Our heartfelt sympathy goes out to the people who have been affected by the Coronavirus Disease (COVID-19).
With the continuing spread of COVID-19, we are, as part of our mission as a pharmaceutical company, taking various actions and measures to contribute to securing the safety of patients and alleviating strain on healthcare resources. The following are our activities and status to date in areas including the stable supply of products, contribution to the R&D of drugs, and assistance to regions where infection is spreading.
Continuation of business and maintaining a stable supply of products
We are currently advising our employees to combine working at an office and working from home in accordance with the situation in each country and region to secure the safety of our employees and to prevent the further spread of the disease. While taking measures to prevent the spread of the disease, we are continuing to gather and provide necessary information to medical institutions in regions around the world consistent with the rules of each respective institution with regards to sales activities.
While placing the highest priority on the safety of our employees, in order to continue our social mission of ensuring a stable supply of drugs, quality control, managing safety, and providing information, our essential business continues to be carried out with strict measures taken to prevent infections.
As for the supply of products, in particular, there are currently no issues caused by COVID-19, as we have been able to manage risks around procuring raw materials and distributing finished products by closely cooperating with suppliers and manufacturers taking into account business continuity and at stable supply.
For ensuring patient safety and alleviating strain on healthcare resources
In an effort to help ensure patient safety and alleviate strain on healthcare resources during the COVID-19 pandemic, we are implementing changes to our clinical trial operations.
- In countries and regions with continuing spread of COVID-19, we are suspending start-up activities involving study sites for new interventional clinical studies. We are also suspending the enrollment of new patients in ongoing studies.
- We have started to reactivate clinical studies in countries such as the US, EU, and Japan, where the activities were suspended due to the COVID-19 pandemic, following the benefit-risk assessment of each study.
- Consistent with the recently issued guidance from authorities including the US and EU regulatory bodies, we are assessing protocols and implementing measures to reduce the burden on healthcare systems while ensuring that the maintenance of patient safety.
- Furthermore, in order to prioritize patient safety, we are also providing measures, when applicable, such as remotely monitoring the safety of a patient via phone, conducting necessary medical exams at medical institutions close to a patient’s home outside of the trial site, and/or sending investigational drug to a patient’s home, in case a patient cannot visit the trial site designated in the protocol.
- We are building flexibility into the protocols to respond to changes related to the ongoing pandemic.
- We will be frequently reassessing this approach, which applies to all interventional clinical trials led by us and our group companies. However, a different approach may be implemented for some clinical trials led by our collaboration partners.
We remain focused on ensuring patient safety, while maintaining regulatory compliance and data integrity across clinical development programs.
Contributing to the R&D of drugs
We will quickly take appropriate action, such as provide drugs, by cooperating with bodies concerned in response to requests by the government.
In Japan, we are providing compounds in response to a request from the Ministry of Health, Labour and Welfare and National Institute of Infectious Diseases to cooperate in the “Basic Screening Plan for Drugs for Coronavirus Disease.”
We are also responding to requests from the European Federation of Pharmaceutical Industries Associations (EFPIA) and the Innovative Medicines Initiative (IMI) to cooperate in the “Activities Aimed at Developing Drugs for the Novel Virus” and providing consultation on countermeasures.
Astellas Pharma Europe Ltd. is a member of the CARE (Corona Accelerated R&D in Europe) Consortium, the largest initiative in Europe addressing the challenges of COVID-19. CARE is funded by IMI, a public-private partnership aiming to speed up the development of better and safer medicines for patients. The goal of the CARE consortium is to deliver treatments for the current COVID outbreak as well as future coronavirus outbreaks.
Furthermore, as part of our membership of the non-profit organization, TransCelerate BioPharma Inc.1, Astellas is participating in the COVID-19 Task Force, alongside 20 other biopharmaceutical member companies, to share industry best practices in managing the continuity of clinical trial operations during the global COVID-19 pandemic while ensuring patient safety and maintaining study integrity.
