By Kuda Pembere
With Zimbabwe being among the 18 top-priority recipients of lenacapavir an HIV preventive drug pending local medicines regulatory approvals, Gilead Sciences, the principal maker has granted a non-exclusive license to leading India headquartered pharmaceutical manufacturer Hetero Group of Companies to manufacture and supply the drug.
Gilead’s decision comes following much advocacy by AVAC to give non-exclusive licenses for the manufacturing of lenapavir.
The partnership will broaden access to this novel HIV treatment usable in combination with other antiretrovirals while supporting efforts to prevent HIV through pre-exposure prophylaxis (PrEP).
The agreement, Gilead said, advances their strategy enable broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally if it is approved.
Gilead is prioritizing registration in 18 Countries with high Incidence to provide Lenacapavir until generic versions are available.
“The licensees announced today will build manufacturing capacity for lenacapavir as quickly as possible, but this process will take time. To provide Gilead-supplied lenacapavir until generic versions are available, Gilead is prioritizing registration in 18 countries that represent about 70% of the HIV burden in the countries named in the license.
“These countries, identified in consultation with external partners, are Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe,” said Gilead.
Gilead said this also aligns with their vision of ending the HIV epidemic across the globe.
“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.
“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,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead. “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.”
This collaboration, Hetero said, marks a significant step in expanding access to life-saving treatments for heavily treatment-experienced patients with multi-drug-resistant HIV and offers a promising option for HIV prevention in underserved regions.
Lenacapavir is a breakthrough HIV-1 capsid inhibitor that works with other antiretroviral drugs to treat multi-drug-resistant HIV-1 infections. It has a unique ability to target multiple stages of the HIV lifecycle, making it highly effective for patients with limited treatment options.
“This partnership with Gilead Sciences strengthens our resolve to push the boundaries of HIV prevention and treatment. For over three decades, Hetero has been at the forefront of the global fight against HIV/AIDS, pioneering affordable, life-saving treatments where the need is greatest.
“With over 30 combinations addressing nearly 40%* of the global HIV/AIDS population, we take immense pride in the positive impact our efforts have made so far. We will further bring quick access to lenacapavir in Africa, India and other LMICs, where we’ve been a cornerstone of HIV/AIDS care,” Managing Director of Hetero Group of Companies Dr. Vamsi Krishna Bandi said.
AVAC in a statement this July said there is much to do before this twice-yearly HIV prevention option can be included in comprehensive prevention programs.
“Following Gilead’s announcement last week that they are developing a direct voluntary licensing program for lenacapavir, it is imperative that Gilead grants non-exclusive licenses to multiple generic manufacturers in multiple geographies before the end of the year; that license agreements are made publicly available; and that the licenses include access to finished product based on public health imperatives, and not on World Bank country classifications or geographical location,” said AVAC.
Aside from Hetero, the other five generic pharmaceutical companies, Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons and Mylan—have been selected to produce and distribute lenacapavir in 120 countries.
