Bloombergs Businessweek published the story on how Gilead scineces prepared for the recently obtained emergency approval of the antiviral drug remdesivir. The story is interesting for the followers of the Cyclodextrin News as remdesivir is formulated with sulfobutyl ether beta-cyclodextrin.
We can learn that remdesivir is tricky to produce—the monthslong process involves 70 raw materials, reagents, and catalysts and there are about 25 chemical steps in the production process. To treat millions in pandemic, however, would require a metric ton or more of the bulk drug. Gilead didn’t have close to that—and still doesn’t.
The Food and Drug Administration, in granting the emergency authorization, didn’t allow Gilead to claim the drug is safe and effective for Covid-19; the agency said only that it’s reasonable to believe the medicine may help.
Gilead, based in Foster City, Calif., is the most successful maker of antiviral drugs in history. The company was founded in 1987, and early on its chemists invented the influenza drug Tamiflu. In the 2000s it started packaging multiple powerful anti-HIV medicines into simple once-a-day pills, replacing complicated multi-pill regimens. In 2013 it came out with Sovaldi, a breakthrough drug for hepatitis C.
A precursor to remdesivir was developed in 2009 by Gilead chemists hunting for hepatitis C drugs. It was difficult to administer, however, and Gilead had more promising drugs for hep C, in pill form, so it mostly sat on the shelf for several years. But in studying the compound, Gilead scientists showed in the test tube that it could slow the replication of a broad number of viruses.
During the Ebola outbreak in West Africa in 2014, Gilead had shown the drug worked against Ebola in laboratory animals and begun human safety trials. But by the time remdesivir was ready for human efficacy trials, the Ebola outbreak was fading.
In 2018 another Ebola outbreak flared up in the Congo, giving Gilead an opportunity to finally test remdesivir in people with Ebola. It didn’t work. But the trials proved one thing: The drug was safe.
After the first good news on the success of remdesivir in China against the novel coronavirus SARS-Cov-2, the management of Gilead recognized that the company would need to make large quantities of remdesivir. The company has begun to assemble a consortium of chemical and pharmaceutical manufacturers in India, Pakistan, and elsewhere to help supply the rest of the world.
Read the whole story: