Indian cos asked to bid for molnupiravir deal

Unitaid, a global health initiative that works with partners to bring about innovations to prevent, diagnose, and treat major diseases in low- and middle-income countries, and Unicef have asked eight Indian generic manufacturers to participate in a rolling tender to supply the experimental covid-19 drug molnupiravir to extend access for the antiviral in low- and middle-income countries. Molnupiravir, which received emergency approval from the US Food and Drug Administration (FDA) earlier this year, is seen as a breakthrough therapy that has reduced the risk of hospitalization among covid-19 patients. MSD, which ran the trial for the drug along with its partner Ridgeback Biotherapeutics, has offered the drug to Geneva-based Medicines Patent Pool royalty-free for use in more than 100 middle- and low-income countries. Indian generic makers are keen to play a key role in scaling up of the drug as at least 12 companies, eight of which are officially licensed by MSD, have started running trials for the drug. Companies such as Sun Pharmaceutical Industries Ltd, Cipla Ltd, Dr. Reddy’s Laboratories, Hetero Pharma, Natco Pharma, and Optimus Pharma are in advanced stages of their clinical trials for molnupiravir. The companies are expected to submit their data to Indian regulators by the end of this month. “We hope the eight Indian generic companies will soon go into production of the generic version of molnupiravir. Unicef is running a rolling tender inviting conditional submissions by generic companies. It is conditional because we still need regulatory approval and World Health Organization (WHO) guidance before this can be supplied to national governments,” Robert Matiru, director, Unitaid, told Mint. Unitaid is a not-for-profit organization that works on finding and supporting innovative solutions for infectious diseases in low- and middle-income countries (LMICs).
The companies have been asked to submit their bids early so that organizations can get ahead of the curve by submitting dossiers, including pricing, which is accessible to LMICs, Matiru said. MSD has announced a price of $700 for the course of treatment, but Indian generic companies that Mint spoke to said that they can offer the drug at less than $15. To encourage companies to manufacture before an official regulatory approval, the Gates Foundation has also announced an insurance policy to start at-risk production, Matiru explained. In October, the Bill and Melinda Gates Foundation announced that it was making a commitment of up to $120 million to accelerate access to molnupiravir for low-income countries. As part of this commitment, the foundation said it will provide a grant of $2.4 million to speed up generic companies’ readiness to apply for WHO prequalification.

Source: livemint