Tackling the Unmet Medical Needs
The Otsuka group aims to be an indispensable contributor to people’s health worldwide through two core businesses under the corporate philosophy "Otsuka-people creating new products for better health worldwide." These businesses are the Pharmaceutical Business, which provides comprehensive health support from diagnosis to treatment of diseases, and the Nutraceutical Business*, which helps people maintain and improve daily health. The group strives to pursue new values by contributing to the overall well-being of society through unique solutions as the social environment continues to change. In the Pharmaceutical Business, the group focuses on "unmet medical needs," prioritizing psychiatry and neurology, oncology, and cardiovascular and renal areas. Our goal is to provide comprehensive healthcare services, from the development of therapeutic drugs to diagnostic support, raising awareness, and support for recovery.
- *Nutraceuticals are products that have scientific evidence to be beneficial for maintaining and improving daily health, created from the combination of "Nutrition" and "Pharmaceuticals."
Otsuka group's business strategy
Psychiatry and Neurology Area
Core Principles
The World Health Organization (WHO) defines mental health as “a state of mental well-being that enables people to cope with the stresses of life, realize their abilities, learn well and work well, and contribute to their community,” and elements such as treatment of mental disorders and rehabilitation are included.
The group contributes to the well-being of patients with mental disorders, their families, and caregivers by providing seamless solutions from diagnosis to treatment, then support for recovery.
Solutions Provided by the Otsuka group
Medical Treatments
Abilify Maintena®/ ABILIFY ASIMTUFII® (Generic Name: aripiprazole |Antipsychotic long-acting injectable)
Abilify Maintena®, a long-acting injectable, contributes to the treatment of diseases by enhancing medication adherence and convenience, which are social issues in the treatment of schizophrenia and bipolar disorder. Additionally, aiming to expand treatment options, the group launched the two-month long-acting injectable aripiprazole (ABILIFY ASIMTFII®/Abilify Maintena®960 mg) in the United States in April 2023 and Europe in March 2024.
Rexulti® (Generic Name: brexpiprazole | Atypical antipsychotics)
In addition to indications for schizophrenia and major depressive disorder, Otsuka Pharmaceutical Co., Ltd. obtained additional indication for Rexulti® in Japan in 2024 as adjunctive treatment for agitation associated with dementia due to Alzheimer's disease, following the United States in 2023. This makes Rexulti® the first and only pharmacological treatment approved in the U.S. and Japan for this indication. This contributes not only to the improvement of symptoms in dementia patients but also to the reduction of the burden on their families and caregivers. Furthermore, the group is expanding into the development of treatments for PTSD (post-traumatic stress disorder), which has not seen new drug approvals for over 20 years. Otsuka Pharmaceutical continues to strive to provide new treatment options to people who suffered from these symptoms.
Otsuka Pharmaceutical＞Pharmaceutical Business Product Information
Pipeline (Drugs in Development)
Since the 1970s, Otsuka Pharmaceutical has consistently aimed to address unmet medical needs in the psychiatry and neurology area and is developing new treatment for PTSD (Post-Traumatic Stress Disorder), ADHD (Attention-Deficit/ Hyperactivity Disorder), and schizophrenia.
Otsuka Group-Pipeline Information (Pharmaceutical products)
Providing New Value through Digital Technology
Otsuka Pharmaceutical develops and provides digital tools, in addition to therapeutic drugs, to comprehensively address psychiatric and neurological diseases.
Digital Therapeutic App for Major Depressive Disorder Rejoyn™
Otsuka Pharmaceutical has developed and provided the world's first-and-only prescription digital therapeutic app for major depressive disorder patients as adjunctive therapy in the United States.
Otsuka Pharmaceutical>News Releases>Digital Therapeutic App Rejoyn™ Launched in the United States
MIREVO® The First Neuropsychological Testing Program in Japan to Support Dementia Treatment
Otsuka Pharmaceutical and Ai-BrainScience Inc. have developed and provided a neuropsychological testing program that allows dementia testing using eye tracking technology easily on tablet devices in Japan. This program was the first Software as a Medical Device (SaMD) in the field of dementia to obtain national health insurance coverage in Japan.
FACEDUO VR Training Programs Supporting Recovery
Otsuka Pharmaceutical has developed and provided various VR training programs in Japan, including the "Social Skills Training Support Program," which allows practice in social situations using Virtual Reality (VR), the "Family Support Program of People with Severe Social Withdrawal(Hikikomori), which aims to teach effective communication points and methods for encouraging social participation, the "Emotion Recognition Training Program," which fosters skills for building good human relationships, and the "Dementia Care Support VR," which aims to help families and caregivers understand the feelings and behaviors of dementia patients and learn specific responses.
Providing Information and Disease Awareness for Patients and Their Families
Smile Navigator (Japan)
Otsuka Pharmaceutical has operated a website that primarily provides information to patients with schizophrenia, bipolar disorder, depression, autism spectrum disorder in children, and dementia, as well as their families and supporters.
The Otsuka Patient Education Network (OPEN) (USA)
Otsuka America Pharmaceutical, Inc. has provided educational materials to help patients, families, and caregivers better understand diseases, primarily focusing on kidney disease, mental illness, and Alzheimer's disease.
Oncology
Core Principles
The number of cancer patients worldwide is on the rise. Additionary, it is said that one in two Japanese people might develop cancer in their lifetime, and its number is expected to increase with aging. The group believes it is important to support cancer patients in a multifaceted manner so that they can "live as themselves" while maintaining their dignity. Diagnostic techniques and treatment options for cancer are expanding year by year, and the group is working on the development of anticancer drugs in collaboration with various stakeholders. The group aims to support the entire patient journey by considering it at each treatment stage and providing the necessary support at each stage. The group will continue to strive to provide innovative treatments to patients as quickly as possible by introducing new technologies and conducting R&D in collaboration with external partners.
Solutions Provided by the Otsuka group
Therapeutic Drugs
Lonsurf® (Generic Name: trifluridine/tipiracil | Anticancer Agent)
Lonsurf® has been approved both domestically and internationally for the treatment of unresectable advanced and recurrent colorectal cancer and unresectable advanced and recurrent gastric cancer. In 2023, the indication for combination therapy with bevacizumab in colorectal cancer was added globally, contributing to the treatment of more patients.
Diagnostic Drugs
HemeSight® (Hematologic Tumor Gene Panel Test)
Otsuka Pharmaceutical has developed and obtained manufacturing and marketing approval for Japan's first gene panel test targeting hematologic tumors and related diseases through a consortium of joint research with medical institutions and academia (universities and research institutions). This test enables diagnosis, treatment selection, and prognosis prediction based on genetic abnormalities, contributing to personalized medicine for patients.
Pipeline (Drugs in Development)
Taiho Pharmaceutical Co., Ltd, a pioneer in oral anticancer drugs, is developing innovative new drugs based on its expertise accumulated over more than 50 years of research and development of anticancer drugs. Currently, Taiho Pharmaceutical is advancing the development of anticancer drugs for non-small cell lung cancer, upper gastrointestinal cancer, and other cancers. Additionally, Otsuka Pharmaceutical is challenging the establishment of new treatments, such as gene-modified T-cell therapy, through collaboration with external partners.
Otsuka Group-Pipeline Information (Pharmaceutical products)
Support for Balancing Treatment and Work
Arirge LEARNING, Arirge SUPPORT
Arirge Co., Ltd. aims to create a society where people believe they can continue working even if they have cancer, and is working to solve social issues related to cancer. Arirge runs the educational portal site "Arirge LEARNING" to support the correct understanding of balancing between cancer treatment and work, as well as accurate knowledge about the disease, which cancer patients seek from their workplace (supervisors and colleagues). Additionally, to address the issues of insufficient information sharing and support systems between medical institutions and companies regarding return-to-work and balancing support in Japan, Arirge has launched "Arirge SUPPORT," Japan's first SaaS (cloud service) that connects medical institutions and companies, striving to the creation of a new society. In addition to support for balancing treatment and work, it provides the cancer screening encouragement service called "Arirge CALL" for companies to protect lives from cancer, and the smoking cessation support service called "Arirge NON-SMOKING" to reduce smoking, a risk factor for cancer.
Cardiovascular and Renal Fields
Core Principles
Cardiovascular and renal diseases are becoming more prevalent due to aging and changes in lifestyle habits and are emerging as global health issues. Although early diagnosis and appropriate treatment intervention are important as these diseases are progressive, they are often difficult to detect until symptoms worsen, which might pose a high risk to prognosis. Additionally, the treatment and management of comorbidities such as hypertension and diabetes are crucial. The Otsuka group believes that addressing unmet medical needs in the cardiovascular and renal areas is important and strives to develop innovative therapeutic drugs and new devices that combine pharmaceutical and medical device know-how through acquisitions and partnerships with companies that have strengths in these areas.
Solutions Provided by the Otsuka group
Therapeutic Drugs
SAMSCA®/JINARC®/GYNARQUE™ (Generic Name: tolvaptan | V₂-receptor antagonist)
SAMSCA®/JINARC®/JYNARQUE™ is approved in 40 countries and regions worldwide for indications such as fluid retention in heart failure and liver cirrhosis, hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH), and autosomal dominant polycystic kidney disease (ADPKD), a hereditary kidney disease.
