Merck has unveiled an aggressive early access strategy for its experimental once-monthly HIV prevention pill, alimatravir, announcing licensing deals with generic drugmakers and manufacturing investments years before the medicine could reach the market.
The move positions Merck to accelerate access in low- and middle-income countries if the drug wins regulatory approval, with licensing agreements already covering 129 countries that account for the vast majority of new HIV infections worldwide.
The announcement comes ahead of the 26th International AIDS Conference in Rio de Janeiro and marks one of the earliest access initiatives ever launched for an HIV prevention medicine while Phase 3 clinical trials are still underway.
Merck said its strategy combines early generic licensing, regional manufacturing partnerships in Africa and Latin America, and upfront investments in production capacity to shorten the time between regulatory approval and patient access.
If approved, alimatravir could become the first once-monthly oral HIV pre-exposure prophylaxis (PrEP) option, offering a single pill designed to provide one month of protection against HIV-1 and predicted to begin protecting within one hour after dosing.
"Scientific innovation only has impact when it reaches those who need it most," said Robert M. Davis, chairman and chief executive officer, Merck.
"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.
"These important first steps reflect years of engagement with advocates and global health stakeholders. As Phase 3 trials progress, we remain committed to advancing our efforts in partnership with the HIV community to help maximize the public health impact of alimatravir, if approved."
Merck has signed seven non-exclusive, royalty-free voluntary licensing agreements with generic manufacturers—three in sub-Saharan Africa (Aspen Pharmacare Holdings, Quality Chemical Industries Limited and UCL Kenya) and four in India (Aurobindo, Cipla, Emcure and Viatris).
The agreements cover both public and private markets, allowing participating manufacturers to develop and supply generic versions of alimatravir across 129 eligible countries once the medicine is approved.
Merck said finalising licensing agreements before Phase 3 trial enrolment is complete is a first for HIV prevention and is intended to speed regulatory work, manufacturing and large-scale rollout.
"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."
Focus on regional manufacturing
The company is also backing regional production, particularly in Africa, where HIV continues to have its greatest impact.
For the first time in an HIV licensing programme, generic manufacturers in sub-Saharan Africa have been included in the initial licensing agreements alongside Indian manufacturers, a move aimed at strengthening local manufacturing capacity and improving long-term supply security.
"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," said Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention.
"We welcome this decision to engage African manufacturers early. Africa must continue to expand its role across the health innovation value chain, from supporting research ecosystems and clinical trial capacity to manufacturing and access. This is how we strengthen health sovereignty and bring new HIV prevention options closer to our people."
Merck is also in discussions with organisations including Brazil's Fiocruz to establish regional manufacturing and supply pathways for Latin America.
