Gilead Sciences announces a deal to manufacture generic versions of lenacapavir, but critics say it excludes many countries where incidence is highest.
Gilead Sciences has authorized manufacturers in Asia and North Africa to produce royalty-free generic versions of lenacapavir in 120 low- and middle-income countries.
Sales of generics for HIV prevention are scheduled to begin in late 2027. The agreement does not apply to most middle- and high-income countries, including Brazil and Russia.
Lenacapavir is a drug in the form of injections administered to patients at six-monthly intervals. Its efficacy was confirmed by the Phase II/III CAPELLA trial - after one year, 83% of HIV-infected patients taking the therapy had reduced their viral load to an undetectable level.
The company said it had signed agreements with six manufacturers to make and sell generic lenacapavir. It said it would also bridge the gap until those manufacturers were up and running by providing Gilead-supplied product, prioritising registration in 18 countries with high HIV rates including Botswana, South Africa and Thailand.
Some experts criticised the decision to arrange licences directly rather than through the UN-backed Medicine Patent Pool. The agreements came with “draconian conditions” that could make it harder for people in excluded countries to get hold of the drug, experts pointed out.
Winnie Byanyima, UNAids executive director, warned that 41% of new infections were in upper middle-income countries, and excluding them from the licences “is deeply worrying and undermines the potential of this scientific breakthrough.”
“The countries that have been excluded can use their legal rights to overcome intellectual property restrictions with a compulsory licence. However, Gilead’s agreement prevents the six licensee companies from selling to those countries. Moreover, this route is fraught with difficulties and can face legal challenges from industry. But it is a country’s right, and should be used if necessary,”
Winnie Byanyima said.
The generic manufacturers are India’s Dr Reddy’s Laboratories, Emcure Pharmaceuticals and Hetero Labs, as well as US-based Viatris’ unit Mylan, Egypt’s Eva Pharma and Pakistan-based Ferozsons Laboratories. UNAids said it would also like to see agreements in countries with high HIV rates such as South Africa.
Wednesday’s licensing deals come as the pharma has faced increasing pressure from various organizations to improve access to its HIV medicine. In July 2024, UNAIDS Executive Director Winnie Byanyima urged Gilead to “move quickly to license lenacapavir to generics producers,” which can “bring the price down and sere all countries where the majority of people who are at risk live.”
The US Food and Drug Administration (FDA) approved Gilead's antiretroviral drug in 2022. In the US, lenacapavir costs $42,250 for a one-year course. Earlier, researchers found that its generic version could cost a thousand times less — as little as $40.
Sources: BioSpace, Guardian, Pharmvestnik
