Pfizer to Manufacture Gilead’s Remdesivir for COVID-19 Treatment

August 11, 2020 - Pfizer recently announced a multi-year agreement with Gilead Sciences to manufacture and supply the company’s investigational COVID-19 treatment, remdesivir.

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As part of the partnership, Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility to measure and scale up supply of the potential coronavirus treatment.

“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,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in the announcement. 

“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.”

Remdesivir was originally used to treat Ebola back in 2013 but recently has been one of the most promising COVID-19 treatments since the beginning of the pandemic. 

Back in February, the National Institutes of Health (NIH) sponsored the first controlled clinical trial in the US to evaluate remdesivir in COVID-19 patients. 

In the trial, remdesivir showed the first signs of fighting against coronavirus, so in April, Gilead expanded access to remdesivir for patients with the greatest need.

Then a study published in the New England Journal of Medicine in mid-April found that 68 percent of COVID-19 patients who had oxygen saturation of 94 percent or less while breathing ambient air and received remdesivir showed clinical improvement.

During the 10-day treatment course, 25 patients were discharged from the hospital while only seven patients died. Mortality was 18 percent among patients receiving invasive ventilation and five percent among those not receiving invasive ventilation. 

Two weeks later, Gilead announced additional positive trial results among patients using remdesivir.

Researchers found that the time to clinical improvement for 50 percent of patients was ten days in the five-day treatment group and 11 days in the ten-day treatment group, researchers stated. 

And over half of patients in both treatment groups were discharged from the hospital by Day 14. At Day 14, 64.5 percent of patients in the five-day treatment group and 53.8 percent of patients in the 10-day treatment group achieved clinical recovery.

Due to the continued success of remdesivir, FDA granted emergency use authorization to Gilead for the antiviral in May. This allowed remdesivir to be distributed in the US and administered intravenously by healthcare providers to treat severe coronavirus in both children and adults. 

More recently, Gilead reported additional data on remdesivir, including a comparative analysis of Gilead’s Phase 3 SIMPLE clinical trial and a real-world retrospective cohort of patients with severe COVID-19.

In the analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care.

Additionally, 83 percent of pediatric patients and 92 percent of pregnant and postpartum women with a broad spectrum of disease severity recovered by Day 28.

“We are working to broaden our understanding of the full utility of remdesivir. To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, in a statement.