07.20.18
Headquarters: Tokyo, Japan
www.otsuka.com
Headcount: 31,800
Year Established: 1921
Revenues: $11,006 (+4%)
Net Income: $1,015 (+23%)
R&D: $1,558 (+4%)
TOP SELLING DRUGS
The Otsuka Group’s pharmaceutical business saw several major drug approvals this year. In a partnership with Lundbeck, Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the FDA for the maintenance monotherapy treatment of bipolar I disorder in adults. The once-monthly injectable formulation was created by Otsuka and co-developed and co-commercialized with Lundbeck.
Also, in collaboration with Proteus Digital Health, the FDA granted approval of a digital medicine system, Abilify Mycite. The drug-device combination product comprises of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker sensor. The Abilify Mycite System includes the Mycite Patch (a wearable sensor, developed by Proteus); the Mycite APP, a smartphone application, used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. The system is to be used for the treatment of schizophrenia, acute manic and mixed episodes, maintenance treatment of bipolar I disorder as monotherapy, and major depressive disorder.
Meanwhile, in Japan, regulatory approval was received for the manufacture and sale of Rexulti Tablets (generic name is brexpiprazole) in 1mg and 2 mg dosage sizes, for the treatment of Schizophrenia. Additionally, the FDA approved Otsuka’s Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.
On the collaboration front, Otsuka Pharmaceutical and X-Chem signed a collaborative research agreement to advance the discovery process for new Otsuka drug compounds. Under the terms of the agreement, X-Chem will utilize its DNA-encoded library (DEXTM) screening and informatics platform to search for novel drug leads for several Otsuka discovery targets. X-Chem received an initial research fee from Otsuka upon the signing of the agreement, and is eligible for future payments based on the achievement of research and development milestones, as well as royalties and sales milestones on compounds identified under the collaboration that receive regulatory approval.
In another strategic collaboration, Otsuka partnered with Science 37, a company focused on “site-less” clinical trials, to support efforts to further digitize Otsuka’s mobile clinical study protocols with a strong focus on psychiatry and behavioral health. The collaboration follows an investment in Science 37 by Otsuka as a minority shareholder as part of the final close of a $35 million Series C investment round earlier this year.
www.otsuka.com
Headcount: 31,800
Year Established: 1921
Revenues: $11,006 (+4%)
Net Income: $1,015 (+23%)
R&D: $1,558 (+4%)
TOP SELLING DRUGS
Drug | Indication | 2017 Sales | (+/-%) |
Abilify Maintena | schizophrenia | $6,293 | 24% |
Abilify | schizophrenia | $5,973 | -29% |
Samsca/JINARC | hyponatremia | $5,698 | 31% |
The Otsuka Group’s pharmaceutical business saw several major drug approvals this year. In a partnership with Lundbeck, Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the FDA for the maintenance monotherapy treatment of bipolar I disorder in adults. The once-monthly injectable formulation was created by Otsuka and co-developed and co-commercialized with Lundbeck.
Also, in collaboration with Proteus Digital Health, the FDA granted approval of a digital medicine system, Abilify Mycite. The drug-device combination product comprises of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker sensor. The Abilify Mycite System includes the Mycite Patch (a wearable sensor, developed by Proteus); the Mycite APP, a smartphone application, used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. The system is to be used for the treatment of schizophrenia, acute manic and mixed episodes, maintenance treatment of bipolar I disorder as monotherapy, and major depressive disorder.
Meanwhile, in Japan, regulatory approval was received for the manufacture and sale of Rexulti Tablets (generic name is brexpiprazole) in 1mg and 2 mg dosage sizes, for the treatment of Schizophrenia. Additionally, the FDA approved Otsuka’s Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease.
On the collaboration front, Otsuka Pharmaceutical and X-Chem signed a collaborative research agreement to advance the discovery process for new Otsuka drug compounds. Under the terms of the agreement, X-Chem will utilize its DNA-encoded library (DEXTM) screening and informatics platform to search for novel drug leads for several Otsuka discovery targets. X-Chem received an initial research fee from Otsuka upon the signing of the agreement, and is eligible for future payments based on the achievement of research and development milestones, as well as royalties and sales milestones on compounds identified under the collaboration that receive regulatory approval.
In another strategic collaboration, Otsuka partnered with Science 37, a company focused on “site-less” clinical trials, to support efforts to further digitize Otsuka’s mobile clinical study protocols with a strong focus on psychiatry and behavioral health. The collaboration follows an investment in Science 37 by Otsuka as a minority shareholder as part of the final close of a $35 million Series C investment round earlier this year.