Indian generic drug maker Everest Organics started manufacturing active pharmaceutical ingredients for Merck’s oral COVID-19 treatment.
News of the production rollout comes in tandem with Merck filing for emergency use authorization from the FDA for the antiviral, molnupiravir, which would be the first newly developed oral treatment to stave off COVID-19.
“After the successful development and commercialization of various COVID-19 drugs, Everest Organics is on its path of expansion of this portfolio and hence has further developed an additional COVID-19 treatment (molnupiravir) API in that segment,” Srikakarlapudi Sirisha, M.D., Everest’s chief executive, said in a filing (PDF) with the BSE.
The company said production of molnupiravir is being done at lab scale.
Merck filed for an EUA with the FDA on Monday, just 10 days after it and partner Ridgeback Biotherapeutics released data from their phase 3 trial.
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Although the drugmaker has yet to release detailed safety data on molnupiravir, the latest trial data showed no patients treated with the drug died compared to eight deaths in the placebo group. The drug uses a novel mechanism of action that drives viral mutations.
An oral drug for COVID-19 is anxiously awaited as global pressure mounts on governments and health organizations to get treatments to middle- and lower-income nations.
Roche, Pfizer and Appili Therapeutics are all expected to complete phase 3 trials of their oral treatments for COVID-19 in the coming weeks.