Otsuka : and Lundbeck’s Rxulti® (brexpiprazole) approved by the European Commission (82KB)
July 31, 2018 at 02:23 am EDT
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June 31, 2018
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 and Lundbeck's Rxulti® (brexpiprazole) approved by the European Commission
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announce that the European Commission has approved Rxulti® (brexpiprazole) for the treatment of schizophrenia in adults. The approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on May 31, 2018.
Lundbeck and Otsuka will now work with local pricing and reimbursement bodies in countries throughout Europe to help ensure that eligible patients are able to access Rxulti®. The medicine is expected to be made available in the first EU markets during first half of 2019.
Brexpiprazole is a once-daily, second-generation (atypical) oral antipsychotic; it provides a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity for these receptors as well as for noradrenaline alpha1B/2C receptors. Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.
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Otsuka Holdings Co. Ltd. published this content on 31 July 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 31 July 2018 06:22:09 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%),
OTSUKA HOLDINGS CO., LTD. 
