Intern Reporter | Jin Tingfan
On July 7 local time, the U.S. government signed a $450 million (approximately RMB 3.356 billion) contract with Regeneron Pharmaceuticals. Under the agreement, Regeneron will manufacture and supply its experimental dual-antibody “cocktail” drug for COVID-19, REGN-COV2, to the U.S. government.
Unlike monotherapy, “cocktail” drug combinations utilize multiple distinct antibodies to reduce the virus’s ability to escape treatment through mutation, thereby achieving superior therapeutic efficacy.
REGN-COV2 is the first antibody “cocktail” therapy approved in the United States for the treatment of COVID-19. It consists of two monoclonal antibodies, one of which was isolated from patients who had recovered from COVID-19. Both antibodies bind non-competitively to the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein, exerting a synergistic therapeutic effect while also helping to prevent further viral mutation within the human body.
This agreement is part of Operation Warp Speed, the U.S. government’s initiative against the coronavirus, marking the first time the Trump administration has allocated funding to support the research, development, and production of COVID-19 treatments. Operation Warp Speed aims to accelerate the development and availability of COVID-19 vaccines and therapeutics. On the same day, the U.S. government also announced a $1.6 billion investment in Novavax to support the testing and production of its COVID-19 vaccine. This investment is also part of Operation Warp Speed, reflecting the U.S. government’s support for vaccine research, development, and production.
Just one day ago, Regeneron announced that it would collaborate with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to conduct a Phase 3 clinical trial of REGN-COV2 to evaluate its efficacy in preventing COVID-19. Meanwhile, the company also announced that two clinical trials assessing whether the drug can treat patients with COVID-19 have entered Phase 2 and Phase 3 stages, respectively.
The Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense have entered into a contract with Regeneron Pharmaceuticals, Inc. Under this agreement, the U.S. government will purchase from Regeneron a batch of active pharmaceutical ingredients (APIs) expected to be manufactured by this fall, along with subsequent filling and storage services. It is estimated that this batch of APIs will be sufficient for 70,000 to 300,000 potential therapeutic doses, or 420,000 to 1.3 million potential prophylactic doses. The specific dosing regimen will be evaluated and determined in clinical trials.
REGN-COV2 produced under this contract will be owned by the U.S. federal government. Upon successful clinical trials and the U.S. Food and Drug Administration’s (FDA) issuance of an Emergency Use Authorization (EUA) or approval for REGN-COV2, the U.S. government may deploy the drug for use. Meanwhile, the U.S. government has committed to providing this batch of the drug free of charge to Americans and undertaking its distribution.
The drug entered clinical trials in June this year. However, Regeneron had already decided to expand production of the drug in the spring of this year. The funding provided by this contract will support Regeneron’s continued manufacturing of REGN-COV2, enabling the U.S. government to rapidly secure the drug for the prevention or treatment of COVID-19 upon FDA approval.
Just a day ago, Regeneron announced that Kevzara, a drug it co-owns with Sanofi, failed to demonstrate efficacy against COVID-19 in clinical trials, leading to the termination of the trial.
In terms of market performance, the stock price of Regeneron Pharmaceuticals rose by 2.17% on July 7 local time, closing at $640.88 (approximately RMB 4,494.30).