Unitaid strengthens African manufacturing capacity for next-generation HIV prevention medicines

Unitaid today announced support for three leading African pharmaceutical manufacturers as they prepare for the potential regional production of quality-assured alimatravir (MK-8527), a once-monthly HIV prevention pill currently in Phase 3 development, pending successful clinical trial results and regulatory approval.

Quality Chemical Industries Limited (Qcil) in Uganda; Universal Corporation Limited (UCL) in Kenya and Aspen Pharmacare in South Africa will receive end-to-end support to strengthen their manufacturing capabilities, helping lay the foundations for more sustainable regional production of future HIV prevention medicines across the continent.

Developed by MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), alimatravir is an investigational once-monthly oral pre-exposure prophylaxis (PrEP) medicine currently in Phase III clinical trials. If proven safe and effective and approved by regulators, it could become an important new prevention option alongside existing daily oral PrEP and long-acting injectable antiretrovirals (ARVs), offering people greater choice in how they protect themselves from HIV.

“Aspen pioneered Africa’s first generic antiretroviral in 2003, and we have argued ever since that this continent should not wait years for novel medicines originated elsewhere. If the science on alimatravir holds, we intend to be ready to supply it in the quickest possible time. With Unitaid’s support through MedSuRe, we can accelerate the capability to make this once-monthly prevention pill here on the African continent before approval rather than years after it,” said Stavros Nicolaou, Group Senior Executive, Strategic Trade at Aspen Pharma Group.

“We are proud to contribute our manufacturing expertise and long-standing experience in HIV medicines to support the future availability of alimatravir and broaden HIV prevention options for communities across Africa,” said Ajay Kumar Pal, CEO of Qcil.

“This collaboration marks an important step in advancing regional pharmaceutical manufacturing excellence in Africa. With Unitaid support, UCL is strengthening its capabilities to produce innovative, quality-assured HIV prevention products and enhance regional health security. To fully realise the potential of these innovations, continued commitment to regional manufacturing, technology transfer and strategic procurement will be essential to building a resilient and self-reliant pharmaceutical sector across Africa.” said Perviz Dhanani, Founder and Managing Director, Universal Corporation Limited, Kenya.

Qcil, UCL and Aspen Pharmacare have established track records producing quality-assured medicines for HIV, malaria and other priority diseases. Through the MedSuRe program, Unitaid will strengthen the technical expertise, systems and partnerships needed to manufacture health products such as alimatravir locally.

This effort is part of Unitaid’s broader Regional Manufacturing for Equitable Access (RMEA) portfolio which aims to strengthen the ability of countries in Africa to produce their own medicines and diagnostics. Support to the three manufacturers will be provided through the MedSuRe Africa program which works to improve sustainable Africa-based production of critical medicines used for the prevention and treatment of malaria, HIV/AIDS, and maternal health conditions such as post-partum hemorrhage, and is implemented by the United States Pharmacopeia (USP). By investing in regional manufacturing capabilities early, partners aim to enable innovative HIV prevention medicines to be produced closer to where they are needed, supporting faster, more equitable and sustainable access once they become available.

Dr. Philippe Duneton, Executive Director at Unitaid said, “Scientific innovation is absolutely key for health and, particularly for HIV prevention, innovation has to come with access plans to improve health outcomes. The capacity to manufacture low-priced, quality-assured medicines where they are needed is part of this access plan we need. Through MedSuRe, we are working alongside African manufacturers to strengthen the expertise, systems and partnerships that will help ensure future HIV prevention innovations can be produced closer to the communities they are intended to support.”

Ronald T. Piervincenzi, Ph.D., Chief Executive Officer of USP said, “New, innovative HIV prevention options have the potential to transform lives, but impact ultimately depends on closing the gap between innovation, availability, and quality. Through the work of the MedSuRe program, we are strengthening capacity to make these products in more places and in ways that support quality, build more resilient supply chains, and strengthen global health security.”

This announcement recognizes MSD’s commitment to rapid, broad and sustainable access to alimatravir and follows recent agreements between MSD and the three manufacturers for the future supply of generic alimatravir, reflecting a shared commitment to strengthening pharmaceutical manufacturing capacity on the continent.

In parallel, Unitaid is investing early in preparing health systems for the rapid introduction of alimatravir and other next-generation HIV prevention products. Building on its broader PrEP portfolio, including a further US$15 million investment announced on 23 July, the organization will support the integration of new HIV prevention options into differentiated service delivery approaches that simplify access for the people and communities who stand to benefit most.

As the HIV prevention landscape continues to evolve, strengthening regional manufacturing will be critical to ensuring that innovative products reach low- and middle-income countries more quickly, more reliably and at a sustainable scale. Partnerships such as MedSuRe are helping build the manufacturing capacity needed to support that future.

About MedSuRe

The Medicines Supply Resilience (MedSuRe) Africa program, funded by Unitaid and the European Union, and led by USP, aims to increase regional production of quality-assured, African-made medicines, including those to prevent and treat malaria, HIV/AIDS, and post-partum hemorrhage (PPH), in ways that are cost-competitive and climate-smart. The program is implemented in partnership with Maisha Meds, Market Access Africa, and Medicines for All Institute at Virginia Commonwealth University, and with additional collaboration from the Medicines Patent Pool and Health 4 Development.

About USP:

USP is a private, non‑profit scientific organization that collaborates with stakeholders around the world to develop public quality standards and solutions that support quality across the development, manufacturing, and delivery of regulated health products; strengthen regulatory systems; enhance supply reliability; and support the adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in increasing the availability of quality medicines, dietary supplements, and food ingredients worldwide.