COVID-19 oral antiviral molnupiravir wins FDA nod

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801). 

In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir. 

FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir). 

FDA’s authorization of molnupiravir covers its use to treat mild-to-moderate COVID-19 in individuals at least 18 “who are at high-risk for progression to severe COVID-19.” The authorization constrains the use of the drug to individuals who cannot feasibly use other authorized COVID-19 treatments. FDA does not recommend the medication for patients who are hospitalized with COVID-19. 

The authorization does not support the use of molnupiravir as pre-exposure or post-exposure prophylaxis for COVID-19.

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A course of Merck’s COVID-19 pill could cost more than $700

Merck’s (NYSE:MRK) oral drug molnupiravir (MK-4482) could be a COVID-19 game-changer, assuming it wins emergency use authorization.

The medicine could also be lucrative for Merck, assuming it finds widespread use.

Costing $712 for a treatment course, according to a contract obtained by Knowledge Ecology International, molnupiravir’s retail cost would be almost 40 times more than its production cost. It takes about $17.74 to produce a five-day course of the drug, according to an estimate from a pricing analysis from the Harvard School of Public Health and King’s College Hospital in London.

Knowledge Ecology International obtained the contract via a Freedom of Information Act lawsuit targeting the HHS and the Army regarding U.S. government COVID-19 contracts.

Merck did not immediately respond to a request for comment on its pricing plans related to the drug.

In initial contracts with the U.S., the Pfizer-BioNTech vaccine has a price tag of $1…

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Merck results miss in Q2

Merck (NYSE: MRK) posted second-quarter results today that missed the consensus forecast on Wall Street, though the company expects up to 14% sales growth this year.

The Kenilworth, N.J.–based pharmaceutical giant reported profits of $1.213 billion, or 48¢, off $11.402 billion in sales, nearly halving its bottom line while boosting sales 19% from Q2 2020. Merck adjusted earnings and revenue to take into account its June 2021 spinoff of Organon, which brought Merck a $9 billion windfall.

Adjusted to exclude one-time items, earnings per share were $1.31, 13¢ behind The Street, where analysts looked for EPS of $1.44 on sales of $11.54 billion.

Related: FDA approves Merck’s Keytruda to treat certain types of breast cancer

“We are encouraged by the strong momentum of our underlying business led by our key growth drivers as the impact of the pandemic on our performance lessens,” said Merck CEO Rob Davis said in a news release. “We are confident that we …

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