Ferozsons Laboratories Limited (Ferozsons) has entered into a non-exclusive voluntary license agreement with Gilead Sciences Ireland UC (Gilead Sciences) for the manufacture and sale of licensed generic lenacapavir in resource-constrained, high burden and resource-limited countries in the developing world. Ferozsons is one of six global partners to have successfully signed a voluntary license agreement with Gilead to produce high-quality generic of lenacapavir.

Lenacapavir is approved by US FDA 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 (one hundred twenty) 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.

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.

Gilead Press statement is given below:

https://www.gilead.com/news/news-details/2024/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries