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.
EVALUATING ONE OF OUR EXISTING MEDICINES FOR SEVERE COVID-19
Based on recent clinical data from studies in China with another IL-6 inhibitor, we believe there is a potential role for Kevzara® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with our collaborators at Sanofi, we are conducting controlled clinical studies to evaluate Kevzara in this setting. The use of Kevzara to treat people with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
- The global trial program is now enrolling patients at medical centers in the United States, Italy, Spain, Germany, France, Canada and Russia.
- The Phase 2/3 trial is designed to enroll approximately 400 patients. To determine eligibility, speak to your doctor to discuss your condition and possible treatment.
- Visit clinicaltrials.gov for more information.
DEVELOPING A NEW ANTIBODY MEDICINE
We are using our end-to-end antibody technologies to discover and develop brand new therapeutic antibodies for this disease. Our planned ‘cocktail’ treatment of two antibodies will be studied to see if it could be used to prevent infection or to treat patients already infected with the virus.
To date, we have produced hundreds of virus-neutralizing antibodies in our genetically-engineered mice, and are currently selecting the most potent candidates. We are aiming to have enough quantities ready to begin human testing by early summer, and we hope to scale up production to 200,000 preventative doses or approximately 20,000 treatment doses per month by the end of August.
From discovery to large-scale manufacturing, our VelociSuite technologies provide unmatched precision and speed in developing targeted antibody medicines.
COVID-19 BUSINESS UPDATES
Operations: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 team: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, it is mandatory for colleagues to work from home if their job allows it. We have taken additional precautionary measures to protect our critical laboratory and manufacturing colleagues whose jobs require they be on site. Given the “essential” nature of our work, Regeneron colleagues working in our labs and manufacturing facilities are exempt from NY State Governor Cuomo’s recent Executive Order requiring businesses to have employees work from home.
Clinical trials:Regeneron conducts clinical trials and has operational trial sites in multiple countries across the world. We are aware of and assessing the potential of the COVID-19 outbreak to disrupt our ongoing trials. Regeneron continues to plan for new trials, which we anticipate will start enrolling once prevalence of COVID-19 decreases in individual trial site locations. In addition, we are working with regulators and following the recent FDA-issued guidance as it pertains to clinical trial operations, and we will provide further updates as needed.
Supply chain:As a matter of practice, we are always working to ensure the stability of our supply chain. Given the current pandemic situation, we are paying additional attention to help secure the continued availability of our medicines both commercially and for clinical studies.
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 are supporting our employees’ giving and select charities with the goal of 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.