Regeneron and Roche Collaborate to Significantly Increase Global Supply of Investigational Antibody Cocktail REGN-COV2 for Treatment and Prevention of COVID-19

August 19, 2020 /BioValleyBIOON/ --Currently, the COVID-19 pandemic continues to spread rapidly worldwide. According to Baidu's "Real-time Updates on the Novel Coronavirus Pneumonia Epidemic"Big DataReport》, as of 14:00 on August 19, 2020, the global cumulativeConfirmed cases exceed 22.3 million，More than 784,000 deaths.

Recently, Regeneron and Roche jointly announced that they will join forces to combat COVID-19 by developing, manufacturing, and distributing Regeneron’s investigational antiviral worldwide.Antibody Cocktail Therapy REGN-COV2. This therapy is being developedFor the treatment and prevention of COVID-19 infection, offering a much-needed treatment option for individuals already exhibiting COVID-19 symptoms and showing potential to prevent infection among high-risk populations exposed to the virus, thereby slowing the spread of the global pandemic.

Through this collaboration, the two parties expect to increase the supply of REGN-COV2 by at least 3.5-fold from current capacity, with potential for further expansion. This will significantly increase the number of available doses for people in the United States and around the world.

REGN-COV2 was developed for the treatment and prevention of COVID-19 infection. Currently, two Phase II/III clinical trials are evaluating its efficacy in treating COVID-19, and one Phase III clinical trial is assessing its use for preventing COVID-19 among household contacts of infected individuals. IfClinical TrialsUpon demonstrating its safety and efficacy and obtaining regulatory approval, Regeneron will distribute and record sales of REGN-COV2 in the United States, while Roche will be responsible for sales outside the United States.

Research, Development, Manufacturing, andClinical TrialsPartially funded by the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS). In addition, under an agreement signed with BARDA and the U.S. Department of Defense, Regeneron was awarded a $450 million contract to supply REGN-COV2 to the U.S. government. The agreement stipulates that Regeneron will manufacture a fixed number of batches of REGN-COV2 active pharmaceutical ingredient starting in the summer of 2020, and begin fill-and-finish and storage activities in the third quarter of this year. REGN-COV2 produced under this agreement will be owned by the U.S. federal government.

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Pursuant to the terms of the collaboration agreement, Regeneron and Roche have each committed to dedicating a certain amount of annual production capacity for REGN-COV2, and both parties have initiated the technology transfer process. Each party shall bear its own distribution costs within its respective designated territory. The parties will jointly fund and conduct ongoing Phase III prevention studies and Phase I safety studies in healthy volunteers, as well as any additional global studies to further evaluate the potential of REGN-COV2 in the treatment or prevention of COVID-19. Following initial approval by the European Medicines Agency (EMA), Roche will be primarily responsible for obtaining approvals from regulatory authorities outside the United States and conducting any additional studies required for such approvals.

Roche PharmaceuticalsChief Executive Officer Bill Anderson stated, “We are encouraged by the potential of a single therapeutic agent to both treat infected individuals and protect those exposed to the virus from infection. REGN-COV2 may serve as a critical line of defense against the COVID-19 pandemic. We are committed to leveraging our manufacturing expertise and capabilities, along with our global distribution network, to make Regeneron’s highly promising antibody cocktail therapy available to as many people worldwide as possible.”

Leonard S. Schleifer, M.D., President and Chief Executive Officer of Regeneron, stated: “Regeneron is advancing the REGN-COV2 development program at a record pace and working tirelessly to maximize our internal manufacturing capacity. This significant collaboration with Roche will provide essential scale and global expertise to deliver REGN-COV2 to more patients in the United States and around the world.”(Bio Valley Bioon.com)

Original Source: Regeneron and Roche Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Cocktail for COVID-19