Race to make antiviral pill Molnupiravir heats up

INDIA – Indian antiviral manufacturers are becoming increasingly important as the first-ever COVID-19 oral treatment Molnupiravir is introduced, promising to hasten the world’s recovery from the coronavirus pandemic.

Molnupiravir reduces the risk of hospitalization or death in half of people with mild to moderate COVID-19, while Pfizer’s blockbuster antiviral pill, Paxlovid reduces the aforementioned risks by close to 90 percent.

Molnupiravir can be taken at home and allows a broader population to receive COVID-19 treatments in a true outpatient setting, where challenge to the treatment’s accessibility and affordability

Certainly, the orally administered Molnupiravir tablets will be far less expensive than the infusion drugs currently used to treat COVID-19, such as Remdesivir or monoclonal antibody (mAb) cocktails.

However, experts believe that the pills will continue to be out of reach for a large portion of the world’s population.

And this is where Indian contract manufacturing organizations (CMOs) come in with their undeniable strength: cost-optimized manufacturing prowess and scalable production capabilities.

Merck, known as MSD in India, has already entered into voluntary licensing agreements with at least eight Indian manufacturers to produce low-cost generic versions of the investigational antiviral.

The first-of-its-kind move allows the companies to produce Molnupiravir pills not only for the Indian population, but also for more than 100 other low- and lower-middle-income countries

Merck collaborates with Indian companies

In another first, five of Merck’s collaborating companies—Cipla, Sun Pharma, Dr. Reddy’s Lab, Emcure Pharma, and Torrent Pharmaceuticals—have agreed to collaborate on clinical trials of Molnupiravir on Indian patients.

One of them (Dr. Reddy’s) will conduct the clinical trial using its version of Molnupiravir, as directed by the Subject Expert Committee of India’s regulatory body. The other four companies are required to demonstrate that their products are equivalent to the ones used in the clinical trial.

The obvious goal is to produce as many pills of this desperately needed treatment as possible in the shortest amount of time.

Merck has designated Divi’s Labs as the authorized manufacturer for Active Pharmaceutical Ingredient (APIs) and is permitted to supply this raw material to its manufacturing partners in India.

The Hyderabad-based CMO, a key player in APIs, was recently in the news for successfully developing four key intermediates used in the synthesis of Remdesivir, an injectable antiviral.

Many others in the API space have also begun manufacturing Molnupiravir, anticipating a high demand for the pill in the coming days. Everest Organics, based in Hyderabad, announced the start of production of Molnupiravir API in October.

Cost estimation studies to determine a sustainable generic price for molnupiravir show that the API can be synthesized at a fraction of the current market price by Indian CMOs using highly efficient processes.

The US government has ordered 1.7 million Molnupiravir treatment courses at a cost of about $700 per patient.

Merck, which developed Molnupiravir has stated that it intends to use a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their pandemic health response.

Many manufacturers are racing to develop the pill because they see an urgent need for therapeutics that can keep patients out of hospitals because a large proportion of the global population have yet to be immunized against the pandemic virus.

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