FEROZ enters agreement with Gilead Sciences to manufacture HIV drug

October 03, 2024 (MLN): Ferozsons Laboratories (PSX: FEROZ) has teamed up with Gilead Sciences Ireland UC through a non-exclusive voluntary license agreement to manufacture and distribute generic lenacapavir in high-need, resource-limited countries.

This groundbreaking partnership aims to make HIV treatment more accessible in some of the world’s most vulnerable regions.

US FDA approves Lenacapavir for infection caused by the human immunodeficiency virus (HIV) for heavily treatment-experienced patients (“HTE”) and is being investigated for use in HIV prevention.

The agreement covers lenacapavir for HIV prevention (pending approval), in addition to the approved indication of HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.

Under this non-exclusive license, Ferozsons or its affiliates can manufacture and sell, subject to required regulatory approvals, its licensed generic of Gilead proprietary compound Lenacapavir in 120 primarily low- 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.

Lenacapavir is available in two dosage forms: (a) an injectable drug product in a vial kit configuration containing 309 mg/mL Lenacapavir, or, (b) an oral tablet drug product containing 300mg of Lenacapavir.

The injectable drug product will be manufactured at Ferozsons’ JV Subsidiary, BF Biosciences Limited (BFBIO), while the oral variant will be manufactured at Ferozsons’ oral solid dosage (OSD) facility.

What is Lenacapavir?

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

The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

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.

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.

Lenacapavir is being developed as a foundation for potential future HIV therapies to offer both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. 

Importance of Lenacapavir

According to the WHO, an estimated 39.9 million people were living with HIV by the end of 2023, including 1.4 million children (ages 0–14) and 38.6 million adults (ages 15+). Sub-Saharan Africa, which accounts for just 10% of the global population, is home to two-thirds of those affected, with most cases concentrated in lower- and middle-income countries.

Each week, around 4,000 teenage girls and young women in Africa contract HIV, as reported by NPR.com.

The voluntary license for the manufacture and sale of Lenacapavir is specifically for lower-income countries. This partnership aims to increase access to vital HIV treatments in regions facing the highest disease burden, providing a crucial avenue for addressing the epidemic.

The preliminary checks indicate that Lenacapavir is already approved for treating HIV. Recent trials have shown promising data suggesting that the drug may also help prevent HIV.

If approved by the FDA, it is anticipated that two injections per year could be enough for adults to achieve protection against the virus.

Copyright Mettis Link News