We are actively seeking various proposals from within or outside of Astellas for our owned technology and potential use of our drugs that are under development or on the market against COVID-19, and we are swiftly evaluating each of them.
We are also responding to requests from various governments to provide compounds for the research phase. While placing the highest priority on safety, we will at the same time continue to contribute in our efforts to swiftly evaluate various possibilities in research and development of drugs for COVID-19.
Activities in each country and region
We will make a donation worth 5 million yen to Astellas Foundation for Research on Metabolic Disorders2 as grant for COVID-19 related research in Japan. The foundation will subsidize COVID-19 related research in the research funding applications for FY2020 by utilizing this donation. Further, the foundation will provide up to 10 million yen of financial assistance to researchers who are studying abroad with the support from the foundation and who have been economically affected by COVID-19.
Astellas Pharma China, Inc. donated one million yuan to the Red Cross Society of China for purchasing protective clothing, masks, disinfecting solutions, and other equipment for healthcare professionals serving at hospitals in Wuhan, China, and procuring medical treatment equipment.
In addition, we have donated approximately 300,000 yuan worth of personal protective equipment to the same society, which has been distributed to hospitals in Wuhan City.
Astellas Pharma US, Inc. and the Astellas Global Health Foundation have each expanded support to local and global communities fighting COVID-19 by providing more than $2.7 million of financial assistance, in aggregate, to meet the urgent demand for resources to help patients, health care workers, and first responders.
- At a national level in the United States, Astellas has provided support to help humanitarian organizations working to support communities affected by COVID-19. This includes Astellas’ corporate donations to Americares, the American Red Cross, and Direct Relief to help their emergency efforts. Additionally, in the U.S., through its Corporate Charitable Donation process, Astellas has issued a request for proposal (RFP) process to non-profit healthcare organizations that align with the company’s focus areas as outlined in the RFP, to aid in the fight against COVID-19. The company has also coordinated opportunities to mobilize equipment, personal protective equipment (PPE) donations, blood donations in alignment with the Centers for Disease Control and Prevention guidance, employee contributions, and volunteerism to meet the critical demand for time and resources where needs are most pressing. Locally at the Astellas- US headquarters in Illinois, Astellas is partnering with multiple state organizations, as a Founding Partner to the Governor’s Illinois COVID-19 Response Fund and the Illinois Biotechnology Innovation Organization (iBIO) COVID-19 PPE Relief Fund.
- The Astellas Global Health Foundation will provide a combined $2 million in new and redirected emergency relief focused on improved healthcare infrastructure, COVID-19 training and education impacting more than 725,000 lives in Kenya, Dominican Republic, South Sudan, Democratic Republic of the Congo (DRC), Ghana, Ethiopia and Nigeria. The funding addresses the urgent needs of partners seeking to prevent the immediate spread and combat the long-term effects of COVID-19 in particularly vulnerable and hard-to-reach communities.
Furthermore, as part of the company’s ongoing commitment to ensuring that patients have access to our products, we have implemented changes to our patient assistance programs in the US offered through Astellas Pharma Support SolutionsSM, which offers support to patients needing access and reimbursement assistance. The changes were made to make the application and verification process easily accessible for patients who have lost their jobs or insurance coverage as a result of COVID-19 and increase customer service capacity in light of the influx of patients requiring assistance.
In Italy, our group company, Astellas Pharma S.p.A., has made a donation worth 174,800 euros for the necessary supply of goods to public medical institutions and NPOs.
In Spain, our group company, Astellas Pharma S.A., has made a donation worth 200,000 euros to the country’s health ministry for the necessary supply of goods to medical institutions.
Furthermore, to assist health care systems coping with increasing demands by government or non-profit organizations presented by the escalation of COVID-19 around the world, Astellas will authorize a maximum of 4 weeks of paid leave (in accordance with each country’s provision) to employees who are medically qualified and wish to contribute by participating in volunteer activities within their community.
Astellas, upon accurately ascertaining situations that change from day to day, will continue to work in cooperation with relevant authorities and organizations of each country by quickly gathering information and promptly taking necessary measures.
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