When Merck announced positive results for its antiviral COVID-19 treatment molnupiravir at the start of this month, rich countries flocked to buy up supplies before the experimental therapy even got regulatory approval—an eventuality that will probably only come around later this year. Experts understandably worried that the world was about to see a repeat of the situation with COVID-19 vaccines, where developing countries have been pushed to the back of the queue.
However, on Wednesday the pharma firm and the UN-backed Medicines Patent Pool (MPP) announced that, as long as the pandemic is underway, Merck will allow the production of quality-assured generic versions of molnupiravir, so low- and middle-income countries can get supplies.
It’s the first producer of any COVID-19 medical technology to take this step, and the move does not seem to have knocked its share price; indeed, Merck stock was mildly up on the day, at the time of publication.
“Merck’s mission to save and improve lives is a truly global commitment,” said the company’s head of human health, Frank Clyburn, in a statement. “This agreement with MPP is another important element in our multifaceted strategy to accelerate broad, affordable access to molnupiravir, if approved or authorized, for patients no matter where they live, including in countries where governments face greater challenges to finance health care.”
Expanding access
Molnupiravir—initially developed by researchers at Emory University before being licensed by Merck partner Ridgeback Biotherapeutics—is a COVID treatment that is designed to be taken at home, soon after the onset of symptoms. This has caused great excitement, as current COVID therapies require intravenous drips in clinical settings. The results unveiled earlier this month suggest a five-day course of the pill halves the risk of hospitalization and death; it doesn’t beat vaccination, but its benefits seem clear.
A course of molnupiravir reportedly costs $17.74 to produce, and the U.S. will pay more than $700, representing a 40-fold markup. However, Merck has been clear from the start that it would implement a tiered pricing system to enhance access in poorer countries.
The Medicines Patent Pool has been around for more than a decade, existing largely to expand access to HIV, tuberculosis, and hepatitis C drugs, until its remit was expanded to include COVID last year. In May 2021—following encouragement by France, the U.K., Japan, and Norway—MPP again expanded its mandate to focus on COVID vaccine and treatment-related technology licensing.
Essentially, the public health organization is trying to help willing pharmaceutical companies strike voluntary licensing agreements for their COVID vaccines and treatments, and Merck is the first company to bite. That means forgoing royalties for sales under this agreement, until the pandemic is through.
“This transparent, public health–driven agreement is MPP’s first voluntary license for a COVID-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others,” the patent pool’s executive director, Charles Gore, said in the statement. Gore also told the Financial Times he was disappointed at the failure of vaccine makers such as Pfizer/BioNTech and Moderna to also strike such agreements.
Timelines
In the U.S., the Food and Drug Administration is likely to authorize molnupiravir in December. In the EU, the European Medicines Agency started reviewing the treatment at the start of this week.
In the poorer countries that Merck and MPP are targeting with Wednesday’s deal, approval of the generics can only take place once generic manufacturers have expressed interest in signing up, received their licenses, and developed their versions.
With COVID vaccines, many of these countries don’t have the regulatory resources to properly analyze what’s on offer, which is why the World Health Organization does so on their behalf, before approving vaccines for distribution through the COVAX facility.
However, an MPP spokesperson said the organization’s experience with HIV and hepatitis C generics suggested medicines get an easier ride, because local regulators are happier to rely on data from their international peers than they are where vaccines are concerned.
“MPP will be working closely with the WHO, Unicef [which will be procuring molnupiravir], and the whole of the ACT Accelerator to address this issue and support rapid approval of generic versions of molnupiravir,” the spokesperson said.
Correction: This article was updated Oct. 28 to remove a reference to Merck being German.
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