Merck (MRK) and Ridgeback Biotherapeutics announced today that they submitted an emergency use authorization (EUA) to the Food and Drug Administration (FDA) for their COVID-19 pill, molnupiravir, the first oral antiviral of its kind.
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The EUA submission comes 10 days after the pharmaceutical companies announced that the pill cuts the risk of hospitalizations or deaths by half. The drug could be a game-changer in controlling the pandemic around the globe: it doesn’t require access to a healthcare facility, as antiviral treatments can be taken at home, so it could also alleviate the strain on healthcare systems.
The news sent the stock soaring 10% upon the initial announcement.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, Merck CEO and president, said in the announcement. “I also want to take this moment to applaud our colleagues in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19 — medicines and vaccines are both essential to our collective efforts.”
The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months, according to the announcement.
Merck said that in anticipation of the results, it had been producing molnupiravir at risk. The company said it expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
In addition, earlier this year, Merck entered into a procurement agreement with the U.S. Government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the FDA, the company said. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
Earlier this month, CFRA Research reiterated its buy rating following second-quarter results, according to a note sent to GOBankingRates last week.
“We think MRK is in the midst of a transformation with the Organon spin-off (women’s health, legacy brands, and biosimilars), which took place in June, and leadership change, as the long-tenured CEO K. Frazier retired and was replaced by the CFO, R. Davis,” CFRA analysts said.
“We welcome MRK’s decision to spin off Organon into a new company, enabling faster growth and greater focus on key growth drivers. Based on our estimates, Organon amounted to 14% of 2020 Merck’s revenues and the transaction is expected to generate $1.5 billion in operating efficiency by 2024.”
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