Otsuka’s Economic and Health Impact in the United States highlights the contributions of Otsuka’s U.S. pharmaceutical subsidiaries — Otsuka America Pharmaceutical, Inc. (OAPI) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). Collectively, the subsidiaries comprise nearly 2,000 employees at three corporate offices and other locations in the United States working in all aspects of bringing new medicines to market, from research and development to commercialization.

Otsuka Holdings Co., Ltd. has decided to donate 20 million yen (approximately USD 164,000) through the Japanese Red Cross Society for humanitarian assistance to people whose lives have been severely affected in Ukraine and who have been evacuated to surrounding countries.

In addition, Otsuka Holdings is providing support to patients and people involved in treatment through the provision of Otsuka products, including pharmaceuticals.

Otsuka and Lundbeck announce the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of REXULTI^® (brexpiprazole) for the treatment of schizophrenia in pediatric patients 13 to 17 years of age. The FDA previously granted Priority Review for the sNDA, a designation for a drug application that, if approved, would represent a significant improvement in the safety and/or effectiveness of the treatment, diagnosis, or prevention of a serious medical condition. REXULTI was approved in the U.S. in 2015 for the treatment of schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults.

The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs.

Otsuka America Pharmaceutical, Inc. (OAPI), acknowledges the importance of the favorable opinion of Otsuka’s Hospital Free Trial Program by the Department of Health and Human Services (HHS) Office of Inspector General (OIG), which provides guidance for the design of manufacturer inpatient free trial programs that provide long-acting anti-psychotic injectable (LAI) products for the treatment of serious mental illness in a hospital setting.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) report that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti^® (brexpiprazole) and has granted Otsuka and Lundbeck Priority Review. Up to one-third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the U.S. for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults.

Sunovion Pharmaceuticals Inc. (Sunovion), its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135.

Sumitomo Dainippon Pharma Co., Ltd., its U.S.-based subsidiary Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Co., Ltd. announce today that we have executed a collaboration and license agreement for worldwide joint development and commercialization of the following four novel candidate compounds (hereinafter referred to as the "four compounds") currently under development in psychiatry and neurology area by Sumitomo Dainippon Pharma and Sunovion.