India's Jubilant Life Sciences has signed a non-exclusive licensing agreement for selling Gilead Sciences Inc's experimental COVID-19 treatment remdesivir in 127 countries, including India, it said on Tuesday.
Earlier this month, Gilead received the U.S. Food and Drug Administration's authorization for emergency use for remdesivir as a treatment against COVID-19, after data showed that the drug has been helpful in treating patients.
Shyam Bhartia and Hari Bhartia of Jubilant Life Sciences said, "We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s active pharmaceutical ingredient (API) in-house helping it cost effectiveness and consistent availability.”
Gilead had earlier announced of being in stages of discussion with many drug makers in India and elsewhere to produce its remdesivir for Europe and Asia and the developing world by 2022. The drug has raised considerably intrest globally due to the lack of any approved treatments or vaccines for the novel coronavirus.
The Emergency Use Authorization (EUA) allows the drug to be used in a broader capacity for hospitalized patients who have been seriously afflicted with the Covid-19 disease.
The EUA was based on the available data from two global clinical trials – US National Institute of Allergy and Infectious Diseases’ placebo-controlled phase 3 study in patients with moderate to severe symptoms of the COVID-19, and Gilead’s global phase 3 study evaluating the drug in patients with severe symptoms of coronavirus.
(With inputs from Reuters)