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At Astellas, we are committed to improving access to medicines while ensuring our therapies reach as many patients as possible. This commitment will enhance the VALUE we are bringing to patients through our research and development efforts, which focus on serious diseases for which there is a high unmet medical need. These disease areas typically require an even greater commitment to providing comprehensive access programs due to the pioneering and complex nature of our therapeutic approaches, the often challenging diagnostic requirements and the significant healthcare needs of the patients we serve.
Improving access to medicinal products require investment at all stages of the product lifecycle, from early planning and discovery through to clinical research, development and ultimately, bringing therapies to market. We are working to ensure our end-to-end access to medicines strategy influences where we are delivering our therapies.
Enrollment in clinical trials is the most effective way for patients to access investigational Astellas therapies before they have been approved. We are committed to improving the experience for patients, their families and caregivers by making participation in our trials more accessible. Whenever possible, we conduct decentralized clinical trials to allow for greater participation from home and local treatment centers. Outside of the clinical trial setting, we run early access*1 and post-trial access programs*2 to support patients with serious and life-threatening diseases seeking access to our investigational medicinal products.
For some therapies, our international import program supports patients seeking access to medicinal products after regulatory approval and before reimbursement in their respective countries. Additionally, our international pharmacy program can facilitate access to certain therapies in countries where an investigational therapy is not yet approved.
Astellas also has an end-to-end holistic planning process to widen affordability and access for all therapies and in all markets where our medicinal products are available.
Once our therapies become commercially available in a specific country, we are committed to exploring ways that make our medicinal products affordable and accessible. For example, our patient access initiatives provide financial assistance to eligible patients who face challenges paying for care. We also consider the feasibility of donation programs for certain medicinal products to help make our therapies accessible in countries where they are not commercially available.
Improving access to medicines is complex and challenging, requiring collaboration between different stakeholders and healthcare providers at every stage of the patient journey. At Astellas, we work with multiple partners – including patient and non-profit organizations, governmental bodies, academia and other leading life science companies – at both the global and local level on a broad range of initiatives to help ensure our therapies can reach the patients who will most benefit.
At Astellas, we recognize that improving access to medicines is critical to the long-term health and sustainability of society. Providing access to medicines is a foundational element of our Corporate Strategic Plan and a key measure for evaluating both personal and team success for our leadership and employees.
While we are making progress, we recognize there is more work to be done to improve the lives of patients worldwide, equitably and sustainably, through greater access to medicines. We are continually exploring ways in which we can expand access to medicines worldwide.
Astellas implements access programs for our medicinal products throughout the product lifecycle to provide patients with sustainable access to our innovative therapies.
Ensuring physicians can access the therapies their patients need is a high priority for Astellas. Healthcare professionals can submit a request for Astellas medicinal products on behalf of their patients using our Request Platform. The platform provides healthcare professionals with one central and accessible location for submitting product requests.
Click here for the Access to Medicines Request Platform. For general inquiries or questions about Astellas products, please complete this form.
Astellas has a culture of doing good for others, which centers on putting patients, wherever they are, at the core of everything we do. We believe we will only fully deliver on our vision to turn innovative science into VALUE for patients if we improve access to medicines for the patients who need them most.
We won’t rest until we achieve this goal.
*1 *2 For details, please visit the following website
https://www.astellas.com/en/about/policies-and-position-statements?param=expend-tit-medicines#access_to_health
References
Areas of Interest https://www.astellas.com/en/innovation/areas-of-interest#focus-area-approach: January 2022
Astellas focuses on improving global health and access to medicines. We have donated Prograf® products to patients in Tanzania since FY 2023 and have supported more than 200 patients to date.
The partnership with Direct Relief ensures that the donated Prograf® will be used effectively in Tanzania, aiding patients who require immunosuppressive therapy to maintain their health post-transplantation. This collaboration is a testament to Astellas’ mission of making a positive impact on global health through sustainable practices and strategic partnerships, and aligns with its Access to Medicines Strategy to improve access to medicines throughout the product lifecycle.
