Cipla becomes 2nd firm to enter tie-up with Gilead to make remdesivir in India
Cipla will be permitted to manufacture the active pharmaceutical ingredient (API) and finished product, and market it in 127 countries including India and South Africa under Cipla's own brand name.
New Delhi Leading pharmaceutical company Cipla on Wednesday announced it has signed a non-exclusive licensing agreement with US-based Gilead Sciences for the manufacturing and distribution of antiviral drug remdesivir.
Cipla is the second firm after Noida-based Jubilant Life Sciences whose subsidiary Jubilant Generics Ltdhas inked a pact with Gilead Sciences on Tuesday to manufacture and sell remdesivir, which is under clinical trials globally as a potential treatment of COVID-19 disease.
As part of the agreement, Cipla will be permitted to manufacture the active pharmaceutical ingredient (API) and finished product, and market it in 127 countries including India and South Africa under Cipla's own brand name.
"At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic," said Umang Vohra (MD and Global CEO, Cipla Limited).
Cipla will receive the manufacturing know-how from Gilead Sciences to manufacture the drug at a commercial scale.
The emergency use authorization (EUA) by the US FDA 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.
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.
"As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals," said Vohra.
The Health Ministry recently said that it is examining remdesivir, which was used during the Ebola outbreak, as one protocol in the treatment for Covid-19.