Merck And Ridgeback: U.S. Government To Buy 1.4 Mln Addl Courses Of Molnupiravir After FDA Approval

Biopharmaceutical major Merck & Co., Inc. (MRK) and Florida-based Ridgeback Biotherapeutics announced Tuesday that the U. S. government will purchase a total of 1.4 million additional courses of molnupiravir, if authorized, for approximately $1 billion.

The government will exercise two of its options for the purchase if molnupiravir, an investigational oral antiviral medicine for the treatment of mild-to-moderate COVID-19 in at risk adults, is granted Emergency Use Authorization or EUA or approval by the U.S. Food and Drug Administration.

With these exercised options, the government has now committed to purchase a total of around 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022.

The government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract.

Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

The companies previously announced the submission of an EUA application to the U.S. FDA for molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at risk for progressing to severe COVID-19 and/or hospitalization.

The application will be discussed at the FDA's Antimicrobial Drugs Advisory Committee meeting on Nov. 30, 2021.

In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022.

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