Homegrown pharma major Cipla Ltd on Wednesday said it has signed a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distribution of investigational drug remdesivir, a potential therapy for COVID-19. The medicine has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) to treat COVID-19 patients.
"This agreement is part of Cipla's efforts to enhance global access to life-saving treatments for patients affected by the pandemic," the company said in a statement.
Under the agreement, Cipla will be permitted to manufacture the API (active pharmaceutical ingredient) and finished product, and market it in 127 countries, including India and South Africa under Cipla's own brand name, it added.
The company further said it will receive the manufacturing know-how from Gilead Sciences Inc to manufacture the API and finished product at a commercial scale.
"Cipla's extensive geographical and commercial footprint will help make this therapy accessible to more patients and markets," the pharma major said.
The EUA by USFDA will facilitate broader use of remdesivir to treat hospitalized patients with severe symptoms of COVID-19.
The EUA is based on available data from two global clinical trials – US National Institute for Allergy and Infectious Diseases' placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead's global Phase 3 study evaluating remdesivir in patients with severe disease, the company said.
Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a potential treatment for COVID-19.
"Remdesivir continues to be an investigational drug that has not been approved by the FDA," it said.
ALSO READ | Remdesivir to be produced in India as Gilead signs agreement with Cipla, Jubilant Life
Latest Business News
