Our COVID-19 Rapid
Regeneron is applying our 30 years of scientific and technology expertise to combat the COVID-19 pandemic. We feel uniquely positioned to meet this public health threat using our proprietary VelociSuite® technologies and our track record for rapid response against infectious diseases, such as Ebola.
Developing our Novel
Anti-Viral Antibody Cocktail
We are using our end-to-end technologies to develop the novel antibody cocktail of casirivimab and imdevimab, a combination therapy being studied for its potential both to treat appropriate patients with COVID-19 and to prevent SARS-CoV-2 infection.
Casirivimab and imdevimab are investigational therapies and have been authorized by FDA for the emergency use described below. Casirivimab and imdevimab must be administered together. Casirivimab and imdevimab are not FDA approved for any use. Safety and effectiveness of casirivimab and imdevimab have not been fully established for the treatment of COVID-19.
Our COVID-19-related discovery efforts started in early 2020, when we began producing hundreds of virus-neutralizing antibodies in our genetically-engineered mice and identifying similarly-performing antibodies from human COVID-19 survivors. By June, we had moved the two most potent and non-competing antibodies, casirivimab (REGN10933) and imdevimab (REGN10987) that form the therapy into cell production lines for large-scale manufacturing purposes and began clinical trials. In September and October, we announced data from the ongoing Phase 2/3 trial of non-hospitalized patients, which showed that our antibody cocktail significantly reduced viral load and medical visits in patients with COVID-19.
Emergency Use Authorization for Our Antibody Cocktail
In November, the FDA granted an Emergency Use Authorization (EUA) for casirivimab and imdevimab administered together for the treatment of mild-to-moderate COVID-19 in adults, as well as in pediatric patients weighing at least 40 kg who are at least 12 years of age, with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Casirivimab and imdevimab are not authorized for use in patients who are hospitalized due to COVID-19, or who require oxygen therapy due to COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Benefit of treatment with casirivimab and imdevimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.
The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of the unapproved product. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Due to the COVID-19 public health emergency, this EUA will provide appropriate patients more ready access to this therapy. For information about the authorized use of the antibody cocktail and mandatory requirements of the EUA in the U.S., please review the FDA Letter of Authorization for the EUA here. Health care providers should also review the HCP fact sheet for mandatory requirements of the EUA and information on the authorized use of casirivimab and imdevimab, including the definition of high risk patients, Warnings and Precautions for Hypersensitivity, including anaphylaxis and infusion-related reactions and limitations of benefit and potential for risk in patients with severe COVID-19, as well as adverse reactions, including serious adverse reactions, and information about use in specific populations. Additionally, please refer to the Dear HCP Letter about the prevention of medical errors. A patient fact sheet is available for reference when discussing with patients. Casirivimab and imdevimab administered together are an unapproved investigational antibody combination therapy, and there are limited clinical data available.
The Clinical Program
The antibody cocktail of casirivimab and imdevimab is being studied in four ongoing late-stage clinical trials: two Phase 2/3 trials for the treatment of certain hospitalized and non-hospitalized (“ambulatory”) COVID-19 patients, the open-label, Phase 3 RECOVERY trial of hospitalized COVID-19 patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in uninfected people who are at high-risk of exposure to a COVID-19 patient (such as the patient’s housemate). The Phase 3 prevention trial is being jointly conducted with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. We are actively working to maximize production capacity of casirivimab and imdevimab and ensure the antibody cocktail reaches as many people as possible in the U.S. and around the world, should ongoing clinical trials be successful and regulatory approvals are granted. Initially, we expect to have treatment doses for approximately 300,000 patients in total delivered between November and the end of January 2021. As part of Operation Warp Speed, in July the U.S. Government and Regeneron signed an agreement for this initial supply. The U.S. Government will coordinate with state authorities to allocate doses on a weekly basis based on the number of COVID-19 cases in each state. The government has committed to providing these 300,000 doses at no cost to patients, although healthcare facilities may charge fees related to infusion administration.
We are also collaborating with Roche to significantly increase the global supply of casirivimab and imdevimab. When both companies are manufacturing at full capacity in 2021, we expect to produce treatment doses for at least 2 million people per year. If approved or authorized by regulatory bodies, Regeneron will distribute the therapy in the U.S. (beyond the initial U.S. Government supply) and Roche will be responsible for distribution outside the U.S.
