BF Biosciences Limited (BFBL), a subsidiary of Ferozsons Laboratories Limited has successfully concluded its non-exclusive license agreement with Gilead Sciences, Inc. for the manufacture and sale of Remdesivir under Gilead’s Global Patient Solutions Programme serving the developing world, informed the company in a notice to the Pakistan Stock Exchange on Wednesday.
“Once production starts, we are confident that BFBL will have sufficient quantities over time to serve the needs of the patients in Pakistan and access countries abroad. BFBL management is actively taking up the matter with the relevant stakeholders for the necessary regulatory approvals and API arrangements so that Remdesivir is made available to patients on an urgent basis,” the notice added.
Gilead has signed nonexclusive voluntary licenses agreements with five South Asian manufacturers – Hetero, Jubilant Lifesciences, Cipla, Mylan and BFBL – to manufacture Remdesivir for distribution in 127 countries. Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for Remdesivir to enable them to scale up production more quickly.
Remdesivir has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) and authorities in Japan to treat hospitalised patients with severe COVID-19 disease. The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease.