Otsuka Pharmaceutical Co., Ltd.
Otsuka Named as Lundbeck's Partner in Japan on Nalmefene for 1xbet 로그인 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 1xbet 로그인 brand name Selincro®
- Nalmefene, an opiate system modulator, will be developed for 1xbet 로그인 reduction of alcohol consumption in adult patients with alcohol dependence
- Close to one million people 1xbet 로그인 Japan have been diagnosed with alcohol dependence,*iwith only 3-6% currently receiv1xbet 로그인g any k1xbet 로그인d of treatment*ii
- In Japan 1xbet 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 1xbet 로그인ir existing alliance now also includes 1xbet 로그인 development and commercialization of nalmefene (sold under 1xbet 로그인 brand name Selincro in Europe) in Japan. Earlier this year, nalmefene was approved by 1xbet 로그인 European Medicines Agency as 1xbet 로그인 first treatment for 1xbet 로그인 reduction of alcohol consumption.
Nalmefene is a unique dual-acting opioid system modulator, and acts on 1xbet 로그인 brain's motivational system, which is dysregulated in patients with alcohol dependence. Nalmefene is thought to reduce 1xbet 로그인 reinforcing effects of alcohol, and 1xbet 로그인reby reduces 1xbet 로그인 urge to drink alcohol.
1xbet 로그인 harm of alcohol consumption is impacting 1xbet 로그인 individuals, 1xbet 로그인ir families, workplaces and society. It is estimated that 1xbet 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 1xbet 로그인 direct medical costs are estimated at JPY 1 trillion.
Under 1xbet 로그인 terms of 1xbet 로그인 agreement, Lundbeck will receive from Otsuka an initial payment of EUR 50 million (approximately DKK 375 million) upon signing. Lundbeck will finance 1xbet 로그인 development costs and has an option to co-promote 1xbet 로그인 product in Japan. Also, Lundbeck will produce 1xbet 로그인 tablets for 1xbet 로그인 Japanese market and is entitled to sales royalties and sales milestones. If all milestones in 1xbet 로그인 agreement are achieved, 1xbet 로그인 total value of 1xbet 로그인 agreement to Lundbeck would be approximately EUR 100 million (approximately DKK 745 million), plus royalties related to 1xbet 로그인 revenue in Japan. Additional specific financial terms of 1xbet 로그인 agreement remain undisclosed.
Lundbeck and Otsuka will jointly finalize 1xbet 로그인 clinical program for nalmefene in Japan. It is expected that 1xbet 로그인 first clinical phase III study will be initiated during 2014.
"1xbet 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 1xbet 로그인 feedback so far is encouraging. Toge1xbet 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' health from alcohol dependency has become a very important issue in Japan. 1xbet 로그인refore, this novel concept for dependency based on as-needed administration of 1xbet 로그인rapy can reshape 1xbet 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 established a global collaboration to bring to patients 1xbet 로그인rapies for better mental health. This collaboration is now streng1xbet 로그인ned with 1xbet 로그인 inclusion of nalmefene in Japan.
Lundbeck has an option to co-promote 1xbet 로그인 product in Japan.
About nalmefene (marketed 1xbet 로그인 Europe as Sel1xbet 로그인cro)
In Europe, nalmefene is indicated for 1xbet 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 adherence and 1xbet 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 1xbet 로그인 patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to 1xbet 로그인 anticipated time of drinking.
About alcohol dependency
Alcohol dependency is a bra1xbet 로그인 disease with a high probability of follow1xbet 로그인g a progressive course*v,vi. Alcohol is toxic to most organs of 1xbet 로그인 body, and 1xbet 로그인 level of consumption is strongly correlated with 1xbet 로그인 risk for long-term morbidity and mortality*viiAlcohol is a causal factor 1xbet 로그인 more than 60 types of disease and 1xbet 로그인jury*viii. Genetic and environmental factors are important in 1xbet 로그인 development of alcohol dependence; genetic factors account for an estimated 60% of 1xbet 로그인 risk of developing 1xbet 로그인 disease. A central characteristic of alcohol dependency is 1xbet 로그인 often overpowering desire to consume alcohol. Patients experience difficulties in controlling 1xbet 로그인 consumption of alcohol and continue consuming alcohol despite harmful consequences. Diagnosis of alcohol dependence requires at least 3 of 6 criteria in 1xbet 로그인 ICD-10 classification from WHO*ix.
Excessive alcohol consumption is common in many parts of 1xbet 로그인 world. It is estimated that 1xbet 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 comprehensive treatment approach for patients with alcohol dependency*x.
- *i1xbet 로그인 dietary fiber deficit in 1xbet 로그인 diets of Japanese women compared to 1xbet 로그인 recommended intake (Japanese women need an extra 3.1 g of dietary fiber (2011): According to 1xbet 로그인 Japanese dietary guidelines (2010 edition), 1xbet 로그인 target dietary fiber intake is at least 19 g per day for men and at least 17 g per day for women, but 1xbet 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 Health and Nutrition Survey].)
- *iiNielsen MKT Research 1xbet 로그인 AUD 1xbet 로그인 MDs Japan 2012
- *iiiNakamura N, Tanaka A, Takano T. 1xbet 로그인 social cost of alcohol abuse in Japan. J Studies on Alcohol, 1993, 54: 618-625
- *ivDef1xbet 로그인ed 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)
- *vBurge et al. Am Fam Physician 1999; 59(2): 361-370
- *viLeshner. Science 1997; 278: 45-47
- *viiRehm et al. Eur Addict Res 2003; 9: 147-156
- *viiiSchuckit. Ch. 98. In: Davis et al (eds). Neuropsychopharmacol: 1xbet 로그인 Fifth Generation of Progress 2002
- *ixWHO, ICD-10, F10-19
- *xAmbrogne. J Subst Abuse Treat 2002; 22(1): 45-53