With Merck's oral COVID-19 med molnupiravir set for authorization, U.S. spends another $1B for 1.4M courses

Merck
An FDA advisory committee will meet on Nov. 30 to discuss Merck and Ridgeback's submission for emergency use authorization of its oral antiviral, molnupiravir, a potential game-changer in the treatment of at risk patients with mild-to-moderate COVID-19. (Merck & Co.)

With molnupiravir, Merck & Co. and Ridgeback’s oral treatment for COVID-19, apparently on the doorstep of authorization, the U.S. has moved to secure additional doses of the drug, which has been hailed as a potential gamechanger in the fight against the virus.

On Tuesday, the companies revealed that it has signed a deal to provide 1.4 million courses of molnupiravir for $1 billion, pending FDA emergency use authorization of the antiviral for those with mild-to-moderate COVID and at risk for progressing to a severe form of the disease.

The agreement brings Merck’s total supply of molnupiravir to the U.S. to 3.1 million courses for a $2.2 billion haul. With the recent deal, the U.S. exercised two contract options. The U.S. will be able to acquire another 2 million courses of the drug by exercising the remaining options on the contract, the companies said.

On Nov. 30, an FDA advisory committee will discuss Merck’s submission for authorization of molnupiravir. Two weeks ago, the European Medicines Agency kicked off a rolling review of the drug, which will continue until enough evidence is available for the company to submit a formal marketing authorization application.

Last week, the U.K. became the world’s first country to approve molnupiravir, which will be sold under the brand name Lagevrio. On Monday, the government said it would roll out the pill through a trial later this month. Merck agreed to supply 480,000 courses of the drug to the U.K.

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Merck is in talks with other governments and said it will sell to countries on a tiered pricing approach based on World Bank income criteria.

Also on Tuesday, Bangladesh’s Beximco Pharmaceuticals revealed that it will become the first company to sell a generic version of the drug upon its approval. In India, Merck has set up a network of manufacturers to produce generic versions of molnupiravir.  

Merck says it will produce 10 million courses of molnupiravir by the end of this year and will have the capability to manufacture an additional 20 million courses in 2022. Last month, the company inked a deal with the Medicines Patent Pool that allows the health organization to sublicense molnupiravir and supply the COVID-19 oral medication to 105 low- and middle-income countries.

Molnupiravir opened eyes earlier this fall when it reported trial data that showed it reduced hospitalization and death by 50%. The treatment would fill a gap in the pandemic drug arsenal as it would provide a more convenient and less expensive option than the current offerings for mild-to-moderate at-risk COVID patients.

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While molnupiravir already has blockbuster potential, Bernstein analyst Ronny Gal estimates that the oral antiviral market will reach $6 billion annually even once the world moves into the endemic phase with COVID-19. Besides the treatment setting, Merck is evaluating molnupiravir as a post-exposure prophylaxis.

Roche and Pfizer are developing oral treatments, as well. Last week, Pfizer reported that its oral antiviral Paxlovid cut the risk of hospitalization or death by 85% in a late-phase trial. The result prompted the company to stop the study and race to seek emergency use authorization from the FDA.

Last month, Roche and its partner Atea Pharmaceuticals suffered a big blow to their bid to bring an oral antiviral for COVID-19 to market, as a phase 2 trial of the candidate missed its primary endpoint. This has prompted Atea and Roche to consider changes that will delay data from the pivotal study by around one year.