First and foremost, we’d like to express our sincere sympathy to all the people around the world who have been adversely affected by the novel coronavirus. We sincerely wish for the speedy recovery of those afflicted, and we hope for an end to the pandemic as soon as possible. Moreover, we would like to take this opportunity to express our sincere gratitude to the healthcare professionals around the world working on the frontlines of the fight against the coronavirus to save patients under extraordinary and difficult circumstances.
As part of Daiichi Sankyo’s efforts to combat the spread of the virus that causes COVID-19, the Daiichi Sankyo group is actively engaged in various measures and initiatives such as, but not limited to, contributing to vaccination and drug research and development, ensuring a continuous supply of the Daiichi Sankyo group products, and providing disaster relief supports.
In addition, we are also proactively taking measures to prevent the spread of infection and protect employees and their families by the limiting of face-to-face interactions and by promoting the group-wide implementation of working from home.
[Video message from Daiichi Sankyo’s President & CEO, Sunao Manabe, Regarding COVID-19]
We have submitted this video message to the UN Global Compact’s "CEOs Taking Action" website, which is part of #UnitingBusiness, a coordinated international plan involving the business sector to respond to COVID-19 initiative.
1. R&D Activities for COVID-19 Vaccines and Therapeutics
Daiichi Sankyo established a company-wide task force in April 2020 to promote the R&D of vaccines and therapeutic agents targeting COVID-19. By leveraging the best use of our past and present research properties, technologies, and accumulated R&D knowledge and experience as an innovative pharmaceutical company, and also in collaboration with external institutions, we are proactively contributing to R&D to improve the medical infrastructure for COVID-19, which is currently an urgent, global social need.
1. R&D of genetic (mRNA) vaccines
For the prevention of COVID-19, Daiichi Sankyo is currently participating in "Fundamental Research on the Control of a Novel Coronavirus (2019-nCoV*1)"*2 (Principal investigator: Prof. Yoshiro Kawaoka, Institute of Medical Sciences, The University of Tokyo), which is an initiative supported by the Japan Agency for Medical Research and Development (AMED). In addition, using novel nucleic acid delivery technology*3 developed by Daiichi Sankyo itself, we are taking part in a basic research project on a genetic (mRNA) vaccine with the title "Development of a Genetic Vaccine for 2019-nCoV".
Recently, in a pharmacological evaluation of a prototype mRNA vaccine using animal models, we achieved an increase in antibody titers to the novel coronavirus. Leveraging this result, we will position the development of a mRNA vaccine as a priority project and start to consider an increase in scale toward establishing a supply system. At the same time, we aim to proceed to clinical studies in Japan around March 2021.
In our role as a Japanese pharmaceutical company engaged in the vaccine business, Daiichi Sankyo will contribute to bringing the COVID-19 pandemic to an early end to restore people’s peace of mind and safety in our society. Through collaboration with Japan’s Ministry of Health Labour and Welfare, the Pharmaceutical and Medical Devices Agency (PMDA), our research partner the University of Tokyo, and other organizations, we will proceed with the research and development of this mRNA vaccine and make efforts to ensure that it can be supplied as soon as possible.
Daiichi Sankyo plans to use the facilities of the “New Influenza Vaccine Development and Production System Development Project” to develop the supply system. With the aim of starting supply of COVID-19 vaccines in Japan as soon as possible, we will prioritize efforts toward establishing a production platform and ensuring a stable supply.
- *1 2019-nCoV is synonymous with SARS-CoV-2.
- *2 A vaccine development initiative determined for support by AMED under urgent government-wide efforts against the worldwide spread of COVID-19.
- *3 Technology focusing on forming lipid nanoparticle structures, stabilizing pharmaceutical active ingredients and delivering nucleic acids into immune cells. Compared to conventional vaccine technology, it has been demonstrated to induce a more optimal immune response.
2. Collaborative R&D of Nafamostat Inhalation Formulation
Daiichi Sankyo reached a basic agreement in June 2020 on collaborative R&D with the University of Tokyo, RIKEN, Nichi-Iko Pharmaceutical Co., Ltd on a Nafamostat inhalation formulation for the treatment of COVID-19.
