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.