The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics.
The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the drug in Great Britain. Furthermore, it has allowed emergency use authorization of the drug for Northern Ireland.
MHRA recommends that the drug be used in people with mild-to-moderate COVID-19 who have at least one risk factor predisposing them to severe illness. MHRA further recommended that the drug be used as soon as possible after a positive COVID-19 test and “within five days of symptoms onset.”
Merck will market the drug as Lagevrio.
MHRA also noted that it does recommend the drug as an alternative to vaccination.
The UK authorization of molnupiravir has positive credit implications for Merck in the short- to medium-term, said Moody’s SVP Michael Levesque. The drug has “high earnings potential over 2021-2022,“ Levesque said. And other regulators are also reviewing molnupiravir. “Merck has entered contracts to supply the drug upon regulatory authorizations, including a $1.2 billion U.S. contract,“ Levesque added. “But the duration of molnupiravir revenue will depend on the evolution of the pandemic, and is unlikely to provide sustained improvement in Merck’s credit metrics.”
Merck has also vowed to make the drug available internationally, assuming it passes the requisite regulatory hurdles. Developing nations could pay approximately $20 for a single course of the medication, while countries such as the U.S. spend more than $700.
The UK has purchased some 480,000 courses of the drug.
COVID-19 infections in the UK remain stubbornly high despite an aggressive vaccination program.
Merck projects that it can produce 10 million courses of the drug by the end of 2021. It will also tap several generic drug makers to help make the drug.
Merck has also entered into a voluntary licensing agreement with the Medicine Patent Pool, which helps developing nations negotiate drug licenses.
Filed Under: Infectious Disease
