105 Countries Set to Receive Generic Versions of New Merck Anti-COVID Drug, Molnupiravir
Merck laboratory that developed the new oral COVID treatment, molnupiravir

The Medicines Patent Pool (MPP) said Thursday that it had already signed agreements with 27 generic manufacturing companies for the manufacturing of the oral COVID-19 antiviral medication molnupiravir and supply in 105 low- and-middle-income countries (LMICs).

The sublicense agreements are the result of the voluntary licensing agreement signed by MPP and MSD in October 2021 to facilitate affordable global access for the new COVID treatment, one of two that has recently received approval from the US Food and Drug Administration.

In comparison with Pfizer’s Paxlovid, Monulpiravir emerged with lower efficacy ratings and more potential adverse effects, in the FDA’s final reviews of clinical trial results. This has dampened enthusiasm about the drug in some countries, including India which has so far refrained from recommending it as a COVID treatment. even though the drug is already in production with a local manufacturer.

Even so, experts also the Merck drug is still regarded as an important new tool in countries’ arsenals because it can be administered to certain patients unable to tolerate Paxlovid.

MPP licenses come even before WHO issues recommendation on use of new oral drugs

Strikingly, WHO has yet to approve either Paxlovid or monulpiravir – a step that is usually regarded as preliminary to the negotiation of manufacturing licenses by a UN-supported group like the MPP.

A WHO Guidelines Development Group meeting that is scheduled to review Paxlovid [nirmatrelvir] on 9 February, a WHO spokesperson told Health Policy Watch last week, but declined to comment on when the Merck drug will be reviewed.

The non-exclusive licenses allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself.

In a press release, the Geneva-based MPP said that the companies that were offered the sublicense successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug and 9 companies will produce the finished drug. The companies span 11 countries, Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.

While MSD negotiated an agreement with MPP that establishes the terms and conditions, the requests for sublicences from generic producers were reviewed solely by MPP and presented to MSD. Neither MSD nor its collaborators in the R&D at Ridgeback Biotherapeutics, nor Emory University, which invented the drug, will receive royalties from sales of molnupiravir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sublicence for molnupiravir through MPP,” said Charles Gore, MPP Executive Director. “This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment and we are confident that, as manufacturers are working closely with regulatory authorities, the anticipated treatments will be rapidly available in LMICs.”

“Accelerating broad, affordable access to molnupiravir has been a priority for MSD from the start, which led us to partner with MPP on a licensing agreement to expand access to quality-assured generic versions of molnupiravir, subject to local regulatory authorisation,” said Paul Schaper, Executive Director, Global Public Policy, MSD. “We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”

More on MPP’s licence on molnupiravir and on the sublicence agreements : https://medicinespatentpool.org/licence-post/molnupiravir-mol

Image Credits: Merck .

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