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Merck signs $1.2bn supply deal with US government for Molnupiravir

The oral antiviral COVID-19 candidate has not yet been approved by the FDA

Merck HQ

Merck, known as MSD outside the United States and Canada, has agreed to supply the United States government with approximately 1.7 million courses of molnupiravir (MK-4482). The deal, worth $1.2bn, is contingent upon the US Food and Drug Administration (FDA) issuing an Emergency Use Authorization (EUA) or approval for the treatment.

The treatment, being developed by Merck in collaboration with Ridgeback Biotherapeutics, is currently being evaluated in a phase 3 clinical trial.

The trial, know as the MOVe-OUT study, is evaluating molnupiravir in the treatment of non-hospitalised patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes.

“Merck is pleased to collaborate with the US 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 authorised or approved,” said Rob Davis, president, Merck.

“In addition to this agreement with the US government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfil Merck’s commitment to widespread access.”

Merck expects to have more than ten million courses of the treatment available by the end of 2021.

Merck is also looking at supplying molnupiravir to countries outside the US and is currently in discussions with other countries about possible advance purchase agreements for the treatment. The company also plans to submit applications for emergency use or approval to regulatory bodies in other countries outside the US.

In an effort to provide global access to molnupiravir, Merck announced in a statement that it ‘has also entered into non-exclusive voluntary licensing agreements with established generic manufacturers to accelerate availability of molnupiravir in 104 low- and middle-income countries (LMICs), following approvals or emergency authorisation by local regulatory agencies’.

Merck is also currently collaborating with Johnson & Johnson to support the manufacture of its COVID-19 vaccine.

Article by
Iona Everson

9th June 2021

From: Regulatory

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