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March 25, 2009

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Antipsychotic agent ABILIFY® Oral Solution 0.1% to be Launched on April 10, 2009 in Japan

Tokyo, Japan, March 25, 2009 -- Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) today announced the launch of ABILIFY® Oral Solution 0.1%, a new formulation of its atypical antipsychotic agent ABILIFY® (non-proprietary name: aripiprazole) in Japan, on April 10, 2009.

ABILIFY® Oral Solution 0.1% is a solution packaged in small bag for excellent portability and can be taken without water. In addition, the preparation is orange-flavoured and sweet and is agreeable even for patients who cannot readily take previous agents. Otsuka Pharmaceutical commenced marketing ABILIFY® in Japan in June 2006 and currently sells four formulations, ABILIFY® Tablets 3 mg, ABILIFY® Tablets 6 mg, ABILIFY® Tablets 12 mg and ABILIFY® Powder 1%. The new addition of ABILIFY® Oral Solution 0.1% (packaging forms: 3-mL, 6-mL and 12-mL bags*) shall increase the treatment options to suit the situation of the patient.

  • *Contains 1 mg of aripiprazole per 1mL.

Dr. Nakao Iwata, Professor, Department of Psychiatry, Fujita Health University School of Medicine commented on the launch of ABILIFY® Oral Solution 0.1%, saying "In the treatment of schizophrenia, it is vital to enhance adherence** to prevent relapses. In this context, the increase in the range of options with the addition to the ABILIFY® formulations of an oral solution that patients find agreeable and easy to continue taking is welcome both for healthcare professionals and for patients. "

  • **The positive attitude of the patients themselves in accepting the illness, participating in decisions on the course of treatment and actively seeking treatment.

Otsuka Pharmaceutical discovered aripiprazole in 1988, went onto develop the drug and in November 2002 obtained approval in the United States as a drug for the treatment of schizophrenia. To date, ABILIFY® is sold in over 60 countries and regions worldwide including Japan. ABILIFY® is described as a dopamine system stabilizer (DSS). It shows inhibitory action when large amounts of dopamine are released in the brain and stimulatory action when only small amounts are released, thus it is stabilizing dopamine neurons. This mechanism of action enables the drug to improve both the positive and negative symptoms of schizophrenia which are thought to be induced by dopamine abnormalities. At the same time, since it is less likely to cause drowsiness or weight gain, the drug can be used for long-term continuous treatment.

Schizophrenia is the most chronic and debilitating of the various psychiatric disorders and the lifetime prevalence is reported to be approximately 1% of the population. It interferes with a person's social ability such as clear thinking, emotional control, decisiveness and interpersonal relationships. The disease often develops in early adulthood and is characterized not only by positive symptoms such as hallucinations and delusions, but also by negative symptoms such as poor emotion, inability to communicate with others and lack of motivation.

Based on its corporate philosophy of 'Otsuka - people creating new products for better health worldwide', Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to the health of people around the world.

About ABILIFY Oral Solution 0.1%

Product name ABILIFY Oral Solution 0.1% (packaging forms: 3-mL, 6-mL and 12-mL bags)
Non-proprietary name Aripiprazole
Therapeutic category Antipsychotic drug
Indications Schizophrenia
Dosage and administration The usual adult dosage for oral use is 6-12 mg (6-12mL, starting dose) and 6-24 mg (6-24mL, maintenance dose) of aripiprazole daily in one or two divided doses. The dosage may be adjusted according to the patient's age and symptoms, but should not exceed 30 mg (30mL) per day.
Date of approval January 6, 2009
Date of listing in the NHI reimbursement price March 23, 2009
Price 95.40 yen/ mL

Information in this news release was current as of the original release date.

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