TARRYTOWN, NY – On July 7, Regeneron Pharmaceuticals, Inc. announced that, as part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2.
REGN-COV2 is Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 infection.
Greek-American Dr. George Yancopoulos, Co-Founder, President and Chief Scientific Officer of Regeneron, had previously spoken to The National Herald about the company’s efforts in developing the anti-viral antibody cocktail.
Regeneron began scaling up manufacturing of REGN-COV2 at business risk in spring of 2020. This agreement supports continued manufacturing so that the product could be made available immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or product approval. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses (estimated range of 70,000 to 300,000) or prevention doses (estimated range of 420,000 to 1,300,000) available from these lots in total. Initial doses may be ready as early as end of summer. If EUA or product approval is granted, the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution.
"Regeneron's thirty years of investment in our innovative VelociSuite antibody discovery and development technologies and our large-scale manufacturing facilities, coupled with the expertise and passion of our people, has enabled us to move the REGN-COV2 program forward at remarkable speed," said Leonard S. Schleifer, MD, PhD, Co-Founder, President and Chief Executive Officer of Regeneron. "We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic."
Regeneron continues to work to maximize manufacturing capacity of REGN-COV2 within Regeneron and with potential partners.
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically-modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail with the company's in-house VelociMab and manufacturing capabilities. REGN-COV2's two antibodies bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications. More recent research also demonstrates coverage against the now prevalent D614G variant.
Regeneron used the same 'rapid response' capabilities and cocktail approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA. REGN-COV2's development and manufacturing has been funded in part with federal funds from the BARDA under OT number: HHSO100201700020C.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.