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Rio de Janeiro, Brazil, 24 July 2026 — AVAC and Access Bridge applaud Merck’s announcement today that it has granted seven direct licenses to generic manufacturers to produce their investigational monthly pill for HIV prevention, known as MK-8527, or alimatravir, while Phase 3 clinical trials are still enrolling.
The announcement from Merck/MSD reflects responsiveness to advocates’ longstanding calls to accelerate access to PrEP options. Since 2012, each successive PrEP introduction has gone faster than the previous one, yet the time to market and to public health impact remains too slow.
In advance of the AIDS 2026 conference, Merck, known as MSD outside the US and Canada, today announced voluntary licensing agreements with seven manufacturers, including three in East and Southern Africa, to produce and market alimatravir for PrEP in 129 countries.
“Today’s news reflects truly positive momentum in future access to alimatravir for PrEP, if proven safe and effective,” said Mitchell Warren, AVAC’s executive director. “Granting licensing agreements to generic manufacturers while clinical trials are still enrolling, before it is known if the product is effective, should significantly reduce the time to market for the product. The timeline announced today gives us ample opportunity to work with ministries of health, donors, communities, and Merck to plan for broad access to the monthly PrEP pill. This option lends itself to innovative delivery models – from pharmacies to community-based distribution approaches. While trials are still enrolling, we have the time to collectively ensure models are well-conceived and planned, adequately funded, and set up for success. With this timeline in hand, there’s no excuse for getting it wrong.”
“Merck’s early access announcement represents significant potential time-savings, compared to the experience with cabotegravir (CAB) and lenacapavir (LEN) in both timeline for licensing, and inclusion of those with greatest need. With three generic manufacturers in Kenya, Uganda, and South Africa included, these agreements go beyond those put in place for CAB and LEN and help to ensure that countries with some of the highest HIV burdens and largest PrEP markets will be able to make the product locally, should alimatravir prove safe and effective in phase 3 trials,” Warren added. “But while these voluntary licenses are essential, they are not sufficient on their own to translate exciting science into public health impact. Ultimately, access is about far more than licensure alone.”
Merck has worked with communities and advocates throughout the development of alimatravir, as exemplified by community representatives helping conceptualize the design of the phase 3 trials, even before Merck spoke to regulators. “We’ve appreciated the partnership between Merck and advocates in the research process. We’re seeing that commitment to community priorities translate into product introduction and access steps. As advocates, we will continue to watchdog this space, ensure communities remain at the center of access planning as it moves forward, and ensure accountability among all stakeholders,” said Stacey Hannah, AVAC’s Director of Research Engagement.
Every step in the process of moving a product to market can and should go faster with alimatravir than it went with CAB and LEN. To ensure the monthly PrEP pill is introduced and broadly accessible with speed, scale, and equity, AVAC and Access Bridge call on the broad range of stakeholders ensure these critical actions take place:
- Merck/MSD, governments, and donors to commit to reach at least two million people with alimatravir within the first year of product launch and five million people within the first two years.
- Merck/MSD to agree to sell the product to any public health procurer or donor at a price no more than the price of generic daily oral PrEP and injectable lenacapavir.
- Merck/MSD to guarantee that alimatravir will be available in low and middle-income countries within three months of first approval; halving the timeline it took for LEN to become available.
- Merck/MSD to articulate a transparent and robust plan for ensuring affordable, equitable access to alimatravir in Latin America, with a specific priority on countries hosting the EXPrESSIVE 11 trial, and direct work with advocates to navigate country specifics where voluntary licenses are not in place.
- WHO to accelerate the guidelines development process. Merck/MSD to clarify its regulatory strategy and prioritize broad regulatory submissions in parallel with its FDA submission, working with the WHO’s Collaborative Registration Procedure, the EMA’s Medicine4All program, and the African Medicines Agency.
- Donors working with WHO and ministries of health to design and embed a robust implementation science agenda within programmatic rollout to answer critical questions, particularly about adherence, for this new, monthly method of prevention, as part of introduction.
- All stakeholders to create and plan now for innovative service delivery that continues to simplify PrEP, working with private pharmacies, community-based organizations, and other innovative service delivery efforts.
- National governments start to prepare ambitious and costed implementation plans, guidelines, and comprehensive programs to integrate alimatravir into existing HIV prevention programs.
“Today’s announcement shows that the HIV prevention field can learn and apply lessons in real time. LEN for PrEP is now in limited distribution in ten African countries within two years of proven efficacy; this was a huge step forward, but we as a field can still do better,” said Wawira Nyagah, executive director of Access Bridge. “Now is the time to plan for even speedier and wider access if alimatravir works. This must include pricing transparency from Merck and their generic licensees, accelerated investments by donors to design and implement integrated programs that offer the monthly pill as part of choice of product and service delivery models that actually reach people who need and can benefit from it, everywhere, based on public health imperatives, and not on World Bank country classifications or geographical location. Anywhere the HIV epidemic is increasing must be included, full stop.”
For more than a decade, AVAC has mapped the roadmap and timelines for moving PrEP products from earliest research stages to market. With each successive option, AVAC has flagged what is failing, where the global community is watching, where things are improving, and where there’s room to do better still. As a result of this work, the global community is executing better, faster, more inclusively, and more equitably with every new option. Learn more about AVAC’s work on alimatravir. AVAC and Access Bridge will continue to monitor the research, approval processes and product implementation of PrEP options at https://avac.org/prevention-option/prep/ and www.prepwatch.org.
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About AVAC
AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on BlueSky and LinkedIn and find more at avac.org and prepwatch.org.
About Access Bridge
Access Bridge is an independent, Africa-anchored organization advancing timely, sustainable, and equitable introduction of and access to HIV prevention and related health products. Incubated at AVAC and rooted in African leadership and global collaboration, Access Bridge leads a globally recognized portfolio of product introduction and access projects. Follow Access Bridge on LinkedIn and find more at healthaccessbridge.org and prepwatch.org.