Gilead agrees 127-country remdesivir licence with generic makers
Gilead has agreed to license its antiviral remdesivir to five generic makers for distribution during the COVID-19 pandemic.
The deal will see the drug licensed to Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences, and Mylan for distribution in 127 countries.
The licence covers mostly low and lower-middle-income countries. It will be royalty-free until the World Health Organization (WHO) declares the end of the Public Health Emergency of International Concern regarding COVID-19, which came into effect on January 30.
Alternatively, the licence will no longer be royalty-free once an alternative treatment or vaccine is approved to treat or prevent COVID-19.
The company has been under increasing pressure to facilitate widespread access to the drug ever since that it emerged as a potential treatment for the virus.
After some clinical trial results last month, remdesivir was fast-tracked for approval in the US and Japan. The drug had already been available in the US on a limited “compassionate use” basis for some patients with severe cases of COVID-19.
The Japanese Ministry of Health, Labour and Welfare approved Gilead’s remdesivir product Veklury last Thursday, May 7, a week after the US Food and Drug Administration (FDA) announced it had cleared the drug for the emergency treatment of COVID-19.
The FDA granted what is known as an emergency use authorisation, meaning it can be distributed to more hospitals and administered to more patients than under the more limited compassionate use scheme.
The pharmaceutical regulator has not approved remdesivir as a standard treatment for the virus, and clinical trials into its efficacy and safety are ongoing.
Japan’s approval of remdesivir as a treatment for COVID-19 is more wide-ranging, and is the only country to formally approve the drug.
“The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic,” said Gilead’s chief medical officer Merdad Parsey.
The National Institute of Allergy and Infectious Diseases effectively ended its clinical trial of remdesivir, after it chose to prescribe the drug to patients who had been in the placebo group.
That decision came after a finding that the mortality rate of patients on the clinical trial was 8% with remdesivir, and 11.6% on the placebo group. The exact role of the antiviral, if any, in contributing to the lower mortality rate is not yet clear.
