TARRYTOWN, N.Y., July 29, 2020 /PRNewswire/ --
REGN-EB3 is a novel anti-viral antibody cocktail developed
using the same rapid response technologies as REGN-COV2,
Regeneron's investigational COVID-19 antibody cocktail
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today
that the Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services (HHS), has entered into an agreement to procure
REGN-EB3 as part of the HHS' goal of building national preparedness
for public health emergencies.
REGN-EB3 is Regeneron's investigational triple antibody cocktail
treatment for Ebola virus infection and is currently under Priority
Review by the U.S. Food and Drug Administration (FDA), with a
target action date of October 25,
2020. Contingent on FDA approval,
Regeneron expects to deliver an established number of
treatment doses over the course of six years and receive
compensation of approximately $10
million in 2021 and an average of $67
million per year for each of the next five years
(2022-2026).
"Developed using Regeneron's proprietary
VelociSuite® rapid response technologies,
REGN-EB3 was shown to save lives in the PALM trial, which evaluated
multiple therapies against the previous standard of care for
Ebola," said Leonard S. Schleifer,
M.D., Ph.D., Co-Founder, President and Chief Executive Officer of
Regeneron. "Regeneron's thirty years of investment in our
technology and people enabled the development of REGN-EB3, which
reinforces the importance of having at-the-ready tools to fight
emerging pathogens. As we push through the current COVID-19
pandemic, it's important for governments and industry to ensure
preparedness for the next global health crisis by continuing to
invest in innovative science and broad manufacturing capacity."
"The current COVID-19 pandemic provides an important lesson in
preparation for potential biological threats to our nation's health
security," said BARDA acting director Gary
Disbrow, Ph.D. "REGN-EB3 is the result of years of
collaboration, which demonstrates the fundamental value of
public-private partnership in protecting Americans from global
epidemics. Whether the next one is another coronavirus, an Ebola
virus or a completely novel disease, we must do everything we can
to be prepared."
In 2019, the randomized controlled PALM clinical trial conducted
in the Democratic Republic of the
Congo was stopped early when preliminary results showed that
REGN-EB3 crossed the pre-specified superiority threshold for
preventing death compared to the control arm, ZMapp®.
REGN-EB3 demonstrated superior efficacy compared to ZMapp across
multiple measures, including reduced mortality and fewer days until
the Ebola virus was no longer detected in the bloodstream. During
the trial, there were three serious adverse events for REGN-EB3,
compared to seven for ZMapp. REGN-EB3 is being developed with
collaboration and funding provided by BARDA under ongoing USG
Contract Nos. HHSO100201700016C and HHSO100201500013C.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune®, which uses
unique genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements.
Words such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these
risks and uncertainties include, among others, the impact of
SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on
Regeneron's business and its employees, collaborators, and
suppliers and other third parties on which Regeneron relies,
Regeneron's and its collaborators' ability to continue to conduct
research and clinical programs, Regeneron's ability to manage its
supply chain, net product sales of products marketed by Regeneron
and/or its collaborators (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and
Regeneron's product candidates and research and clinical programs
now underway or planned, including without limitation REGN-EB3
(Regeneron's investigational triple antibody cocktail treatment for
Ebola virus infection) and REGN-COV2 (Regeneron's
investigational COVID-19 antibody cocktail); uncertainty
of market acceptance and commercial success of Regeneron's Products
and product candidates and the impact of studies (whether conducted
by Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products and product candidates;
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's product candidates (such as
REGN-EB3 and REGN-COV2) and new indications for Regeneron's
Products; safety issues resulting from the administration of
Regeneron's Products and product candidates (such as REGN-EB3 and
REGN-COV2) in patients, including serious complications or side
effects in connection with the use of Regeneron's Products and
product candidates in clinical trials; whether Regeneron will be
able to deliver the established number of treatment doses set forth
in its agreement with the Biomedical Advanced Research and
Development Authority, part of the Office of the Assistant
Secretary for Preparedness and Response within the U.S. Department
of Health and Human Services (HHS), (collectively, the "U.S.
Government") discussed in this press release (the "Supply
Agreement"), the amount of payments (if any) Regeneron may receive
pursuant to the Supply Agreement, and whether the Supply Agreement
is terminated by the U.S. Government or otherwise prior to
completion; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and product candidates, including without limitation
REGN-EB3 and REGN-COV2; ongoing regulatory obligations and
oversight impacting Regeneron's Products, research and clinical
programs, and business, including those relating to patient
privacy; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and product candidates; the availability and extent of
reimbursement of Regeneron's Products from third-party payers,
including private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron's Products and product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may be replicated in other
studies and/or lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's Products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license or
collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), to be cancelled or
terminated without any further product success; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent®
(dupilumab), and Praluent® (alirocumab)), other
litigation and other proceedings and government investigations
relating to the Company and/or its operations, the ultimate outcome
of any such proceedings and investigations, and the impact any of
the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the
quarterly period ended March 31,
2020. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to
update publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Contacts:
Media Relations
Alexandra
Bowie
Tel: +1 (914) 847-3407
alexandra.bowie@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.