In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”
Gilead is partnering with the U.S. State Department to make its newly approved, twice-yearly HIV pre-exposure prophylactic Yeztugo accessible to patients in resource-limited countries.
In collaboration with the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the pharma aims to “accelerate access” to Yeztugo in primarily low- and lower-middle-income countries, Gilead CEO Daniel O’Day said in a prepared statement on Thursday. It is not clear what the exact commitments of each party are under this partnership, though O’Day revealed that his company will provide Yeztugo “at no profit” under the agreement.
Gilead is currently working with PEPFAR and other global groups to gauge demand for Yeztugo in these target countries. Gilead did not specify which countries the partnership was targeting, though in its statement the company said it was preparing regulatory submissions for a series of countries with heavy HIV burdens, including Botswana, Mozambique and the Philippines.
This accessibility push follows the FDA’s June approval of Yeztugo, a long-acting preventive therapy that can provide protection against HIV for up to six months. In Phase III studies, twice-yearly Yeztugo hit efficacy as high as 100%.
In July, Gilead teamed up with the international non-profit the Global Fund to Fight AIDS, Tuberculosis and Malaria, with the similar goal of making Yeztugo broadly available to low- and middle-income countries. At the time, the partners said their effort would mark “the first time in history” that an HIV prophylactic will be made available in lower-income countries “at the same time as in high-income countries.”
In announcing the new U.S. government partnership, Gilead said it has also entered into royalty-free agreements with six generic drugmakers covering 120 lower-income countries with high HIV incidence rates.
Thursday’s agreement with Gilead comes after Health Secretary Robert F. Kennedy Jr. in June pulled U.S. funding from the global vaccine alliance Gavi, alleging that the group ignored safety concerns linked to vaccines.
