US Acquires 1.7B Courses of Merck’s COVID-19 Treatment

The Biden Administration recently announced that the US government will procure nearly 1.7 million courses of Merck’s investigational antiviral COVID-19 treatment, molnupiravir (MK-4482).

This agreement is part of the Biden Administration’s whole-of-government approach to develop new COVID-19 treatments and to respond to the health needs of the public through partnership between agencies, including HHS and the DoD.

The approach leverages all expertise and resources available to respond to COVID-19, such as funding the development and manufacturing of therapeutics, including antivirals.

The US government will acquire courses of MK-4482 pending emergency use authorization or approval from FDA. 

“Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved,” Rob Davis, president of Merck, said in an announcement. 

“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,” Davis continued. 

MK-4482 is an oral novel investigational antiviral agent being developed in collaboration with Ridgeback Bio. Phase 2/3 trial evidence from patients infected with COVID-19 suggest that MK-4482 may reduce replication of the SARS-CoV-2 virus. 

Additionally, in previous studies, MK-4482 demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus.

The antiviral is currently being evaluated in Phase 3 clinical trials in both hospitals and outpatient settings to assess potential risk of hospitalization or death in non-hospitalized patients who have symptoms for five days or less and are at high risk for severe illness.

Merck’s MOVe-OUT study is an ongoing Phase 2/3 trial that is randomized, placebo-controlled, and double-blind. The trial is evaluating the efficacy, safety, and pharmacokinetics of 800 milligrams of MK-4482 in non-hospitalized participants infected with COVID-19. 

Participants in the study also had at least one risk factor associated with poor disease outcomes. 

The trial plans to enroll a total of 1,850 patients globally with final data expected in fall 2021.

If MK-4482 is approved by FDA, Merck will receive nearly $1.2 billion to supply the 1.7 million courses of the antiviral to the US government. The company also anticipates 10 million courses of therapy to be available by the end of 2021.

Under terms of agreement, BARDA collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army contracting Command on the $1.2 billion purchase agreement for the courses of MK-4482. 

The government’s procurement of Merck’s antiviral courses comes five months after the company discontinued development of its COVID-19 vaccine candidates, V590 and V592. The stop was based on findings from Phase 1 studies which showed immune responses were lesser than those reported for other COVID-19 vaccines. 

Merck then shifted its research strategy to advancing MK-4482 and MK-7110.

MK-7110 is a first-in-class investigational recombinant fusion protein that regulates the inflammatory response to COVID-19 by targeting a novel immune pathway checkpoint.

Additionally, Merck is contributing to the pandemic response by collaborating with Johnson & Johnson to support the manufacturing of its COVID-19 vaccine.

In March, The Biden Administration announced a historic collaboration between Johnson & Johnson and Merck to expand production of COVID-19 vaccine, Ad26.COV2.S.

The collaboration will boost the manufacturing of vaccine drug substance and its fill-finish capacity, which are two of the greatest challenges that Johnson & Johnson has faced during the production of its vaccine.  

HHS will collaborate with Merck to repurpose some of its existing Merck facilities for rapid, large-scale manufacturing of vaccines and therapeutics for use in public health emergencies, the agency said in the announcement.