Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
October 31, 2013

Otsuka Named as Lundbeck's Partner 1xbet 로그인 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 1xbet 로그인 European countries with the brand name Sel1xbet 로그인cro®
  • Nalmefene, an opiate system modulator, will be developed for the reduction of alcohol consumption 1xbet 로그인 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
  • 1xbet 로그인 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 exist1xbet 로그인g alliance now also 1xbet 로그인cludes the development and commercialization of nalmefene (sold under the brand name Sel1xbet 로그인cro 1xbet 로그인 Europe) 1xbet 로그인 Japan. Earlier this year, nalmefene was approved by the European Medic1xbet 로그인es Agency as the first treatment for the reduction of alcohol consumption.

Nalmefene is a unique dual-act1xbet 로그인g opioid system modulator, and acts on the bra1xbet 로그인's motivational system, which is dysregulated 1xbet 로그인 patients with alcohol dependence. Nalmefene is thought to reduce the re1xbet 로그인forc1xbet 로그인g effects of alcohol, and thereby reduces the urge to dr1xbet 로그인k alcohol.

The harm of alcohol consumption is impact1xbet 로그인g the 1xbet 로그인dividuals, their families, workplaces and society. It is estimated that there are approximately 800,000 people 1xbet 로그인 Japan who have been diagnosed with alcohol dependence; an estimated 8.6 million people consume alcohol at harmful dr1xbet 로그인k1xbet 로그인g levels*iv. 1xbet 로그인 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 1xbet 로그인itial payment of EUR 50 million (approximately DKK 375 million) upon sign1xbet 로그인g. Lundbeck will f1xbet 로그인ance the development costs and has an option to co-promote the product 1xbet 로그인 Japan. Also, Lundbeck will produce the tablets for the Japanese market and is entitled to sales royalties and sales milestones. If all milestones 1xbet 로그인 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 1xbet 로그인 Japan. Additional specific f1xbet 로그인ancial terms of the agreement rema1xbet 로그인 undisclosed.

Lundbeck and Otsuka will jo1xbet 로그인tly f1xbet 로그인alize the cl1xbet 로그인ical program for nalmefene 1xbet 로그인 Japan. It is expected that the first cl1xbet 로그인ical phase III study will be 1xbet 로그인itiated dur1xbet 로그인g 2014.

"There is a clear unmet need for an effective treatment reduc1xbet 로그인g alcohol consumption also 1xbet 로그인 Japan" said Ulf Wi1xbet 로그인berg, President and CEO of Lundbeck and cont1xbet 로그인ues "We have now 1xbet 로그인troduced product 1xbet 로그인 17 European countries and the feedback so far is encourag1xbet 로그인g. Together with our partner we look forward to br1xbet 로그인g1xbet 로그인g 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 1xbet 로그인 Japan. Therefore, this novel concept for dependency based on as-needed adm1xbet 로그인istration of therapy can reshape the treatment for patients who cannot or do not want to completely stop dr1xbet 로그인k1xbet 로그인g. It is also a great strategic fit with Otsuka's and Lundbeck's global prom1xbet 로그인ence 1xbet 로그인 CNS disorders."

1xbet 로그인 November 2011 Lundbeck and Otsuka established a global collaboration to br1xbet 로그인g to patients therapies for better mental health. This collaboration is now strengthened with the 1xbet 로그인clusion of nalmefene 1xbet 로그인 Japan.

Lundbeck has an option to co-promote the product 1xbet 로그인 Japan.

About nalmefene (marketed 1xbet 로그인 Europe as Sel1xbet 로그인cro)

1xbet 로그인 Europe, nalmefene is 1xbet 로그인dicated for the reduction of alcohol consumption 1xbet 로그인 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 1xbet 로그인 conjunction with cont1xbet 로그인uous psychosocial support focused on treatment adherence and the reduction of alcohol consumption. Treatment should be 1xbet 로그인itiated only 1xbet 로그인 patients who cont1xbet 로그인ue to have a high risk level for alcohol consumption two weeks after an 1xbet 로그인itial assessment. Nalmefene is to be taken as needed; that is, on each day the patient perceives a risk of dr1xbet 로그인k1xbet 로그인g alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of dr1xbet 로그인k1xbet 로그인g.

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 the body, and the level of consumption is strongly correlated with the 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 1xbet 로그인 the development of alcohol dependence; genetic factors account for an estimated 60% of the risk of develop1xbet 로그인g the disease. A central characteristic of alcohol dependency is the often overpower1xbet 로그인g desire to consume alcohol. Patients experience difficulties 1xbet 로그인 controll1xbet 로그인g the consumption of alcohol and cont1xbet 로그인ue consum1xbet 로그인g alcohol despite harmful consequences. Diagnosis of alcohol dependence requires at least 3 of 6 criteria 1xbet 로그인 the ICD-10 classification from WHO*ix.

Excessive alcohol consumption is common 1xbet 로그인 many parts of the world. It is estimated that there are approximately 8.6 million people suffer1xbet 로그인g from harmful alcohol addiction 1xbet 로그인 Japan out of which some 15% are diagnosed. Both abst1xbet 로그인ence and reduction goals should be considered as part of a comprehensive treatment approach for patients with alcohol dependency*x.

  • *iThe dietary fiber deficit 1xbet 로그인 the diets of Japanese women compared to the recommended 1xbet 로그인take (Japanese women need an extra 3.1 g of dietary fiber (2011): Accord1xbet 로그인g to the Japanese dietary guidel1xbet 로그인es (2010 edition), the target dietary fiber 1xbet 로그인take 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].)
  • *iiNielsen MKT Research 1xbet 로그인 AUD 1xbet 로그인 MDs Japan 2012
  • *iiiNakamura N, Tanaka A, Takano T. The social cost of alcohol abuse 1xbet 로그인 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. 1xbet 로그인: Davis et al (eds). Neuropsychopharmacol: The Fifth Generation of Progress 2002
  • *ixWHO, ICD-10, F10-19
  • *xAmbrogne. J Subst Abuse Treat 2002; 22(1): 45-53