Initiatives to Improve Access to Medicines

Despite the rapid progress in technology and knowledge of modern medicine, unmet medical needs remain in a wide range of therapeutic areas, and every R&D-based pharmaceutical company is charged with the mission of addressing these issues by creating innovative new medicines. Furthermore, there are many countries and regions where people are unable to equally access adequate medical treatment due to immature medical systems and/or poverty. To solve these issues, which are recognized as "access to medicines" or "access to healthcare," in addition to our R&D efforts on innovative medicines, we are actively working with international organizations, governments and research institutions, and civil society, as well as through our R&D efforts on innovative medicines.

Partnership Initiative "Access Accelerated"

Sumitomo Pharma is participating in a partnership initiative called "Access Accelerated." Access Accelerated is a coalition of more than 20 pharmaceutical companies and several international institutions around the world formed to improve access to healthcare for non-communicable disease in low- and low-middle-income countries. Access Accelerated has also worked with Boston University to develop a common measurement framework for individual access programs implemented by each company to promote these efforts effectively. Sumitomo Pharma has its health improvement program for mothers and children in Cambodia registered under this framework. The initiative is now in Phase 2, which runs from fiscal 2020 to fiscal 2022, following Phase 1, which ran from fiscal 2017 to fiscal 2019, and Sumitomo Pharma has been participating since the initiative was launched in fiscal 2017.
In fiscal 2019, a total of 107 individual access programs by different companies were implemented in 136 low- to middle-income countries in Africa and Asia, while programs on pharmaceutical regulatory easing, healthcare specialist development and public education for citizen awareness were promoted centering on three target countries: Kenya, Ghana and Vietnam.

・View Access Accelerated Year Three Report, for its 2019 activities:

・Visit Access Observatory, a reporting framework for Access Accelerated developed with Boston University:

Initiatives to Improve Access to Healthcare in Developing Countries

Sumitomo Pharma supports initiatives to improve access to healthcare in developing countries. The Company has cooperated with the NPO Future Code to implement the training and education of nurses in Bangladesh, and in Haiti to implement regular medical examinations for tuberculosis as well as the training of physicians. We have also cooperated in malaria prevention and awareness raising activities, hygiene education, including the installation of toilets, and the operation of an orphanage in Burkina Faso.

Training for nurses<br>in Bangladesh

Training for nurses
in Bangladesh

Free medical examination<br>for tuberculosis in Haiti

Free medical examination
for tuberculosis in Haiti

Malaria prevention and awareness<br>raising activities in Burkina Faso

Malaria prevention and awareness
raising activities in Burkina Faso

Responding to Demands for Development of Unapproved or Off-Label Drugs

Japan's Ministry of Health, Labour and Welfare (MHLW) invites requests for the development of unapproved or off-label drugs that have been approved for use in Europe and the United States but have yet to be approved in Japan. Upon receipt of such a request, MHLW, through a meeting of the Evaluation Committee on Unapproved or Off-Label Drugs with High Medical Needs, evaluates the medical need for the drug concerned and ascertains the validity of clinical studies required to support an application for approval and the drug's eligibility for an Application Based on Public Knowledge, thus promoting the development of such drugs by pharmaceutical manufacturers.

Sumitomo Pharma is responding to invitations and requests for development of the following drugs:

Invitation / request for development Product name Indication(s) Development status
4th round METGLUCO® Ovulation induction for patients with polycystic ovary syndrome Approved on September 16, 2022
Controlled ovarian stimulation in assisted reproductive technology for patients with polycystic ovary syndrome
2nd round RETHIO® Conditioning treatment prior to autologous hematopoietic stem cell transplantation for pediatric malignant solid tumors Approved on March 26, 2019
Conditioning treatment prior to autologous hematopoietic stem cell transplantation for malignant lymphoma Approved on March 25, 2020
1st round Amlodin® Additional indication of hypertension in pediatric patients Approved on June 22, 2012
1st round METGLUCO® Additional indication of type 2 diabetes in pediatric patients Approved on August 29, 2014