Gilead Sciences Signs New Joint Procurement Agreement with the European Commission for Veklury® (Remdesivir)

– New Agreement Continues to Enable Rapid and Equitable Access to Veklury for COVID-19 Patients in EU and EEA Countries —

Gilead Sciences and the European Commission today signed a new joint procurement agreement (JPA) that will ensure continued rapid and equitable access to Veklury® (remdesivir) for participating Member States across the European Union (EU) and European Economic Area (EEA).

The agreement covers purchases of Veklury over the next twelve months and has the option to be extended for an additional six months. It follows the expiration of the original JPA agreement, the first for a COVID-19 therapeutic, signed in October 2020.

“We welcome this new JPA for Veklury which will continue to help governments across Europe ensure they have rapid access to this critical treatment,” said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. “Veklury is the antiviral standard-of-care treatment for appropriate hospitalized patients across a spectrum of COVID-19 disease severity. It has helped hundreds of thousands of patients across Europe recover faster and reduce hospital stays, which generate savings for healthcare systems. Following the recent expanded indication to patients at risk for disease progression, Veklury now has the potential to help even more patients so we are pleased this JPA will help ensure Veklury is available for patients when they need it.”

In the EU and EEA Veklury is the only antiviral indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation). In December 2021, the European Commission expanded the indication for Veklury to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.

The expanded European conditional marketing authorization was supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for the treatment of COVID-19 in patients at high risk for disease progression. In this study, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008; in the study, there were no deaths in either arm through the primary endpoint. The study was also the basis for the World Health Organization’s updated Therapeutics and COVID-19 living guideline, which now conditionally recommends Veklury for use in patients with non-severe COVID-19 at the highest risk of hospitalization.

About Veklury

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal drug interactions in diverse populations. It can help reduce disease progression across a broad spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and generating savings to healthcare systems.

Veklury is a nucleotide analog that directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. In vitro laboratory testing in multiple independent studies show that Veklury continues to retain activity against SARS-CoV2 as it evolves, including the Omicron variant and its subvariants BA.1 and BA.2. As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.

Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead’s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Source link:https://www.gilead.com/

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