SOURCE: Biotie Therapies Oyj

January 03, 2011 02:11 ET

Biotie Announces Positive Results from First Two Phase III Studies with Nalmefene in Alcohol Dependence

TURKU, FINLAND--(Marketwire - January 3, 2011) -


Biotie Announces Positive Results from First Two Phase III Studies with Nalmefene in Alcohol Dependence

* According to headine results from ESENSE1 and SENSE, nalmefene is safe and efficacious in helping individuals to reduce their alcohol consumption

* ESENSE2, a second 24-week efficacy study, is expected to conclude in 2Q 2011

* Lundbeck is on track to submit an MAA in Europe in 2H 2011, pending the successful completion of ESENSE2

Biotie's partner, H. Lundbeck A/S (Lundbeck), has today announced that it has completed two Phase III clinical trials evaluating nalmefene for the treatment of alcohol dependence (ESENSE1, SENSE). Lundbeck expects to complete a further efficacy study (ESENSE2) in 2Q 2011 and plans to file a marketing authorisation application (MAA) in Europe in 2H 2011, depending on the outcome of the final study. Lundbeck plans to submit detailed efficacy and safety data for presentation at scientific and medical meetings after all three trials have been completed.

Timo Veromaa, Chief Executive Officer of Biotie stated: "We are delighted with the continued favourable profile of nalmefene and look forward to the results from ESENSE2 later this year. We believe that nalmefene could significantly transform the treatment of alcohol dependence by providing patients with a real alternative to current abstinence-based therapies. Helping patients to reduce harmful levels of alcohol consumption is an important clinical goal and we believe the unique "as needed" approach with nalmefene - which aims to put the patient back in control of their disease - could create a real paradigm shift in the management of alcohol dependence. We are excited to be working with our partner Lundbeck, a global leader in CNS drug development, to bring this important product to market."

ESENSE1, a 24-week efficacy study, and SENSE, a 52-week safety study, were designed to investigate efficacy and safety of 20mg nalmefene taken "as needed" versus placebo in patients with alcohol dependence. In both studies, which enrolled around 1,300 patients in total, psychosocial intervention consisted of a brief, standardised programme focussed on adherence and follow-up. No abstinence treatment goals were imposed. The data from these studies is consistent with the profile of nalmefene observed in previous clinical studies. The most frequent adverse events included dizziness, insomnia and nausea.

Lundbeck has indicated it will initiate a dialogue with the healthcare agencies, as well as scientific advisors, to discuss the outcomes from these clinical trials and its plans for submitting a European Marketing Authorization Application (MAA) for nalmefene as a treatment for alcohol dependence. "We expect Lundbeck to assess the full data package, including results from the final Phase III trial (ESENSE2), before filing nalmefene in Europe", commented Dr. Veromaa.

Biotie has previously conducted three Phase II studies and two Phase III studies in alcohol dependence. The largest of the previous Phase III trials, conducted in 400 patients with alcohol dependence, demonstrated that nalmefene, taken "as needed", significantly reduced the average alcohol intake per patient and the number of heavy drinking days (classed as intake above five standard drinks of alcohol). Previous trials have also shown nalmefene to be well-tolerated and safe. Biotie's patient dossier for nalmefene includes approximately 1,100 patients and will expand to approximately 3,000 patients when all three Phase III studies being conducted by Lundbeck have been completed.

Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with nalmefene is not aimed at keeping the patients from drinking. Instead, nalmefene helps to control and limit the intake of alcohol. Reduction of alcohol consumption to less harmful levels is supported by specialists as a valuable treatment option to increase willingness among patients to initiate treatment and to keep the patients in treatment. In addition, nalmefene 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.

About the Phase III programme

Based on the results of earlier Biotie-sponsored trials, Lundbeck is conducting an extensive Phase III clinical trial programme for nalmefene in Europe, including two 24-week efficacy studies (ESENSE1, ESENSE2) and a 52-week long- term safety study (SENSE), enrolling in total around 2,000 patients. Patients are randomised to receive nalmefene (20 mg as needed, orally) or placebo. ESENSE1 and ESENSE2 are primarily aimed to demonstrate the efficacy of nalmefene, whilst the primary objective of SENSE, is to confirm the safety and tolerability of nalmefene, as well as to investigate the benefit of treatment over a prolonged period of time.

About nalmefene

Nalmefene is a small molecule opioid receptor antagonist that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances. As a result, nalmefene removes a person's desire 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 nalmefene and on the product reaching certain predetermined sales. Lundbeck will be responsible for manufacturing and registration of the product.

About alcohol dependence

Alcohol dependence, otherwise commonly known as alcoholism, 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. While close to 270 million adults are estimated to drink alcohol up to 20g (women) or 40g (men) per day, over 58 million adults (15%) consume above this level, with 20 million of these (6%) drinking the equivalent of 5 - 6 standard drinks every day. Looking at addiction rather than drinking levels, it is estimated that 23 million Europeans (5% of men, 1% of women) are dependent on alcohol in any one year[1].

Alcohol is the third leading cause of ill health after tobacco smoking and hypertension; there are more risks associated with alcohol than with elevated cholesterol levels and obesity. Excessive consumption of alcohol, which increases the risk of developing a number of diseases such as cancer, cardiovascular diseases, cerebral atrophy, ulcer and cirrhosis of the liver, is a common problem in many parts of the world. One in ten deaths in the Western world is alcohol-related. Despite this, alcoholism 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 addiction require abstinence from drinking as a starting point - a high hurdle for an alcohol dependence patient. There are only a few pharmaceutical compounds that have received marketing approval to help alcoholics maintain abstinence. All these treatments, including psychosocial counseling measures, cannot prevent a high relapse rate of the patients and permanent cure is thus still the exception rather than the rule.

There are no approved therapies on the market yet to proactively help curb a person's urge to drink.

Turku, 3 January 2011

Biotie Therapies Corp.

Timo Veromaa
President and CEO

NASDAQ OMX Helsinki Ltd
Main Media

About Biotie Therapies

Biotie is a specialized drug development company focused on central nervous system and inflammatory diseases. It has several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential, including addiction and a broad range of inflammatory conditions such as rheumatoid arthritis or chronic obstructive pulmonary disease (COPD). The most advanced product, nalmefene for alcohol dependence, is currently in phase III clinical development by licensing partner H. Lundbeck A/S.

Biotie is based in Turku, Finland and its shares are listed on NASDAQ OMX Helsinki Ltd.

For more information, please refer to


[1] Alcohol in Europe - A public health perspective; A report for the European Commission; June 2006

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Source: Biotie Therapies Oyj via Thomson Reuters ONE


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