Lundbeck initiates phase III clinical trials with nalmefene as a new method of treatment of alcohol dependence
Release No 360 15 December 2008
Lundbeck initiates phase III clinical trials with nalmefene as a new method of treatment of alcohol dependence H. Lundbeck A/S (Lundbeck) is continuing the development of nalmefene for the treatment of alcohol dependence as scheduled, initiating three phase III clinical trials with the compound. Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, the treatment with nalmefene is not aimed at keeping the patients from drinking. Nalmefene instead removes the desire to drink more, thereby controlling and limiting the intake of alcohol. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time. A previous study documented nalmefene's ability to significantly limit both the patient's average alcohol intake and the number of days with an intake above five units of alcohol. This means a sharp reduction in patients' risk of developing diseases such as various cancers, cardiovascular diseases and cirrhosis of the liver. Previous trials have also shown nalmefene to be well-tolerated and safe. Based on the earlier trials, Lundbeck is now launching three phase III trials enrolling more than 1,800 patients randomised into groups receiving nalmefene and placebo respectively. The first two trials, in which patients are treated over a period of six months, primarily aim to demonstrate the efficacy of nalmefene, whilst the objective of the last study, in which patients are treated for 12 months, is particularly to confirm that the compound is well-tolerated. The first data from the trials are expected in the first half of 2011. “Nalmefene offers a rare opportunity for us to provide a new and more effective treatment of alcohol dependence, which causes major harm to millions of people worldwide,” says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. About nalmefene Nalmefene is a so-called opioid receptor antagonist. The compound acts by blocking the mechanism in the brain that can cause a continuing and uncontrolled intake of alcohol. This helps to control and limit the intake. Nalmefene was originally developed by BioTie Therapies Corp. of Finland. Lundbeck holds the global rights to the compound with the exception of North America, Mexico, Turkey and South Korea. About alcohol dependence The World Health Organization (WHO) estimates that more than 76 million people worldwide suffer from alcohol abuse. An estimated 3-5% of Europe's population are believed to be alcoholics. In Denmark, it is estimated that 860,000 persons drink more than the maximum intake recommended by the National Board of Health. Of these, at least 200,000 are believed to be actual alcoholics. 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. Alcohol is poison for most body organs, which can be harmed by the intake of alcohol. According to WHO, the intake of alcohol involves an increased risk of contracting more than 60 different diseases and damage. The extent of the damage depends on how much and for how long a period a person drinks alcohol. The risk of bringing on such damage differs from one person to the next, and some may suffer organ damage even though they would say that they never had an alcohol problem. The content of this release will have no influence on the Lundbeck Group's financial result for 2008. Lundbeck contacts -------------------------------------------------------------------------------- | Investors: | Media: | -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- | Jacob Tolstrup | Jens Harder Højbjerg | -------------------------------------------------------------------------------- | Director | Media Relations Manager | -------------------------------------------------------------------------------- | +45 36 43 30 79 | +45 36 43 28 33 | -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- | Palle Holm Olesen | | -------------------------------------------------------------------------------- | Head of Investor Relations | | -------------------------------------------------------------------------------- | +45 36 43 24 26 | | -------------------------------------------------------------------------------- Release No 360 - 15 December 2008 About Lundbeck H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2007, the company's revenue was DKK 11 billion (approximately EUR 1.5 billion or USD 2.0 billion). The number of employees is approx. 5,300 globally. For more information, please visit www.lundbeck.com.