TARRYTOWN, N.Y., Sept. 30, 2021 /PRNewswire/ --
Trial met primary endpoint, showing REGEN-COV significantly
reduced viral load within 7 days of treatment; trial conducted in
patients hospitalized with COVID-19 who did not require high-flow
oxygen or mechanical ventilation at baseline
Numeric improvements with REGEN-COV observed for all clinical
endpoints, including a 36% reduced risk of death by day 29 in the
overall population, increasing to 56% reduced risk in patients who
were seronegative at baseline
Similar efficacy observed with both doses (2,400 mg and 8,000
mg); U.S. FDA is currently reviewing request to add treatment in
hospital settings to REGEN-COV authorization
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced that a trial assessing investigational
REGEN-COV™ (casirivimab and imdevimab) in patients hospitalized
with COVID-19 met its primary endpoint. Trial results will be
presented at IDWeek 2021 today, and show that REGEN-COV
significantly reduced viral load in patients hospitalized with
COVID-19 who entered the trial without having mounted their own
antibody response (seronegative) and required low-flow or no
supplemental oxygen (p=0.0172). The trial also had clinical results
supportive of the much larger UK RECOVERY trial in hospitalized
patients, with numeric improvements observed across all clinical
endpoints assessed.
"COVID-19 continues to have a devastating impact on patients,
our communities and healthcare systems, and has so far killed more
than one in every 500 Americans," said Eleftherios Mylonakis, M.D., Ph.D., primary
investigator of the trial and Professor of Medicine, Molecular
Microbiology and Immunology, and Director of Infectious
Disease at Brown University and the
Lifespan hospitals. "We need a multi-faceted approach to best
manage the virus' impact, including vaccination and effective
treatment when patients become ill. These data show that REGEN-COV
can benefit certain patients even after they are hospitalized,
reducing the amount of virus and clinical consequences. Taken
together with results announced earlier this year from the RECOVERY
trial and other studies, these results have the potential to inform
personalized care for hospitalized patients with this protean
disease that presents with such high clinical variability."
REGEN-COV is an investigational medicine authorized by the U.S.
Food and Drug Administration (FDA) under an emergency use
authorization to treat people who are at high risk of serious
consequences from COVID-19 infection who are either already
infected (non-hospitalized) or in certain post-exposure
prophylaxis settings. In the U.S., it is not currently
authorized in patients who are hospitalized due to COVID-19
infection.
The trial, which was stopped due to slow enrollment after
recruiting just over one third the patients originally planned,
found that patients who received REGEN-COV (2,400 mg or 8,000 mg)
in addition to standard-of-care (SOC) experienced numeric
improvements across all clinical endpoints assessed, compared to
SOC alone (placebo). Researchers did not observe any clinical
difference between the two REGEN-COV doses (2,400 mg or 8,000 mg),
or any serious or dose-dependent safety signals in REGEN-COV
treated patients. In a safety analysis involving 2,007 patients
(REGEN-COV=1,340, placebo=667) serious adverse events occurred in
21% REGEN-COV patients (n=285) and 26% placebo patients (n=174).
Infusion-related reactions and hypersensitivity reactions that were
grade ≥2 occurred more commonly among REGEN-COV patients (2% and 1%
respectively) than placebo patients (1% and <0.5% respectively).
The trial originally assessed a broader group of patients; however
in late 2020 the trial was adjusted to exclude patients who
were on mechanical ventilation or high-flow oxygen at baseline
based on a potential safety signal identified by an Independent
Data Monitoring Committee in 199 patients on mechanical ventilation
or high flow-oxygen, a finding that was not replicated in the much
larger RECOVERY trial that enrolled hospitalized patients with
a broad range of severe COVID-19, including these patient
groups.
