Ferozsons To Manufacture Gilead’s HIV Prevention Drug In Pakistan.
✧ GENERATE BRIEFING +
Pakistan’s Ferozsons Laboratories Limited has partnered with US-based Gilead Sciences under an expanded royalty-free, non-exclusive licensing agreement to manufacture and supply the investigational once-yearly HIV prevention drug, lenacapavir, across 120 low- and lower-middle-income countries. Ferozsons disclosed the development via a notice to the Pakistan Stock Exchange (PSX) on Thursday.Under the arrangement, the injectable version of lenacapavir will be produced at Ferozsons’ joint-venture subsidiary, BF Biosciences Limited (BFBIO), through contract manufacturing, while Ferozsons will directly handle the oral formulation. The agreement facilitates comprehensive technology transfer and manufacturing readiness while Gilead advances its Phase 3 PURPOSE 365 trial. While twice-yearly lenacapavir is already approved globally for treatment and prevention in various markets, the once-yearly formulation remains under clinical development. Ferozsons joins an elite group of international generic manufacturers selected for the initiative, alongside Dr Reddy’s, Emcure, Eva Pharma, Hetero, and Mylan.
Pakistan’s Ferozsons Laboratories Limited has joined a global group of pharmaceutical manufacturers licensed by US-based Gilead Sciences to prepare for the manufacture and supply of its investigational once-yearly HIV prevention drug, lenacapavir, across 120 primarily low- and lower-middle-income countries.
Ferozsons disclosed the development in a notice to the Pakistan Stock Exchange on Thursday, saying the expanded royalty-free, non-exclusive licensing agreement will support manufacturing readiness, technology transfer and future supply planning while Gilead continues its Phase 3 PURPOSE 365 trial.
Under the agreement, Ferozsons will be able to manufacture and sell a licensed generic version of lenacapavir in the 120 covered countries, subject to the required regulatory approvals. The company will also receive technology transfer of Gilead’s manufacturing process to enable it to scale production.
The injectable version will be manufactured at Ferozsons’ joint-venture subsidiary BF Biosciences Limited (BFBIO) under a contract manufacturing arrangement, while Ferozsons will manufacture and sell the oral formulation directly.
If approved for HIV prevention, once-yearly lenacapavir could provide protection through a single annual dose, potentially offering an alternative to existing pre-exposure prophylaxis (PrEP) options and addressing adherence barriers associated with more frequent dosing.
The agreement expands an existing partnership between Ferozsons and Gilead. In 2024, Gilead granted six generic manufacturers, including Ferozsons, royalty-free licences covering lenacapavir for 120 low- and lower-middle-income countries.
Gilead said the six licensing partners were selected based on their capabilities in producing complex sterile injectable medicines and their experience as existing voluntary licensing partners. The other manufacturers include Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma, Hetero and Mylan Laboratories.
Ferozsons said twice-yearly lenacapavir is already approved in multiple countries for HIV prevention, while the drug is also approved in several markets for treatment of multidrug-resistant HIV when used with other antiretroviral medicines. The once-yearly prevention formulation, however, remains under clinical development and is not yet approved for that use.
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