Quality Chemical Industries Limited (Qcil), a Ugandan pharmaceutical manufacturer, has been included in a global licensing arrangement that could allow it to produce a new monthly oral HIV prevention pill for supply to low- and middle-income countries. Merck, known as MSD outside the United States and Canada, has signed voluntary licensing agreements with seven generic drug manufacturers for alimatravir, also known as MK-8527, an investigational once-monthly oral pre-exposure prophylaxis (PrEP) drug currently in Phase 3 clinical trials.
Quality Chemical Industries Limited (Qcil) is among the seven manufacturers. The other African companies included in the arrangement are Aspen Pharmacare of South Africa and UCL Kenya, while four manufacturers are based in India. The agreements cover 129 low- and middle-income countries and are intended to support regional manufacturing and expand access to the medicine if it is shown to be safe and effective and subsequently approved by regulatory authorities.
For Uganda, the arrangement could create an opportunity for local production of a next-generation HIV prevention product and potentially strengthen supply chains for PrEP in the region. The licensing agreement is notable because it has been reached before the completion of alimatravir’s Phase 3 efficacy trials.
Advocates say preparing generic manufacturing capacity at this stage could reduce the delay that often occurs between successful clinical trials, regulatory approval, licensing and the availability of affordable generic versions. The move is also part of a broader effort to increase African manufacturing capacity for newer HIV prevention medicines.
Unitaid said Qcil, UCL Kenya and Aspen have established experience producing quality-assured medicines for HIV, malaria and other priority diseases. However, alimatravir is not yet an approved HIV prevention medicine. The licensing agreement therefore does not mean the pill is currently available to Ugandans.
The drug is being developed as a once-monthly oral PrEP option, potentially offering an alternative to prevention methods that require daily dosing or more frequent clinic visits. Its effectiveness and safety are still being evaluated in clinical trials.
The development comes at a difficult time for Uganda’s HIV response, which has faced disruptions following reductions in US-funded HIV programmes.
UNAIDS reported that the 2025 US funding disruption affected HIV services in Uganda, including distribution and community-based prevention activities. The agency warned that disruptions to funding posed risks to HIV prevention, treatment and other services.
Research published in 2026 has also documented the effects of the loss of PEPFAR support in eastern Uganda, reporting declines in viral suppression and other HIV programme outcomes.
The funding challenges have increased attention on the need for more sustainable HIV financing and stronger local health systems, even as new prevention technologies are being developed.
The licensing of Qcil could therefore become important beyond the production of a single medicine, particularly if Uganda is able to build on its pharmaceutical manufacturing capacity to improve the regional supply of HIV commodities.
At the global level, the licensing announcement comes amid concerns about declining resources for the HIV response. UNAIDS reported at the AIDS 2026 conference in Rio de Janeiro that international HIV assistance declined by 18 percent between 2024 and 2025, while new HIV infections globally remained largely unchanged for a third consecutive year.
The funding pressures have raised concerns that scientific advances in HIV prevention may not translate into wider access if countries lack the resources and health-system capacity to deliver them.
The inclusion of a local manufacturer in the alimatravir licensing programme offers Uganda an opportunity to bring production closer to one of the regions with a significant HIV burden.
The immediate next step, however, is completion of the clinical trials and regulatory review.
Only after the medicine is shown to be safe and effective and receives the necessary approvals can generic production translate into wider access to alimatravir.
Globally, 1.2 million people acquired HIV in 2025, approximately 3,300 each day. Today, multiple HIV prevention options are available, including daily oral PrEP, long-acting injectable PrEP, and other evidence-based prevention tools.
According to the 2024 UNAIDS report, only 3.5 million people were using oral PrEP in 2023, demonstrating the urgent need to expand access and uptake to reach the global goal of 20 million people receiving PrEP by 2030.
MSD said in a statement that new access programs should enable rapid, broad and sustainable scale-up, and focus on the persistent barriers that may be limiting PrEP use, including stigma and affordability. “Scientific innovation only has impact when it reaches those who need it most,” said Robert M. Davis, chairman and chief executive officer, Merck.
“Merck has a deep legacy in HIV and a longstanding commitment to public health. Recognizing the urgent, unmet needs in HIV prevention, we are acting early to enable rapid, broad and sustainable access to alimatravir, an investigational once-monthly oral PrEP option, in low- and middle-income countries”
To reduce the time between potential regulatory approval of alimatravir and its availability in Low- and Middle-Income Countries, Merck is investing early in its product manufacturing capacity as Phase 3 trials continue. These efforts are intended to help ensure that sufficient product supply is made available, if approved, in areas of high unmet need following the anticipated U.S. approval to enable early program implementation and ambitious scale-up.
Merck expects to provide initial supply and continue supplying product as needed while licensed generic manufacturers complete development, obtain the necessary regulatory approvals, and prepare to supply the licensed territories.
The goal is to help avoid delays in access by providing an initial supply pathway until generic manufacturing capacity is established and brought online. These actions represent important early steps to help support the future availability and supply of alimatravir in countries with a high burden of HIV, subject to applicable regulatory approvals and requirements.
Merck said it is committed to continuing to advance its access plans, working in close collaboration with communities and global health stakeholders, as Phase 3 trials continue.
Alimatravir is currently being evaluated in two ongoing Phase 3 clinical trials. With financial support from the Gates Foundation, the Phase 3 trial is evaluating the safety and efficacy of alimatravir in adolescent girls and young women in Kenya, South Africa and Uganda.
The study enrolled 350 participants, 18–65 years of age, with low likelihood of HIV-1 exposure.
It has been noted that sustainable access for HIV prevention requires reliable supply chains, strong local partnerships and country ownership and prioritization.
The voluntary licensing strategy for alimatravir is designed to help support sustainable access across Africa and other high-burden geographies by enabling regional manufacturing, strengthening supply resilience and supporting long-term availability following approval.
Africa has the highest burden of HIV worldwide. With this announcement, for the first time in HIV, generic manufacturers in sub-Saharan Africa have been included in the initial voluntary licenses granted, alongside generic manufacturers in India, enabling planning for introduction and scale-up by local manufacturers.
“People across Africa need more options to prevent HIV. A once-monthly pill could provide a different choice for people in how to protect themselves, subject to successful trials and regulatory approval,” said Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention.
“We welcome this decision to engage African manufacturers early. Africa must continue to expand its role across the health innovation value chain, from supporting research ecosystems and clinical trial capacity to manufacturing and access. This is how we strengthen health sovereignty and bring new HIV prevention options closer to our people.”-URN. Give us feedback on this story through our email: kamwokyatimes@gmail.com
