Ferozsons secures Gilead license for once-early HIV prevention drug

September 17, 2026 (MLN): Ferozsons Laboratories Limited (PSX: FEROZ) has entered into a royalty-free voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP).

The agreement, expanded from the existing twice-yearly lenacapavir access strategy, covers 120 primarily low- and lower-middle-income, high-incidence countries and will support manufacturing readiness, technology transfer and future supply planning while the Phase 3 PURPOSE 365 trial continues.

Ferozsons is one of six global partners to sign the expanded voluntary license agreement with Gilead to produce a high-quality generic of lenacapavir.

Once-yearly lenacapavir, if approved, could provide a full year of HIV prevention with a single dose, expanding prevention choice and addressing barriers that limit PrEP uptake and persistence.

The expanded agreement represents one of the earliest HIV prevention access planning efforts undertaken during Phase 3 development, building on Gilead's two decades of experience developing global access pathways for HIV medicines, including its work on twice-yearly lenacapavir.

Twice-yearly lenacapavir is already approved in multiple countries as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents at risk, and is also approved in multiple countries for treatment of multi-drug-resistant HIV in adults in combination with other antiretrovirals.

Unlike most antivirals that act on a single stage of viral replication, lenacapavir inhibits HIV at multiple stages of its lifecycle and has shown no known cross-resistance to other existing drug classes.

It is being evaluated as a long-acting option in ongoing and planned early and late-stage clinical studies within Gilead's HIV prevention and treatment research program, including a once-yearly injection for prevention.

Under the non-exclusive license, Ferozsons can manufacture and sell, subject to required regulatory approvals, its licensed generic of the Gilead proprietary compound in the 120 covered countries, with the right to receive a technology transfer of Gilead's manufacturing process to scale up production.

The injectable drug product will be manufactured at Ferozsons' joint venture subsidiary, BF Biosciences Limited (BFBIO), under a contract manufacturing agreement and sold by Ferozsons, while the oral variant will be manufactured and sold directly by Ferozsons.

The aforementioned information was disseminated through a notification to Exchange.

Copyright Mettis Link News