Tropical Diseases

Under Eisai’shuman health care(hhc) concept, we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. We position our efforts towards neglected tropical diseases (NTDs) and malaria as an important business domain guided by our corporate concept.

We began research on infectious diseases in the 1980s when Tsukuba Research Laboratories was established, and have been developing therapeutic drugs for NTDs and malaria in collaboration with many partners, including the Drugs for Neglected Diseases initiative (DNDi). Since 2010, together with global partners such as the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, we have been working on elimination of lymphatic filariasis (LF), one of the NTDs, by providing LF treatment diethylcarbamazine (DEC) tablets free of charge, and raising awareness of the disease.
Based on our hhc concept, we will continue to promote research activities by further strengthening our collaboration with global partners, and aim to realize a world free of burden caused by neglected diseases such as tropical diseases.

In 1990, a project aimed at creating therapeutic drugs for visceral mycosis (candidiasis, aspergillosis and others) was initiated. After being selected as a clinical development candidate compound in 1994, ravuconazole was developed as fosravuconazole (development code: E1224), a prodrug of ravuconazole.

In 2002, activities for malaria were initiated at Tsukuba Research Laboratories throughhhcactivities (activities to plan and implement ideas found through socialization with patients and people in the daily living domain in business operations) based on the idea of applying the concept of antifungal drugs to malaria.
We discovered that the protein GWT1, which we had previously identified as a target molecule for antifungal drug, is also present in the parasite that causes malaria. After initiating drug discovery and research in 2010, we developed an in-house compound which inhibits GWT1. As a result of optimization, E1511 was selected as a clinical candidate in 2021.

In 2003, Professor Urbina (Venezuelan Institute of Scientific Research) reported that ravuconazole which was being developed as an antifungal agent, showed potent activity against Trypanosoma cruzi, the parasite that causes Chagas disease. This prompted us to commence joint research with DNDi. In 2009, we signed a collaboration and license agreement with DNDi for the clinical development of fosravuconazole for the treatment of Chagas disease, and carried out a Phase II study (a combination study of fosravuconazole and benznidazole) in Bolivia. Although the clinical trial could not verify combination therapy’s efficacy compared to benznidazole monotherapy, it contributed to evidence creation for a potential new standard of treatment as incidence of side effects, an issue associated with benznidazole monotherapy, decreased. Based on this evidence, it is expected that access to treatment will improve by significantly shortening the administration period of benznidazole monotherapy, and the results of the study were published in the Lancet, one of the world’s five leading medical journals.

In 2010, Eisai signed a joint statement with the WHO committing to provide DEC tablets, a treatment for LF, for free. It was the first partnership formed by a Japanese company with the WHO to provide a medicine for NTDs free of charge. In the joint statement, Eisai agreed to develop and manufacture high-quality DEC tablets and provide a total of 2.2 billion tablets to the WHO free of charge by 2020. In 2017, Eisai announced our commitment to provide DEC tablets to endemic countries that need them until elimination is achieved in these countries.

In 2012, together with twelve other global pharmaceutical companies, the Bill & Melinda Gates Foundation, the WHO, the U.S. and U.K. governments, the World Bank, and governments from NTD-endemic countries, Eisai pledged its support as the only Japanese company to the London Declaration, a coordinated effort to eliminate NTDs and the largest ever global public-private partnership of its kind at that time.

In 2013, Eisai co-established the Global Health Innovative Technology Fund (GHIT Fund), an international public-private partnership fund for global health R&D that mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Staff from five Japanese pharmaceutical companies including Eisai, as well as the Bill & Melinda Gates Foundation and the Government of Japan contributed to the establishment.

Eisai-produced DEC tablets were officially recognized by meeting the WHO’s quality standards and received WHO prequalification, making it first case in the world where an NTD treatment is prequalified by the WHO. Subsequently, we commenced free provision of the tablets to LF endemic countries.

In our joint research project with the Broad Institute for the development of new antimalarial drugs, we identified of a group of candidate compounds with a novel mechanism of action which may lead to the development of new innovative antimalarial drugs, and the results were published in the scientific journal Nature in 2016. E1018 was selected from the group of candidate compounds as a candidate for clinical study.

In 2014, Professor Fahal (the Khartoum University Mycetoma Research Center in Sudan) and others reported that ravuconazole showed potent activity against Madurella mycetomatis, the pathogen that causes eumycetoma. In 2015, we entered into an agreement to proceed with the clinical development of fosravuconazole as a potential new treatment of eumycetoma, which is a fungal form of mycetoma with high unmet medical need. In 2017, DNDi and the Khartoum University Mycetoma Research Center initiated the first-ever double-blind Phase IIb/III randomized clinical trial for eumycetoma in Sudan to evaluate the efficacy of fosravuconazole. The results were presented at an international conference in 2022. Currently, we are engaging in discussions regarding registration with the regulatory authorities (National Medicines and Poisons Board) in Sudan.

Eisai signed the Kigali Declaration announced at the “Kigali Summit on Malaria and NTDs” on June 23, 2022 in Kigali, the capital of the Republic of Rwanda, and expressed our continued support for the elimination of NTDs towards the achievement of a road map for NTDs 2021-2030 launched by the World Health Organization (WHO).

In 2023, Eisai declared its support for “Nagasaki Outcome Statement”, which reaffirms the Kigali Declaration and calls for “Accelerating Research and Development, and Access and Delivery for NTDs” to eliminate NTDs, at the symposium held along with G7 Health Ministers’ Meeting.