Gilead Sciences is pushing full speed ahead with its strategy to ensure global access to its long-acting HIV pre-exposure prophylaxis (PrEP) drug Yeztugo (lenacapavir), tapping the Global Fund to Fight AIDS, Tuberculosis and Malaria to help with the effort.
With the Global Fund on board, Gilead and its partner aim to supply enough Yeztugo doses for up to 2 million people over a span of three years, according to a July 9 press release. Under the deal, Gilead plans to provide the doses at no profit.
The Global Fund, an international organization focused on funding and partnerships, will prioritize which countries get early access to the drug based on HIV epidemiology, national prevention strategies and other available resources. The organization invests more than $4 billion each year to support specific healthcare initiatives and has saved more than 50 million lives since its founding, according to its website.
“For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic—but only if we get it to the people who need it most,” Executive Director of the Global Fund, Sepeter Sands, said in the release. “Our ambition is to reach 2 million people with long-acting PrEP. But we can only do that if the world steps up with the resources required.”
The partnership is part of Gilead's effort to maintain enough of an affordable supply of the drug until licensed Yeztugo generics can effectively meet demand in many countries around the world. The company previously inked agreements with six generic drug manufacturers to make and sell the drug across 120 high-incidence, resource-limited countries in October, before the drug had even crossed the regulatory finish line.
The voluntary license program was the “earliest and most geographically expansive ever developed for an anti-HIV agent,” according to today's press release from Gilead.
"This is all part of our unprecedented approach to access for a medicine that could help end the HIV epidemic," Gilead CEO Daniel O’Day said in the release.
Another major spoke in Gilead’s access wheel is its Yeztugo application through the EU-Medicines for all (EU-M4all) regulatory track, which would allow regulatory authorities in other countries to leverage the European Medicines Agency’s decision for their own review processes.
To that end, the company is “actively consulting” with global aid organizations, including the Global Fund, to collaborate on potential distribution and get a better sense of international product demand.
The EMA validated Gilead’s application for the long-acting PrEP drug in February.
Still, some countries, such as many in Latin America, have a high burden of HIV but aren’t covered by the voluntary license program. While Gilead says it's working through “multiple strategies” to support access, including tiered pricing and potential public-private partnerships, the discrepancy in access to Latin America is a point of contention for some advocates, including those at Public Citizen.
“We’re seeing countries in Latin America systematically excluded from access to medical innovation—not because of science, but because of profit,” director of global advocacy and policy at the AIDS Healthcare Foundation, Guillermina Alaniz, said in a Public Citizen press release. “That’s why we’re standing with Public Citizen and other allies to demand fair pricing, legal reform, and a regional push to break Gilead’s monopoly on lenacapavir.”
Public Citizen has long been spearheading its own campaign to ensure broader access to Yeztugo and is working with 100 health groups across Latin America to do so.
Yeztugo earned its world-first approval from the FDA in June. Soon after, the company released its access strategy, highlighting its schedule for regulatory applications across the globe.