"These new results, combined with the nearly 10,000-patient
RECOVERY trial, further validate how REGEN-COV can change the
course of illness for patients even after they are hospitalized
with COVID-19," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "Patients who received REGEN-COV in this
trial experienced a 36% reduced risk of dying within 29 days of
receiving treatment, and in patients who were seronegative when
they entered the trial the risk was reduced by 56%. It's important
to remember that while results from this and the RECOVERY trial
indicate that patients unable to develop their own antibodies
against COVID-19 historically had the poorest prognosis – and hence
the greatest benefit from REGEN-COV treatment – both were largely
conducted before widespread vaccination or the emergence of
variants such as Delta. Consequently, serostatus may be less
informative for treatment decisions in the future because it might
not be practical to assess whether patients' antibodies are for
their current SARS-CoV-2 infection."
The robust REGEN-COV development program has reported positive
Phase 3 trial results across the spectrum of COVID-19 infection,
from prevention to hospitalization:
- Prevention of symptomatic infection in both uninfected and
infected asymptomatic household contacts of SARS-CoV-2 infected
individuals
- Treatment of non-hospitalized patients already infected with
SARS-CoV-2
- Treatment of certain patients hospitalized due to COVID-19
infection (as detailed in the IDWeek presentation),
including the RECOVERY trial
Multiple analyses have shown that the antibody cocktail retains
potency against the main variants of concern circulating within the
U.S., including Delta (first identified in India), Gamma (first identified in
Brazil), Beta (first identified in
South Africa) and Mu (first
identified in Colombia), with
information available in the Fact Sheet for Healthcare Providers.
Consequently, REGEN-COV remains available for use across the U.S.,
and Regeneron will continue actively monitoring the potency of
REGEN-COV against emerging variants.
In the U.S., REGEN-COV is available for free to eligible people,
as part of a U.S. government funded program and earlier this month
Regeneron announced a new agreement with the U.S. government
to supply an additional 1.4 million 1,200 mg doses of
REGEN-COV. Information on how to access REGEN-COV throughout
the U.S. is available from the Department of Health and Human
Services and the National Infusion Center
Association.
The development and manufacturing of REGEN-COV have been funded
in part with federal funds from the Biomedical Advanced Research
and Development Authority, part of the U.S. Department of Health
and Human Services' Office of the Assistant Secretary for
Preparedness and Response, under OT number: HHSO100201700020C.
About the Trial
The Phase 2/3, randomized,
double-blind, placebo-controlled trial evaluated REGEN-COV in
hospitalized adult patients with COVID-19. Of the 1,197 patients
included in the efficacy analysis, 530 entered the trial with no
supplemental oxygen and 667 were on low-flow oxygen. The safety
analysis included results from all patients in the efficacy
analysis plus additional patients from earlier stages of the
clinical program who were on low-flow oxygen at baseline.
Patients were randomized 1:1:1 to receive a one-time infusion of
REGEN-COV 8,000 mg, REGEN-COV 2,400 mg or placebo. All patients
entering the trial were hospitalized with laboratory-confirmed
COVID-19, and all received other background SOC as required
including corticosteroids (75%) and remdesivir (55%).
On average, patients included in the efficacy analysis had
experienced symptoms for 6 days prior to entering the trial, and
nearly half (43%) were seronegative. Approximately 30% were
Hispanic and 12% were African American. Patients were on average 62
years of age, 54% were male and 46% were female.
About the REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab and imdevimab) is a cocktail of two monoclonal
antibodies that was designed specifically to block infectivity of
SARS-CoV-2, the virus that causes COVID-19, using Regeneron's
proprietary VelocImmune® and
VelociSuite® technologies. The two potent,
virus-neutralizing antibodies that form the cocktail bind
non-competitively to the critical receptor binding domain of the
virus's spike protein, which diminishes the ability of mutant
viruses to escape treatment and protects against spike variants
that have arisen in the human population, as detailed
in Cell and Science.
REGEN-COV has not been approved by the FDA, but is
currently authorized in the U.S.
for the treatment and post-exposure prophylaxis in
certain high risk individuals. Post-exposure prophylaxis with
REGEN-COV is not a substitute for vaccination against COVID-19.
REGEN-COV is not authorized for pre-exposure prophylaxis for
prevention of COVID-19 or for use in patients who are hospitalized
due to COVID-19 or require oxygen therapy, or for people currently
using chronic oxygen therapy because of an underlying comorbidity
who require an increase in baseline oxygen flow rate due to
COVID-19. This authorization is for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C.
