Oct 8, 2020   SOURCE: BusinessWire

Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)

Gilead 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.

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.

About Veklury (remdesivir)

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19. Data from three randomized clinical trials in hospitalized patients with COVID-19 have consistently demonstrated the clinical benefits of treatment with Veklury. In the double-blind, placebo-controlled ACTT-1 study of more than 1,000 patients with COVID-19, Veklury improved clinical outcomes over a broad range of assessments, including significantly improving time to recovery and also reducing the likelihood of disease progression compared with placebo. Additional ongoing, international Phase 3 clinical trials continue to evaluate the efficacy and safety of Veklury for the treatment of COVID-19, in different patient populations and formulations, and in combination with other therapies.

In recognition of the current public health emergency and based on available clinical data, the approval status of Veklury varies by country. To date, Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.

In the United States, the U.S. Food and Drug Administration (FDA) granted Veklury an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. Veklury has not been approved by the U.S. FDA for any use. For information about the authorized use of Veklury and mandatory requirements of the EUA in the United States, please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more information on Gilead’s response to the coronavirus outbreak, please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the European Commission may not extend or convert the conditional marketing authorization into an unconditional marketing authorization for Veklury as a treatment for COVID-19. Veklury is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) for any use, and it is not yet known if Veklury is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving Veklury and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of Veklury or that FDA and other regulatory agencies may not approve Veklury, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Veklury may never be successfully commercialized. In addition, there is also the risk that Gilead may be unable to effectively manage the global supply and distribution of Veklury. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.