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 globally, 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 forbidding our employees in countries and regions with continuing spread of COVID-19, except those instructed by the company, to work in offices and instead are having them work from home by using online digital tools. While we are basically refraining from sales activities, we continue to gather and provide necessary information to medical institutions in regions around the world in accordance with rules of each institution.
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 by those who have been instructed by the company under the business continuity plan with strict measures taken to prevent infections.
As for the supply of products, in particular, there are currently no problems, as we have been able to manage risks of raw materials and finished products supply, by closely cooperating with outsourcing manufacturers and suppliers of raw materials taking into account the continuation of business and the stable supply of products.
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 enrollment of new patients in ongoing studies.
- In countries no longer experiencing a rapid growth of COVID-19 cases, we are resuming or continuing study activities.
- Consistent with the recently issued guidance from authorities including US and EU regulatory bodies, we are assessing protocols and implementing measures to reduce the burden to healthcare systems while ensuring that patient safety is maintained.
- 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 will frequently reassess this approach, which applies to all interventional clinical trials led by us and our subsidiaries and affiliates. 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 continue to quickly take appropriate action by cooperating with bodies concerned in response to requests by the government such as the provisions of drugs.
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 “Activities Aimed at Developing Drugs for the Novel Virus” and providing consultation on countermeasures.
Furthermore, we receive various proposals from within or outside of Astellas for 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 in 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 against COVID-19.
Activities in regions where infection is spreading
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 are each expanding support for global and local communities fighting COVID-19 by providing up to $2 million of new 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 is preparing 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. The company is also coordinating 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 has recently completed its COVID-19 request for proposal process, with funding to be awarded later this year to the selected national and global humanitarian organizations who are working tirelessly to fight COVID-19 in countries where Astellas does not have a commercial presence.
Furthermore, we have implemented changes to our patient assistance programs in the US, including Astellas Pharma SupportSM, which offers support to patients needing access and reimbursement assistance as part of the company’s ongoing commitment to ensuring that patients have access to our products. 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 increased 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 150,000 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 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.