Otsuka group medical-related businesses develop revolutionary new medications in fields where unmet medical needs exist and deliver them worldwide.
One focus area for Otsuka is diseases of the central nervous system (CNS), including schizophrenia, depression, bipolar disorder, and Alzheimer’s disease. The underlying causes of these diseases have yet to be precisely elucidated, making research and development of treatments extremely challenging. Cures remain elusive, while expectations from patients and their families for new, better drugs remain high.
Otsuka Pharmaceutical began research into central nervous system diseases in the 1970s, which ultimately led to the US launch of ABILIFY, an antipsychotic and the first-ever dopamine partial antagonist, in 2002. The drug has been used to benefit the lives of patients in approximately 60 countries and regions worldwide.
CNS diseases and their treatments are often accompanied by adherence issues: patients may lack an understanding of their condition, dislike the side effects of their medication and stop taking it, or forget to take it. This often leads to disease relapses. For better patient outcomes and improved adherence, in 2013 Otsuka launched ABILIFY MAINTENA, a prolonged-release version of ABILIFY administered as a once-monthly, intramuscular injection. Additionally, as a new treatment option, the company first launched REXULTI, an antipsychotic with a new mechanism of action in the US in 2015. REXULTI was subsequently in other markets, including in Japan in April 2018.
In 2015 Otsuka Pharmaceutical acquired Avanir Pharmaceuticals, which developed NUEDEXTA, the first-ever treatment approved specifically for pseudobulbar affect (PBA*). Acquiring Avanir Pharmaceuticals has enabled Otsuka to expand its therapeutic reach in the neurologic area and complement its extensive capabilities in psychiatric diseases.
In the area of oncology, Otsuka Pharmaceutical is focusing on blood cancers, developing and commercializing ICLUSIG to treat patients with chronic myeloid leukemia. Additionally, in the cardio-renal disease areas, the company developed Samsca, the first-ever treatment to slow the progression of autosomal dominant polycystic kidney disease (ADPKD), an orphan kidney disease. (Samsca is marketed outside Japan for ADPKD under the brand names JINARC/JYNARQUE.)
In infectious diseases, one of Otsuka’s focus areas is tuberculosis, a critical public health issue worldwide. The company introduced the anti-tuberculosis drug DELTYBA in Europe and Japan in 2014. DELTYBA was included in the Model List of Essential Medicines published by the World Health Organization in 2015, and patients in more than 80 countries have accessed the drug.in more than 80 countries. Through Visterra, a US-based subsidiary acquired in 2018, Otsuka is pursuing research and development on infectious diseases such as influenza.
Taiho Pharmaceutical is one of Japan’s foremost creators of anticancer agents, with over 50 years of experience in chemotherapies. Taiho Pharmaceutical pioneered oral anticancer formulations before they became more widely available worldwide. In 1974, the company introduced the oral anticancer agent Futraful, and has since brought to market UFT (in 1984), TS-1 (in 1999), and LONSURF (in 2014).
The company strives to meet patients’ needs, including new formulations (UFT in capsules and enteric granules; and TS-1 in capsules, granules, and orally disintegrating tablets) and development of UZEL (in 2003) with the aim of strengthening the efficacy of UFT in treating colorectal cancer. These oral formulations are recommended in medical guidelines for a number of different cancers. In particular, LONSURF, a treatment approved for refractory metastatic colorectal cancer deployed as a global product, is recommended under treatment guidelines in Europe and North America. While there has been enormous recent progress in cancer treatments, significant unmet medical needs remain. Following its development in Japan, in 2015 Taiho Pharmaceutical launched Yondelis, a treatment for soft tissue sarcoma that is recommended in European and North American medical guidelines. The company also is committed to developing treatments for rare cancers in cases where unmet medical needs are deep. This company is assessing unmet medical needs from clinical practice, and is aiming for more rapid discovery and development of oncology drugs. With the patient perspectives in mind, the Otsuka group is committed to research and development on new anticancer drugs that will be integral in future cancer treatments and others that will help with supportive care, such as antiemetic agents and drugs to alleviate cancer pain.
Otsuka Pharmaceutical Factory undertakes research and development with a global frame of reference, prioritizing clinical nutrition, surgical products, and regenerative medicine with the aim of creating new value. In the area of clinical nutrition, the company used its pioneering IV container technology to develop an antibiotics kit that enables antibiotics and solvents to be prepared in a sterile environment with a single press, as well as ELNEOPA Injection No. 1 and No. 2, high-calorie, total parenteral nutrition solutions containing glucose, electrolytes, amino acids, multiple vitamins, and trace elements in the first-ever, quad-chamber bag. These revolutionary new products help improve convenience and prevent medical errors.
In 2017, Otsuka Pharmaceutical Factory launched ELNEOPA NF Injection No. 1 and No. 2, new formulas developed on the basis of prescriptions written outside Japan where ELNEOPA is widely used. In addition to working on improvements of existing products, the company also focuses on research into next-generation clinical nutrition products with treatment applications.
Otsuka Pharmaceutical Factory is also engaged in the development of surgical products. In 2015 Olanedine became the first new topical antiseptic solution to be approved in Japan in over 50 years, and the company has accelerated research expected to lead to the development of next-generation products to help prevent infectious diseases and post-surgery complications. Otsuka Pharmaceutical Factory engages in regenerative medicine research in both the US and Japan. The company focuses on bioartificial pancreas islets, an area that shows promise as a more effective method of type 1 diabetes treatment, as well as research intended to help create highly functional products that will enable a wide range of hospitals and clinics to provide cellular treatment. In addition to these priority areas, Otsuka Pharmaceutical Factory has also established project teams for the purpose of creating revolutionary new drugs.
In order to create the products that patients truly need, the company is committed to listening to patients and healthcare professionals from the earliest stages to identify issues that could emerge in the future, and consequently develop a flexible approach that is not confined to existing frameworks.
* Pseudobulbar affect (PBA) is a neurological disorder in which individuals cannot control their feelings or actions. It is characterized by involuntary outbursts of crying in front of others and laughing in inappropriate situations.