Merck signs pact to broaden generic manufacturing of COVID pill

Merck’s pill has the potential to alter the course of the pandemic. Earlier this month, the company and partner Ridgeback Biotherapeutics released data showing molnupiravir could cut the risk of hospitalization or death from COVID-19 in half. The partners then quickly filed for emergency authorization from the Food and Drug Administration.

To date, the most successful treatments for COVID-19 have been monoclonal antibody medicines that require infusions at a healthcare facility. At best, such treatment can be inconvenient for patients in higher-income countries, while in lower-income nations they may be much more difficult to access.

Merck has been trying to lay the groundwork for more people to receive the pill even before it’s approved by regulators. In April, the company signed non-exclusive licensing agreements with five Indian generic drug manufacturers. Merck has also begun large-scale manufacturing of the drug and expects to produce 10 million courses by the end of 2021.

The Bill & Melinda Gates Foundation, meanwhile, announced last week it will spend $120 million to speed access to molnupiravir in lower-income countries. Both the Gates Foundation and the Medicines Patent Pool, established in 2010, are building on work they previously did to make HIV drugs more affordable and accessible throughout the world.

The U.S. government has already pre-purchased a supply of molnupiravir for domestic use, agreeing in June to pay $1.2 billion for about 1.7 million courses of the drug, which was originally discovered at Emory University.

Emory’s innovation arm licensed the medicine to privately held Ridgeback Biotherapeutics, which then sold rights to Merck in May 2020.

Dive Brief:

• Merck said international access to its experimental COVID-19 pill will increase after signing an agreement with a United Nations-backed public health organization dedicated to bringing medicines to lower income nations.
• Under the agreement, the Medicines Patent Pool can grant non-exclusive sublicenses to manufacturers to boost the supply of the drug, known as molnupiravir. Merck said Wednesday it expects the arrangement to help create “broad access” to the pill in 105 low- and middle-income countries.
• The medicine, which could become the first pill to treat COVID-19, would be available in countries where regulators have cleared its use. Merck and its development partners also said they will forgo royalties as long as the World Health Organization considers COVID-19 a public health emergency of international concern.

BioPharma Dive