Society ＞ Together with Patients and Healthcare Professionals Solving Issues Related to Improving Access to Healthcare
There are many intractable diseases in the world for which no cure has been found, as well as many difficult-to-cure diseases. Notably, research and development of therapeutic agents for infectious diseases such as malaria, tuberculosis, and NTDs, which are prevalent in developing countries, is not progressing due to unpromising marketability. Furthermore, inadequate medical systems, poverty, and disasters in developing countries prevent them from receiving needed medicines and medical services.
To address these issues of access to healthcare, the Group will leverage its strengths in drug discovery, and work in partnership with NPOs/NGOs, industry groups, and others based on our MISSION of “Creating hope for all facing illness.”
Intractable Disease Initiatives
We have created treatment options for intractable diseases such as inflammatory bowel disease and multiple sclerosis.
Providing new options for diseases for which there has been no cure is our MISSION itself. We seek to realize precision medicine for diseases for which unmet medical needs remain, especially in the central nervous system and immunoinflammatory areas. In addition, we will contribute to improving the quality of life of patients and their families by providing solutions based on therapeutic medicine from prevention to prognosis.
For the materiality monitoring indicator, we have designated a new “Development pipeline quantity for rare and intractable diseases,” and have disclosed the pertinent results from fiscal 2021.
Development and Provision of Therapeutic Drugs
Edaravone was developed as a treatment for amyotrophic lateral sclerosis (ALS), which causes progressive muscular atrophy and muscle weakness as its principal symptoms. Based on the results of clinical trials in Japan, we obtained approval in Japan, followed by South Korea, the United States, Canada, Switzerland, and Asian countries.
Additionally, edaravone oral suspension, which is intended to reduce patient burden, was approved in the U.S. in May 2022, and the product was launched in June of the same year. In Japan, it was approved for use in December 2022, and launched in April 2023. We are continuously working to expand the number of approved countries to provide our products to more patients and have received approval for use in Canada and Switzerland. Furthermore, we are working to develop around the pill solutions that help improve the quality of life of patients and their families.
- Approval of edaravone oral suspension and support treatment for ALS patients
Until now, the use of edaravone for treatment of ALS has been restricted to intravenous administration. However, we have developed an oral suspension that can be administered orally, a new treatment option intended as both a treatment and to improve patients’ quality of life, alleviating the pain caused by injections and reducing the burden imposed on patients by hospitalization or hospital visits for administration. Edaravone oral suspension was approved in the United States in May 2022, followed by Canada in November, Japan in December, and then Switzerland in May 2023.
In March 2023, Business Insider Japan showcased our initiatives for providing information in support of nutritional management in ALS treatment, as well as introducing our path to development and approval of edaravone oral suspension.
(https://www.businessinsider.jp/post-265047) (Japanese language only)
Dersimelagon is being developed as a new treatment option for erythropoietic protoporphyria and X-Linked protoporphyria, which causes painful skin symptoms when exposed to sunlight. In 2021, we began clinical trials of Dersimelagon as a treatment for systemic sclerosis, which is a rare disease and characterized by hardening of the skin and internal organs.
Going forward, we will work on research and development to attain our MISSION and contribute to the realization of a healthy and sustainable society by offering a promising option to a large number of patients around the world who are struggling with intractable diseases, as well as to their families.
Controlling infectious diseases that are prevalent in developing countries leads to improved living conditions for people and the overcoming of poverty, creating a virtuous cycle not only in developing countries but throughout the world. As a drug discovery company, we believe that leveraging our strengths in drug discovery is the best way to contribute, and we are conducting research on therapeutic drugs for infectious diseases through the GHIT Fund. We also provide various support through collaborative research efforts with non-profit organizations aimed at creating new antimicrobial medications for use against drug-resistant bacteria, and by paying attention to intellectual property in developing countries and donating to NPOs and NGOs.
Participation in the Global Health Innovative Technology Fund
The Global Health Innovative Technology Fund (GHIT Fund), is Japan's first public-private partnership to promote the creation of innovative treatment agents for infectious diseases that affect people in developing countries, such as malaria, tuberculosis, and neglected tropical diseases (NTDs). We support the GHIT Fund’s objective of contributing to global health, and financially support the fund.
Meanwhile, with funding from the GHIT Foundation, we are researching with our partners infectious disease treatments that are widespread in developing countries.
