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

Ferozsons Laboratories Limited (Ferozsons), a Pakistani pharmaceutical, has entered into a non-exclusive voluntary license agreement with Gilead Sciences Ireland UC, a US-based biopharmaceutical company, for the manufacture and sale of licensed generic lenacapavir.

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

Ferozsons informed that it is one of six global partners to have signed a voluntary license agreement with Gilead to produce high-quality generic of lenacapavir.

“Lenacapavir is approved by US FDA [Food and Drug Administration] for infection caused by the human immunodeficiency virus (HIV) for heavily treatment-experienced patients (HTE), and is being investigated for use in HIV prevention,” said the company.

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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.

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

“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,” read the statement.

Ferozsons shared that 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.

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Ferozsons Laboratories Limited was established in 1956, being one of Pakistan’s first pharmaceutical manufacturing companies.

The company’s clients include the United Nations and Federal Supply Services, among other international relief agencies. It also exports to countries such as Australia, Hong Kong, Singapore, Turkey, etc.