Astellas’ Access to Medicines (AtM) Steering Committee is committed to advancing sustainable access to medicines and improving health outcomes in communities worldwide where Astellas does not have a business presence.
Further details on the Astellas' Access to Medicines commitment can be found on its website. Click here.
About Direct Relief
Direct Relief is a humanitarian organization committed to improving the health and lives of people affected by poverty and emergencies. By mobilizing and providing essential medical resources, Direct Relief aims to bring health and hope to the most vulnerable populations.
Country
Tanzania
Main targets
Creating innovation
In 2021, more than 247 million incidences of malaria were observed with 619,000 deaths. Malaria has led to serious social problems and innovative drugs to treat this disease are desperately needed.
Astellas is pursuing collaborative research to discover new drugs for the treatment of Malaria from the so-called "Big Three" infectious diseases that have ravaged developing world populations.
The research program below is funded by the Global Health Innovative Technology Fund (“GHIT Fund”). Program result is published on the GHIT Fund’s website.
Exploration of antimalarial drugs
Astellas conducted a collaborative research with Medicines for Malaria Venture (MMV) for the exploration of an antimalarial drug from October, 2017. Initial profiling of the hit compounds discovered in the Screening Collaboration appear to have novel drug-like chemotypes and mechanism of action, different from current antimalarial drugs in use or compounds in the clinical pipeline, suggesting efficacy against all known field resistance. Astellas, MMV and TCGLS entered into a new collaborative research agreement on Feb 25, 2022 to identify lead compounds with acceptable pharmacological activity, pharmacokinetics, as well as safety from optimising multiple hit compounds obtained from the Screening Collaboration.
Main targets
Creating innovation
Neglected Tropical Diseases (NTDs) are mainly parasitic, bacterial, viral or fungal infections prevalent among people living in poverty in developing nations in tropical and subtropical regions. At least 1 billion people worldwide are reported to be infected with the 20 NTDs listed by the World Health Organization (WHO), many of which cause serious social difficulties. Astellas is working with external partners on collaborative research to discover new drugs for the treatment of NTDs.
Participation in NTDs drug discovery booster
In March 2018, Astellas participated in the Neglected Tropical Diseases Drug Discovery Booster*1, a consortium established to identify lead compounds*2 for leishmaniasis and Chagas disease, both of which are neglected tropical diseases (NTDs). Through this consortium, Astellas will contribute to the discovery of new drugs for patients suffering from leishmaniasis and Chagas disease. The consortium is supported by funding from the Global Health Innovative Technology Fund (“GHIT Fund”).
*1Neglected Tropical Diseases Drug Discovery Booster: A consortium launched by the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit organization engaged in the development of new treatments for neglected diseases. In addition to Astellas, seven pharmaceutical companies, specifically Eisai Co., Ltd., Shionogi & Co., Ltd., Takeda Pharmaceutical Company Limited, AstraZeneca plc., Celgene Corporation, Merck KGaA and AbbVie, also participate in the consortium as partners.
*2Lead compound: A compound with confirmed pharmacological activity against a target disease. Optimization research (for improvement of activity, physical properties, pharmacokinetics, toxicity, etc.) is conducted based on lead compounds.
Involvement in collaborative research on New Chagas
From November 2021 until September 2023, Astellas is engaged as an advisor to the collaborative research project "Autophagy as a novel drug-development target for Chagas disease." The project has been conducted by the National Institute of Advanced Industrial Science and Technology (AIST) together with the Non-profit organization Drugs for Neglected Diseases initiative.
In addressing the issues of Access to Health identified as materiality, a key pillar of Astellas’ Access to Health strategy focuses on collaborating with external partners and supporting their activities by leveraging Astellas’ strength with external partners.
