Africa CDC endorses MSD licensing agreement for monthly oral PrEP candidate MK-8527

ETHIOPIA— The Africa CDC has welcomed voluntary licensing agreements between MSD and three African pharmaceutical manufacturers to develop and manufacture an investigational once-monthly oral HIV pre-exposure prophylaxis (PrEP) candidate known as MK-8527.

The agreements mark a step towards strengthening Africa’s pharmaceutical manufacturing capacity while expanding access to innovative HIV prevention technologies across the continent.

They also align with the Africa CDC’s Health Security and Sovereignty Agenda, which seeks to build stronger local capacity for the research, development and production of essential health products.

Three African manufacturers join partnership

Under the agreements, MSD will work with Aspen Pharmacare in South Africa, Quality Chemicals Industries Limited (QCIL) in Uganda and Universal Corporation Limited (UCL) in Kenya.

The partnerships bring together Africa’s growing clinical research capabilities and pharmaceutical manufacturing infrastructure.

By establishing manufacturing capacity closer to the populations that need new health technologies, the initiative aims to support more sustainable and equitable access to innovative medicines, subject to regulatory approvals and the candidate’s successful development.

The agreements also highlight the increasing role of African pharmaceutical manufacturers in the development and production of next-generation health products.

Strengthening these capabilities could help countries reduce dependence on imported medicines and improve their preparedness to respond to major public health challenges.

Welcoming the partnership with Aspen Pharmacare, South African President Cyril Ramaphosa said the agreement demonstrates confidence in the country’s pharmaceutical capabilities and in Africa’s ability to manufacture medicines for the future.

Africa CDC backs regional health sovereignty

Africa CDC Director General Dr Jean Kaseya described the agreements as more than a manufacturing initiative, placing them within the continent’s broader efforts to strengthen health sovereignty.

According to Kaseya, the partnership introduces a model in which African countries can contribute to generating scientific evidence, prepare local manufacturers to produce innovative health products and ultimately improve access for patients across the continent.

The Africa CDC said it is prepared to work with African Union Member States, regulatory authorities, manufacturers and other partners to support manufacturing readiness and facilitate rapid and equitable access to innovative health products.

The agency also highlighted the potential role of the African Pooled Procurement Mechanism in supporting access to a licensed product once it becomes available.

The mechanism is designed to strengthen countries’ purchasing power by enabling coordinated procurement of health products across participating African markets.

MK-8527 is being investigated as a once-monthly oral PrEP option for HIV prevention.

If successfully developed and approved by relevant regulatory authorities, a longer-acting oral prevention option could expand the choices available to people seeking to prevent HIV infection.

The agreements therefore connect pharmaceutical innovation with efforts to strengthen Africa’s domestic manufacturing ecosystem, while positioning African companies to participate more directly in the production of emerging health technologies.