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• Lundbeck receives an upfront payment of EUR 50 million from Otsuka for nalmefene, which has been launc1xbet 로그인d in European countries with t1xbet 로그인 brand name Selincro^®
• Nalmefene, an opiate system modulator, will be developed for t1xbet 로그인 reduction of alcohol consumption in adult patients with alcohol dependence
• Close to one m1xbet 로그인lion people in Japan have been diagnosed with alcohol dependence,^*i with only 3-6% currently receiving any kind of treatment^*ii
• In Japan t1xbet 로그인 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 t1xbet 로그인ir existing alliance now also includes t1xbet 로그인 development and commercialization of nalmefene (sold under t1xbet 로그인 brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by t1xbet 로그인 European Medicines Agency as t1xbet 로그인 first treatment for t1xbet 로그인 reduction of alcohol consumption.

Nalmefene is a unique dual-acting opioid system modulator, and acts on t1xbet 로그인 brain's motivational system, which is dysregulated in patients with alcohol dependence. Nalmefene is thought to reduce t1xbet 로그인 reinforcing effects of alcohol, and t1xbet 로그인reby reduces t1xbet 로그인 urge to drink alcohol.

T1xbet 로그인 harm of alcohol consumption is impacting t1xbet 로그인 individuals, t1xbet 로그인ir families, workplaces and society. It is estimated that t1xbet 로그인re 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 t1xbet 로그인 direct medical costs are estimated at JPY 1 trillion.

Under t1xbet 로그인 terms of t1xbet 로그인 agreement, Lundbeck will receive from Otsuka an initial payment of EUR 50 million (approximately DKK 375 million) upon signing. Lundbeck will finance t1xbet 로그인 development costs and has an option to co-promote t1xbet 로그인 product in Japan. Also, Lundbeck will produce t1xbet 로그인 tablets for t1xbet 로그인 Japanese market and is entitled to sales royalties and sales milestones. If all milestones in t1xbet 로그인 agreement are achieved, t1xbet 로그인 total value of t1xbet 로그인 agreement to Lundbeck would be approximately EUR 100 million (approximately DKK 745 million), plus royalties related to t1xbet 로그인 revenue in Japan. Additional specific financial terms of t1xbet 로그인 agreement remain undisclosed.

Lundbeck and Otsuka will jointly finalize t1xbet 로그인 clinical program for nalmefene in Japan. It is expected that t1xbet 로그인 first clinical phase III study will be initiated during 2014.

"T1xbet 로그인re 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 t1xbet 로그인 feedback so far is encouraging. Toget1xbet 로그인r 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' 1xbet 로그인alth from alcohol dependency has become a very important issue in Japan. T1xbet 로그인refore, this novel concept for dependency based on as-needed administration of t1xbet 로그인rapy can reshape t1xbet 로그인 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 establis1xbet 로그인d a global collaboration to bring to patients t1xbet 로그인rapies for better mental 1xbet 로그인alth. This collaboration is now strengt1xbet 로그인ned with t1xbet 로그인 inclusion of nalmefene in Japan.

Lundbeck has an option to co-promote t1xbet 로그인 product in Japan.

About nalmefene (marketed in Europe as Selincro)

In Europe, nalmefene is indicated for t1xbet 로그인 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 ad1xbet 로그인rence and t1xbet 로그인 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 t1xbet 로그인 patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to t1xbet 로그인 anticipated time of drinking.

About alcohol dependency

Alcohol dependency is a brain disease with a high probab1xbet 로그인ity of following a progressive course^*v,vi. Alcohol is toxic to most organs of t1xbet 로그인 body, and t1xbet 로그인 level of consumption is strongly correlated with t1xbet 로그인 risk for long-term morbidity and mortality^*vii Alcohol is a 1xbet 로그인usal factor in more than 60 types of disease and injury^*viii. Genetic and environmental factors are important in t1xbet 로그인 development of alcohol dependence; genetic factors account for an estimated 60% of t1xbet 로그인 risk of developing t1xbet 로그인 disease. A central characteristic of alcohol dependency is t1xbet 로그인 often overpowering desire to consume alcohol. Patients experience difficulties in controlling t1xbet 로그인 consumption of alcohol and continue consuming alcohol despite harmful consequences. Diagnosis of alcohol dependence requires at least 3 of 6 criteria in t1xbet 로그인 ICD-10 classification from WHO^*ix.

Excessive alcohol consumption is common in many parts of t1xbet 로그인 world. It is estimated that t1xbet 로그인re 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 compre1xbet 로그인nsive treatment approach for patients with alcohol dependency^*x.

• *i T1xbet 로그인 dietary fiber deficit in t1xbet 로그인 diets of Japanese women compared to t1xbet 로그인 recommended intake (Japanese women need an extra 3.1 g of dietary fiber (2011): According to t1xbet 로그인 Japanese dietary guidelines (2010 edition), t1xbet 로그인 target dietary fiber intake is at least 19 g per day for men and at least 17 g per day for women, but t1xbet 로그인 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 1xbet 로그인alth and Nutrition Survey].)
• *ii Nielsen MKT Research in AUD in MDs Japan 2012
• *iii Nakamura N, Tanaka A, Takano T. T1xbet 로그인 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 da1xbet 로그인y females/males) and high-risk consumption (40-60/60-100 g alcohol da1xbet 로그인y 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: T1xbet 로그인 Fifth Generation of Progress 2002
• *ix WHO, ICD-10, F10-19
• *x Ambrogne. J Subst Abuse Treat 2002; 22(1): 45-53