Gilead Sciences has announced that cheaper versions of its “gamechanger” HIV prevention drug, lenacapavir, will be made available in 120 low and middle income countries.
Lenacapavir is an approved HIV treatment given as a twice-yearly injection.
It stopped infection in a trial involving girls and women in South Africa and Uganda, and offered almost complete protection in a second trial that mainly involved men across Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US.
In a statement, the company said it had signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers, to make and sell generic lenacapavir to these countries.
The manufacturers are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris.
Gilead Sciences said the agreements were signed in advance of any global regulatory submissions, to enable these countries to quickly introduce generic versions of lenacapavir for HIV prevention.
The company said it would also bridge the gap until those manufacturers were up and running, by providing Gilead-supplied product, prioritising registration in 18 countries with high HIV rates.
These countries are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.
“The agreements advance Gilead’s strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if approved, and align with Gilead’s vision of ending the HIV epidemic for everyone, everywhere,” the company said.
“Gilead will support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing program, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand.
“Additionally, the agreements cover not only lenacapavir for HIV prevention (pending approval), but also lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.”
Daniel O’Day, chief executive officer of Gilead, said given the transformative potential of lenacapavir, the focus is on making it available as quickly and broadly as possible.
“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved,” he said.
