Research & Development

Eisai's Research & Development Activities for the Improvement of Access to Medicines (Product Creation)

August 26, 2022

At the Eisai Group, research and development (R&D) activities, which are the fundamentals of the subsequent downstream value chains through to the patients, are defined as “Product Creation”. For us, our R&D objective is not to simply carry out research and development, but rather it must be to provide patients with final drug products beneficial for them as a result of our efforts. By terming such activities as “Product Creation,” we are always reminded of our objective and our commitment to increasing patient benefits. Based upon ourhhcphilosophy, we are trying to understand the realities faced by patients and aiming to improve their quality of life by providing innovative medicines to satisfy both of their explicit and implicit healthcare needs. We believe that this is the objective of our Product Creation activities.

According to the concept of Product Creation, “Access to Medicines” (ATM) should be improved and secured for all patients. For example, proactive efforts toward developing medicines that address clear needs in developing countries, such as treatments for NTDs and three major infectious diseases (Malaria, TB and HIV/AIDS), are required to improve ATM, even though pharmaceutical companies in developed countries have not focused on those diseases so far. Eisai is working on various activities in order to deliver its medicines to more patients and people at risk around the world including developing countries without delay.

Regarding NTDs, Product Creation requires resources such as tools and technologies in order to do research into those diseases, experience with clinical trials in disease endemic regions and networks to clinical sites. Eisai has been establishing many partnerships for research projects, also known as Product Development Partnerships. These are formed as collaborative partnerships with international non-profit organizations that carry out specialized research on NTDs, are highly skilled at conducting clinical trials in disease endemic regions and have established global research networks. These partnerships maximize the strengths of each partner, and by utilizing public-private funding and external funds who support global health, allow for research and development to progress while sharing development risks and funding.

