Pakistan’s Ferozsons to manufacture US-based Gilead's HIV prevention drug

Ferozsons Laboratories Limited (FEROZ), a Pakistani pharmaceutical company, has joined a select group of global manufacturers in Gilead Sciences’ expanded royalty-free licensing programme for its investigational once-yearly lenacapavir for HIV prevention, covering 120 high-incidence countries.

The listed pharma disclosed the development in a notice to the Pakistan Stock Exchange (PSX) on Thursday.

“The agreement, expanded from the existing twice-yearly lenacapavir for HIV prevention access strategy, covers 120 high-incidence countries (which are primarily low- and lower- middle-income) and will support manufacturing readiness, technology transfer and future supply planning while the Phase 3 PURPOSE 365 trial is ongoing,” read the notice.

If approved, once yearly lenacapavir could provide a full year of HIV prevention with a single dose, expanding prevention choice and helping address barriers that can limit pre-exposure prophylaxis (PrEP) uptake and persistence, said FEROZ.

The pharma shared that twice-yearly lenacapavir is approved in multiple countries as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition.

“Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals.

“The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance exhibited in vitro to other existing drug classes.”

Manufacturing HIV drug in Pakistan: Ferozsons partners with US-based Gilead

FEROZ shared that Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program, including a once-yearly injection for HIV prevention.

“Under this non-exclusive license, Ferozsons can manufacture and sell, subject to required regulatory approvals, its licensed generic of Gilead’s proprietary compound Lenacapavir in 120 primarily low- and lower- middle income countries.

“Under the licensing agreement, the company has a right to receive a technology transfer of the Gilead manufacturing process for lenacapavir to enable it to scale up production,” it added.

Ferozsons will manufacture the injectable drug product at its JV subsidiary, BF Biosciences Limited (BFBIO), under a contract manufacturing agreement and sell it. In contrast, it will manufacture and sell the oral variant directly.