A licensing agreement has been signed between Cipla, a homegrown pharma major and Gilead Sciences Inc on investigational drug remdesivir, a potential therapy for COVID-19. As per the agreement, Cipla will have manufacturing and distribution rights.
The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to remdesivir to treat COVID-19 patients, a PTI report said.
“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.
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.