In the first stage of infection by the causative virus of COVID-19, SARS-CoV-2, the outer envelope of the virus, fuses with the host cell surface membrane. Prof. Junichiro Inoue, Institute of Medical Science, The University of Tokyo (at the time of the study, currently Senior Professor at the University of Tokyo) and others discovered that by preventing this fusion, Nafamostat could efficiently inhibit the viral entry process. Nafamostat is an injectable that has been prescribed for many years in Japan mainly as a treatment for acute pancreatitis and disseminated intravascular coagulation, and adequate safety-related clinical data has been accumulated.
RIKEN has established the program for drug discovery and medical technology platforms in order to optimize the medical seeds generated from basic research at RIKEN and at universities for use in the drug discovery process at pharmaceutical companies, and in clinical practice, as a bridge to companies and medical institutions. In this case, RIKEN will also support this collaborative R&D using RIKEN's multidisciplinary advanced technologies.
Nichi-Iko, the marketing authorization holder of FUTHAN® (generic name: nafamostat mesilate), will provide data collected on the product over many years as well as supply the Active Pharmaceutical Product (API) for this collaborative R&D.
Daiichi Sankyo will carry out R&D on the Nafamostat inhalation formulation using technology gained in the development of its anti-influenza virus agent, Inavir®. Non-clinical studies are scheduled to begin in Japan in July 2020, and after consultation with authorities, aim to proceed to clinical studies by March 2021.
Through this partnership, Daiichi Sankyo hopes to provide patients with a new treatment option for COVID-19 as early as possible.
3. Drug Repositioning
In addition to the aforementioned activities, Daiichi Sankyo is also conducting a "drug repositioning" to search for COVID-19 treatments in which we, in collaboration with academia and others, are not only evaluating the potential applications of our existing products for COVID-19 treatment but are also focusing on selecting potential target molecules and chemical compounds for COVID-19 therapeutics using the knowledge and experience of our past and current R&D projects.
Through this drug repositioning, Daiichi Sankyo aims to provide patients with a new treatment option for COVID-19.
2. Product Manufacturing, Supply and Delivery
1. Manufacturing and Supply of Potential COVID-19 Vaccine
Daiichi Sankyo entered the agreement to proceed with discussions with AstraZeneca for the stable supply in Japan of a potential novel corona virus vaccine being developed by AstraZeneca and Oxford University.
AstraZeneca has agreed to advance specific discussions with the Japanese government toward the introduction of the vaccine in Japan, and based on that agreement, Daiichi Sankyo has decided to advance discussions with AstraZeneca to formulate the vaccine, including vial filling, packaging, and storage in Japan.
Daiichi Sankyo Biotech Co., Ltd., a subsidiary of Daiichi Sankyo, plans to receive the undiluted solution from AstraZeneca and then carry out the formulation procedures using the “New Influenza Vaccine Development and Production System Development Project” facilities.
In order to restore people’s peace of mind and safety by helping to end the COVID-19 pandemic as soon as possible, Daiichi Sankyo will advance the necessary preparations for the stable supply of a vaccine in Japan in consultation with AstraZeneca.
2. Continuous Supply and Delivery of Existing Products
We are taking necessary measures to ensure the supply and delivery of our products worldwide. To date, there has been no disruption to our supply chain or to the delivery of our medicines to the people who need them. Nevertheless, we will continue to closely monitor our supply chain situation for any changes.
3. Clinical Trials
As the safety of patients is our first priority, we are conducting clinical trials in close collaboration with our clinical trial investigators and CROs in light of the recent guidance from local health regulatory authorities and in consideration of the situations at study locations, and also taking into account heavy burden of the virus on primary care facilities and public health.
We have experienced temporary suspensions of new patient study enrollment in some studies due to conditions in local areas and the need to focus healthcare resources to combating the pandemic. Some of these trials have resumed to enroll new patients while others remain temporarily suspended.
We recognize this is a rapidly evolving situation and we will continue to adapt and provide timely updated guidance related to Daiichi Sankyo clinical research. In particular, we are working closely with our clinical trial investigators and other relevant personnel to help to assure everyone’s safety and allow continued trial treatments to participants.
4. Disaster Relief
In support of relief efforts for countermeasures against COVID-19, Daiichi Sankyo has made a donation of US $1 million to the COVID-19 Solidarity Response Fund for the World Health Organization (WHO) through the Japan Center for International Exchange. The COVID-19 Solidarity Response Fund was established to support the work of the WHO and is backed by the United Nations Foundation and the Swiss Philanthropy Foundation. This donation is part of Daiichi Sankyo’s global contribution to society in light of the need to support worldwide measures against COVID-19 and concerns about the rapid spread of infections in the future in areas where access to healthcare in inadequate.
Daiichi Sankyo also made a donation of 1 million yuan through the Chinese Red Cross Association, in addition to a donation of medicine to primary care facilities in Wuhan City was made by a local group company, to support local responses to the virus outbreak in China in February 2020.
Other Daiichi Sankyo group companies around the world have also already provided a variety of support, including donations, to meet specific needs in their own countries or regions.
Our U.S. affiliate, Daiichi Sankyo, Inc., has made donations totaling USD $645,000 to Healthcare Ready, Americares, the American Red Cross, and other local organizations with programs dedicated to addressing the COVID-19 pandemic. Furthermore, US employees with appropriate medical or healthcare credentials are allowed to take extra time away from work to volunteer their time to help alleviate the pressure on those on the healthcare front-lines who are taking care of patients.
Our European affiliates have supported a large number of local and regional organizations in the form of both financial and in-kind donations, including equipment for hospitals.
- In Germany, our European Headquarters, Daiichi Sankyo Europe GmbH, has made a donation of 100,000 euros to the city of Pfaffenhofen, near Munich, where one of our production sites is located. This money is earmarked for purchasing face protection masks. We also donated money to local food banks and to a welfare organization supporting refugees.
- In Italy, the company donated 40,000 euros to provide necessary medical equipment and sanitary products to medical institutions. A matching gift program for individual contributions by employees was also conducted, and the company has made an unconditional contribution to provide the new portal site named “COVID-19 and heart”, which supports healthcare professionals in the treatment of patients and was created on the initiative of IRCCS Multimedica. In addition and in cooperation with an Italian association, the company also sponsored the publication of an educational pamphlet to educate and protect elderly people against disinformation and fake news related to COVID-19, and the establishment of a telephone helpline for elderly people coping with the prolonged isolation.
- In Spain, the company donated 340,000 euros worth of urgently needed medical equipment to medical institutions.
- In Portugal as well as in the Netherlands, webinars focusing on cardiovascular risk patients and COVID-19 were organized.
- In Belgium, France, Ireland, Portugal and Turkey, Daiichi Sankyo group companies donated a total of 70,000 euros to healthcare institutions and associations.
In Asia outside of China, group companies donated a total of an equivalent of USD $28,000 to hospitals and organizations in Thailand and South Korea.
Details of further support by Daiichi Sankyo group companies worldwide will be made public on this page as they become available.
5. Measures to Prevent Spread of Infection and Supporting our Employees
In our Tokyo HQ we have established an “Emergency Response Team” led directly by our CEO, Sunao Manabe. As a company we have taken numerous measures to prevent the spread of the infection, taking into consideration the views of the Japanese government, governments in countries where we have affiliates, and other experts.
In countries or regions where the infection rapidly expanded and/or is still pervasive, Daiichi Sankyo Group employees and contractors who are able to work from home are being proactively encouraged to do so. Given the nature of our work, it is not possible for everyone to work remotely. We share immense appreciation for our colleagues dedicated to ensuring the continuous and safe supply of our medicines who continue to serve our patients working hard in our manufacturing and packaging sites globally. We have still ceased face-to-face interactions with customers, healthcare providers, and other business associates as much as possible in addition to continuing to adhere to the extensive travel restrictions in the countries and regions mentioned above.
Our affiliates globally have also established a wide variety of supportive programs and activities to help our employees and consultants as we all navigate through this crisis.
At the Daiichi Sankyo group, we will continue to strive to prevent the further spread of COVID-19, as well as provide timely, updated guidance related to our efforts, measures, and initiatives.