BARDA, DOD Award $450-Million COVID-19 Manufacturing and Supply Contract to Regeneron

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense have awarded Regeneron Pharmaceuticals a $450-million contract to manufacture and supply REGN-COV2, Regeneron's investigational double antibody cocktail in development for treating COVID-19. The contract is part of Operation Warp Speed, Regeneron announced in a July 7, 2020 press release.

REGN-COV2 is currently in two Phase II/III clinical trials for the treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 infection. Regeneron began scaling up manufacturing of the investigational drug in the Spring of 2020.

The BARDA agreement supports continued manufacturing so that the product could be made available immediately in the United States if clinical trials are successful and 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 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. Regeneron has said that initial doses may be ready as early as the end of Summer 2020. 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 CEO of Regeneron, in the company press release. "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 [e]mergency [u]se [a]uthorization 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."

Clinical trial progress

Regeneron earlier announced that it has begun a Phase III clinical trial in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study REGN-COV2 in the prevention of COVID-19 infection, according to a July 6, 2020 press release. The Phase III trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate). REGN-COV2 is currently in Phase II/III portion of two adaptive Phase I/II/III trials testing the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19.

The Phase III prevention trial is being conducted at approximately 100 sites and is expected to enroll 2000 patients in the US to assess SARS-CoV-2 infection status. The two Phase II/III treatment trials in hospitalized (estimated enrollment of 1850) and non-hospitalized (estimated enrollment of 1050) patients are planned to be conducted at approximately 150 sites in the US, Brazil, Mexico, and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer. All trials are adaptively designed, and the ultimate numbers of patients enrolled will depend on trial progress and insights from Phase II studies.

"We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic," said George D. Yancopoulos, MD, PhD, co-founder, president, and chief scientific officer of Regeneron, in the press release. "We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine."

Meanwhile, Regeneron continues to work to maximize manufacturing capacity of REGN-COV2 within Regeneron and with potential partners.

Source: Regeneron Pharmaceuticals