Merck announced early components of a strategy to provide access in low- and middle-income countries to alimatravir, an investigational once-monthly oral pill being developed as pre-exposure prophylaxis for HIV-1, if approved. The plan includes early generic licensing covering 129 countries, support for regional manufacturing in Africa and Latin America, and early investment in product manufacturing, with the initial steps announced ahead of the 26th International AIDS Conference in Rio de Janeiro.
Merck has signed seven non-exclusive, royalty-free voluntary licensing agreements with generic manufacturers, including three in sub-Saharan Africa, Aspen Pharmacare Holdings, Quality Chemical Industries, and UCL Kenya, and four in India, Aurobindo, Cipla, Emcure, and Viatris. The agreements cover both public and private sectors across 129 low- and middle-income countries that account for a substantial majority of new HIV diagnoses globally. Merck said entering these licensing agreements before Phase 3 enrollment is complete represents a first in HIV prevention, intended to help generic manufacturers accelerate development and regulatory work ahead of a potential approval.
Alimatravir is currently being evaluated in two ongoing Phase 3 trials: EXPrESSIVE-10, which is studying adolescent girls and young women in Kenya, South Africa, and Uganda with financial support from the Gates Foundation, and EXPrESSIVE-11, which is evaluating people with greater likelihood of HIV-1 exposure across 16 countries. Those trials build on a Phase 2 study of 350 participants that found similar rates of adverse events between alimatravir and placebo groups, with no clinically meaningful changes in lymphocyte or CD4 T-cell counts. If approved, Merck said alimatravir would offer one month of HIV-1 protection in a single pill, with protection predicted to begin within one hour of dosing. Merck is also in active discussions with organizations including Fiocruz to support rapid availability of the drug in Latin America, where Brazil recorded approximately 55,000 new HIV infections in 2024.
KEY QUOTES:
“Scientific innovation only has impact when it reaches those who need it most. 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.”
Robert M. Davis, Chairman and Chief Executive Officer, Merck
“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. 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.”
Mark Suzman, Chief Executive Officer, Gates Foundation
“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. We welcome this decision to engage African manufacturers early.”
Jean Kaseya, Director General, Africa Centres for Disease Control and Prevention
