Gilead Sciences Update on Supply and Distribution of Veklury® (remdesivir) in the United States
October 01 2020 - 2:00PM
Business Wire
-- Supply of Veklury Is Meeting Real-Time
Demand in the U.S. --
-- Clinical Benefits of Veklury Consistently
Demonstrated Across Three Randomized, Clinical Trials Are Now
Available to All Clinically Appropriate Hospitalized COVID-19
Patients in the U.S. --
-- Veklury Distribution Has Transitioned
from the U.S. Government to Gilead --
Since the COVID-19 pandemic began, Gilead has worked diligently
to ramp up production and rapidly expand the supply of our
investigational antiviral drug Veklury® (remdesivir) by making
significant investments to increase internal manufacturing
capacity, expand our contract manufacturing network and implement
process improvements. While working to increase our manufacturing
capacity over these past months, the company also donated 1.5
million vials of Veklury and provided clinical drug supply at no
cost for evaluation as an investigational agent in clinical trials
around the world. As a result of the decision to make early
investments to increase Veklury manufacturing efforts, Gilead is
now meeting real-time demand for Veklury in the United States and
anticipates meeting global demand for Veklury in October, even in
the event of potential future surges of COVID-19.
Starting on October 1, Gilead will be responsible for
distributing Veklury in the United States upon conclusion of the
previous distribution agreement with the U.S. Federal government.
To ensure stable management of drug supply in the near term,
AmerisourceBergen will continue to serve as the sole U.S.
distributor of Veklury through the end of this year and will sell
the product directly to hospitals. This distribution model closely
reflects the traditional model hospitals use to procure medicines.
Hospitals will control the quantity of Veklury that they order,
enabling them to have ample, predictable supply of Veklury in
advance of any anticipated increase in COVID-19 incidence.
Results from three randomized, controlled clinical trials have
consistently demonstrated the clinical benefits of Veklury. These
data support the use of Veklury as a standard of care in
hospitalized COVID-19 patients. 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 and, in turn, increase healthcare provider capacity
and reduce healthcare system costs.
Contact Information for U.S. Veklury Orders
Hospitals interested in ordering Veklury beginning in October
may contact AmerisourceBergen Specialty Division directly at
800-746-6273.
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, controlled clinical
trials in hospitalized patients with COVID-19 have consistently
demonstrated the clinical benefits of treatment with Veklury. In
the placebo-controlled ACTT-1 study, Veklury significantly improved
time to recovery and also reduced the likelihood of disease
progression. Additional ongoing international Phase 3 clinical
trials continue to evaluate the safety and efficacy 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.
Veklury has not been approved by the U.S. Food and Drug
Administration (FDA) for any use, and its safety and efficacy have
not been established. Gilead submitted a new drug application for
Veklury on August 7, 2020; the NDA is currently under FDA review.
Veklury is currently authorized for temporary use under an
Emergency Use Authorization (EUA) for the treatment of hospitalized
patients with COVID-19, including patients with moderate to severe
disease, regardless of the need for supplemental oxygen. 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. For information about the authorized use of
Veklury and mandatory requirements of the EUA in the U.S., 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. Veklury
is an investigational drug that has not been approved by the 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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version on businesswire.com: https://www.businesswire.com/news/home/20201001006002/en/
Media Contact: Sonia Choi (650) 425-5483
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