Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in Pakistan and India to further expand the supply of remdesivir.
The agreements allow the companies – Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences, and Mylan – to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.
Ferozsons Laboratories Limited’s 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.
Ferozsons is the only Pakistani company that has signed the license agreement and will be distributing remdesivir in Pakistan and other neighboring 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. The licensees also set their own prices for the generic product they produce, said the official statement released by Gilead.
The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.
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, 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,” said the Ferozsons in a filing to the PSX.
At the time of filing this report, FEROZ’s share surged by 7.50% or Rs. 23.26 to Rs. 334.93 on Tuesday. It went on to touch the upper circuit breaker of the day with a turnover of 810,400 shares. In the space of three days, FEROZ’s share price has increased from Rs. 269.62 to Rs. 334.93, after its announcement, to manufacture and sell Remdesivir under Gilead’s Global Patient Solutions Program.