“The extraordinary impact of this pandemic” – the US has averaged 1,600 to 2,000 deaths per day in recent weeks – “demands that we move with unprecedented urgency,” Merck CEO Robert Davis said in a statement announcing the filing on Oct. 11. Given the company’s fast action, analysts and other market watchers see Merck’s candidate, aimed at treating mild-to-moderate Covid-19, as the current runner in the race to have an antibody cocktail approved and on the market. Already, several Asian countries have closed supply deals.

The US drugs giant’s pill is also seen as having potential to be a game changer in Covid treatment. To be effective, the antivirals now on the market, developed by companies such as Gilead, Regeneron or Eli Lilly, need to be deployed at a very early stage in the infection, and up to now difficulties in administering these injectable drugs have hampered progress. Another advantage of Merck’s pill is that it can be taken by patients at home.

The drugmaker recently inked a US government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course. Merck has said it will produce 10 million courses by the end of this year. To distribute them equitably, it has agreed to license the treatment to several India-based generics makers that in turn are expected to supply more than 100 low- and middle-income countries worldwide.

Reporting on a Phase 3 trial earlier this month, Merck and Ridgeback presented data showing that molnupiravir cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease. However, all that glitters is not gold, and some have identified potential stumbling blocks to the Merck candidate’s becoming the unquestioned gold standard in this potentially lucrative market.

To start, many believe there should be potential to improve on the survival rate, and in this sense are watching competitors due to report Phase 3 trial reports next month. Roche, in partnership with Atea Pharmaceuticals, in addition to Pfizer and Appili, are hot on Merck’s heels, for instance.

Also, as trade journal Fierce Pharma notes, Merck has not yet presented detailed safety data from the molnupiravir trial, which excluded vaccinated people. What’s more, it is still unclear how regulators and payers will determine eligibility. Currently, the US federal government is supplying post-infection antivirals to the states to use at their discretion.

Author: Dede Williams, Freelance Journalist