Gilead, Cipla partner on remdesivir expansion
Under the agreement, Mumbai-based Cipla will manufacture the active pharmaceutical ingredient (API) as well as finished product, marketing it under its brand name in 127 countries. In turn, Gilead Sciences will offer manufacturing expertise on manufacturing the API and product on a commercial scale.
The emergency use authorization (EUA) recently issued by the US Food and Drug grants expanded use of remdesivir to treat hospitalized COVID-19 patients suffering from severe symptoms. The EUA is built on data from two clinical trials: the US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase III study in patients with moderate to severe symptoms of COVID-19, and Gilead’s Phase III study evaluating the drug for patients with severe disease.
Additionally, numerous additional clinical trials are underway in different parts of the globe to assemble more data regarding remdesivir’s safety and efficacy as a COVID-19 treatment. To date, the drug continues to be an investigational treatment and has not received FDA approval.
According to Cipla CEO Umang Vohra, collaborations such as the one between his firm and Gilead, are necessary to defeat the pandemic-causing virus.
“As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together,” he said. “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 endeavor to ensure that no patient is denied access to life-saving treatments,” he added. “Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic.”
In late March, Gilead rescinded its application to receive orphan status for remdesivir as a potential COVID-19 treatment.