Indian drugmakers Dr Reddy’s, Hetero to sell generic HIV prevention drug for $40 a year

(Reuters): Indian drugmakers Dr Reddy’s Laboratories and Hetero Labs said on Wednesday that they will sell generic versions of a new and highly effective HIV prevention drug for roughly $40 per year beginning in 2027.

Lenacapavir, developed by Gilead Sciences and approved earlier this year for HIV prevention under the brand name Yeztugo, is a twice-yearly injection that was nearly 100% effective at preventing HIV in large trials.

Some AIDS experts, including activists and doctors, say it could help control the 44-year-long epidemic that still infects 1.3 million people a year, and which the World Health Organization estimates has killed 44 million.

ENABLING BROADER ACCESS

The price tag, which will enable much broader access in low-and middle-income countries, compares with an estimated U.S. price of around $28,000 a year for branded Yeztugo.

Unitaid, a WHO-hosted global health agency that works on bringing new tools and medicines to countries more cheaply, is providing technical and financial support to Dr Reddy’s for the low-cost effort, alongside the Clinton Health Access Initiative and South Africa’s Wits Reproductive Health and HIV Institute (Wits RHI), part of University of the Witwatersrand.

The Gates Foundation is working with Hetero.

“Generic manufacture of lenacapavir is essential to ensure this breakthrough HIV prevention option is not limited to a privileged few,” said Professor Saiqa Mullick, director of implementation science at Wits RHI.

The generic version with its low price point could be a preferred choice by millions affected in low-income countries, Mullick said.

The two manufacturers are among six Gilead granted royalty-free licenses to last year, to produce and sell the drug in 120 low- and lower-middle income countries with the highest global HIV disease burden by 2027, subject to approvals.

“The ($40) price that we have negotiated… brings the product in parity with the cost of the oral PrEP,” Carmen Perez Casas, Unitaid’s strategic lead for HIV, told Reuters, using the short phrase for pre-exposure prophylaxis, or preventive, drugs.

Injections at six-month intervals could benefit people for whom stigma, logistics, and other barriers make it difficult to take a pill every day, she added.

CHEAP GENERICS NEEDED FOR LONG-TERM DEMAND

U.S. biotech Gilead has faced criticism from patient advocacy groups and activists for not including upper-middle- income countries such as those in Latin America in the generics agreement.

“We are supporting organizations and countries to reflect on how we could overcome those access barriers (in excluded nations),” Casas said, noting that some countries, including Brazil, took part in trials of the medication but could not access the generics as the agreement with Gilead stands.

Gilead is already working with the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. government to get doses of its branded drug at a reduced price to 2 million people starting this year while generics ramp up production.

But experts estimate that long-term demand is likely to be closer to 10 million people or more, highlighting the need for cheaper generics at scale.

“The availability of generics at an affordable price… will magnify the impact of this game-changing innovation,” Peter Sands, chief executive of the Global Fund, told Reuters.