Merck & Co. To Supply Oral COVID Drug to US, JapanBy
Merck & Co. has announced agreements with the US government and the Japanese government for the respective purchases of 1.4 million courses and 1.6 million courses of molnupiravir, the company’s investigational oral antiviral medicine for treating mild-to-moderate COVID-19 in adults.
The US government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir for approximately $1 billion, provided that the medicine is granted emergency use authorization or approval by the US Food and Drug Administration (FDA).
With these exercised options, the US government has now committed to purchase a total of approximately 3.1 million courses of molnupiravir for approximately $2.2 billion between authorization and early 2022. The US government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract.
Last month (October 2021), Merck filed for emergency use authorization with the FDA for molnupiravir. The drug’s application will be discussed at the FDA’s Antimicrobial Drugs Advisory Committee meeting on November 30, 2021.
Separately, the Japanese government will purchase, upon authorization or approval, approximately 1.6 million courses of molnupiravir. Under the agreement, if molnupiravir receives authorization or approval by Japan’s Pharmaceuticals and Medical Devices Agency, Merck will supply approximately 1.6 million courses of molnupiravir to the Japanese government for approximately $1.2 billion, including applicable taxes.
Molnupiravir was developed by Merck & Co. in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company. In anticipation of the results from a Phase III trial and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of the medicine by the end of 2021, with at least 20 million courses to be produced in 2022.
Earlier this month (November 2021), the UK’s Medicines and Healthcare products Regulatory Agency granted authorization in the UK for molnupiravir. Additionally last month (October 2021), the European Medicines Agency initiated a rolling review of the company’s marketing authorization application.
Merck has entered into additional supply and advance purchase agreements for molnupiravir with governments worldwide, including the UK government for 480,000 courses of therapy, and is currently in discussions with additional governments.
Merck has a licensing agreement with the Medicines Patent Pool, a United Nations-backed public health organization, to increase broad access for molnupiravir in low- and middle-income countries and has non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries.