Remdesivir is an investigational medicine that has been granted the US Food and Drug Administration (FDA) EUA to treat Covid-19 patients
Indian pharmaceutical firm Cipla has signed a non-exclusive licensing agreement with Gilead Sciences for the manufacturing and distribution of Remdesivir.
Remdesivir is an investigational medicine, which has been granted the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) to treat Covid-19 patients.
The US regulatory agency authorisation would facilitate the wider use of Remdesivir to treat hospitalised patients with severe symptoms of Covid-19.
Cipla MD and global CEO Umang Vohra said: “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.
“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.”
Remdesivir is an investigational Covid-19 treatment that has been granted FDA EUA
Under the terms of the agreement, Cipla will be responsible for manufacturing the API and finished product, and marketing the product in 127 countries including India and South Africa under its brand name.
The company will acquire the manufacturing know-how from Gilead Sciences to manufacture the API and Finished product at a commercial scale, and its extensive geographical and commercial network will help the therapy to reach more patients and markets.
The World Health Organisation (WHO)’s tracker reported that more than four million people around the world are affected by Covid-19 infection.
The US FDA has granted the EUA based on available data from two global clinical trials, including US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study, and Gilead’s global Phase 3 study evaluating Remdesivir, both in patients with Covid-19 disease.
Also, several additional clinical trials are generating more clinical data on the safety and efficacy of Remdesivir as a potential treatment for Covid-19.
Cipla claimed that the agreement with Gilead will underline its efforts to enhance global access to the life-saving treatments for patients affected by the Covid-19 pandemic.