Drug maker Gilead Sciences has signed licensing agreements with six pharmaceutical manufacturers that will allow them to produce and sell a generic version of Gilead’s six-month injectable lenacapavir for HIV prevention (known as PrEP) in 120 countries.
Announcement of the licensing agreements was made Oct. 2.
The drug still needs to be approved in those countries before the agreements can go into effect but this will allow for the manufacturers to act quickly once it is approved.
In the U.S., lenacapavir has been FDA approved as treatment for people living with HIV who are heavily treatment-experienced—marketed in the U.S. under the brand name Sunlenca, the shot is administered every six months and is part of a regimen that includes other HIV medications.
In an email to POSITIVELY AWARE, a spokesperson for Gilead confirmed that the licensing agreements cover lenacapavir for HIV prevention, pending approval in those countries, and for HIV treatment in heavily treatment-experienced adults with multidrug-resistant HIV.
The agreements are seen as a big win in the effort to prevent HIV in low- to middle-income countries around the world that have the highest rates of HIV. Although the agreements do not cover the U.S., it was praised by advocates who had urged Gilead to make lenacapavir more accessible by reducing its price at July’s AIDS 2024 international conference in Munich, Germany.
The company’s move to license generic lenacapavir overseas will not affect the drug’s cost in the U.S. Still, U.S. advocates hailed the agreement.
“This announcement speaks to the power of global advocates who have built a movement around access to long-acting injectable HIV prevention options,” said Jeremiah Johnson, executive director of PrEP4All, a U.S. advocacy organization. “However, we cannot leave behind U.S.-based communities that have been shut out of PrEP access due to Gilead’s price gouging and manipulation of the entire domestic PrEP response. We still do not have commitments from the company for a public health price for lenacapavir in the U.S.–currently priced at $42,250 per year for HIV treatment.”
There are limits to the licensing agreement, and one organization has criticized Gilead for it.
“Gilead’s licensing deal has left behind countries where the epidemic is growing fastest, including among key populations of gay and bisexual men, people who inject drugs, transgender women, sex workers, and other marginalized and criminalized populations, including in Argentina, Brazil, Mexico and Peru, countries where people put their bodies on the line and participated in the scientific research that showed lenacapavir’s efficacy, but where Gilead will most certainly price lenacapavir out of reach,” said Brook Baker, professor emeritus at Northeastern University School of Law and senior analyst at HealthGAP, a global accessibility advocacy nonprofit.
“License terms also prevent its six designated licensees from supplying excluded countries even if those countries do not have patents on lenacapavir and even if the excluded countries issue compulsory licenses,” he added.
“Lenacapavir must be available to everyone, everywhere, and governments can and should take steps now to overcome barriers presented by Gilead’s patents,” Baker said.
Gilead has been testing lenacapavir as a standalone HIV prevention drug under a series of clinical trials called PURPOSE, conducted in the U.S. and in various countries around the world including Brazil, Mexico, Peru, South Africa, Thailand and Uganda.
Phase 3 results of the PURPOSE 1 study that tested lenacapavir as PrEP in 2,134 adolescent girls and young women were so promising—the drug had an unprecedented 100% rate in protecting them from HIV—that the study was halted early, in June.
In mid-September, phase 3 results of PURPOSE 2—among more than 3,200 cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth—found lenacapavir was 96% effective and so the trial was stopped early, too.
Based on data from these PURPOSE studies, Gilead will begin applying for lenacapavir’s approval in the U.S. and in other countries by year’s end. The company is exploring frameworks such as the European Medicines Agency’s EU Medicines for All to expedite national regulatory procedures and gain prequalification from the World Health Organization.
The generic companies that will manufacture and supply lenacapavir to the 120 countries are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris. Gilead has previously worked with these companies on HIV drugs and medications for other conditions.
“Our voluntary licensing partners will set their own prices,” the Gilead spokesperson said.