Why Merck’s Molnupiravir banks heavily on India

Three Indian pharmaceutical firms lead the supply of the active pharmaceutical ingredient (API, or the key raw material) of molnupiravir—the investigational oral antiviral medicine that has just been found to be effective in treating Covid-19 patients.

Melissa Barber, a Harvard University researcher who did a cost estimation to arrive at a sustainable generic price for molnupiravir has identified the three Telangana based firms—Optimus Drugs Private Ltd, Honour Lab, and Maithri Laboratories—as the global source for molnupiravir API. Barber's observation comes in a yet to be peer-reviewed working paper jointly written by her and Dzintars Gotham of Kings College Hospital London. The paper depends on the mean market price for molnupiravir API charged by the suppliers to suggest that a full course of medicine can be made available at the cost of $ 19.99 per patient.

The findings of Barber—tweeted by the researcher herself on October 2—came a day after the U.S. drug major MSD (Merck) announced that its anti-Covid-19 drug, molnupiravir significantly reduced the risk of hospitalization or death in Covid-19 patients. Based on the results of interim analysis of the Phase 3 clinical trial, the company stated that it plans to apply for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible and plans to submit marketing applications to other regulatory bodies worldwide. MSD had in April 2021 itself entered into non-exclusive voluntary licensing agreements with five Indian drug majors؅—Cipla Limited, Dr. Reddy’s Laboratories Ltd, Emcure Pharmaceuticals Limited, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals Limited—to manufacture and supply molnupiravir to India and over 100 low and middle-income countries (LMICs). Later the five companies had announced a collaboration for the clinical trial of molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.

The Harvard researcher points out that the price at which the U.S. government has already ordered 1.7 million treatment courses of molnupiravir, at about $700/patient, is equal to about 35 times the estimated sustainable generic price using current market prices for the API observed in their analysis. "Assuming optimization of molnupiravir synthesis, and a resulting drop in API cost, the U.S. price would be equal to about 161 times the estimated sustainable generic price", the working paper notes.