Astellas Pharma : Efforts against the Spread of the Coronavirus Disease

Our heartfelt sympathy goes out to the people who have been affected by the Coronavirus Disease (COVID-19).

With the rapid 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 in the 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, 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, complying with laws and regulations, 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 maintain an adequate inventory level of raw materials and finished products, 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 with a rapid growth of new COVID-19 cases, 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 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.

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 protecting patients, employees and our business, 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.

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, it has donated up to approximately 300,000 yuan worth personal protective equipment to the same society, which have 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 the COVID-19 outbreak. This includes Astellas' corporate donations to the 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 Astellas' US-headquarters in Illinois, Astellas is partnering with multiple state organizations with their response to COVID-19, 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 open a Request for Proposal in April to enable emergency funding to select additional national and global humanitarian organizations who are working tirelessly to fight COVID-19 in countries where Astellas does not have a commercial presence.

In Italy, our group company, Astellas Pharma S.p.A., has decided on 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 decided on a donation worth 200,000 euros to its 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 organization 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 wishes 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.

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