In particular, the eradication of malaria and NTDs presented below is listed as one of the 169 targets linked to the 17 goals of the United Nations’ Sustainable Development Goals (SDGs). Improving medical access is also a materiality for our company, so we will continue to actively promote it.
Joint research with Medicines for Malaria Venture (MMV)
The Company provided its pharmaceutical compound library (50,000 compounds) to Medicines for Malaria Venture (MMV), a research institution that focuses on the discovery of new anti-malaria drugs. Three types of promising hit compounds that have the potential to become pharmaceutical products have been identified. In addition, we promoted joint research and from one of these compounds, we acquired two lead compounds as new anti-malaria drug candidates. In April 2019, we moved to the next phase and continue conducting research in collaboration with MMV to create candidate compounds.
Joint research with Drugs for Neglected Diseases initiative (DNDi)
Together with the Drugs for Neglected Diseases initiative (“DNDi”), an international organization involved in non-profit drug development, we began drug discovery research for lead compounds targeting Chagas disease and leishmaniasis in April 2021. MTPC and DNDi have been conducting compound discovery screening for these diseases since September 2019 and succeeded in acquiring nine types of hit compounds. Since the acquired hit compounds fulfilled the criteria for advancing to the lead compound search, the next step in drug discovery, we have set the acquisition of compounds that meet the lead stage criteria as the final goal of the two-year project.
Patents in Countries Where Access to Healthcare Is Difficult
Mitsubishi Tanabe Pharma Group has established a policy on intellectual property that forms the basis for providing new healthcare opportunities in order to appropriately protect and make effective use of its globally competitive intellectual property. On the other hand, in countries where serious economic problems make access to healthcare difficult, we need to consider enforcing our patent rights. The Group contributes to healthcare access in economically deprived areas around the world. Therefore, as a general rule, we do not enforce our patent rights in the Least Developed Countries (LDCs) stipulated by the United Nations.
Please see “Protection of Intellectual Property Rights” for details.
|Description of initiatives
|Providing vaccines and school meals to children in developing countries
|Group employees have participated in vaccine support activities for children in developing countries, which are conducted by the NPO Japan Committee, Vaccines for the World's Children (JCV). This is an international contribution activity wherein donated used books and other items are sold and that amount is donated to JCV and used to deliver vaccines to children in developing countries. Furthermore, at the employee cafeterias, we participate in TABLE FOR TWO (TFT), in which one meal is provided to a child in a developing country for each meal ordered by an employee from our healthy menu. This is a support program conducted by the NPO TABLE FOR TWO International. School meals that are provided through donations are expected not only to help solve hunger among children but also lead to gains in the children’s fundamental strength and help prevent disease. We are actively promoting these initiatives to help raise employee awareness.
|Myanmar, Laos, Uganda, Rwanda, etc.
|Child palliative care in developing countries
|In the hope of providing palliative care services equally to all children, Mitsubishi Tanabe Pharma Indonesia donates and provides pharmaceuticals to the NGO Rachel House, a pioneer in palliative care in Indonesia. Through this activity, we help children suffering from serious illnesses in areas outside Jakarta where medical care is unavailable.
Please see “Contributions to Medical Care and Welfare” for details about these initiatives.
- Support for the Kenya Research Station (Nairobi), Institute of Tropical Medicine, Nagasaki University
In developing countries, where medical institutions are not well established, many infants die from the exacerbation of infectious diseases. Through Nagasaki University’s Institute of Tropical Medicine, which conducts collaborative research on rotavirus gastroenteritis, we donated lab equipment to the institute’s Nairobi Research Station laboratory. Further, as part of our development of next-generation human resources, we hired as research interns young Kenyans who aspire to be researchers and engaged them in the work of collecting samples and data at the medical facility and conducting experiments in the lab.
The Nairobi Research Station is located on the premises of the Kenya Medical Research Institute, and is a P2/P3 level facility with molecular biology and pest laboratories. A total of seven administrative teams and 50 staff members including collaborators are on the research team and are active in area fields where epidemiological research is conducted. Although the joint research with MTPC was completed in March 2021, the Nairobi Research Station will continue to study tropical infectious diseases and public health peculiar to Africa to address various medical issues not only in Kenya but also in Sub-Saharan Africa. Moreover, we are developing entry-level human resources through the African Business Education for Youth and the JICA Project for Infectious Disease Control Human Resources Development together with Japan International Cooperation Agency (JICA).