Ferozsons Laboratories signs licensing deal with Gilead for single dose HIV prevention drug

Ferozsons Laboratories Limited has entered into a royalty-free voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir, a pre-exposure prophylaxis (PrEP) medicine for HIV prevention, according to a filing to the Pakistan Stock Exchange.

The agreement expands on Ferozsons' existing access strategy for twice-yearly lenacapavir and covers 120 primarily low- and lower-middle-income countries. It will support manufacturing readiness, technology transfer and future supply planning while Gilead's Phase 3 PURPOSE 365 trial for the once-yearly formulation is still ongoing. Ferozsons is one of six global partners to sign the expanded voluntary license agreement with Gilead to produce a high-quality generic version of lenacapavir.

If approved, once-yearly lenacapavir could offer a full year of HIV prevention with a single dose, potentially expanding prevention choices and addressing barriers that limit uptake and persistence of existing PrEP options. The company said the expanded agreement represents one of the earliest HIV prevention access planning efforts undertaken during a Phase 3 trial, building on Gilead's two decades of work developing global access pathways for HIV medicines.

Twice-yearly lenacapavir is already approved in multiple countries as PrEP to reduce the risk of sexually acquired HIV in at-risk adults and adolescents, and is also approved for treating multi-drug-resistant HIV in combination with other antiretrovirals. Lenacapavir's mechanism differs from most existing antivirals, which target only one stage of viral replication; it is designed to inhibit HIV at multiple stages of its lifecycle, with no known cross-resistance to other existing drug classes.

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

Ferozsons said it is actively preparing for upcoming generic availability as part of continued efforts to make twice-yearly HIV prevention medicine available to more people in regions with the greatest unmet need. The injectable formulation will be manufactured at Ferozsons' joint venture subsidiary, BF Biosciences Limited, under a contract manufacturing agreement and sold by Ferozsons, while the oral variant will be manufactured and sold by Ferozsons directly.