As of July 2022

NTDs/Three Major Infectious Diseases Research Project Portfolio

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    Please click each item for details.
table Chagas vaccine (using Eisai's immunostimulant E6020) Exploratory research on Trypanosoma PDE inhibitors BRD5018 Screening of novel compounds SJ733 (Phase II study Malaria vaccine (using Eisai's immunostimulant E6020) Exploratory research on prophylaxis by ASOs E1224 - Eumycetoma (Phase II/III study) Inhibitor of Mycobacterium tryptophan synthase DNDI-6174 Inhibitor of DHODH E1511 SJ733 (suppository formulation) Anti-CSP monoclonal antibody AWZ1066S (Phase I study) Inhibitors of Plasmodium falciparum lysyl t-RNA synthetase
WIPO Re:Search NTD Drug Discovery Booster TB Drug Accelerator
COVID-19 Therapeutics Accelerator AMR Screening Consortium
Disease
Chagas Disease
Project Name
Chagas vaccine (using immunostimulant E6020)
Partner
Sabin Vaccine Institute
In August 2014, Eisai entered into a joint research agreement with the Sabin Vaccine Institute (Washington D.C., United States, “Sabin”), the Baylor College of Medicine (Houston, Texas, United States) and Aeras (Rockville, Maryland, United States) to develop a vaccine for Chagas disease. This research was jointly initiated by Eisai and Sabin in 2012 with the aim of developing a new vaccine that utilizes Eisai's in-house discovered selective TLR4 agonist, E6020, as a novel adjuvant (a substance that enhances immune effects). If development of this novel anti-Chagas disease vaccine succeeds, it could potentially prevent cardiac complications from Chagas disease and slow onset of the disease.
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Disease
Chagas Disease
Project Name
Exploratory research on Trypanosoma PDE inhibitors
Partner
Universidad Nacional de La Plata (UNLP)
There is an urgent need for new treatments for Chagas disease. Given their integral roles in trypanosome signaling and low homology with human counterparts, phosphodiesterases (PDEs) have been positioned as drug targets for Chagas disease.
This project aims to validate PDEs as drug targets for Chagas disease and identify selective inhibitors using a computationally-enhanced screening cascade.
Related URL
Related URL
Disease
Leishmaniasis
Project Name
DNDI-6174
Partner
DNDi
DNDI-6174 presents a new mode of action to the leishmania portfolio as well as good characteristics of compound in the early research stage. It was nominated as a pre-clinical candidate, and Eisai and Drugs for Neglected Diseases initiative (Headquarters: Geneva, Switzerland, “DNDi”) collaborate to prepare the way for future Phase I clinical development.
Disease
Filariasis
Project Name
AWZ1066S
(Phase I study)
Partner
Liverpool School of Tropical Medicine
University of Liverpool
In March 2014, Eisai commenced research in collaboration with the Liverpool School of Tropical Medicine (Liverpool, United Kingdom) and the University of Liverpool (Liverpool, United Kingdom) to jointly identify new drugs effective against lymphatic filariasis and onchocerciasis (river blindness), both major types of filariasis. The goal is to develop a treatment that can effectively eradicate the worms that cause filariasis by first eliminating the Wolbachia bacteria inside them which the worms (filariae) depend upon for growth, development and survival. AWZ1066S was identified as a candidate drug, and is now investigated in a clinical study.
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Disease
Mycetoma
Project Name
E1224 - Eumycetoma (Phase II/Ⅲ study)
Partner
DNDi
In September 2015, the Drugs for Neglected Diseases initiative (Headquarters: Geneva, Switzerland, “DNDi”) and Eisai signed an agreement to proceed with clinical development of Eisai's anti-fungal drug E1224 (fosravuconazole) for the treatment of eumycetoma, a fungal form of mycetoma, one of the world's most neglected diseases. E1224 is being investigated in a clinical trial started in 2017 in collaboration with the Mycetoma Research Center (MRC) of the University of Khartoum, Sudan.
Related URL
Disease
Malaria
Project Name
SJ733  (Phase II study)
Partner
University of Kentucky
Eisai entered into a joint research agreement with University of Kentucky (Lexington, Kentucky, the United States) to develop a new antimalarial medicine. This partnership aims to develop a new medicine that will be rapidly effective and cure, and provide lasting protection against reinfection. A Phase II clinical study was initiated in April 2021. If development succeeds, the treatment could potentially solve the problem of increased resistance faced by current antimalarial medicines.
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Disease
Malaria
Project Name
BRD5018
Partner
Broad Institute
Department of Defense
In September 2014, Eisai entered into a joint research agreement with the Broad Institute (Cambridge, Massachusetts, United States, “Broad”) to develop a new antimalarial treatment. Eisai and Broad work together to jointly evaluate compounds screened from Broad's library and identified BRD5018, a compound with the potential to be used in clinical trials. The goal of this research is to develop an oral medicine that will rapidly cure malaria, and by interrupting the transmission of plasmodium (the parasite that causes malaria), will prevent malaria reinfection.
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Disease
Malaria
Project Name
E1511
Partner
MMV
Eisai has identified GWT1 as a novel drug target of malaria parasites, and furthermore, has identified in-house compounds that inhibit the function of GWT1. Exploratory research starting from these identified compounds in collaboration with Medicines for Malaria Venture (Headquarters: Geneva, Switzerland, “MMV”) is in progress, and is currently at the compound optimization stage.
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Disease
Malaria
Project Name
SJ733 (suppository formulation)
Partner
University of Kentucky
MMV
Severe malaria (SM) is a medical emergency requiring immediate parenteral treatment. SM affects two million people per year. The current WHO treatment of choice is available in some developing countries, but is not registered in the US, Europe, Australia, Japan, and many other countries. Given the relatively narrow availability of current treatment, potential issues with resistance, and the tolerability and safety issues of the older drugs there is an emerging interest in developing drugs for severe disease. SJ733 (suppository formulation) is expected to be a strong candidate for the treatment of SM.
Related URL
Disease
Malaria
Project Name
Anti-CSP monoclonal antibody
Partner
Ehime University, GlaxoSmithKline plc., PATH
In October 2021, the WHO recommended the world's first RTS, S malaria vaccine (RTS, S) to immunize children in endemic areas. RTS.S shows the efficacy by inducing high-titer antibodies against the amino acid repeat region of the CS protein (CSP) of Plasmodium falciparum. This project aims to isolate and develop a potent anti-CSP monoclonal antibody (mAb) for malaria, and conduct preclinical and clinical development as a preventive antibody drug for malaria.
