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 in Japan 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 (approximately EUR 30 billion) 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 treatment opportunities for the reduction of alcohol consumption also in Japan” said Ulf Wiinberg, President and CEO of Lundbeck and continues “We have now introduced the 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.

Financial guidance

The content of this release will have no influence on the Lundbeck Group's financial guidance for 2013.

The initial payment of EUR 50 million (approximately DKK 375 million) is a non-refundable cash payment which will be split and EUR 5 million (approximately DKK 37 million) will be booked under Other revenue for the fourth quarter of 2013 and the additional non-refundable cash payment of EUR 45 million (approximately DKK 335 million) will be booked in the P&L during the development program.

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 drinking risk level (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 reducing alcohol consumption. Nalmefene should be initiated only in patients who continue to have a high drinking risk level two weeks after initial assessment. Nalmefene is to be taken as needed; 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].

Lundbeck contacts

Otsuka contact (in Japan)

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 50 years, we have been at the forefront of research within neuroscience. Our development and distribution of pioneering treatments continues to make a difference to people living with brain diseases. Our key areas of focus are alcohol dependence, Alzheimer’s disease, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia and stroke.

Our 5,800 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales, and are committed to improving the quality of life of people living with brain diseases. Our pipeline consists of several late-stage development programs and our products are available in more 100 countries. We have research centers in China, Denmark and the United States, and production facilities in China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately DKK15 billion in 2012 (EUR 2 billion; USD 2.6 billion).

Lundbeck’s shares are listed on the stock exchange in Copenhagen under the symbol ”LUN”. Lundbeck has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol ”HLUYY”. For additional information, we encourage you to visit our corporate site www.lundbeck.com.

About Otsuka Pharmaceutical Co, Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately €10 billion (USD 13 billion) for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical warmly welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.

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[i] Osaki Y, Matsushita S, et al. Nationwide survey of alcohol drinking and alcoholism among Japanese adults.   Japanese Journal of Alcohol Studies & Drug Dependence, 2005, 40(5), 455-470.

[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