ASTELLAS PHARMA INC. 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
In order to secure the safety of our employees and to prevent the further spread of the disease, in accordance with the situation in each country and region, we are currently advising our employees, except those instructed by the company to do otherwise, to continue working from home by using online digital tools. While we are basically refraining from sales activities, 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.
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 the business continuity and the 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 enrollment of new patients in ongoing studies.
In countries and regions no longer experiencing rapid COVID-19 cases growth, 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 can be 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 group companies. 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 by cooperating with bodies concerned in response to requests by the government such as the provisions of drugs.
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We are also responding to requests from the
Furthermore, 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 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 each country and region
In addition, we have donated approximately
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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.
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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.
Contact:
Tel: +81-3-3244-3000
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