Related URL
Disease
Malaria
Project Name
Inhibitor of DHODH
Partner
Broad Institute, MMV
In 2018, the Broad Institute (Cambridge, Massachusetts, United States, “Broad”) and Eisai have started joint research for the development of new anti-malaria drugs based on the inhibition of dihydroorotate dehydrogenase (DHODH). The aim of this study is to optimize the compounds found in Broad and to contribute to the elimination of malaria in combination with appropriate partner therapeutics for candidate compounds to reduce the resistance emergence in clinical practice.
Disease
Malaria
Project Name
Screening of novel compounds
Partner
MMV
The project is unique in that three Japanese pharmaceutical companies collaborate with Medicines for Malaria Venture (MMV) and its partners. Funded by the GHIT Fund, each company will screen its own compound library for new pharmacologically relevant anti-malaria targets.
Related URL
Disease
Malaria
Project Name
Malaria vaccine (using immunostimulant E6020)
Partner
Fiocruz
Aiming to develop vaccines or treatments that target malaria and other neglected tropical diseases (NTDs), Eisai agreed to work together comprehensively on joint research with Fundação Oswaldo Cruz (Rio De Janeiro, Brazil, “Fiocruz”) in October 2012. Under this agreement, fundamental research will be conducted for the development of a vaccine for malaria. Eisai will provide its in-house discovered selective TLR4 agonist, E6020, for use as a vaccine adjuvant (a substance that enhances immune effects).
Related URL
Disease
Malaria
Project Name
Inhibitors of lysyl t-RNA synthetase
Partner
University of Dundee, MMV
Optimization of multistage inhibitors of Plasmodium falciparum lysyl t-RNA synthetase for the treatment of malaria In collaboration with University of Dundee and MMV, we will optimize inhibitors of an enzyme called lysyl tRNA synthetase as a potential new treatment of malaria. This enzyme is critical for all cells to make proteins; essential building blocks in cells. It is expected to be a novel mechanism of action for antimalarials.
Related URL
Disease
Malaria
Project Name
Exploratory research on prophylaxis by ASOs
Partner
University of California, San Diego (UCSD)
Development of effective new liver-stage prophylactic agents is a priority. Antisense oligonucleotides (ASOs) are well-matched to this unmet need, offering the possibility of long-duration activity and benefiting from effective delivery to hepatocytes using well-established conjugation technology. Furthermore, ASOs are a platform technology that enable highly selective targeting of essential Plasmodium genes, with the potential to access previously undruggable targets and accelerate development of additional drugs following initial validation.
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Disease
Tuberculosis
Project Name
Inhibitor of tryptophan synthase
Partner
Broad Institute
Colorado State University
The University of Chicago
The Broad Institute (Cambridge, Massachusetts, United States, “Broad”) and Eisai entered into a joint research agreement for the development of a novel anti-tuberculosis (TB) treatment in March 2018. Novel azetidine compounds that demonstrate anti-TB activity discovered so far by Broad are being jointly evaluated, and an optimal candidate drug will be identified for advancing clinical studies. This research aims to find a small molecule compound that possesses favorable physicochemical properties and pharmacokinetics, potent anti-TB activity that inhibits tryptophan synthase in Mycobacterium sp., and exhibits positive safety and efficacy.
Related URL
Consortium Project Name
WIPO Re:Search
Partner
WIPO
BVGH
Eisai is a member of the World Intellectual Property Organization (WIPO) Re:Search Consortium, an international joint enterprise for the development of treatments for NTDs led by WIPO. Based on requests from academic researchers worldwide involved in research into NTD treatments, Eisai is providing various biologically active compounds free of charge through this consortium. The intellectual property rights associated with these compounds are basically provided royalty free for use in development of NTD treatments and commercialization in countries where target NTDs are endemic.
Related URL
Consortium Project Name
NTD Drug Discovery Booster
Partner
DNDi
The “Neglected Tropical Diseases Drug Discovery Booster” consortium was formed in May 2015 with the aim of accelerating early stage drug discovery for Leishmaniasis and Chagas disease, through a multilateral, coordinated search process across screening systems and compound libraries owned by participating companies under the leadership of the Drugs for Neglected Diseases initiative (DNDi). Eisai joined the consortium as one of four founding companies (Eisai Co. Ltd., Shionogi & Co. Ltd., Takeda Pharmaceutical Ltd., and AstraZeneca plc). Currently, more companies have joined the consortium. This innovative research model has the potential to cut up to two years from the early drug discovery process, which generally takes approximately five years or more.
Related URL
Consortium Project Name
TB Drug Accelerator
Partner
Bill & Melinda Gates Foundation
In November 2013, Eisai became a signatory to the Tuberculosis Drug Accelerator (TBDA) partnership, a groundbreaking initiative that aims to speed up the discovery of essential new treatments for tuberculosis (TB). Jointly launched in June 2012 through a collaborative agreement among seven pharmaceutical companies and six research institutions with support from the Bill & Melinda Gates Foundation, this partnership targets the discovery of new TB drugs by working together on early-stage research. Accordingly, Eisai and all other participating companies will provide their compound libraries for screening anti-TB drugs, and by sharing candidate compounds with the other partners when they are identified, will cooperate in order to rapidly and efficiently create a new therapy for TB.
Related URL
Consortium Project Name
COVID-19 Therapeutics Accelerator
Partner
Bill & Melinda Gates
Foundation
Eisai is participating in the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation in collaboration with Wellcome and Mastercard. Eisai is engaging in research and development of new drugs for COVID-19 as well as preparedness for future pandemics.
Related URL
Consortium Project Name
AMR Screening Consortium
Partner
GARDP (Global Antibiotic Research and Development Partnership)
In this project, compounds, which have never been screened for antibacterial activity, will be screened from the collaborating pharmaceutical companies' chemical libraries developed by latest medicinal chemistry efforts.
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