Merck has announced an early access strategy for alimatravir (MK-8527), its investigational once-monthly oral HIV pre-exposure prophylaxis (PrEP) candidate currently in Phase 3 clinical development.
The strategy aims to ensure rapid, broad, and sustainable access to the medicine in 129 low- and middle-income countries (LMICs) following regulatory approval. As part of the initiative, Merck has signed seven royalty-free voluntary licensing agreements with generic manufacturers in sub-Saharan Africa and India to support future production and supply.
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“Merck’s early and proactive efforts to enable quick access to its new PrEP option, if approved, are important to help protect the communities most affected by HIV,” said Mark Suzman, chief executive officer of the Gates Foundation, which aims to end or significantly reduce preventable infectious diseases, including HIV, in the next two decades. “We look forward to continuing to work with Merck and other partners who will help advance these plans and expand access to HIV prevention options.”
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The company is also investing in regional manufacturing capacity in Africa and Latin America while expanding its own manufacturing capabilities to help ensure timely availability in regions with high HIV burden.
Alimatravir is being evaluated as a potential once-monthly oral PrEP option that could provide one month of HIV-1 protection with a single pill. Two global Phase 3 trials EXPrESSIVE-10 and EXPrESSIVE-11 are currently enrolling participants across multiple countries.
