Otsuka Pharmaceutical Co., Ltd.

October 31, 2013

Otsuka Named as Lundbeck's Partner in Japan on Nalmefene for the Reduction of Alcohol Consumption

  • Lundbeck receives an upfront payment of EUR 50 million from Otsuka for nalmefene, which has been launched in European countries with the brand name Selincro®
  • Nalmefene, an opiate system modulator, will be developed for the reduction of alcohol consumption in adult patients with alcohol dependence
  • Close to one million people in Japan have been diagnosed with alcohol dependence,*i with only 3-6% currently receiving any kind of treatment*ii
  • In Japan the medical costs associated with alcohol consumption are estimated at JPY 4 trillion per year*iii

Valby, Denmark and Tokyo, Japan, 31 October 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co. Ltd. (Otsuka) today announced that their existing alliance now also includes the development and commercialization of nalmefene (sold under the brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by the European Medicines Agency as the first treatment for the reduction of alcohol consumption.

Nalmefene is a unique dual-acting opioid system modulator, and acts on the brain's motivational system, which is dysregulated in patients with alcohol dependence. Nalmefene is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol.

The harm of alcohol consumption is impacting the individuals, their families, workplaces and society. It is estimated that there are approximately 800,000 people in Japan who have been diagnosed with alcohol dependence; an estimated 8.6 million people consume alcohol at harmful drinking levels*iv. In Japan, medical costs associated with alcohol consumption were estimated to be over JPY 4 trillion per year of which the direct medical costs are estimated at JPY 1 trillion.

Under the terms of the agreement, Lundbeck will receive from Otsuka an initial payment of EUR 50 million (approximately DKK 375 million) upon signing. Lundbeck will finance the development costs and has an option to co-promote the product in Japan. Also, Lundbeck will produce the tablets for the Japanese market and is entitled to sales royalties and sales milestones. If all milestones in the agreement are achieved, the total value of the agreement to Lundbeck would be approximately EUR 100 million (approximately DKK 745 million), plus royalties related to the revenue in Japan. Additional specific financial terms of the agreement remain undisclosed.

Lundbeck and Otsuka will jointly finalize the clinical program for nalmefene in Japan. It is expected that the first clinical phase III study will be initiated during 2014.

"There is a clear unmet need for an effective treatment reducing alcohol consumption also in Japan" said Ulf Wiinberg, President and CEO of Lundbeck and continues "We have now introduced product in 17 European countries and the feedback so far is encouraging. Together with our partner we look forward to bringing this treatment to Japan as well".

Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. noted, "Damage to peoples' health from alcohol dependency has become a very important issue in Japan. Therefore, this novel concept for dependency based on as-needed administration of therapy can reshape the treatment for patients who cannot or do not want to completely stop drinking. It is also a great strategic fit with Otsuka's and Lundbeck's global prominence in CNS disorders."

In November 2011 Lundbeck and Otsuka established a global collaboration to bring to patients therapies for better mental health. This collaboration is now strengthened with the inclusion of nalmefene in Japan.

Lundbeck has an option to co-promote the product in Japan.

About nalmefene (marketed in Europe as Selincro)

In Europe, nalmefene is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high risk level for alcohol consumption (>60g/day for men, >40g/day for women) without physical withdrawal symptoms and who do not require immediate detoxification. Nalmefene should be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and the reduction of alcohol consumption. Treatment should be initiated only in patients who continue to have a high risk level for alcohol consumption two weeks after an initial assessment. Nalmefene is to be taken as needed; that is, on each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking.

About alcohol dependency

Alcohol dependency is a brain disease with a high probability of following a progressive course*v,vi. Alcohol is toxic to most organs of the body, and the level of consumption is strongly correlated with the risk for long-term morbidity and mortality*vii Alcohol is a causal factor in more than 60 types of disease and injury*viii. Genetic and environmental factors are important in the development of alcohol dependence; genetic factors account for an estimated 60% of the risk of developing the disease. A central characteristic of alcohol dependency is the often overpowering desire to consume alcohol. Patients experience difficulties in controlling the consumption of alcohol and continue consuming alcohol despite harmful consequences. Diagnosis of alcohol dependence requires at least 3 of 6 criteria in the ICD-10 classification from WHO*ix.

Excessive alcohol consumption is common in many parts of the world. It is estimated that there are approximately 8.6 million people suffering from harmful alcohol addiction in Japan out of which some 15% are diagnosed. Both abstinence and reduction goals should be considered as part of a comprehensive treatment approach for patients with alcohol dependency*x.

  • *i The dietary fiber deficit in the diets of Japanese women compared to the recommended intake (Japanese women need an extra 3.1 g of dietary fiber (2011): According to the Japanese dietary guidelines (2010 edition), the target dietary fiber intake is at least 19 g per day for men and at least 17 g per day for women, but the amounts that men and women age 20 years and over typically receive is 14.4 g for men and 13.9 g for women [2011 National Health and Nutrition Survey].)
  • *ii Nielsen MKT Research in AUD in MDs Japan 2012
  • *iii Nakamura N, Tanaka A, Takano T. The social cost of alcohol abuse in Japan. J Studies on Alcohol, 1993, 54: 618-625
  • *iv Defined as very high-risk consumption (>60/100 g alcohol daily females/males) and high-risk consumption (40-60/60-100 g alcohol daily females/males)
  • *v Burge et al. Am Fam Physician 1999; 59(2): 361-370
  • *vi Leshner. Science 1997; 278: 45-47
  • *vii Rehm et al. Eur Addict Res 2003; 9: 147-156
  • *viii Schuckit. Ch. 98. In: Davis et al (eds). Neuropsychopharmacol: The Fifth Generation of Progress 2002
  • *ix WHO, ICD-10, F10-19
  • *x Ambrogne. J Subst Abuse Treat 2002; 22(1): 45-53