May 13, 2020 (MLN): Ferozsons Laboratories Limited has announced that its subsidiary, BF Biosciences Limited (BFBL), 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 Program serving the developing world.
As per the notification issued by Ferozsons Laboratories to Exchange, Gilead has signed non-exclusive voluntary license 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.
Moreover, Remdesivir has been granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) and authorities in Japan to treat hospitalized 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 the disease.
Once production starts, the company believes it 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.
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