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Gilead signs deals with 6 generic drugmakers to sell HIV drug in low-income countries
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Gilead signs deals with 6 generic drugmakers to sell HIV drug in low-income countries
Oct 2, 2024 11:14 PM

Oct 2 (Reuters) - Gilead Sciences ( GILD ) said on

Wednesday it has granted royalty-free licenses to six generic

drug manufacturers to make and sell cheaper copycat versions of

its HIV prevention medicine in 120 low and lower-middle income

countries.

The U.S.-based drugmaker also plans to provide the companies

branded version of the drug, lenacapavir, in 18 countries, such

as Botswana, Ethiopia and Kenya, until they set up manufacturing

capacity and can fully support demand, Gilead said. These

countries represent about 70% of HIV cases.

Gilead signed licensing agreements with India's Dr. Reddy's

Laboratories, Emcure Pharmaceuticals and

Hetero Labs, as well as US-based Viatris' ( VTRS ) unit Mylan,

Egypt's Eva Pharma and Pakistan-based Ferozsons Laboratories

.

The deals come on the back of pressure from activists and

civil rights groups and allows for manufacturing and supply of

generic lenacapavir, if it is approved, in 120 countries,

including India, Ukraine, Philippines and Thailand.

People's Medicines Alliance, an advocacy group, however,

criticized Gilead's agreements for not including several

countries, especially in Latin America.

Lenacapavir is not approved for the prevention of HIV, but

has regulatory nod in multiple countries, including U.S., for

treatment of multi-drug-resistant HIV in combination with other

antiretrovirals.

The agreement also covers lenacapavir as a treatment of HIV

in adults with multi-drug-resistant form of the disease who had

received multiple medicines earlier.

In the U.S., the drug is approved for multi-drug resistant

HIV and sold under the brand "Sunlenca" for an annual list price

of $42,250 per year.

Patient advocacy groups and activists have criticized Gilead

for the drug's high price and lack of access in lower income

countries, considering the disease affects an estimated 39.9

million people globally, according to World Health Organization

data.

The drugmaker said it will start filing for global

regulatory approval as a prevention regimen for HIV for the drug

by the end of this year.

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