Gilead Signs Deals with 6 Generic Manufacturers to Sell HIV Drugs in Low-Income Countries | The mighty 790 KFGO

(Reuters) – Gilead Sciences said on Wednesday it has granted royalty-free licenses to six generic drugmakers to make and sell cheaper copycat versions of its HIV prevention drugs in 120 low- and lower-middle-income countries.

The U.S.-based drugmaker also plans to offer the branded version of the drug, lenacapavir, to the company in 18 countries such as Botswana, Ethiopia and Kenya until they build up manufacturing capacity and can fully meet demand, Gilead said. These countries account for approximately 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 unit Mylan, Egypt's Eva Pharma and Pakistan-based Ferozsons Laboratories.

The deals come after pressure from activists and civil rights groups and, if approved, will allow generic lenacapavir to be manufactured and supplied in 120 countries, including India, Ukraine, the Philippines and Thailand.

But the advocacy group People's Medicines Alliance criticized Gilead's agreements for not including several countries, particularly in Latin America.

Lenacapavir is not approved for HIV prevention, but is approved in several countries, including the United States, for the treatment of multidrug-resistant HIV in combination with other antiretroviral drugs.

The agreement also includes lenacapavir for the treatment of HIV in adults with a multidrug-resistant form of the disease who have previously received multiple medications.

The drug is approved in the US for multidrug-resistant HIV and is sold under the brand “Sunlenca” at an annual list price of $42,250 per year.

Patient advocacy groups and activists have criticized Gilead over the drug's high price and lack of access in lower-income countries, considering the disease affects an estimated 39.9 million people worldwide, according to the World Health Organization.

The drugmaker said it would begin filing for global regulatory approval as an HIV prevention therapy for the drug by the end of this year.

(Reporting by Sneha SK in Bengaluru; Editing by Leroy Leo)