Pfizer Enters Into Multi-Year Agreement with Gilead to Manufacture Investigational Antiviral Remdesivir for COVID-19

(New York, NY, USA) has entered into a multi-year agreement with Gilead Sciences (Foster City, CA, USA) to manufacture and supply Gilead’s investigational COVID-19 treatment remdesivir.

Remdesivir is an antiviral product that is being studied in multiple ongoing international clinical trials. The drug has not been approved by the US Food and Drug Administration (FDA) for any use but has been granted an Emergency Use Authorization (EUA) in the US for the treatment of hospitalized patients with severe COVID-19.

Under the terms of the agreement, Pfizer will provide contract manufacturing services at its facility in McPherson, Kansas to manufacture and supply remdesivir for Gilead. Pfizer is one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Gilead has taken multiple steps to ramp up production and rapidly build supply of remdesivir, preparing for potential global demand at risk, in recognition of the lengthy manufacturing timeline. In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead has expanded its global network of both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity around the world. The company’s manufacturing network of partners for remdesivir now includes more than 40 companies in North America, Europe and Asia.

Gilead has increased supply of remdesivir by more than 50-fold since January and expects to meet the real-time global demand starting in October. The company plans to produce more than two million treatment courses by the end of the year and anticipates producing several million more in 2021, if needed. Additionally, Gilead has also entered into voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries that represent nearly all low-income and lower-middle income countries. Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process.

“From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer’s agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions,” said Albert Bourla, Chairman and Chief Executive Officer. “Together, we are more powerful than alone. As one of the largest manufacturers of vaccines, biologics and sterile injectables, it is a privilege to offer our expertise and infrastructure to help fight this pandemic. In that spirit, we are pleased that Gilead is using our manufacturing capacity to help facilitate supply of this medicine to patients as quickly as possible.”

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