Otsuka : Applies for the Additional Indication in Japan of Bipolar Disorder for ABILIFY MAINTENA for Suspended Release Injectable Suspension (63KB)
September 26, 2019 at 02:28 am EDT
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September 26, 2019
For Immediate Release
Company name
Otsuka Holdings Co., Ltd.
Representative
Tatsuo Higuchi
President and Representative Director, CEO
Code number
4578 First Section , Tokyo Stock Exchange
Inquiries
Yuji Kogure
Director, Investors Relations Department
Otsuka Applies for the Additional Indication in Japan of Bipolar Disorder for
ABILIFY MAINTENA for Suspended Release Injectable Suspension
Otsuka Pharmaceutical Co., Ltd. announces that it has filed an application in Japan for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar disorder for ABILIFY MAINTENA (aripiprazole), a long-acting injectable suspension.
The application covers the 300 mg and 400 mg vials (for injection) and the 300 mg and 400 mg dual-chamber syringes.
ABILIFY MAINTENA is a depot preparation for intramuscular injection that provides uninterrupted medication coverage for up to 30 days. Otsuka Pharmaceutical created ABILFY MAINTENA, an atypical antipsychotic, which first received regulatory approval in 2013 in the U.S. and E.U. for the treatment of adult schizophrenia. In 2015, it was approved in Japan for the same indication. In the United States and Canada, the indication as maintenance therapy for adult bipolar I maintenance therapy was added in 2017.
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Otsuka Holdings Co. Ltd. published this content on 26 September 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 September 2019 06:27:03 UTC
Otsuka Holdings Co, Ltd. is a holding company organised around 4 areas of activity:
- manufacture and sale of pharmaceutical products (65.2% of sales): prescription drugs and intravenous solutions mainly for the treatment of central nervous system disorders, cancer, cardiovascular, gastrointestinal and ophthalmic diseases. In addition, the group sells diagnostic products and medical devices;
- manufacture and sale of nutraceutical products (25.1%): functional foods and beverages, OTC products, nutritional supplements;
- production of mineral waters, beverages and foods (2.1%);
- other (7.5%): manufacture of functional chemicals and fine chemicals, provision of logistics services, manufacture of electronic products, etc.
Net sales by source of income are divided between sales of products (93.8%), sales of licences and royalties (1.8%) and other (4.4%).
Net sales are distributed geographically as follows: Japan (43.2%), North America (34%),