Regeneron Pharmaceuticals, Inc. Announces Japan Becomes First Country to Approve Regeneron Antibody Cocktail (Casirivimab and Imdevimab) for the Treatment of Mild to Moderate Covid-19
July 20, 2021 at 01:00 am EDT
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Regeneron Pharmaceuticals, Inc. announced that Japan'sMinistry of Health, Labour and Welfare (MHLW) has approved Regeneron's casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19. This marks the first time the antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve™ in other countries, has received a full approval to treat COVID-19. Emergency or temporary pandemic use authorizations are currently in place in more than 20 countries, including in the U.S., European Union, India, Switzerland and Canada. In Japan, the antibody cocktail was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The approval was based on results from a Phase 3 trial in high-risk non-hospitalized patients, which showed the antibody cocktail reduced the risk of hospitalization or death by 70%, as well as results from a Phase 1 trial that examined the safety, tolerability and pharmacokinetics in Japanese people. Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the U.S. In December 2020, Chugai obtained development and exclusive commercialization rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail. The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
Regeneron Pharmaceuticals, Inc. specializes in research, development, producing, and selling drugs used in treating ophthalmologic and inflammatory diseases and cancers. Net sales break down by type of revenue as follows:
- revenues from product sales (56.6%);
- revenues from collaboration agreements (40.4%): collaboration with Sanofi (58.1% of revenues), Bayer (29.1%) and Roche (12.8%);
- other (3%): primarily revenues from sales of technology licenses and subcontracted research services.
At the end of 2022, the group had a portfolio of approximately 35 products in clinical development.
Regeneron Pharmaceuticals, Inc. Announces Japan Becomes First Country to Approve Regeneron Antibody Cocktail (Casirivimab and Imdevimab) for the Treatment of Mild to Moderate Covid-19