Oct 2 (Askume) – Gilead Sciences Inc (GILD.O) said on Wednesday it has granted royalty-free licenses to six generic drugmakers to produce and sell HIV/AIDS-discontinued versions of anti-viral prevention drugs in 120 low- and lower-middle-income countries.
Gilead said the U.S. drugmaker plans to produce a branded version of the drug in 18 countries, including Botswana, Ethiopia and Kenya, until it can build up production capacity and fully meet demand. These countries account for about 70% of HIV cases.
Gilead has partnered with India’s Dr. Reddy’s Laboratories (REDY.NS), Emcure Pharmaceuticals (EMCU.NS) and Hetero Labs, as well as US Viatris Mylan (VTRS.O) , Egypt’s Eva Pharma and Pakistan’s FERO.PSX .
The agreement, reached under pressure from activists and civil rights groups, if approved, will allow the production and supply of generic lencapsavir in 120 countries, including India, Ukraine, the Philippines and Thailand.
However, advocacy group People’s Drug Alliance criticized Gilead’s dealMany countries are not included , especially those in Latin America.
Lenacapasvir is not yet approved for HIV prevention, but it has regulatory approval in several countries, including the United States, for use in combination with other antiretroviral drugs to treat multidrug-resistant HIV.
The agreement also covers lenacapavir for treating HIV in adults with multidrug-resistant disease who have previously been treated with multiple drugs.
The drug is approved in the United States for the treatment of multidrug-resistant HIV and is sold under the brand name “Sunlenca” at a price of $42,250 per year.
Patient advocacy groups and activists have criticized Gilead’s drug for being expensive and unavailable in low-income countries as the disease affects an estimated 39.9 million people worldwide, according to the World Health Organization.
The drugmaker said it will begin applying for global regulatory approval as an HIV prevention drug by the end of this year.
