TARRYTOWN, N.Y., April 16, 2020 /PRNewswire/ --
- REGN-EB3 developed via same rapid response platform
currently being leveraged to develop novel COVID-19 antibody
therapy
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the U.S. Food and Drug Administration (FDA) has accepted for
Priority Review a new Biologics License Application (BLA) for
REGN-EB3, an investigational triple antibody cocktail treatment for
Ebola virus infection. The target action date for the FDA decision
is October 25, 2020.
The REGN-EB3 BLA is supported by data from the randomized,
controlled PALM clinical trial conducted in the Democratic Republic of Congo. In August 2019, the trial 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.
"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 current standard of care," said
George D. Yancopoulos, M.D., Ph.D.,
Co-Founder, President and Chief Scientific Officer of Regeneron.
"Regeneron is now applying this same approach to develop an
antibody medicine that can potentially prevent and treat COVID-19,
with initial clinical trials expected to begin in June."
Regeneron's VelociSuite technologies enable
the efficient creation and selection of potent fully-human
antibodies against a specific biological target, which is
particularly critical for addressing new and/or quickly-spreading
pathogens such as Ebola and COVID-19. These technologies
facilitate the rapid cloning and generation of optimized
fully-human antibodies from
both VelocImmune® mice (which are
genetically-engineered to have genetically-humanized immune
systems) and convalescing human volunteers, and allow for the rapid
escalation of fully-human antibodies into manufacturing-quality
cell line production and large-scale bioreactor
manufacturing. Once strong therapeutic antibody candidates are
identified, the company's in-house preclinical, clinical and
commercial-scale manufacturing capabilities allow for fast scale-up
and flexibility to adapt to current need.
REGN-EB3 has received Orphan Drug and Breakthrough Therapy
designation from the FDA. It is being developed under an ongoing
collaboration and with funding provided by 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 (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, 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 Regeneron's
investigational triple antibody cocktail treatment for Ebola virus
infection ("REGN-EB3") and Regeneron's novel antibody cocktail for
the prevention and treatment of the SARS-CoV-2 virus (the "COVID-19
Multi-antibody Therapy"); 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 lead to
therapeutic applications; the likelihood, timing, and scope of
possible regulatory approval and commercial launch of Regeneron's
product candidates (such as REGN-EB3 and the COVID-19
Multi-antibody Therapy) and new indications for Regeneron's
Products; unforeseen safety issues resulting from the
administration of Regeneron's Products and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and 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 product candidates; ongoing regulatory
obligations and oversight impacting Regeneron's Products, research
and clinical programs, and business, including those relating to
patient privacy; 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 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 Regeneron's Products and
product candidates; 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), as
well as the agreements with the Biomedical Advanced Research and
Development Authority of the U.S. Department of Health and Human
Services referenced in this press release, 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
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. 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.
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 (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
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.