According to Reuters, Merck has signed seven voluntary licensing agreements with generic drug manufacturers to make and sell lower-cost versions of its experimental once-monthly oral HIV pill, alimatravir, in 129 low- and lower-middle-income countries. The agreements cover both the public and private sectors and will enable supply of generic alimatravir in these markets that account for a substantial majority of new HIV diagnoses globally. As reported by Reuters, the agreements are with three sub-Saharan Africa manufacturers - Aspen Pharmacare Holdings (APNJ.J), Quality Chemical Industries and UCL - and four Indian companies, which are Aurobindo, Cipla, Emcure and Viatris. Gregg Szabo, head of Merck's global vaccines and infectious diseases unit, noted that this marks the first time that sub-Saharan African manufacturers have been included in licenses from the very beginning. The announcement comes ahead of the 26th International AIDS Conference in Rio de Janeiro, Brazil.
As reported by Reuters, the company will manufacture and supply generic alimatravir that meets internationally recognised standards following regulatory approvals. According to the filing, these markets account for the majority of new HIV diagnoses globally. The early execution of the agreements is intended to enable the required scale-up of manufacturing, with the company positioned among a select group of global generic manufacturers to sign the agreement. According to Reuters, Paul Schaper, head of global pharmaceutical public policy at Merck, stated that they're likely not to have any trial results until the second half of next year, but this will give time for the generic licensees to start working to scale up their production. Merck plans to provide initial supplies while licensed manufacturers complete product development and obtain regulatory approvals.
According to Reuters, alimatravir is currently in late-stage development and is expected to provide one month of protection from HIV-1 starting within one hour after dosing. The drug is in Phase 3 trials with patient enrollment still ongoing. Merck is investing early in its product manufacturing capacity as trials continue. In 2024, Gilead Sciences granted royalty-free licenses to six generic drug manufacturers to make and sell cheaper copycat versions of its HIV prevention medicine, lenacapavir, in 120 low and lower-middle income countries, setting a precedent for this current initiative. The company said it intends to provide trial participants with access to Alimatravir after the studies conclude, pending regulatory approval.
According to Aurobindo Pharma's latest financial results, the company reported consolidated revenue of ₹33,653 crore for FY26, representing a year-on-year growth of 6.08%. The company maintained a robust operating margin of 20.4% with consolidated EBITDA of ₹6,856 crore for the full year. This royalty-free licensing agreement positions Aurobindo as one of only four Indian generic manufacturers selected by MSD for this early generic licensing program. The deal leverages Aurobindo's robust backward-integrated API and formulation capabilities to maintain a low cost-of-goods-sold advantage. The agreement is expected to be structurally positive for Aurobindo's long-term export formulations business, with the royalty-free rights in 129 countries ensuring a strong pipeline entry in the HIV-1 prophylaxis market.
As reported by Reuters, about 40.9 million people globally were living with HIV in 2025, with sub-Saharan Africa accounting for more than half of all the people living with HIV worldwide, according to UNAIDS data. The World Health Organization has urged governments and drugmakers to improve access to affordable HIV medicines, including through voluntary licensing and greater generic competition. According to Merck, only 3.5 million people were using oral PrEP in 2023, far below the global target of 20 million by 2030, despite an estimated 1.2 million new HIV infections recorded in 2025. Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention, welcomed the decision to engage African manufacturers early, stating that "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." Merck is also in active discussions with organizations including Fiocruz to enable rapid availability and broad supply of alimatravir in Latin America, where approximately 55,000 people acquired HIV in 2024. The company expects to provide initial supply while licensed generic manufacturers complete development and obtain regulatory approvals.
