Commentary: Merck & Co. commits to broadening access to HIV prevention in LMICs

What was announced: Merck & Co. (MSD) has entered into royalty-free, non-exclusive voluntary licensing (NEVL) agreements with three manufacturers in sub-Saharan Africa and four with sites in India to manufacture generic versions of alimatravir (MK-8527), an experimental long-acting oral pre-exposure prophylaxis (PrEP) administered once monthly.  

Why it stands out:  

• Early licensing: The announcement of the NEVL comes before the PrEP candidate has completed Phase III clinical trials – a first in the HIV prevention space. By enabling planning for generic production ahead of regulatory approval, the agreement helps accelerate access once the product is approved, allowing eligible countries to benefit sooner. 

• Generic selection: The geographic distribution of selected generic manufacturers extends beyond India to include sites in Kenya, South Africa and Uganda, with three of these four countries ranking among the ten countries with the highest HIV burdens globally. The involvement of a high number of manufacturers could foster competition, which helps improve affordability, while strengthening local production capacity and supporting future access to PrEP. 

• Diversity in clinical trials: The inclusion of manufacturers headquartered in Kenya, South Africa and Uganda aligns with ongoing Gates Foundation-supported clinical trials evaluating alimatravir in adolescent girls and young women in these countries. 

Latin America remains partially covered: While this licence expands geographic coverage compared with previous agreements (such as the NEVL for lenacapavir), reaching countries that account for more than 65% of new HIV cases globally, several countries across Latin America remain outside the agreement. This includes LMICs that participated in the company’s clinical trials, such as Brazil, Colombia and Peru. Notably, Brazil ranks fourth globally for HIV incidence, underscoring the importance of ensuring affordable access. 

What’s next: Further details will help clarify the agreement’s potential impact and contribution to broader access to alimatravir: 

• Population reach targets: MSD has not yet disclosed the number of people it plans to reach with the monthly PrEP under the licensing agreements. The impact is highly dependent on whether supply can meet the expected demand among people who could benefit from alimatravir. 

• Affordability considerations: More clarity is needed on affordability for countries outside the agreements, where MSD has not yet disclosed equitable pricing strategies. While the company has committed to enabling rapid availability and broad supply of alimatravir in the excluded Latin American countries, affordability should be considered from the outset through developing equitable pricing strategies. 

• Regulatory strategy: A clear regulatory pathway, including broad submissions alongside FDA application (e.g., through the WHO Collaborative Registration Procedure, the EMA’s Medicine4All programme and the African Medicines Agency), would help maximise the agreement’s impact and accelerate access.