H. Lundbeck A/S (Lundbeck) announced the completion of two out of three pivotal studies in the phase III clinical programme for nalmefene in alcohol dependence (ESENSE1 and SENSE). The studies were conducted in Europe and enrolled about 1,300 patients with alcohol dependence. A concomitant psychosocial intervention in the studies was a brief, standardised programme focussed on adherence and follow-up. No abstinence treatment goals were imposed.
In both studies the overall safety profile of nalmefene was consistent with observations and data provided in previous studies. The most frequent adverse events included dizziness, insomnia and nausea.
"We are pleased that these data demonstrate that nalmefene is on track to become the first drug to make a difference for the many people in need of a reduction of their harmful alcohol consumption" says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck, and continues: "We will now finalise the last efficacy study in the programme to assess the full data package in order for us to prepare the registration of nalmefene in Europe."
We expect to complete the third and final phase III study (ESENSE 2) in the second quarter of 2011. Lundbeck will be initiating a dialogue with the healthcare agencies as well as scientific advisors to discuss the study outcomes and the plans for submitting a European Marketing Authorization Application (MAA) for nalmefene as a treatment for alcohol dependence. It is Lundbeck's view that nalmefene is on track for submission of the European MAA in the second half of 2011, but it will as planned depend on the outcome of the final short-term pivotal efficacy study. The presentation of the efficacy and safety data at scientific meetings and conferences is planned following the completion of all three pivotal studies.
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. Instead, nalmefene helps to control and limiting the intake of alcohol. Reduction of alcohol consumption to less harmful levels is supported by specialists as a valuable treatment option to keep the patients in treatment and to increase the willingness among patients to initiate treatment. 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 and for the aim of maintaining abstinence.
About the clinical phase III programme
Based on the results of earlier trials, Lundbeck has initiated three phase III trials in Europe enrolling approximately 2,000 patients randomised into two groups receiving nalmefene (20 mg as needed, orally) and placebo, respectively. Two of the three trials (ESENSE1 and ESENSE2), in which patients were treated over a period of six months, primarily aimed to demonstrate the efficacy of nalmefene, whilst the primary objective of the third study (SENSE), in which patients are treated for 12 months, is to confirm the safety and tolerability of the compound.
About nalmefene
Nalmefene is an opioid receptor antagonist. The compound acts by blocking a mechanism in the brain that can cause a continuing and uncontrolled intake of alcohol. This helps to control and reduce alcohol intake.
Nalmefene was originally developed by Key Pharmaceuticals and IVAX/Baker Norton in the 1980s and 1990s. Biotie Therapies Corp. (Biotie) in Finland obtained the rights to the compound in 1998 and started clinical development within alcohol disorders in 1999. In 2006, Lundbeck purchased the rights to nalmefene from Biotie. Under the terms of the agreement, Biotie received an execution fee of EUR 12 million. In total, Biotie is eligible for up to EUR 84 million in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product in its territory.
Lundbeck holds the global rights to the compound.
About alcohol dependence
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 at over 40g (women) or 60g per day (men). 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.
Alcohol dependence remains a highly stigmatised, under-diagnosed and undertreated disease.
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose, Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion).
1. Alcohol in Europe - A public health perspective; A report for the European Commission; June 2006