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 the part of Cipla’s efforts to enhance global access to life-saving treatments for the patients that affected by the pandemic,” as the company told 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 on a commercial scale.
“Cipla’s extensive geographical and also the commercial footprint would help make this therapy accessible to more patients and markets as well,” as the pharma major told.
The EUA by USFDA will facilitate the broader use of remdesivir to treat hospitalized patients with severe symptoms of COVID-19.
The EUA is based upon available data from the two global clinical trials US National Institute for Allergy and also Infectious Diseases’ placebo-controlled Phase 3 study in the patients with moderate to severe symptoms of corona virus, and also Gilead’s global Phase 3 study evaluating remdesivir in patients with severe disease, as the company said.
Multiple additional clinical trials are ongoing to generate the more data on the safety and also efficacy of remdesivir as a potential treatment for corona virus.
“Remdesivir continues to be the investigational drug that has not been approved by the FDA,” as it told.