A storm is brewing over the pricing and licensing of Merck’s antiviral pill molnupiravir, which the pharmaceutical giant says could halve the risk of hospitalization and death in high-risk COVID-19 patients.
Merck’s advance purchase agreement with the US government is estimated to cost the five-day treatment at around $700. But an independent analysis by public health researchers at Harvard estimated that a sustainable normal value — in which a 10 percent profit margin is made — would be just $20 per treatment. In addition, rival generic manufacturers in India are expected to offer $15 or less for a treatment once the drug is already authorized for use.
Given that, the $700 price tag in the US represents a 46-fold markup for the drug, which is named after Thor’s hammer, Mjölnir.
In a statement earlier this week, Doctors Without Borders/Medicines Sans Frontieres (MSF) took a hard hit on the pricing as well as Merck’s licensing agreements. Leena Menghani, South Asia Head of MSF’s Access Campaign, said, “Instead of offering a wide open license to all competent manufacturers in different countries, a narrow voluntary license approved by Merck in April 2021 only covers Indian generic companies. ” a statement. “This prevents countries like Brazil from being able to produce and import generic versions and raw materials. Middle-income countries excluded from license had 30 million COVID-19 infections in the first half of 2021—of all infections. 50 percent of low- and middle-income countries.”
Another strike against Merck’s plans so far is that, while the pharmaceutical giant is expected to make billions in profits, it was not responsible for drug development; Merck research and development costs aren’t recouping here. Molnupiravir was developed by researchers at Emory University $35 million estimated in federal funds, including grants from the National Institutes of Health and the Department of Defense. This drug had been working for years before the pandemic. Pharmaceutical company Ridgeback Biotherapeutics bought the rights to the drug in early 2020 and partnered with Merck a few months later.
Merck is not only selling molnupiravir to the US government at a 46x markup; It is selling a drug that the US government has already spent millions to develop. Industry analysts have estimated that Merck will generate $5.3 billion in sales in 2022 alone and $22 billion by 2030, According to Business Insider.
needs and costs
MSF warned that if Merck does not reduce its pricing and/or allow more generic manufacturing, “it could significantly reduce global access to the world’s first oral antiviral treatment for COVID-19″. will limit it.”
MSF’s “if approved for use, the first oral anticancer treatment of molnupiravir could be a major step forward in the provision of potentially lifesaving care for COVID-19 patients in resource-constrained settings, where billions of people remain unvaccinated and susceptible to disease.” It is,” said Menghani. “The drug will need to be made available and affordable as quickly as possible to those who need it everywhere. Oral drugs will be easier to use than the treatments currently available for COVID-19 and as long as they are affordable , till then they will allow more comprehensive administration.”
In an emailed statement to Ars, Merck said the price the US government is paying with its advance purchase agreement does not determine the official price of the drug going forward.
A Merck spokesperson told Ars, “If authorized or approved by local regulatory agencies, we plan to implement a tiered pricing approach based on World Bank data, which will help determine their health responsiveness to the pandemic.” Recognizes the relative capacity of countries to finance the response.” Merck is “in discussions with various governments and other organizations regarding the accessibility approach,” the spokesperson said.
On Monday of the Week, Merck and Ridgeback applied for emergency use authorization for molnupiravir from the Food and Drug Administration. In addition to controversial pricing, if the drug is authorized in the US, it is likely to be a cheaper and simpler treatment option than previously available treatments. As Business Insider notes, the US government pays $2,100 for an infusion of Regeneron’s COVID-19 antibody cocktail and $3,200 for a five-day intravenous course of Gilead Sciences’ antiviral remdesivir.
Highly effective and safe COVID-19 vaccines – which can prevent hospitalization, death, disease spread and the need for all these expensive drugs – cost in the US from $10 to $40 per shot.