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NEWS 2012

March 27, 2012 R & D

New Drug Application of drug for support maintenance of abstinence from alcohol in patients with alcohol dependence

KYOTO, JAPAN - (March 27, 2012) -  Nippon Shinyaku Co.,Ltd, (Headquarters: Kyoto, Japan; President: Shigenobu Maekawa) today announced that it has submitted a New Drug Application (NDA) of drug for support maintenance of abstinence from alcohol in patients with alcohol dependence, NS-11 (generic name: Acamprosate) to Ministry of Health, Labor and Welfare (MHLW). NS-11 was licensed-in from French company, Merck Santé s.a.s.1in 2003 and has been developed in Japan by Nippon Shinyaku since then.

Alcohol dependence is one of the dependences against psychotropic substances and mainly characteristic of desire to drink alcohol, which is often very strong and sometimes irresistible.

Final treatment goal of alcohol dependence is to recover healthy family life and social life from alcohol dependence.  It is said that a lifetime abstinence is necessary to achieve the goal.

Acamprosate affects on central nerve system and reduces the  hyperactivity of glutamatergic  nerve system  induced by alcohol dependence, which is considered to lead to reduce desire of drinking in patients with alcohol dependence.

Acamprosate has been launched over 30 countries all over the world, including EU and US.  In Japan, May 2010, acamprosate was designated as unapproved drugs with high medical needs by MHLW and Nippon Shinyaku was requested to develop it.

According to results of clinical studies conducted in Japan, NS-11 shows significant improvement on success rate of abstinence (complete abstinence rate at the end of 24-week administration period) than placebo when NS-11 is used as supplemental drug for psychosocial treatment including psychotherapy such as counseling or joining self-help groups

Since it is reported that there are 800,000 alcoholics in Japan and no drug other than alcohol deterrent drugs is currently available in Japan, a development of new drug has been looked forward for long time. Nippon Shinyaku believes that the early launch of NS-11 contributes the treatment of alcohol dependence in Japan.

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[1] Merck Santé s.a.s. is a subsidiary of Merck KGaA, Darmstadt, Germany, operating within the Merck Serono division