The American Pharmacist Merck & Co. announced on Wednesday an agreement that could see generic versions of its drug for COVID patients widely distributed in poorer countries, for the first time during the pandemic.
Agreement will help create broad access to molnupiravir in 105 low-income countries
The Global Drug Patent Fund (MPP) said it had signed a voluntary license agreement with Merck to facilitate affordable worldwide access for its investigational COVID-19 oral antiviral drug molnupiravir.
Subject to regulatory approval, the agreement will help create broad access to molnupiravir in 105 low- and middle-income countries.
Drug regulators in the United States and the European Union are already reviewing the drug.
How does molnupiravir work?
Antivirals such as molnupiravir work by decreasing the ability of a virus to replicate itself, which slows down the disease.
Given to patients within days of a positive test, the treatment cuts the risk of hospitalization in half. This, according to a clinical trial conducted by Merck, also called MSD outside the United States.
The Geneva-based MPP is an international organization backed by the United Nations. Which works to facilitate drug development for low- and middle-income countries.
Under the agreement, Merck licenses MPP, under which the organization can sub-license generic drug manufacturers.
The agreement means that the drug’s developers will not receive sales royalties. This, while COVID-19 remains classified as a public health emergency of international concern (PHEIC) by the World Health Organization.
Price not yet established
“The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool. To help address the current health crisis, ”said MPP Executive Director Charles Gore.
Merck is developing molnupiravir in conjunction with Ridgeback Biotherapeutics.
The Miami-based company’s CEO Wendy Holman said the deal meant that “quality-assured generic versions of molnupiravir can be developed and distributed rapidly after regulatory clearance.”
MPP was founded by Unitaid, which works on innovations to prevent, diagnose and treat major diseases in the poorest countries.
Prices for molnupiravir have yet to be determined, but its simplicity, plus competition among generic manufacturers, should mean low prices in the 105 poorest countries, Unitaid spokesman Herve Verhoosel said.
He said that in countries with low vaccination rates, millions would need the drug to prevent progression to serious disease.
“We also need to see this license followed by others as soon as possible for other promising and key products that are expected to come out of the portfolio soon, for which we must also ensure ample supply and affordability,” added Verhoosel.
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