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Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)
– Agreement Enables Rapid and Equitable Access to the Clinical Benefits of Veklury for Appropriate COVID-19 Patients in the Majority of Countries of the EU
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n– Agreement Enables Rapid and Equitable Access to the Clinical Benefits of Veklury for Appropriate COVID-19 Patients in the Majority of Countries of the EU and EEA –\n\n– Greatly Expanded Supply of Veklury Expected to Meet European Real-Time Demand and Stockpiling Needs in October –\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences (Nasdaq: GILD) and the European Commission today 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.\n\nThe 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.\n\nThe 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.\n\nSupply 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...