Molnupiravir, the investigational Covid-19 pill developed by (MSD) and Ridgeback Biotherapeutics, has been hailed as a potential game-changer when it comes to treating the virus and reducing its burden on hospitals.
According to interim analysis, molnupiravir reduced the risk of hospitalisation or death by around 50%, and Merck has this week submitted an emergency use authorisation application for the oral antiviral drug to the US Food and Drug Administration (FDA).
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By GlobalDataAs well as vaccines, effective antivirals are crucial to fighting Covid-19, and nowhere is this truer than in low- and middle-income countries (LMICs), which have been hit hardest by the pandemic. Poorer nations have received disproportionately low supplies of Covid-19 vaccines 鈥� has received at least one vaccine dose, for example 鈥� while wealthy, largely-vaccinated countries have hoarded doses for booster shot programmes and the vaccination of younger age groups.
Approval of Merck鈥檚 highly effective Covid-19 pill would be an important step towards tackling the pandemic 鈥� but will those in low- and middle-income countries, who need the treatment most desperately of all, be able to access it?
Molnupiravir production: Merck鈥檚 agreements with Indian drugmakers
In April, Merck entered into non-exclusive, voluntary licensing agreements for molnupiravir with five Indian generics manufacturers. The purpose of the deals, , is to boost availability of the antiviral drug in more than 100 LMICs, including India.
The agreements, signed with , Dr. Reddy鈥檚 Laboratories, , Hetero Labs and Sun Pharmaceutical, license the manufacturers to produce generic molnupiravir for India and other LMICs. Merck said it is also in discussions with the United Nations-backed Medicines Patent Pool about potentially providing additional licenses for the medicine.
The pharma giant鈥檚 CEO Kenneth Frazier, who was commenting as a deadly second wave of infections swept through India in April, said: 鈥淭he scale of human suffering in India at this moment is devastating, and it is clear that more must be done to help alleviate it.
鈥淭hese agreements, toward which we have been working as we have been studying molnupiravir, will help to accelerate access to molnupiravir in India and around the world.鈥�
One of the chosen generics manufacturers, Hyderabad-based Hetero Labs, from a clinical trial of molnupiravir and submitted the data to India鈥檚 medicines regulator in July.
Separately, two Indian drugmakers are currently producing the active pharmaceutical ingredient (API) for molnupiravir. Divi鈥檚 Laboratories that it had been authorised to manufacture the Covid-19 drug鈥檚 API and supply it to Merck鈥檚 partners in India.
The bulk drug manufacturer was this week joined by , which said it had successfully developed the molnupiravir API and would be producing it at lab scale.
Another inequitable rollout?
Despite Merck鈥檚 efforts to boost molnupiravir production and availability in LMICs, there are fears that poor countries could be left behind once again as wealthier nations scramble to buy up supplies of the drug.
Though molnupiravir is yet to gain regulatory approval, a number of countries 鈥� including the US, Australia and New Zealand 鈥� have secured orders for hefty deliveries of the drug. The US alone is set to receive 1.7 million courses of the medicine upon FDA authorisation, following a $1.2bn agreement with Merck in June.
An commissioned by the World Health Organization has expressed concern that the therapeutics arm of the ACT-Accelerator 鈥� a global collaboration to accelerate equitable access to Covid-19 tests, treatments and vaccines 鈥� does not yet have a clear plan to supply LMICs with Covid-19 drugs or negotiate contracts.
The report said advanced purchase agreements, such as the US鈥檚 deal with Merck for molnupiravir, could mean challenges for the ACT-Accelerator when it comes to procuring sufficient supplies of effective treatments for poorer nations.
While concerns about supplies of molnupiravir for LMICs remain, Merck, at least, is working to meet growing demand for the drug. This week, the that the company is planning to double its own production of molnupiravir to at least 20 million treatment courses by 2022.
Merck has also said it plans to implement 鈥溾�� for supplies of its Covid-19 pill. Based on World Bank country income criteria, the approach would see countries pay different prices depending on their 鈥渞elative ability to finance their health response to the pandemic鈥�.
