Lundbeck submits European Marketing Authorization Application for Selincro(TM) (nalmefene)

Published: 08:30 CET 21-12-2011 /Thomson
Reuters /Source: Biotie Therapies Oyj /XHEL: BTH1V /ISIN: FI0009011571

Biotie's partner Lundbeck submits European Marketing Authorization Application for Selincro(TM) (nalmefene)


Biotie's partner Lundbeck submits European Marketing Authorization Application for Selincro(TM) (nalmefene)

Biotie Therapies announced today that its partner Lundbeck has submitted a marketing authorization application (MAA) through the centralized procedure to the European Medicines Agency (EMA) for Selincro(TM) (nalmefene), a novel opioid receptor ligand intended for the treatment of alcohol dependence. The dossier has been accepted for review by the EMA.

Timo Veromaa, Chief Executive Officer of Biotie said, "Filing of Selincro(TM) in Europe is an important step in bringing this novel treatment to patients. Existing drugs for alcohol dependence require abstinence, which is a very high treatment hurdle. Selincro(TM) provides a solution for patients by allowing them to take the drug on an as needed basis, leading to a reduction in their alcohol consumption and number of heavy drinking days."

Lundbeck plans to present efficacy and safety data from its Phase 3 program at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic, 3-6 March 2012.

In Turku, 21 December 2011

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Timo Veromaa
President and CEO

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About the Phase 3 program

Based on the results of previous trials sponsored by Biotie, Lundbeck initiated three Phase 3 clinical studies in Europe in 2008 enrolling a total of approximately 2,000 individuals with alcohol dependence who were randomized into two groups receiving SelincroTM (18 mg tablet as needed, orally) or placebo, in addition to a brief medical compliance program focused on motivation and adherence. Two of the three trials (ESENSE1 and ESENSE2), in which individuals were treated over a period of six months, were primarily aimed to demonstrate the efficacy of nalmefene, whilst the third study (SENSE), in which individuals were treated for 12 months, was primarily conducted to confirm the safety and tolerability of the compound.

Lundbeck assessed a wide range of primary and secondary endpoints in its Phase 3 program for nalmefene including: number of heavy drinking days per month, total alcohol consumption, proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function and other laboratory tests, pharmaco-economic outcomes and treatment discontinuation effects. All assessments were consistently in favour of nalmefene compared to placebo, and overall, nalmefene reduced heavy drinking days and total alcohol consumption by more than 50% compared to pre-treatment baseline. The effect was observed already during the first month of treatment and was maintained throughout the study period in the three trials.

Furthermore, data from the 12-month safety study (SENSE) confirmed that the treatment effect of nalmefene was maintained and even improved after 1 year of treatment. Approximately two-thirds of the individuals in the studies had previously not been treated for alcohol dependence, despite an ongoing affliction, indicating that reduction of alcohol intake represents an attractive treatment objective compared to current treatments which all require abstinence.

The safety profile of nalmefene was consistent with observations and data provided in earlier studies, including Biotie's previously completed Phase 3 program. The most frequent adverse events in patients taking nalmefene were dizziness, insomnia and nausea. These adverse events were usually mild and transient in nature. The three studies in the Lundbeck Phase 3 clinical program were conducted in Europe and enrolled about 2,000 individuals with alcohol dependence. Including prior studies conducted by Biotie, the total clinical database now contains more than 3,000 patients with alcohol dependence.

About Selincro(TM) (nalmefene)

Selincro(TM) (nalmefene) is a small molecule distinct opioid system 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(TM) removes a person's desire to continue to drink.

Biotie has licensed global rights to nalmefene to Lundbeck. Under the terms of the agreement, Biotie is eligible for up to EUR 84 million in upfront and milestone payments plus royalties on sales from Lundbeck. Biotie has already received EUR 12 million from Lundbeck. Further milestone payments are expected on commercial launch of SelincroTM and on the product reaching certain predetermined sales. Lundbeck will be responsible for manufacturing and registration of the product.

About alcohol dependence

Alcohol dependence is a disease in which the afflicted person continually craves alcohol, is unable to limit his or her drinking, needs to drink greater amounts to get the same effect and has withdrawal symptoms after stopping alcohol use. Alcohol dependence also has potentially fatal consequences such as liver cirrhosis and cancer, among others. As a result, this disease is one of the most serious health concerns in the western world, both socially and economically, with estimated associated costs to society of at least EUR 200 billion per annum. It is estimated that in any given year approximately 3.4% of EU citizens over 15 years of age suffer from alcohol dependence, corresponding to more than 14 million people. Despite this, alcohol dependence tends to be severely under-diagnosed with only approximately 13% of alcohol dependants receiving treatment, characterizing it as a large unmet medical need.

Currently, conventional methods of treating alcohol dependence require abstinence from drinking as a starting point - a high hurdle for an alcohol dependent patient. There are only a few pharmaceutical compounds that have received marketing approval to help alcohol dependent patients maintain abstinence. All these treatments, including psychosocial counseling measures, cannot prevent patients from relapsing and the long term prognosis remains poor. There are no approved therapies on the market yet to proactively help curb a person's urge to drink.

About Biotie

Biotie is an international biopharmaceutical company focused on the development of innovative, clinically differentiated medicines to address unmet medical needs primarily associated with neurological and psychiatric diseases and selected inflammatory diseases. Biotie aims to develop treatment solutions that will improve the lives of patients with conditions such as Parkinson's and Alzheimer's diseases, drug dependence and inflammatory liver disease.

Biotie's highly experienced development teams in Europe and the US are focused on efficiently delivering safety and efficacy data for the company's compounds. For niche indications, Biotie will consider bringing products to market by itself. For larger indications, it will seek strategic partnerships with pharmaceutical partners for late-stage development and commercialization. Current pharmaceutical partners include Lundbeck, Roche, UCB Pharma, and Seikagaku.

Biotie's most advanced product is nalmefene (SelincroTM) for alcohol dependence. SelincroTM has completed Phase 3 clinical development and a marketing authorization application has been submitted for review to the European Medicines Agency by licensing partner Lundbeck.

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