Gilead signs deals with 6 generic drugmakers to sell HIV drug in low-income countries
Oct 2 (Reuters) -Gilead Sciences GILD.O 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 REDY.NS, Emcure Pharmaceuticals EMCU.NS and Hetero Labs, as well as US-based Viatris' VTRS.O unit Mylan, Egypt's Eva Pharma and Pakistan-based Ferozsons Laboratories FERO.PSX.
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.
Reporting by Sneha S K in Bengaluru; Editing by Leroy Leo
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