SWITZERLAND – The Medicines Patent Pool (MPP) has announced that it has signed contracts with 27 manufacturers to manufacture Merck’s COVID-19 pill.

MPP’s agreements with generic manufacturers cover the production of the oral COVID-19 antiviral medication molnupiravir, with supplies planned for 105 low- and middle-income countries (LMICs).

The agreements are the result of a voluntary licensing agreement signed by MPP and MSD, a brand of Merck, to facilitate affordable global access to an antiviral drug developed by MSD in collaboration with Ridgeback Biotherapeutics.

Companies that were awarded sublicenses, which allow generic manufacturers to produce molnupiravir raw ingredients and/or the finished drug itself, successfully demonstrated their ability to meet MPP’s requirements for production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines.

Molnupiravir has been shown to cut hospitalization rates in patients with early signs of COVID-19 in half. In recent months, the United Kingdom, the European Union, and the United States have all approved its use.

In the FDA’s final review of clinical trial results, Monulpiravir received lower efficacy ratings and had more potential adverse effects than Pfizer’s Paxlovid.

This has dampened interest in the drug in some countries, including India, which has yet to recommend it as a COVID treatment. despite the fact that the drug is already in production with a local manufacturer.

Nonetheless, experts believe the Merck drug is an important new tool in countries’ arsenals because it can be administered to certain patients who are unable to tolerate Paxlovid.

Merck announced in October that it would permit other pharmaceutical companies to manufacture molnupiravir.

Generic manufacturers from 11 countries

According to the group, 27 generic drug manufacturers in 11 countries, including Bangladesh, China, Egypt, Vietnam, Kenya, and South Africa, will begin producing Merck’s pill soon.

Five companies will focus on producing raw ingredients, 13 on producing both raw ingredients and the finished drug, and nine on producing the finished drug.

Aspen Pharmacare in South Africa, Hikma in the Middle East, Universal Corporation Ltd in Kenya, and Beximco in Bangladesh are among the generic companies that have signed sublicenses.

Merck, Ridgeback Biotherapeutics, and Emory University have agreed to waive sales royalties as long as COVID-19 is designated as a public health emergency of international concern under the International Health Regulations.

Health organizations have praised the agreement as a positive step, but after the initial agreement was announced, Doctors Without Borders said it didn’t go far enough, in part because it excluded key upper-income countries that have been hard hit by the virus, such as China and Brazil.

An antiviral pill that people could take at home to reduce their symptoms and speed recovery could be game changer, relieving the strain on hospitals and aiding in the control of outbreaks in poorer countries with underdeveloped health-care systems.

It would also strengthen a two-pronged approach to the pandemic: medication treatment and prevention, primarily through vaccinations.

Merck and Ridgeback announced an agreement with UNICEF earlier this week to supply up to 3 million molnupiravir courses for distribution to more than 100 LMICs in the first half of the year, subject to regulatory approval.

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