Words by Jade Williams
A new licensing agreement between Gilead Sciences and six generic drug manufacturers is poised to transform HIV prevention efforts in resource-limited countries with high prevalence rates. The deal gives the go-ahead for the production and distribution of Gilead’s PrEP injectable lenacapavir.
The royalty-free initiative aims to accelerate access to this vital HIV prevention tool in 120 nations and is part of Gilead’s broader strategy to ensure widespread, sustainable access to PrEP solutions globally.
“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, 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.”
The company’s two-pronged approach includes establishing a robust voluntary licensing framework and providing lenacapavir on a not-for-profit basis in these regions until generic manufacturers can meet demand. The agreements cover both the drug for HIV prevention and, subject to approval, for the treatment of heavily treatment-experienced adults with multidrug-resistant HIV.
Winnie Byanyima, Executive Director, UNAIDS, welcomed the announcement, stating that “to stem the tide of new infections, and protect people most at risk from HIV, including young women and people from marginalised communities, long-acting HIV medicines are vital”. She added that lenacapavir was particularly game changing as it only requires two injections a year.
While generic manufacturers of the drug make regulatory submissions to produce themselves, Gilead is prioritising lenacapavir registration in 18 high-incidence countries, representing approximately 70% of the HIV burden in the licensed regions. These countries include Botswana, South Africa, Thailand, Vietnam and others.
While a positive step, Byanyima reinforced, “HIV prevention products need to be deployed where new HIV infections are highest – and right now, 41% of new infections are in upper-middle income countries”. UNAIDS therefore urges Gilead to secure licenses for access across all low and middle-income countries, to ensure no one who needs the treatment is left behind.
The pharmaceutical partners involved in producing generic lenacapavir are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan – a subsidiary of Viatris.
