US-based biopharmaceutical company Gilead Sciences has signed royalty-free licensing agreements with six generic drugmakers to enhance access to its HIV drug lenacapavir.
The companies include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris.
Under the terms of the voluntary agreement, the six companies will manufacture and sell Gilead’s lenacapavir in 120 low- and lower-middle-income countries with high incidences of HIV.
Lenacapavir, sold under the brand name Sunlenca, is an antiretroviral medication used for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals.
Gilead said the licence agreements before any global regulatory submissions enable the target countries to launch generic versions of its HIV drug swiftly when approved.
Also, the licensing agreements advance its strategy to enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) worldwide, said the US drugmaker.
Gilead chairman and CEO Daniel O’Day said: “Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest.
“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.”
Gilead intends to promote low-cost access to its HIV drug through a voluntary licensing programme and supply the product at no profit until generic drugmakers fully support demand.
In addition, the agreements not only cover HIV prevention, which is pending approval, but also HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.
Gilead selected licensees under guidance from global health advocates and organisations, who advised partnering with manufacturers from multiple countries and continents.
The US company said that all six partners have previously collaborated with the company to produce generic medicines for HIV or other infectious diseases.
It is prioritising the lenacapavir supply in 18 countries, which represent about 70% of the HIV burden in licensed countries until generic versions are available.
The 18 countries include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.
