TARRYTOWN, N.Y., Aug. 12, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the Company was informed by study investigators that a randomized,
controlled trial evaluating four investigational therapies for
Ebola virus infection was stopped early because REGN-EB3 was
superior to ZMapp in preventing death. ZMapp served as the control
arm of the trial because it was considered the standard-of-care
based on the previous PREVAIL II clinical trial. The protocol
specified that the PALM trial would only be stopped early for a
highly statistically significant result. The independent data
safety monitoring board decided to stop the trial after reviewing
interim mortality data from 499 patients. The trial was conducted
in the Democratic Republic of
Congo (DRC), where the current outbreak is ongoing.
The trial was first initiated in 2018 with three treatment arms:
mAb114, remdesivir and ZMapp. The trial protocol was amended after
the World Health Organization (WHO) held an Ad-Hoc Expert
Consultation to assess all preclinical and clinical data on
available investigational products, and recommended the addition of
REGN-EB3 as a fourth treatment arm.
"The Regeneron team worked tirelessly to discover, develop and
produce REGN-EB3 in record time utilizing our
VelocImmune®-based technologies," said Neil
Stahl, Ph.D., Executive Vice President of Research and Development
at Regeneron. "We are moved to know our therapy is helping save the
lives of people facing this deadly infectious disease. We look
forward to reviewing the trial data and are working with
governments and other collaborators, including BARDA, to make
REGN-EB3 available for the current outbreak and future use."
"This trial was conducted in difficult circumstances during a
public health emergency, and we appreciate the efforts of the WHO
and other experts to add REGN-EB3 to the trial," said Sumathi Sivapalasingam, M.D., Senior Director,
Early Clinical Development and Experimental Sciences at Regeneron.
"This trial is a remarkable advance in the decades-long struggle to
respond to Ebola and we appreciate the tremendous efforts of the
many governmental and non-governmental organizations who made it
possible."
REGN-EB3 (also known as REGN3470-3471-3479) was invented by
Regeneron using its VelociSuite® technologies;
the therapy combines three fully-human monoclonal antibodies.
REGN-EB3 has received orphan drug designation from both the U.S.
Food and Drug Administration and the European Medicines Agency.
REGN-EB3 is being developed, tested and manufactured as part of an
agreement established in 2015 with the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the
Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services (HHS). REGN-EB3 is
currently under clinical development and its safety and efficacy
have not been fully evaluated by any regulatory authority.
"REGN-EB3 is a three-antibody cocktail designed with the goal of
enhancing efficacy, reducing the development of viral sequences
that lead to resistance, and increasing potential utility in future
outbreaks as viruses continually evolve," said Christos Kyratsous, Ph.D., Vice President of
Research, Infectious Diseases and Viral Vector Technologies at
Regeneron. "The Regeneron rapid response infectious disease
platform has the opportunity to accelerate our response to future
epidemics and pandemics, and we continue to work on additional
diseases that may pose a threat to public health."
About the PALM Trial
The PAmoja TuLinde Maisha (PALM [together save lives]) clinical
trial was a randomized, multicenter, controlled trial to evaluate
the safety and efficacy of four investigational agents for the
treatment of patients with Ebola virus infection – including three
antibody-based therapies, REGN-EB3, ZMapp and mAb114 (a single
monoclonal antibody); and one small molecule antiviral, remdesivir.
The primary objective of the trial was to compare mortality in
patients with Ebola who received either REGN-EB3, mAb114 or
remdesivir to those who received ZMapp in the control arm. The
National Institutes of Health (NIH) and the Institut National de
Recherche Biomédicale (INRB) in the DRC jointly sponsored and
served as co-principal investigators.
By August 2019, the trial had
enrolled nearly 700 participants across four Ebola Treatment
Centers in the DRC. With the preliminary findings in 499 trial
participants, REGN-EB3 and mAb114 will be the two investigational
treatments given as part of an Extension Phase to further evaluate
safety until final results of the clinical trial are known, after
which an Expanded Access Phase will be initiated using the lead
therapeutics from the trial.
Regeneron and BARDA have several ongoing research collaborations
in addition to the Ebola program, including a collaboration to
develop treatments for Middle East Respiratory Syndrome (MERS) and
a collaboration for the discovery, research, development and
manufacturing of a portfolio of antibodies targeting up to 10
pathogens that pose significant risk to public health.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 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 disease, allergic and
inflammatory diseases, cancer, cardiovascular and metabolic
diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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.
Regeneron 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 Regeneron's products, product
candidates, and research and clinical programs now underway or
planned, including without limitation Regeneron's potential
antibody therapies for the treatment of Ebola (REGN-EB3 or
REGN3470-3471-3479) and Middle East Respiratory Syndrome (MERS);
the extent to which the results from the research and development
programs conducted by Regeneron or its collaborators may be
replicated in later studies and lead to therapeutic applications;
unforeseen safety issues and possible liability resulting from the
administration of products and product candidates in patients,
including without limitation Regeneron's potential antibody
therapies for the treatment of Ebola and MERS; serious
complications or side effects in connection with the use of
Regeneron's products and product candidates (such as Regeneron's
potential antibody therapies for the treatment of Ebola and MERS)
in clinical trials; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates and new indications for marketed products; the
availability and extent of reimbursement of the Company'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;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed 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, such as
Regeneron's potential antibody therapies for the treatment of Ebola
and MERS; competing drugs and product candidates that may be
superior to Regeneron's products and product candidates;
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 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 EYLEA® (aflibercept)
Injection, Dupixent® (dupilumab) Injection, and
Praluent® (alirocumab) Injection, the ultimate
outcome of any such proceedings, 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 United States Securities and Exchange Commission,
including its Form 10-K for the year ended December 31, 2018 and its Form 10-Q for the
quarterly period ended June 30, 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).
Regeneron Contacts:
Media Relations
Ella
Campbell
Tel: +1 (914) 847-7017
ella.campbell@regeneron.com
Investor Relations
Justin
Holko
Tel: +1 (914) 847-7786
Justin.Holko@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.