Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)
October 08 2020 - 3:00AM
Business Wire
– 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 –
– Greatly Expanded Supply of Veklury
Expected to Meet European Real-Time Demand and Stockpiling Needs in
October –
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.
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European Media Contact: Sarah Swift +44 20 8587 2618
U.S. Media Contact: Sonia Choi +1 (650) 425-5483
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