On May 12, 2020, Mylan announced, as part of its ongoing efforts to support patients and public health needs during the COVID-19 pandemic, a global collaboration with Gilead Sciences to expand access to the investigational antiviral remdesivir for the potential treatment of COVID-19.

Under the terms of the license agreement signed with Gilead, Mylan has 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 in this critical time of need, Mylan is confident it will be able to 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. We will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO).

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 been at the forefront of increasing access to HIV and viral hepatitis treatments developed by Gilead, including bioequivalent forms of Atripla®, Sovaldi® and Descovy®, for which Mylan was the first licensee to achieve approval by the WHO’s Prequalification Program or by the U.S. Food and Drug Administration (FDA) under the President’s Emergency Plan for AIDS Relief (PEPFAR). Mylan supplies HIV treatments containing tenofovir to more than 8 million people each year and has reached 1 million patients with hepatitis C treatments containing sofosbuvir, also licensed from Gilead.

The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health. Mylan takes its responsibility seriously and is committed to continuing to work with governments, partners, and others to identify areas of need where our global R&D, regulatory, manufacturing and supply chain expertise can be of service.