alcohol dependence who have high level of alcohol consumption. The marketing authorization applies to all 27 European Union member states. 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.

Lundbeck launched Selincro in the first European markets in April 2013, and by September 2013, it was available to alcohol dependent patients in Norway, Finland, Poland, Estonia, Latvia, Lithuania, Portugal, Iceland, Sweden, the UK, Bulgaria, the Czech Republic, Hungary, Slovenia, Italy and Denmark. Lundbeck will continue the rollout of Selincro in Europe through 2013 and into 2014.

Adapated from Lundbeck - please review - http://www.biotie.com/en/product_and_development/central_nervous_system_disorders/selincro

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