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U.S. to Buy Covid-19 Antiviral Drug in $1.2B Deal

Capsules

(Ranys Tuunainen, Pixabay)

9 June 2021. Two U.S. government health agencies agreed to purchase some 1.7 million doses of a Covid-19 antiviral drug, once the drug receives clearance from FDA. The deal for molnupiravir, a broad-spectrum oral antiviral therapy originally designed in academic labs, could bring global drug maker Merck as much as $1.2 billion once the Food and Drug Administration authorizes or fully approves the drug.

Molnupiravir is an antiviral drug in capsule form designed to prevent RNA viruses, such as SARS-CoV-2 and other coronaviruses, from replicating. The drug is a ribonucleoside analog, a synthetic form of a nucleic acid component that blocks replication of SARS-CoV-2 viruses after infection, thus limiting its spread and severity. Molnupiravir is based on academic research and originally developed as a potential therapy against a wide range of viral diseases by Drug Innovation Ventures at Emory, or Drive LLC, a not-for-profit biotechnology enterprise wholly owned by Emory University in Atlanta.

Drive LLC licensed the drug, originally code-named EIDD-2801, to Ridgeback Biotherapeutics in March 2020 for further development as an oral therapy against the then-emerging SARS-CoV-2 coronavirus. In May 2020, as reported by Science & Enterprise, Merck gained exclusive worldwide rights to take EIDD-2801, later renamed molnupiravir, through clinical trials and commercialization.

Funding from HHS and DoD

The latest round of clinical studies is testing molnupiravir as a therapy for patients testing positive for Covid-19 infection, but with mild to moderate symptoms that do not require hospitalization. An earlier mid-stage trial failed to show clinical benefit for hospitalized Covid-19 patients. The current late-stage trial is testing molnupiravir against a placebo with 1,850 individuals testing positive for SARS-CoV-2 and with at least one high-risk factor for severe disease (e.g. older age or a chronic disease), but not hospitalized.

In the trial, participants are randomly assigned to receive 800 milligrams of molnupiravir or a placebo twice a day for five days. The study team is mainly looking for numbers of participants who die or need hospitalization, as well as individuals experiencing adverse events or who discontinue taking part because of the drug.

Under the new agreement, the U.S. government plans to buy some 1.7 million doses of molnupiravir once the drug receives an emergency authorization or full biologic license from FDA, expected in the second half of 2021. Merck would receive $1.2 billion from the Biomedical Advanced Research and Development Authority, part of Department of Health and Human Services, and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in Department of Defense.

Merck says it aims to produce molnupiravir for patients worldwide as well as those in the U.S. Rob Davis, president of Merck notes in a company statement that “In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access.” Merck says it has non-exclusive licensing agreements with manufacturers of generic drugs to make molnupiravir available in 104 low- or middle-resource countries, at tiered pricing levels reflecting their national incomes.

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