Merck just announced that it granted a royalty-free license for its antiviral drug molnupiravir to Medicines Patent Pool, a United Nations-backed organization dedicated to providing crucial medicines to 105 poorer countries. Will this make a difference in the battle against COVID? I argue that it will.
Putting aside the usual anti-pharma narrative for a moment, Merck, which is seeking emergency use authorization (EUA) for its direct-acting antiviral drug (DAAD) molnupiravir (formerly EIDD-2801) (1) in the US has announced that it will grant a royalty-free license to Medicines Patent Pool, a UN-backed organization created to provide important drugs to countries that wouldn't otherwise be able to afford them.
The agreement will permit drug companies in 105 poorer countries to manufacture and sell (or donate) molnupiravir, something that would normally be prohibited according to US and international patent laws. Good for them.
Will This Make A Difference?
Absolutely. Here is a review of the Phase 3 trial that demonstrated the utility of the drug.
- Double-blinded, randomized clinical trial of 775 enrollees.
- Patients had mild-to-moderate COVID and at least one of the risk factors known to make COVID infection more dangerous.
- Half the group got a placebo, half got the drug over a five-day period.
- The primary endpoint was hospitalization and death 29 days after dosing.
- 53/377 (14.1%) of those who received the placebo needed to be hospitalized; eight died.
- 28/385 (7.3%) of those who received the drug needed to be hospitalized; none died.
- The occurrence of adverse effects was slightly lower (35%) in the drug-treated group vs.40% in the placebo group. (Probably the same)
- More compelling: adverse effects resulting in withdrawal from the trial were1.3% in the drug-treated group, 3.4% in the placebo group. This strongly suggests that the pill made people feel better.
- The drug was effective against the Delta, Gamma, and Mu variants
- Long-term safety is unknown, but this should not be an issue in a drug given for a short period of time.
- In my opinion, molnupiravir should be granted EUA, and this isn't even a difficult decision.
Those of you who cannot possibly accept the fact that the pharmaceutical industry is anything but an evil entity should stop reading now. If you don't, don't blame me if your head explodes (emphasis mine).
“This is the first transparent public health license for a Covid medicine, and really importantly, it is for something that could be used outside of hospitals, and which is potentially going to be very cheap...From a scientific point of view, industry have done a really brilliant job — firstly, providing the vaccines, and now providing treatments."
Charles Gore, director of the Medicines Patent Pool in The New York Times
If the data from the clinical trial hold up in the real world (likely) then molnupiravir will provide a substantial benefit to people in poor countries that are being ravaged by COVID. Pfizer, which has another promising DAAD in development is also in talks with the Medicines Patent Pool. Importantly, the Merck and Pfizer drugs work by different mechanisms, and – as was the case with AIDS – the combination of the two will almost certainly be more effective in fighting COVID than either drug alone, and probably by a lot.
NOTE:
(1) The name EIDD-1931 refers to the Emory Institute for Drug Development. The original drug, aka N-hydroxycytidine was developed well before COVID at Emory University (for other viral infections), which is a real powerhouse in antiviral research. The properties of N-hydroxycytidine were not optimal for a pill (oral absorption) so the institute modified the original molecule to make a pro-drug EIDD-2810, which is now called molnupiravir. Ridgeback Biotherapeutics acquired the drug in 2020 and subsequently partnered with Merck for its development.
