Data presented at the 2012 European Congress of Psychiatry showing that Selincro(TM) reduces total alcohol consumption by two-thirds on average after six months of treatment

Data presented at the 2012 European Congress of Psychiatry showing that Selincro(TM) reduces total alcohol consumption by two-thirds on average after six months of treatment
Mon Mar 5, 2012

Data presented at the 2012 European Congress of Psychiatry showing that Selincro(TM) reduces total alcohol consumption by two-thirds on average after six months of treatment

  • Phase 3 data showed that patients treated with Selincro were able to reduce their total alcohol consumption by 66% on average after six months of treatment
  • Selincro was safe and well tolerated
  • Selincro has significant potential in helping individuals with alcohol dependence reduce their alcohol consumption
  • Selincro is the first medicine targeting reduction of alcohol consumption and it is currently undergoing regulatory review in Europe

Biotie announced today that its partner H. Lundbeck A/S (Lundbeck) has presented results from the phase 3 program of Selincro(TM) (nalmefene), an investigational compound for the treatment of alcohol dependence, at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic. Data from the three placebo-controlled phase 3 studies (ESENSE 1, ESENSE 2 and SENSE) was discussed during the symposium. In addition, the ESENSE 1 study was presented as a poster by Prof. Dr. Karl Mann et al.  Further details of the ESENSE 2 and SENSE studies will be presented at the Annual Research Society on Alcoholism (RSA) Scientific Meeting in San Francisco in June.

"The results presented today reinforce the efficacy and safety of Selincro in patients with alcohol dependence," said Timo Veromaa, President and CEO of Biotie. He continued, "Selincro has the potential to transform the way alcohol dependence is managed by both physicians and patients and we look forward to working with our partner Lundbeck and the regulators to make this important new treatment option available in Europe".

Summary of the results from phase 3 program presented at EPA 2012:

All studies were multi-centre, randomized, double-blind, placebo controlled, parallel group studies of 18 mg Selincro taken as needed in patients with alcohol dependence according to DSM-IV criteria. Patients were instructed to take one tablet on each day they perceived a risk of drinking alcohol, preferably one to two hours prior to the anticipated time of drinking. Medical advice and support to enhance motivation and adherence were included in all treatment arms in the studies. No abstinence treatment goal was imposed.

A total of 1,997 patients were randomized in the three studies, 604 patients in ESENSE 1 (298 on placebo, 306 on Selincro), 718 in ESENSE 2 (360 on placebo, 358 on Selincro), and 675 in SENSE (166 on placebo, 509 on Selincro).

The primary objective of the two identical six month studies ESENSE1 and ESENSE 2 was to evaluate the efficacy of as-needed use of Selincro versus placebo in reducing the number of heavy drinking days (HDD) and the monthly total alcohol consumption (TAC) over a period of six months in alcohol-dependent patients. A heavy drinking day is defined as a day with a consumption of at least 60g alcohol for men and at least 40g alcohol for women. The primary objective of SENSE was to evaluate the long-term safety and tolerability of Selincro versus placebo over a period of 52 weeks in patients with alcohol dependence, as well as to evaluate the efficacy of Selincro versus placebo at six months.

In all studies a wide range of secondary endpoints were assessed, including the proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function, other laboratory tests and pharmaco-economic outcomes (not reported here).

In ESENSE 1 and ESENSE 2, Selincro was superior to placebo in reducing the number of HDDs (p <0.05 in both studies) and TAC (ESENSE 1, p <0.05; ESENSE 2, p = 0.088) at month 6. In SENSE, Selincro was more effective than placebo (p<0.05) in reducing the number of HDDs and TAC at the majority of the time points studied, including 52 weeks, although not at month 6. In all the studies, the effect of Selincro as measured by HDD and TAC was evident already at month one and was maintained throughout the treatment period.

In ESENSE 1, the mean number of HDDs decreased from 19 to 7 days/month and the mean TAC decreased from 84 to 30g/day in the Selincro group at month 6. In the placebo group, the mean number of HDDs decreased from 20 to 10 days/month and the mean TAC decreased from 85 to 43g/day at month 6. Further, improvements in the secondary endpoints Clinical Global Impression and the liver enzymes GGT and ALAT were larger (p<0.05) in the Selincro group than in the placebo group at month 6.

In ESENSE 2, the mean number of HDDs decreased from 20 to 7 days/month and the mean TAC decreased from 93 to 30g/day in the Selincro group at month 6. In the placebo group, the mean number of HDDs decreased from 18 to 7 days/month and the mean TAC decreased from 89 to 33g/day at month 6.

In SENSE, the mean number of HDDs decreased from 15 days/month at baseline to 5 days/month at month 6, and further to 3 days/month at one year in the Selincro group. While the mean TAC decreased from 75g/day at baseline to 22g/day at month 6, and to 16g/day at one year.  In the placebo group, the mean number of HDDs decreased from 15 days/month at baseline to 6 days/month at month 6, while the mean TAC decreased from 75g/day at baseline to 27g/day at Month 6, with essentially no further decreases for both endpoints at one year.

In all three clinical studies the overall safety profile of Selincro was consistent with observations and data provided in previous studies, resulting in a total clinical database of more than 3,000 individuals. The most frequent adverse events included dizziness, insomnia and nausea and these were mild and transient. The majority of these events had an onset within the first days after the initial dose, and then decreased with treatment continuation.

Turku, 5 March 2012

Biotie Therapies Corp.

Timo Veromaa
President and CEO

For further information, please contact:

Virve Nurmi, Biotie Therapies Corp.
tel. +358 2 274 8900
e-mail: [email protected]

Media contact:

Julie Walters, Tudor Reilly
Office: +44 (0) 20 7034 3201
Mobile +44 (0) 775 362 6967

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About Selincro(TM) (nalmefene)

Selincro (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 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 Selincro and on the product reaching certain predetermined sales. Lundbeck will be responsible for manufacturing and registration of the product.

Lundbeck submitted a European Marketing Authorisation Application (MAA) for nalmefene for the treatment of alcohol dependence via the centralized procedure for regulatory approval in Europe in December 2011.

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 (Selincro) for alcohol dependence. Selincro 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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