UnitAid, a global health initiative that works with partners to bring innovation to prevent, diagnose and treat major diseases in low- and middle-income countries, and UNICEF has launched a rolling tender for pilot supplies to eight Indian generic manufacturers. have been asked to participate. The Covid-19 drug mollupiravir to increase the reach of antivirals in low- and middle-income countries.
Molnupiravir, which received emergency approval from the US Food and Drug Administration (FDA) earlier this year, is touted as a breakthrough therapy that has reduced the risk of hospitalization among Covid-19 patients. Have given.
MSD, which ran trials of the drug with its partner Ridgeback Biotherapeutics, has offered the drug royalty-free for use in more than 100 middle- and low-income countries to the Geneva-based Medicines Patent Pool. Indian generic manufacturers are keen to play a key role in expanding the drug as at least 12 companies, of which eight are officially licensed by MSD, have started 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 expect eight Indian generic companies to start production of the generic version of Molnupiravir soon. UNICEF is running a rolling tender to invite conditional submissions by generic companies. This is conditional because we still need regulatory approval and guidance from the World Health Organization (WHO) before it can be supplied to national governments,” Unitaid director Robert Matiru told Mint.
UnitAid is a non-profit organization that works on finding and supporting innovative solutions for infectious diseases in low- and middle-income countries (LMICs).
Matiru said companies have been asked to submit their bids early so that organizations can get ahead of the curve by submitting a dossier including pricing, which is accessible to LMIC.
MSD has announced a price of $700 for the treatment, but the Indian generic companies Mint spoke to said they could offer the drug for less than $15. To encourage companies to build before official regulatory approval, the Gates Foundation has also announced an insurance policy for starting production at risk, Mtiru explained.
In October, the Bill & Melinda Gates Foundation announced that it was making a commitment of up to $120 million to accelerate access to mollupiravir for low-income countries. As part of this commitment, the foundation said it will provide a $2.4 million grant to accelerate the readiness of generic companies to apply for WHO prequalification.
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