Ferozsons Laboratories Limited 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, according to a company filing at the PSX on Thursday.
Ferozsons said that it 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 the US Food and Drug Administration (FDA) for infection caused by the human immunodeficiency virus (HIV) for heavily treatment-experienced patients 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 and lower – 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’ joint venture subsidiary BF Biosciences Limited while the oral variant will be manufactured at Ferozsons’ oral solid dosage (OSD) facility.
Lenacapavir 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.
It is being developed as a foundation for potential future HIV therapies with the goal of offering 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.
Gilead Sciences, Inc. is a US-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.
The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
Ferozsons has been well-known in Pakistan’s pharmaceutical industry since 1956. In addition to its own range of branded generic pharmaceutical products, Ferozsons represents a number of international companies in Pakistan through JVs/distribution agreements covering a broad range of manufactured/imported products including medical devices.
