Pfizer to help Gilead produce COVID-19 drug remdesivir.
Pfizer will produce vials of Gilead's COVID-19 drug remdesivir at its sprawling factory in McPherson, Kansas under a multi-year manufacturing agreement announced by the pharma giant Friday. Faced with high demand for remdesivir from countries around the world, Gilead is working to quickly scale up production of the drug, which was shown in a U.S. government-run study to hasten the time to recovery among patients hospitalized with COVID-19.
Supplies, however, are tight. From start to finish, making the drug takes six months, even after Gilead cut several months from its manufacturing timeline. An agreement with the Trump administration, meanwhile, reserved for the U.S. 100% of the remdesivir Gilead produces in July, and 90% in both August and September.
In addition to its own drugs, Pfizer is also a contract manufacturer for the rest of the industry, a business inherited through the company's 2015 buyout of Hospira.
The McPherson, Kansas site is one of the principal hubs of that network, although the drugmaker has struggled in recent years to clear regulatory citations regarding conditions at the plant.
Under the agreement announced Friday, Pfizer will help manufacture and supply remdesivir for Gilead on a contract basis. The deal is one of many Gilead has entered into to build a manufacturing network of some 40 companies across North America, Asia and Europe, although Pfizer's size likely makes it one of the company's most significant partners.
The biotech, which has sizable production facilities of its own, aims to produce 2 million treatment courses by the end of 2020.
The biotech, which has sizable production facilities of its own, aims to produce 2 million treatment courses by the end of 2020.
Much of that will come in the final months of the year. Through July, Gilead has made some 288,000 treatment courses, and doesn't anticipate supply meeting demand until the beginning of October.
In a statement, Gilead said "the use of 'march-in' rights under the Bayh-Dole Act will do nothing to produce additional doses of remdesivir this year."
Gilead has licensed remdesivir to nine generic drugmakers for supply in 127 low- and lower-middle income countries.
Financial forecasts recently updated by the company suggest Gilead, which plans to spend $1 billion on remdesivir development and manufacturing this year, expects to make several billion dollars in sales of the drug.
Author: Ned Pagliarulo
Published: https://www.biopharmadive.com/news/remdesivir-pfizer-gilead-manufacturing-covid-19/583125