Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN)
today announced that the Biomedical Advanced Research and
Development Authority (BARDA) has entered into an agreement with
Regeneron to support clinical development, clinical manufacturing
and the regulatory licensure process of a next-generation COVID-19
monoclonal antibody therapy for the prevention of SARS-CoV-2
infection. The agreement is part of ‘Project NextGen,’ an
initiative by the U.S. Department of Health and Human Services
(HHS) to advance a pipeline of new, innovative vaccines and
therapeutics for COVID-19.
BARDA, part of the Administration for Strategic Preparedness and
Response at HHS, and Regeneron have previously worked together to
deliver novel medicines for Ebola and COVID-19 at unprecedented
speed and under urgent circumstances. The new program announced
today falls under Regeneron and BARDA’s ongoing Other Transactions
Agreement initiated in 2017 to develop a portfolio of antibodies
targeting up to 10 pathogens that pose significant risk to public
health. For the new COVID-19 program, HHS will fund up to 70
percent of Regeneron’s costs for certain clinical development
activities for a next-generation monoclonal antibody therapy with
broad neutralizing activity against SARS-CoV-2, the virus that
causes COVID-19. The new contract has an estimated value of up to
approximately $326 million of government funding.
“We’re pleased to expand our longstanding BARDA relationship,
which is predicated on Regeneron’s decades of investment in deep
scientific research and enabling technologies,” said Leonard S.
Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief
Executive Officer of Regeneron. “Although COVID-19 has moved to an
endemic stage, many people – including those with
immunocompromising conditions – continue to face exposure that
impacts their everyday life and could cause serious health
consequences. We believe Regeneron can once again apply our drug
discovery and development expertise to help prevent disease in
vulnerable populations. American biopharmaceutical companies
developed remarkable COVID-19 therapeutics and vaccines in record
time, successfully changing the course of the pandemic, and we’re
gratified that the U.S. Government continues to support early
research from this uniquely innovative industry.”
Under the project structure, Regeneron independently invents and
proposes an antibody candidate, which BARDA and Regeneron will then
evaluate and agree upon for further development, manufacturing and
regulatory activities. Regeneron’s most advanced next-generation
antibody candidate under this agreement is expected to enter
clinical trials later this year.
Starting in early 2020, Regeneron scientists rapidly responded
to the COVID-19 pandemic by discovering and manufacturing a highly
potent, anti-spike antibody cocktail that successfully neutralized
many SARS-CoV-2 variants, including Delta. Developed at record
speed and first granted Emergency Use Authorization in November
2020, the antibody cocktail was used as a COVID-19 treatment and
preventative for millions of people around the globe, with nearly 3
million doses delivered to the U.S. Government between 2020 and
2022.
The next-generation antibody project is being funded in part
with federal funds from BARDA under OT number:
HHSO100201700020C.
About Regeneron Regeneron is a leading
biotechnology company that invents, develops, and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, Regeneron’s
unique ability to repeatedly and consistently translate science
into medicine has led to numerous FDA-approved treatments and
product candidates in development, almost all of which were
homegrown in Regeneron's laboratories. Regeneron's medicines and
pipeline are designed to help patients with eye diseases, allergic
and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, hematologic conditions, 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 Regeneron, please
visit www.regeneron.com or follow Regeneron on
LinkedIn.
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 nature, timing, and possible success and therapeutic
applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Products”) and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Product Candidates”) and research and clinical
programs now underway or planned, including without limitation
Regeneron’s next-generation COVID-19 monoclonal antibody therapy
for the prevention of SARS-CoV-2 infection discussed in this press
release (the “next-generation COVID-19 antibody candidate”); the
extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators or
licensees (such as those referenced in this press release related
to the next-generation COVID-19 antibody candidate) may be
replicated in other studies and/or lead to advancement of product
candidates to clinical trials, therapeutic applications, or
regulatory approval; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron’s Product
Candidates and new indications for Regeneron’s Products;
uncertainty of the utilization, market acceptance, and commercial
success of Regeneron’s Products and Regeneron’s Product Candidates
and the impact of studies (whether conducted by Regeneron or others
and whether mandated or voluntary) on any of the foregoing or any
potential regulatory approval of Regeneron’s Products and
Regeneron’s Product Candidates; the ability of Regeneron’s
collaborators, licensees, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron’s Products and Regeneron’s Product Candidates; the
ability of Regeneron to manage supply chains for multiple products
and product candidates; safety issues resulting from the
administration of Regeneron’s Products and Regeneron’s Product
Candidates in patients, including serious complications or side
effects in connection with the use of Regeneron’s Products and
Regeneron’s Product Candidates in clinical trials; 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 Regeneron’s Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron’s Products, research and clinical programs, and business,
including those relating to patient privacy; 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 Regeneron’s 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, collaboration, or supply agreement, including Regeneron’s
agreements with Sanofi and Bayer (or their respective affiliated
companies, as applicable) to be cancelled or terminated; the impact
of public health outbreaks, epidemics, or pandemics (such as the
COVID-19 pandemic) on Regeneron's business; 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 and
REGEN-COV® (casirivimab and imdevimab)), 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, 2022 and its
Form 10-Q for the quarterly period ended June 30, 2023. 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 or otherwise) any
forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Contacts:Media
Relations Tammy
AllenTel: +1 914-306-2698tammy.allen@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443vesna.tosic@regeneron.com |
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