Merck has outlined initial access plans for alimatravir, an investigational once-monthly oral HIV pre-exposure prophylaxis pill in Phase 3 development, aiming to provide rapid, broad, and sustainable availability in low- and middle-income countries if the drug is approved. The company said the strategy is being built now, while Phase 3 trials are still ongoing, in order to accelerate future rollout in regions with high unmet need.
As part of the plan, Merck has signed seven non-exclusive voluntary licensing agreements with generic manufacturers covering 129 countries, including major HIV-burden regions in sub-Saharan Africa and India. The royalty-free agreements include three manufacturers in sub-Saharan Africa and four in India, and they are designed to support supply in both public and private sectors across markets that account for the substantial majority of new HIV diagnoses globally. Merck said making these deals before Phase 3 enrollment is complete is a first in HIV prevention and should help partners begin planning for scale-up earlier.
The company also plans to support regional manufacturing capacity in Africa and Latin America, and it is investing early in product manufacturing so that supply can begin quickly after potential approval. Merck said it expects to provide initial supply while licensed generic manufacturers complete development, secure regulatory approvals, and bring their own capacity online. The company said that approach is meant to avoid delays in access and ensure a bridge to broader generic production.
Merck said alimatravir could offer one month of HIV-1 protection in a single pill, with predicted onset of protection within one hour after dosing. The company said the strategy was shaped by years of engagement with HIV advocates and global health stakeholders, and it will continue as the Phase 3 EXPrESSIVE trials enroll participants in Africa and other regions.
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