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October 08, 2015 11:52 PM ET


Company Overview of Otsuka Pharmaceutical Co., Ltd.

Company Overview

Otsuka Pharmaceutical Co., Ltd. engages in the development, production, distribution, export, and import of drugs for tuberculosis, rehydration, and central nervous system. It offers nutraceuticals, cosmedics, clinical testing equipment, medical device and equipment, medical food products, nutritional drinks, cosmetics, OTC drugs, and other related products. The company was founded in 1964 and is based in Tokyo, Japan with branch and district offices in Japan. It has operations in Asia, Europe, North America, and internationally. Otsuka Pharmaceutical Co., Ltd. operates as a subsidiary of Otsuka Holdings Co., Ltd.

2-9 Kanda Tsukasa-machi


Tokyo,  101-8535


Founded in 1964


81 3 6717 1400


81 3 6717 1499

Key Executives for Otsuka Pharmaceutical Co., Ltd.

President and Executive Director
Age: 65
Managing Director of Accounting, Finance & Business Promotion
Chairman of Otsuka Pharmaceutical Development & Commercialization Inc and Chief Executive Officer of Otsuka Pharmaceutical Development & Commercialization Inc
Senior Managing Director, General Manager of Production Headquarters and Director
Compensation as of Fiscal Year 2015.

Otsuka Pharmaceutical Co., Ltd. Key Developments

U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health

Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health announced that the United States Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for the combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015. This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient - and with the consent of the patient - to the patient’s physician and/or caregiver. Digital Medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs. An estimated average of 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting the effectiveness of those medicines. In the U.S., this may result in an estimated $100-$300 billion in avoidable healthcare costs due to direct costs such as unnecessary escalation of treatment as well as indirect costs. For example, patients suffering from chronic mental disorders such as schizophrenia are often required to take medication for long periods, and it is not unusual for these patients to discontinue taking their medication, or not take their medication as prescribed, which can lead to disease relapse and recurrence. The ABILIFY tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults. If approved by the FDA, healthcare professionals will have the ability to prescribe ABILIFY tablets with the Proteus ingestible sensor embedded in the tablet. This drug-device product can provide the patient with a treatment option to help manage symptoms while allowing the caregiver and healthcare professional to measure medication adherence and other patient metrics. This unique system is filed as an NDA, where the FDA Center for Devices and Radiological Health (CDRH)-cleared ingestible sensor from Proteus will be embedded at the point of manufacture with the FDA Center for Drug Evaluation and Research (CDER)-approved ABILIFY as a combination drug-device, communicating with the Proteus patch and associated medical software. When ABILIFY with the embedded ingestible sensor is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and only with their consent, to their physician and/or their caregivers. Patients view the information using a secure and local software application on their mobile phone or device. Physicians and caregivers view the data using secure web portals. ABILIFY is indicated for: Use as an adjunctive therapy to antidepressants in adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy; acute treatment of manic or mixed episodes associated with Bipolar I Disorder as monotherapy and as an adjunct to lithium or valproate in adult and treatment of Schizophrenia in adults. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death) or infectious in nature. ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or another antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ABILIFY is not approved for use in pediatric patients with depression. Orthostatic Hypotension 'ABILIFY may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics, including ABILIFY. Patients with history of a clinically significant low white blood cell (WBC) count or drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC count in the absence of other causative factors. Seizures/Convulsions: As with other antipsychotic drugs, ABILIFY should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold. Potential for Cognitive and Motor Impairment: Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain ABILIFY does not affect them adversely. Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

SomaLogic and Otsuka Pharmaceutical Extends Initial Collaboration Agreement to Continue the Development of Several Somamer Therapeutics

SomaLogic announced that Otsuka Pharmaceutical has extended its initial collaboration agreement with SomaLogic to continue the development of several SOMAmer therapeutics. Specific projects and financial terms in the extended agreement were not disclosed. SomaLogic is the recognized leader in the development and application of advanced aptamer technologies. The company has designed its proprietary SOMAmer reagents to combine the wide target range of antibodies with the consistency and reproducibility of traditional aptamers. The chemical addition of protein-like side chains to the nucleic acid bases that comprise a SOMAmer molecule results in the ability to discover molecules that bind specifically and tightly to virtually any targeted protein. These properties allow SOMAmer molecules to be used in virtually any laboratory or clinical application that currently uses monoclonal antibodies, including therapeutics. This property, along with other unique characteristics, makes SOMAmer candidates attractive for novel therapeutic discovery and development.

Otsuka Pharmaceutical Co., Ltd. Announces Data from Post-Hoc Subset Analysis of its Phase IIb Clinical Trial

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that data from a post-hoc subset analysis of its Phase IIb clinical trial suggesting potential efficacy of delamanid for the treatment of extensively drug-resistant tuberculosis (XDR-TB) was reported in this week’s New England Journal of Medicine. The analysis found that patients receiving delamanid, plus a World Health Organization (WHO)-recommended optimized background regimen (OBR), had a higher proportion of 2-month sputum culture conversion (SCC), a measurement by which patients are no longer infectious, compared to patients receiving placebo plus OBR alone (7/16, 43.8% vs. 1/10, 10%, p=0.0989)i. In this same open-label analysis, mortality trended lower when patients received six months or more of delamanid compared to patients treated for two months or less (0/17, 0% vs. 2/9, 22.2%, p=0.1108). XDR-TB develops from misuse or mismanagement of second-line TB therapies, which severely limits treatment options.

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