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Gilead Reveals 5 Generic Drugmakers That Will Produce Remdesivir

Gilead announced the drugmakers that will receive non-exclusive voluntary licenses to manufacture remdesivir in 127 countries.
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Shares of drug maker Gilead  (GILD)  fell more than 2% Tuesday after it revealed the five generic drugmakers that will produce its potential coronavirus-fighting drug, remdesivir. 

Ferozsons Laboratories, Hetero Labs, Jubilant Life Sciences, Cipla Ltd., and Mylan  (MYL)  will receive non-exclusive voluntary licenses to manufacture remdesivir in 127 countries. 

The Food and Drug Administration recently granted emergency use authorization for the drug in the U.S. as a treatment for severely ill COVID-19 patients. 

"It is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19," wrote Denise M. Hinton, chief scientist at the FDA.

The agency grants emergency use of drugs in limited circumstances, and the emergency use of remdesivir is only permitted in severe cases of the disease where the patient is hospitalized.

Distribution of the drug will be controlled by the federal government, according to the letter.

Last week, Japanese health officials approved the use of remdesivir as an "investigational treatment" for the coronavirus.

The Japanese Ministry of Health, Labour and Welfare on Thursday approved remdesvir under a so-called exceptional approval pathway.

The exceptional approval was granted due to the Covid-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.

Gilead said that the licenses for remdesivir will be considered royalty-free until either the World Health Organization lifts its public health emergency of international concern declaration, or another drug or vaccine is approved in the meantime.