As a part of this strategy, Astellas supports the research and development of drugs, vaccines, diagnostics and other products for tuberculosis, malaria and other neglected tropical diseases (NTDs) through the participation of the Global Health Innovative Technology Fund (GHIT Fund). In the goal of combatting infectious diseases prevalent in the world’s poorest countries, the GHIT Fund, specializes in global health R&D, has fought these diseases as an international public-private partnership fund (PPP) between the Japanese Government: Ministry of Foreign Affairs, Ministry of Health, Labor and Welfare, private sector, the Bill & Melinda Gates Foundation, the Wellcome and the United Nations Development Programme.
The GHIT Fund has invested a total of approximately 29.1 billion yen in 118 projects over the last ten years. Demonstrating the GHIT Fund’s strength of partnerships, over 170 partners (59 domestic and 111 global groups) have participated in product development thus far(As of May 31, 2023). Japanese innovation and capacities in pharmaceuticals have been directly and effectively leveraged to global health R&D from target research which is initial stage of drug discovery to clinical trials in South America and Africa.
Astellas has contributed to the GHIT Fund since the inception of the Fund. In alignment with Astellas’ Access to Health strategy, one way we contribute to helping to resolve Access to Health issues is through continuous participation as a partner in the third phase of the GHIT Fund.
Related links
Global Health Innovative Technology Fund
Main targets
Creating innovation
Schistosomiasis - a potentially life-threatening infection
Schistosomiasis (also known as bilharzia)*1 is one of the parasitic diseases worldwide, spreading to 78 countries and endemic in 51 countries. More than 240 million people are affected, resulting in a significant public health burden and economic impact. It is a poverty-related disease that is widespread in tropical and subtropical regions where large sections of the population have no access to clean water. Flatworms transmit the disease and people become infected with the parasite through contact with freshwater, for example, while working, swimming, fishing, or washing their clothes. The minuscule larvae penetrate human skin, enter the blood vessels, and attack internal organs. The infection rate is particularly high among children. Schistosomiasis is a chronic condition and is classified by the World Health Organization (WHO) as one of 21 neglected tropical diseases (NTDs). If it is left untreated, schistosomiasis causes anemia, stunted growth, reduced ability to learn, and chronic inflammation of the organs, which can be fatal. Schistosomiasis Infographic
The current standard of care treatment for schistosomiasis is suitable for school-aged children and adults. However, 50 million preschool-aged children have not been treated in public healthcare programs mainly due to the lack of an appropriate formulation for the youngest.
The Pediatric Praziquantel Consortium is an international public-private partnership that aims to reduce the global disease burden of schistosomiasis and improve child health by addressing the medical needs of infected preschool-aged children. Its mission is to develop, register, and provide access to a suitable pediatric drug for treating schistosomiasis in children 3 months to 6 years of age.
Astellas has participated as a founding member of the Pediatric Praziquantel Consortium since 2012 and has been working with Consortium partners - pharmaceutical companies, research institutions, and international non-profit organizations - to (co)-develop a suitable pediatric formulation.
Our innovative formulation technology played a pivotal role, especially in the development of initial formulations of the new pediatric treatment option. The pediatric formulation is made palatable for very young children by reducing the bitter taste associated with the medication and is administered via a 150mg dispersible tablet that is dissolved in water.
The prototype of the pediatric formulation has been developed by Astellas and further optimized by Merck (Germany) for global production using simple manufacturing processes yielding tablets that can remain shelf stable, even in hot and humid tropical climates.
In December 2023, the European Medicines Agency (EMA) granted the positive Committee for Medicinal Products for Human Use (CHMP) scientific opinion on the new pediatric treatment option for preschool-aged children with schistosomiasis. Beyond the steps for inclusion of the new medication into the World Health Organization’s list of prequalified and essential medicinal products, the Consortium’s implementation research program (ADOPT)*2 is ongoing and preparing for the introduction of a new pediatric treatment option in the first endemic countries in Africa. To ensure equitable and sustainable access, it is essential that new procurement and funding mechanisms are collaboratively explored and established.
