The royalty-free agreement allows Ferozsons to prepare for generic production and supply of once-yearly lenacapavir for HIV prevention in 120 countries.
KARACHI, September 17, 2026: 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, expanding the Pakistani pharmaceutical company’s plans for access to the long-acting medicine.
In material information submitted to the Pakistan Stock Exchange (PSX) on Thursday, Ferozsons said the expanded agreement covers 120 high-incidence countries, primarily low- and lower-middle-income markets.
The agreement is intended to support manufacturing readiness, technology transfer and future supply planning while the Phase 3 PURPOSE 365 trial of once-yearly lenacapavir continues.
Ferozsons is among six global partners to have signed the expanded voluntary licensing agreement with Gilead to produce a generic version of lenacapavir, subject to applicable regulatory approvals.
Under the non-exclusive licence, Ferozsons will be able to manufacture and sell its licensed generic version of Gilead’s proprietary lenacapavir in 120 countries, subject to regulatory approvals.
The agreement also gives Ferozsons the right to receive a technology transfer of Gilead’s manufacturing process for lenacapavir, allowing the company to prepare for scaled production.
The injectable drug product will be manufactured at BF Bioscience Limited (BFBIO), Ferozsons’ joint-venture subsidiary, under a contract manufacturing agreement. Ferozsons will market and sell the injectable product.
The oral formulation, meanwhile, will be manufactured and sold directly by Ferozsons Laboratories.
If approved, once-yearly lenacapavir could provide protection against HIV through a single annual dose, potentially expanding options for pre-exposure prophylaxis (PrEP).
The companies said the licensing agreements represent an early HIV prevention access-planning initiative undertaken while the Phase 3 development programme is still under way.
The programme builds on Gilead’s previous efforts to establish 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 among adults and adolescents at risk of acquiring the virus. Lenacapavir is also approved in multiple countries for treating multidrug-resistant HIV in adults in combination with other antiretroviral medicines.
Lenacapavir has a multi-stage mechanism of action that differs from currently approved classes of antiviral medicines.
While many antiviral medicines target a specific stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle.
According to the company, no known cross-resistance to existing drug classes has been observed in laboratory studies.
Lenacapavir is also being evaluated as a long-acting treatment and prevention option in several ongoing and planned early- and late-stage clinical studies under Gilead’s HIV research programme, including the once-yearly injection for HIV prevention.
Ferozsons said it was actively preparing for potential future generic availability as efforts continue to expand access to long-acting HIV prevention medicines in regions with significant unmet medical needs.
The agreement strengthens the company’s preparations to participate in the future supply of generic lenacapavir across eligible markets.
However, the availability of the once-yearly product remains subject to successful clinical development, regulatory approvals and other applicable requirements.