Date: 13-Oct-2020

Gilead Sciences Signs Joint Procurement Agreement With The European Commission For Veklury® Remdesivir

Gilead Sciences (Nasdaq: GILD) and the European Commission signed a joint procurement agreement (JPA) that will enable rapid and equitable access to Veklury® (remdesivir), the first antiviral drug proven to be effective for the treatment of COVID-19 in the European Union (EU). The JPA enables participating countries in the EU and the European Economic Area (EEA) and the UK to purchase Veklury for both real-time demand and stockpiling needs, coordinated by the European Commission. The agreement covers purchases of Veklury over the next six months and has the option to be extended. In the EU, EEA and UK, Veklury is indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen.

The JPA replaces an Emergency Support Instrument (ESI) that enabled the European Commission to procure Veklury for EU Member States, including the UK, from August through October 2020. Both the ESI and JPA temporarily remove the need for country-by-country reimbursement processes that typically follow marketing authorization, in recognition of the current health crisis. Gilead will begin fulfilling orders the week of October 12.

The European Commission granted conditional marketing authorization of Veklury on July 3, 2020, based on data from the randomized, double-blind, placebo-controlled ACTT-1 trial that demonstrated the clinical efficacy and safety of Veklury in COVID-19 patients with pneumonia requiring supplemental oxygen. The filing was also supported by data from two randomized clinical trials demonstrating the efficacy and safety of Veklury in five-day and ten-day dosing durations. The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster, thereby reducing hospital stays and healthcare resource utilization.

Supply of Veklury is expected to meet global demand by the end of this month, enabling the purchase of Veklury both to treat patients and to support national stockpiling of the medicine for current and future surges of COVID-19. The significant increase in Veklury supply is the result of early investments that Gilead made to increase internal manufacturing capacity, expand our external contract manufacturing network and shorten the production timeline through process improvements. More than 40 contract manufacturing organizations, including more than 10 partner sites in Europe, support the production of Veklury supply for patients and clinical trials around the world. Through these efforts, Gilead is on track to produce more than 2 million treatment courses of Veklury this year, increasing supply by more than 400-fold since January 2020, and will produce several million more treatment courses in 2021, if required.