Astellas recognizes Access to Health as a materiality, and through our VISION to be "On the forefront of healthcare change to turn innovative science into VALUE for patients", we are proactively taking a comprehensive approach to solving this issue through the methods defined below.
(1) Astellas’ core business (Rx, Rx+)
(2) Enhancing availability of Astellas products (Access to Medicines)
(3) Collaboration and support for the activities implemented by external partners
Initiatives in the Consortium apply to (3), and the positive CHMP (Committee for Medicinal Products for Human Use) scientific opinion by EMA of a new pediatric treatment option represents a significant milestone in alignment with Astellas’ Access to Health focus.
As a member of the Consortium, Astellas is committed to continue working with the partners to have a new pediatric treatment option available for children in schistosomiasis-endemic countries in Africa.
For more information on the Consortium's activities and partners, please see below. https://www.pediatricpraziquantelconsortium.org/
*1https://www.who.int/en/news-room/fact-sheets/detail/schistosomiasis
*2ADOPT: Adoption of Levo-Praziquantel 150 mg for schistosomiasis by endemic countries
Newly developed pediatric formulation
©Merck
*This movie was created by GHIT Fund on July 2019.
Astellas recognizes that medical science evolves rapidly with new information becoming available continuously. Astellas seeks to advance medical sciences knowledge which plays a crucial role in the research and development (R&D) of medicines and is also important in building the capacity of health systems and human resources. To do this, Astellas supports medical, scientific research and education which contributes to the advancement of medical sciences. This support for medical professionals is executed in line with national guidelines for securing transparency.
Astellas provides support for educational activities in the medical and pharmaceutical fields as part of its Astellas Academic Support. Specifically, the support covers financial support for educational activities of medical and pharmaceutical-related organizations, mainly academic societies.
Astellas has a deep history of supporting academic research activities, while ensuring a high level of transparency and fairness, with the goal of contributing to the development of medicine and life sciences.
Until the end of FY 2019, Astellas donated directly to academic research institutes through a practice called “Shogaku Kifu”. However, due to increased global awareness of these types of donations, high levels of transparency, fairness and accountability were required for funding from pharmaceutical companies to academic institutes. Direct donation as “Shogaku Kifu” from pharmaceutical companies to academic institutes, while compliant with laws and regulations, created the possibility for stakeholders to critique the practice because pharmaceutical companies and academic institutes have a common interest in research. Considering these factors, Astellas Pharma Inc. ended “Shogaku Kifu” donations in March 2020.
After FY 2020, Astellas significantly enhanced support for research activities through the Astellas Foundation for Research on Metabolic Disorders (AFRMD) to ensure a higher level of transparency and fairness, while keeping support research activities in academia. The AFRMD is independent from Astellas and determine grants for strategic researchers and research institutes without input from Astellas’ corporate divisions.
Astellas Foundation for Research on Metabolic Disorders, established in 1969, encourages life science research, especially the development and practical application of drug discovery and therapeutics. The Foundation also contributes to public health measures and medical progress. The Foundation contributes to medical and life sciences by awarding grants for epoch-making research, discovery and nurturing of brilliant young talent and support for researchers through training and opportunities to study outside Japan. Grants support researchers based in Japan who conduct exploratory research proposals that are highly original and pioneering or research proposals that are expected to produce results of high clinical significance. The Foundation also supports researchers in the following fields:
In FY2024, a total of 160 million yen for research donations was awarded to 80 researchers out of 1,155 applicants. In addition, a total of 55.66 million yen for overseas study subsidies was awarded to 11 researchers out of 202 applicants.
