Pharmaceutical major Cipla said on Wednesday it has signed a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distributing investigational medicine Remdesivir which has been issued an emergency use authorisation by the US Food and Drug Administration (FDA) to treat COVID-19 patients.
The company will receive manufacturing know-how from Gilead Sciences to manufacture the API and finished product on a commercial scale. Cipla’s extensive geographical and commercial footprint will help make this therapy accessible to more patients and markets.
“As the world is faced with COVID-19 crisis, it is imperative that we collaborate and fight this virus together,” said Managing Director and Global CEO Umang Vohra.
“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,” he said in a statement.
“Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic,” said Vohra.
According to the World Health Organisation (WHO)’s tracker, the number of reported COVID-19 cases has crossed the four million mark globally.
The emergency use authorisation will facilitate broader use of Remdesivir to treat hospitalised patients with severe symptoms of COVID-19.
The authorisation is based on available data from two global clinical trials — US National Institute for Allergy and Infectious Diseases’ placebo-controlled phase three study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global phase three 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.