Merck & Company IncMerck's investigational HIV prevention pill alimatravir is progressing in Phase 3, with early access plan and voluntary licenses, potentially expanding future demand.
Merck announced initial components of a multi-faceted strategy to provide rapid, broad and sustainable access in low- and middle-income countries to alimatravir, an investigational once-monthly oral pill for HIV-1 pre-exposure prophylaxis currently in Phase 3 development. The plan includes seven non-exclusive voluntary licensing agreements with generic manufacturers covering 129 countries that account for the substantial majority of new HIV diagnoses globally, with royalty-free terms for both public and private sectors. For the first time in HIV prevention, these licenses were signed before Phase 3 trial enrollment is complete, and they include three sub-Saharan African manufacturers—Aspen Pharmacare, Quality Chemical Industries, and UCL Kenya—alongside four Indian companies—Aurobindo, Cipla, Emcure, and Viatris. Merck is also investing early in its own manufacturing capacity to supply product after anticipated U.S. approval while licensed generics complete development, and is in active discussions with organizations including Fiocruz to enable rapid availability in Latin America. The access strategy was shaped by years of engagement with the HIV community and global health stakeholders, and Merck expects to provide initial supply until generic manufacturing capacity is established.
Merck & Company IncMerck's investigational HIV prevention pill alimatravir is progressing in Phase 3, with early access plan and voluntary licenses, potentially expanding future demand.
Viatris IncViatris is one of four Indian generic manufacturers selected for non-exclusive voluntary licensing agreements, enabling future production and revenue.
Merck KGaAQuality Chemical Industries is one of three sub-Saharan African manufacturers included in the licensing agreements, enabling it to produce and supply alimatravir in 129 countries.
Aspen Pharmacare is one of three sub-Saharan African manufacturers selected for non-exclusive voluntary licensing agreements, enabling future production and revenue.
Aurobindo Pharma is one of four Indian generic manufacturers selected for non-exclusive voluntary licensing agreements, enabling future production and revenue.
Cipla is one of four Indian generic manufacturers selected for non-exclusive voluntary licensing agreements, enabling future production and revenue.
Emcure is one of the four Indian generic manufacturers selected for non-exclusive voluntary licensing agreements to produce alimatravir, which will create new revenue opportunities.