Beginning in FY2022, the AFRMD Next-generation Innovators’ Challenge (ANIC) launched as a new way to increase research and development capacity for next generation scientists. Within the ANIC program, scientists can research topics that include drug discovery and development, practical application of treatments, and the creation of new research subject areas. In ANIC, both the number of research grants and the amount awarded to overseas research grants was increased. In addition, a step-up research grant was provided to strengthen unique research that will bring about future innovation in life sciences. In FY2024, a total of 40 million yen for a step-up research grant was awarded to 10 researchers out of 59 applicants.
Astellas conducts its business activities based on our raison d'etre of “Contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products”. Our main efforts to expand Access to Health lie in discovering, developing and providing innovative healthcare solutions for patients. On the other hand, there are also many problems that cannot be solved by medical treatment because the environment surrounding each patient is different.
We believe that social contribution is an important corporate activity along with the business activity of drug development and providing new medicines. In Japan, we are committed to supporting the activities of patient organizations. We call this social contribution activity "Starlight-Partner activities (SLP)”.
Basic policy for Starlight Partner activities
Starlight-Partner activities support the self-reliance and sustainable development of patient organizations by providing the following trainings
FY2024
| Program Title | Contents | Number of participating organizations | Number of participants |
|---|---|---|---|
| Patient Expert Program | Training for future group leaders to learn medical environment and debate skills | 5 | 5 |
| Leadership Training Program | Training for future group leaders to learn management skills and leadership communication | 14 | 21 |
| Peer support training | Training for patients and caregivers to learn the basic knowledge of peer support and communication skills | 24 | 29 |
Astellas supports activities and events of patient organizations such as improving disease awareness in society or learning deeply about their own disease with a donation.
FY2024
| Number of organizations | Amount（yen) |
|---|---|
| 9 | 4,716,300 |
Patient organizations that Astellas has funded are invited to share the impact of their activities with Astellas and other organizations at meetings held.
FY2024（No applicable organization in FY2024, but to be held in FY2025）
| Number of organizations | Number of participants |
|---|---|
| 0 | 0 |
Astellas has dispatched instructors to support the activities of peer support training sponsored by patient groups.
FY2024
| Number of dispatched instructor organizations | Number of participants |
|---|---|
| 2 | 37 |
Astellas has provided free materials for events hosted by patient organizations.
FY2024
| Number of organizations | Total number of provided materials | ||||
|---|---|---|---|---|---|
| Ballpoint pen | Plastic folder | Notebook | Paper bag | Name tag | |
| 17 | 1030 | 70 | 470 | 680 | 240 |
The Access to Medicine Index (ATMI) report* assesses 20 of the world’s largest pharmaceutical companies on their efforts to provide access to medicine in low- and middle-income countries (LMICs). The Access to Medicine Foundation (ATMF) conducts this assessment every two years using a methodology that considers 3 primary areas: Research and Development, Product Delivery and Governance of Access. Astellas has been an active participant in the Access to Medicine Index since 2010.
In the 2024 Access to Medicine Index, Astellas ranked 15th out of 20 pharmaceutical companies, moving up from 16th compared to 2022. Astellas scores high in Governance of Access. Particularly, our Access to Medicine (AtM) strategy is one of our achievements that ATMF has recognized. Astellas acknowledged the need to create a unified, comprehensive strategy driving access to medicines throughout the products' lifecycle. After facilitating discussions, building and ironing out the strategic detail with relevant functions, we created a comprehensive AtM strategy and a playbook to drive execution. On the other hand, capacity building (part of the Product Delivery and R&D category) was identified as an area of opportunity for Astellas.
Astellas’ comprehensive Access to Health focus is connected to the goals stated by the Access to Medicine Foundation, by providing medicines to patients around the world and collaborating with external partners to leverage medical capabilities and technologies on a global level.
The material issues that Astellas addresses are reflected in the ATMI report methodology, such as ethical and responsible business practices, health system strengthening, and quality and supply chain management. This reinforces Astellas’ company-wide commitments to sustainability by transforming into a cutting-edge VALUE-driven life science innovator and strengthening resilient and sustainable business operations to meet expectations of society.
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