• Chugai obtained development and exclusive marketing rights in Japan from Roche for the antibody cocktail of casirivimab and imdevimab for COVID-19
• Multiple late-stage clinical studies for the treatment and prevention of COVID-19 are ongoing

TOKYO, December 10, 2020 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it concluded a license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the development and commercialization in Japan for the antibody cocktail of casirivimab and imdevimab (formerly known as REGN-COV2) for COVID-19.

The antibody cocktail combining two virus neutralizing antibodies, casirivimab and imdevimab, was created by Regeneron for the potential treatment and prevention of COVID-19. Roche and Regeneron are collaborating on developing and commercializing casirivimab and imdevimab. As part of the agreement,  Regeneron will distribute the treatment in the U.S. while Roche will be responsible for manufacturing and distribution outside the U.S. Under the license agreement between Chugai and Roche, Chugai obtained development and exclusive commercialization rights in Japan for casirivimab and imdevimab.

The casirivimab and imdevimab antibody cocktail is currently being studied globally in a phase II/III clinical study for the treatment of patients with COVID-19 who require hospitalization, a phase II/III clinical study for the treatment of non-hospitalized patients with COVID-19, and a phase III clinical study for prevention of infection in COVID-19 household contacts. A phase III open-label clinical study for the treatment of patients with COVID-19 who require hospitalization is also ongoing in the U.K. (the ‘RECOVERY’ trial). In November 2020, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization for casirivimab and imdevimab for the treatment of certain high-risk, non-hospitalized patients with mild-to-moderate COVID-19.

“We are pleased that Chugai can join forces with Roche and Regeneron to provide a potential treatment to fight COVID-19, a disease that has brought unprecedented harm to people’s health and lives as well as disruption to all areas of society,” said Chugai’s President and COO, Dr. Osamu Okuda. “We are committed to delivering the product to people in Japan as soon as possible.”

About casirivimab and imdevimab

Casirivimab and imdevimab were designed specifically by Regeneron scientists to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. They 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. The two potent, virus-neutralizing antibodies administered together, bind non-competitively to the critical receptor binding domain of the virus's spike protein, which may help diminish the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population¹.

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Reference

1. Alina Baum, Benjamin O Fulton, Elzbieta WlogaScience, et al. Science 2020 Aug 21;369(6506):1014-1018.