A new antiviral pill to treat COVID-19 could soon be released to the world's poorest countries. The drugmaker Merck reported that in a clinical trial, the new drug cut hospitalizations and deaths in half.
Merck is granting a royalty-free license for drugmakers worldwide to produce molnupiravir, the potential antiviral, in a move aimed at helping millions of people in poorer countries get access to the potentially life-saving drug, a United Nations-backed public health organization said on Wednesday.
The Medicines Patent Pool (MPP) said in a statement that it had signed a voluntary licensing agreement for molnupiravir with Merck and its partner Ridgeback Biotherapeutics.
The agreement will allow the MPP to grant further licenses to qualified companies who are approved to make the drug. Neither drugmaker will receive royalties under the agreement for as long as the World Health Organization deems COVID-19 to be global emergency. Molnupiravir is the first pill that has been shown to treat the disease.
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“The need for additional treatment options remains key in combating the COVID-19 pandemic,” Dr. Dean Li, president of Merck research laboratories, told analysts.
The FDA has said a panel of outside experts will meet late next month to consider the treatment for use in adults with mild to moderate COVID-19 who are at risk for severe disease or hospitalization.
James Love is the director of Knowledge Ecology International, an NGO in Washington that advocates for affordable medicines worldwide. Love discussed the new pill and license-sharing agreement with The World's host Marco Werman.
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Marco Werman: James, first of all, what does this pill do? Who would it help?
James Love: Well, if it passes all the safety reviews, it's a quite promising treatment. It's designed to be taken early after an infection and the data that we've seen so far is that it's very effective at preventing hospitalization and death.
And just to be clear, it's not an alternative to a vaccine, right?
It's not an alternative to the vaccine, but there are large parts of the world where there's been a shortage of vaccines. So, there are a lot of people, particularly in developing countries, that have not had the opportunity to have vaccines. And so, a treatment like this will really be important.
What do you know about the license-sharing agreement and what does it mark in the COVID-19 timeline?
This is the first open license that we've seen for a COVID therapeutic or COVID vaccine. It's the only one we've seen that allows the manufacturing to be done around the world, and it's the only one that's fully transparent. The license is 69 pages long and you can read every single word of it. It is also, I think, the model agreement for scaling up the manufacturing of a therapeutic or a vaccine because it brings in any capable manufacturer.
How will Merck actually make money on this pill?
If the drug is as effective as they say it is, and if it's as safe as they say it is, it'll be a very profitable product. The license divides the world into two parts, one half of the world, the lower-income part of the world where the average incomes are around $2,500 per year, is set aside for this competitive, generic, low-cost supply Merck preserves for itself for selling. And the other half of the world, where incomes are over $20,000 per capita. So, Merck is going to focus on selling the drug in the countries where people have the most money, and they're allowing the generic suppliers to sell it at very cheap prices in countries that are very low income.
We tend to think of big pharma as focused on big profits. Were you surprised to hear about the license-sharing agreement?
Well, we were happy to see it. I mean, we were kind of surprised we haven't seen more of these licenses. We're almost two years into the pandemic, and this is the first time anyone's made a license to the Medicines Patent Pool. We think this should have been done earlier. It does fall short of what the proposal was initially in the beginning of the pandemic. They wanted these licenses to be global. They didn't want them to be limited to low-income countries. They wanted them to be global. Costa Rica, for example, is excluded from the license. So, it falls short of what the ideal is. But if the benchmark is what other companies have done, what Merck has done is objectively better than what any other company's done so far.
So, those countries that are not on the list, how would they get the pill?
I mean, Merck's going to be selling the drug itself. They've already announced the price in the United States and they're going to be negotiating or setting prices for other countries. But beyond that, the license does provide a pathway for the generic companies to sell outside of the licensed territory if they meet certain conditions. So, there is a pathway, but I think for a lot of sales, there'll just be some additional negotiations with Merck over the price. I know that Merck is in negotiations with Brazil, for example, which is not part of this voluntary license. What Merck has done is explicitly looking at the idea that they have to think about global access. And I think that this is a very constructive step in that direction. ... we're a group that's constantly criticizing the companies over the prices and affordability policies, and we take odds with them on a lot of the negotiations on intellectual property rights, but I think we have to give Merck some credit for having done what they've done. And I hope that this will put pressure on some of the other manufacturers of vaccines and therapeutics to follow and do the same thing.
This interview has been lightly edited and condensed for clarity. AP contributed to this report.