Otsuka Pharmaceurtical > SAMSCA®/JINARC® Product story
Device Treatment for Hypertension (Under Development in Japan)
uRDN (Ultrasound Renal Denervation) System
Paradise™ Ultrasound Renal Denervation (uRDN) System, developed by Recor Medical, Inc., the U.S. subsidiary of Otsuka Medical Devices Co., Ltd., was first approved in the U.S. in November 2023 as an adjunct therapy option for those patients who remain with uncontrolled hypertension despite being on standard–of–care medications and following lifestyle adjustments. In the U.S., insurance coverage is gradually expanding, increasing patient access. Clinical trials are ongoing in Japan.
Pipeline (Drugs in Development)
In addition to strengthening our own drug discovery, Otsuka Pharmaceutical is partnering with companies that have pipelines in the renal area to advance drug discovery for diseases causing renal failure. Among these, IgA nephropathy, a progressive autoimmune chronic kidney disease with no effective drugs, has a high unmet medical need, with about half of patients requiring dialysis within 20 years. Otsuka Pharmaceutical is currently working on the development of sibeprenlimab, which is expected to be the first-in-class biopharmaceutical for this disease.
Otsuka Group Development Pipeline (Pharmaceuticals)
Efforts to Deliver Medicines to More Patients (Access to Medicine)
Enhancing Access to Medicines
The Otsuka group is engaged in the research and development of new drugs and infusions to enhance access to medicines, while also supporting individuals whose access is limited due to economic or other reasons. For example, Otsuka Pharmaceutical has established the Otsuka Global Patient Access Support Policy to enhance patient access to treatment. Specifically, in Asian countries and regions, it is implementing the Otsuka Patient Assistance Program using the leukemia treatment drug Iclusig® providing financial support such as drug provision to patients who cannot afford treatment costs due to insufficient insurance reimbursement or economic reasons.
Efforts to Expand Access to the Tuberculosis Drug, delamanid
Tuberculosis is one of the world's three major infectious diseases, along with AIDS and malaria. In 2023, an estimated 10.8 million people worldwide were infected, and 1.25 million died from it, making it the leading cause of death from infectious diseases (estimated by WHO, 2023). Otsuka Pharmaceutical is working to expand access to its proprietary multidrug-resistant tuberculosis treatment drug, delamanid, to more patients in to order eradicate tuberculosis. By collaborating with organizations such as the “Stop TB Partnership's Global Drug Facility (GDF)”, which aims for sustainable procurement in developing countries with many patients, such as Africa and Asia, Otsuka Pharmaceutical is ensuring this drug available in nearly all countries where it is needed.. Since 2014, it has delivered over 120,000 cases for treatment to countries working to control multidrug-resistant tuberculosis. It is also currently developing a successor tuberculosis treatment drug to delamanid.
Stable Supply of Infusions at Appropriate Prices
The Otsuka group is also engaged in efforts to improve the medical environment surrounding the provision of pharmaceuticals at appropriate prices. For example, infusions are highly necessary for medical care and need to be continuously and stably supplied to the market. Therefore, Otsuka Pharmaceutical Factory, Inc. manufactures infusions locally, contributing to stable supply, appropriate pricing in each country, and job creation, thereby contributing to local communities.
Efforts to Expand Access to Investigational Drugs (Expanded Access Program)
The Otsuka group, through the Expanded Access Program, allows the provision of investigational drugs for patients who cannot expect sufficient efficacy from existing treatments and cannot participate in clinical trials due to their disease condition. These drugs are provided to patients who do not meet the criteria for clinical trial participation, based on physician applications and meeting specified conditions. This program thereby expands access to investigational drugs.
Otsuka Pharmaceutical D&C (U.S.) Initiatives
Taiho Oncology (U.S.) Initiatives
In addition, when starting treatment in the U.S., Taiho Oncology, Inc. provides services such as insurance verification, financial assistance for treatment costs, and personalized nursing support to patients, caregivers, and healthcare professionals.
Patient Support Programs
In some countries and regions, Taiho Oncology offers various programs to support patients and caregivers when purchasing specific Otsuka group products.
Otsuka Pharmaceutical (U.S.)
The Otsuka Patient Assistance Foundation, Inc. (OPAF)
The Otsuka Patient Assistance Foundation, Inc. (OPAF) is a non-profit organization that provides Otsuka's treatment drugs free of charge to uninsured patients or those whose insurance does not sufficiently cover treatment costs.
(U.S.) Otsuka America Pharmaceutical, Inc. (OAPI)
Otsuka Patient Support™ combines resources, tools, and support teams for patients, caregivers, and healthcare professionals to support patients.
Taiho Parma Canada Inc.
Taiho Pharma Canada, Inc. offers personalized patient support program (Conexus Patient support Program™) that includes guidance on medical expense reimbursement, one-on-one support from dedicated nurses, specialized pharmacy services, home delivery services, and educational services for patients, caregivers, and healthcare professionals when starting treatment.