Published Preclinical Research
Two manuscripts published in Science detail the discovery of our antibody cocktail and highlight its potential to protect against ‘viral escape’ of SARS-CoV-2. Viral escape was seen to occur in the setting of a single therapeutic antibody that blocks the ability of a virus to infect healthy cells, and mutant forms of the virus are being ‘selected’ (i.e., are able to survive and proliferate despite the single antibody treatment) and might ‘escape’ or evade the antibody’s blocking action. The findings show our antibody combination therapy may be able to diminish risk of viral escape by binding to the virus’s spike protein in separate, non-overlapping locations, which would require the virus to mutate simultaneously in multiple genetic locations in order to escape – a highly unlikely scenario. The clinical impact of these findings is unknown.
Recent preclinical data demonstrates the efficacy of our antibody cocktail in non-human primates and hamsters, showing its ability to reduce virus load in lower and upper airways and decrease virus-induced pathological impact.
Achieving immunity to SARS-COV-2:Get an overview of how anti-viral antibody medicines and vaccines are similar and different.
From discovery to large-scale manufacturing, our VelociSuite® technologies provide unmatched precision and speed in developing targeted antibody medicines.
COVID-19 Business Updates
Given the ongoing nature of this pandemic, we are regularly assessing any potential impact to our business, including aspects of product supply, clinical development and commercial operations. We will share material updates as warranted.
Our first priority is to protect the health and safety of our colleagues and ensure the continuity of our business. We are monitoring the pandemic situation closely and have established a senior response committee to assess our guidance continually. Currently, many of our colleagues are working from home if their job allows it. We have taken additional health and safety precautions to protect our critical laboratory and manufacturing colleagues whose jobs require they be on-site. These include alternating shift schedules to reduce density on-site, a mask requirement on campus, provision of masks and other personal protective equipment, health monitoring for on-site colleagues, and physical modifications to office and lab spaces. We are also providing regular testing for all colleagues working at our Tarrytown campus.
Regeneron conducts clinical trials in multiple countries across the world. We continue to evaluate the impact of the COVID-19 pandemic on an individual clinical trial basis and expect fully-recruited clinical studies to remain generally on track. After briefly pausing new enrollment in certain studies due to the pandemic, enrollment in both new and ongoing clinical studies started to resume as regions relaxed their restrictions and health care resources started to become more available for non-COVID-19 activities. However, there has been a resurgence of COVID-19 cases in many regions across the world, and any resurgence in the regions where we or our collaborators conduct clinical trials may require timeline adjustments for potentially impacted studies. We continue to work closely with regulators to follow recent Health Authority and Regulatory Agency issued guidance as they pertain to clinical trial operations.
Supply chain & market supply:
As a matter of practice, we are always working to ensure the stability of our supply chain and maintain adequate market supply for all commercialized products. We maintain adequate market supply for all our commercialized products, and our raw material supplies and contract manufacturing support have remained stable despite the current pandemic situation. In order to enable the U.S. manufacturing site to maximize production of casirivimab and imdevimab, we worked with regulatory authorities to accelerate licensing of our Irish facility to manufacture our full portfolio of commercial products.
Supporting our communities:
Regeneron’s community response focuses on raising critical funds, mobilizing resources and supporting the most vulnerable nonprofits, people and communities around the world. Through Regeneron’s COVID-19 Double Matching Gift Campaign, we supported our employees’ giving and select charities by raising $750,000. Locally, we are supporting Afya Foundation’s efforts to deliver critically needed medical supplies to qualified, New York-based health centers. In Rensselaer, we are supporting the Capital Region Community Foundation’s COVID-19 Response Fund, which provides flexible resources for nonprofits working with those who are disproportionately impacted. We are planning additional and expanded efforts to support people in need during this critical time and will share more details in this space.
Regeneron’s Industrial Operations and Product Supply (IOPS) team assisted New York State by making and donating viral transport media (VTM), a critical component of COVID-19 testing kits that has been in short supply. VTM is a liquid used to preserve patient test samples (a swab from the nose or throat) until they can be tested. Regeneron worked to obtain the necessary components, determined formulas and proportions to meet NYS-specifications, and leveraged the specialized skill set of our employees to make sterile VTM and place it into test tubes. We delivered over 500,000 total VTM kits to New York State and donated 100 percent of our supplies and labor for this effort, an approximately $1 million in-kind contribution. Learn more