Recent clinical trial results and the decision by the US Food and Drug Administration (FDA) to issue ”Emergency Use Authorisation” for remdesivir have highlighted the urgency of this work and the importance of planning for access to remdesivir globally
US-based Gilead Sciences has said it is in talks with Indian and Pakistan pharmaceutical companies to produce remdesivir for developing countries. Remdesivir is an investigational anti-viral drug that may be found effective against the virus that causes COVID-19 Gilead said in a statement recently.
Recent clinical trial results and the decision by the US Food and Drug Administration (FDA) to issue ”Emergency Use Authorisation” for remdesivir have highlighted the urgency of this work and the importance of planning for access to remdesivir globally, it said.
The company is also negotiating for long-term voluntary licences with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries, the statement said.
Gilead would provide appropriate technology transfers to facilitate this production.
Finally, the company is in discussion with the Medicines Patent Pool, which Gilead has partnered with for many years, to license remdesivir for developing countries, the drugmaker said. The company is in discussions with some of the world’s leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licences, to produce remdesivir for Europe, Asia and the developing world through at least 2022, it said.
To further facilitate access in developing countries during this acute health crisis, Gilead is in advanced discussions with United Nations International Children’s Emergency Fund (UNICEF) to utilise their vast experience in providing medicines to low- and middle-income countries during emergency and humanitarian crises to deliver remdesivir using its distribution networks.
As the close coordination of remdesivir manufacturing is critical, the USA pharmaceutical major is working to build a consortium of manufacturing partners to bring efforts together to help maximise global supply. Producing the drug requires scarce raw materials, with their own lengthy production time and specialised manufacturing capabilities with limited global capacity. Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so, Gilead added.