Mylan has entered a global collaboration and license agreement with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19.

The license agreement gives Mylan rights to manufacture and distribute remdesivir in 127 low- and middle-income countries, including India. The agreement is non-exclusive, allowing for multiple licensees to ensure extensive access to this treatment, once approved as safe and effective for COVID-19 patients.

To ensure preparedness, Mylan will develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient (API) and the finished dosage form (FDF) in sterile powder lyophilized vials for administration of the medicine by intravenous (IV) infusion. The company aims to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO).

Mylan President Rajiv Malik said: “The unprecedented development timeline at Mylan is a direct reflection of the investments we’ve made to build a first-class, global research and manufacturing platform, including strong technical expertise in injectable dosage forms. As a world leader in the supply of antiretroviral drugs upon which approximately 40% of those being treated for HIV/AIDs depend, we also understand supply chain complexities that must be overcome in order to ensure that the products we manufacture are able to reach the patients who need them. Today’s announcement is another example of how Mylan’s unique global infrastructure and expertise empower other companies to expand their own reach by providing more patients with access to critical medicines worldwide.”

Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate. Mylan has since increased access to HIV and viral hepatitis treatments developed by Gilead, with bioequivalent forms of Atripla, Sovaldi and Descovy.