*

Dr Reddy's, Hetero among six Indian companies with

licensing

deal from Gilead Sciences ( GILD )

*

Global health groups like Unitaid, Gates working with

generic

manufacturers to lower prices, broaden access

*

Experts say twice-a-year injection could help end AIDS

crisis

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Concerns remain not all countries will get affordable

access

By Rishika Sadam and Jennifer Rigby

Sept 24 (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 ( GILD ) 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.

($1 = 88.6930 Indian rupees)