Working to Supply Veklury® for COVID-19
Since the moment the novel coronavirus that causes COVID-19 was identified, Gilead has mobilized every area of our organization to respond to the global health emergency. We are harnessing our decades of expertise in antiviral research and development, including more than 10 years of work on Veklury® (remdesivir) specifically, to advance a treatment for COVID-19 and help meet patient needs.
Since January, Gilead has invested significant capital to establish a supply chain capable of large-scale production of Veklury.
The production of Veklury is a long, linear chemical synthesis process that must be completed sequentially and includes several specialized chemistry steps and novel substances with limited global availability. The process is both resource- and time-intensive, with some individual manufacturing steps taking weeks to complete. Because Veklury is administered intravenously, production also requires sterile drug product manufacturing capabilities, which limits the number of organizations capable of manufacturing the medicine. This complex process impacts the ability to rapidly produce large quantities of drug supply in an emergency situation like the COVID-19 pandemic. In light of these realities, Gilead worked early on, before any clinical trials had started, to procure a steady flow of long-lead-time raw materials that will accelerate large-scale production of Veklury by our current and future partners once these materials become available in significant quantities.
We have also worked to shorten the manufacturing timeline through process improvements. The typical timeline for manufacturing a drug like Veklury at scale is nine to 12 months; we have reduced that period to six to eight months. We continue to work on optimizing the chemical synthesis processes to further accelerate product deliveries and volumes.
Capacity Expansion through External Manufacturing
We have supplemented our internal manufacturing with significant additional capacity from more than 40 manufacturing partners in North America, Europe and Asia. Through these efforts, we are now meeting real-time demand for Veklury in the United States, and we anticipate meeting global demand for Veklury in October 2020 both to treat patients and for stockpiling needs, even in the event of potential future surges of COVID-19.
Current and Projected Supply
As of January 2020, we were not actively manufacturing Veklury. The manufacturing supply chain was scaled to periodically make small amounts of product for a compound in early development. We had inventory of finished product to treat just 5,000 patients.
Since then, we have proactively and rapidly scaled our supply chain. We have worked over the past months to improve processes, shorten timelines and increase volumes as we work to bring Veklury to patients as soon as possible. By the end of June, we produced more than 190,000 treatment courses.
Our goal is to produce a total of:
- More than 2 million treatment courses by December 2020
- Several million treatment courses in 2021, if required
Updated: October 22, 2020