§ 360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner. Additional information about REGEN-COV in the U.S. is
below (authorized uses and important safety information).
In August, Regeneron submitted the first of two Biologics
License Applications (BLAs) for REGEN-COV. The initial submission
included data on the efficacy and safety of REGEN-COV to treat and
prevent SARS-CoV-2 infection in non-hospitalized people.
The second BLA submission will focus on those
hospitalized because of COVID-19, and is expected to be completed
later this year.
Emergency or temporary pandemic use authorizations are currently
in place in more than 40 countries, including the U.S., several
European Union countries, India,
Switzerland and Canada, and the antibody cocktail is fully
approved in Japan and
conditionally approved in the UK.
Regeneron invented REGEN-COV and is collaborating with
Roche to increase global supply, with Roche primarily responsible
for development and distribution outside the U.S. Regeneron and
Roche share a commitment to making the antibody cocktail available
to COVID-19 patients around the globe and will support access in
low- and lower-middle-income countries through drug donations to be
made in partnership with public health organizations.
About Regeneron's VelocImmune
Technology
Regeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's President and
Chief Scientific Officer George D.
Yancopoulos was a graduate student with his mentor
Frederick W. Alt in 1985, they were
the first to envision making such a genetically humanized mouse,
and Regeneron has spent decades inventing and developing
VelocImmune and related VelociSuite technologies. Dr.
Yancopoulos and his team have used VelocImmune technology to
create approximately a quarter of all original, FDA-approved fully
human monoclonal antibodies currently available. This includes
REGEN–COV (casirivimab and imdevimab), Dupixent®
(dupilumab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab,
maftivimab and odesivimab-ebgn).
AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION
Treatment:
REGEN-COV is authorized for the treatment
of mild to moderate coronavirus disease 2019 (COVID-19) in adults
and pediatric patients (12 years of age and older weighing at least
40 kg) with positive results of direct SARS-CoV-2 viral testing,
and who are at high risk for progression to severe COVID-19,
including hospitalization or death
Limitations of Authorized Use (Treatment)
- REGEN-COV is not authorized for use in patients:
-
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to
COVID-19 in those on chronic oxygen therapy due to underlying
non-COVID-19 related comorbidity
- Monoclonal antibodies, such as REGEN-COV, may be associated
with worse clinical outcomes when administered to hospitalized
patients with COVID-19 requiring high-flow oxygen or mechanical
ventilation
Post-Exposure Prophylaxis:
REGEN-COV is authorized in
adult and pediatric individuals (12 years of age and older weighing
at least 40 kg) for post-exposure prophylaxis of COVID-19 in
individuals who are at high risk for progression to severe
COVID-19, including hospitalization or death, and are:
- not fully vaccinated or who are not expected to mount an
adequate immune response to complete SARS-CoV-2 vaccination (for
example, individuals with immunocompromising conditions including
those taking immunosuppressive medications) and
-
- have been exposed to an individual infected with SARS-CoV-2
consistent with close contact criteria per Centers for Disease
Control and Prevention (CDC) or
- who are at high risk of exposure to an individual infected with
SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other
individuals in the same institutional setting (for example, nursing
homes, prisons)
Limitations of Authorized Use (Post-Exposure
Prophylaxis)
- Post-exposure prophylaxis with REGEN-COV is not a substitute
for vaccination against COVID-19
- REGEN-COV is not authorized for pre-exposure prophylaxis for
prevention of COVID-19
REGEN-COV has not been approved, but has been authorized for
emergency use by FDA
These uses are authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use under section 564(b)(1) of the Act,
21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner
Healthcare providers should review the Fact Sheet for
Healthcare Providers for information on the authorized
uses of REGEN-COV and mandatory requirements of the EUA and must
comply with the requirements of the EUA. The FDA Letter of
Authorization is available for reference, as well
as the Dear Healthcare Provider Letter and Patient
Fact Sheet
Criteria for Identifying High Risk Individuals
Please refer to the Fact Sheet for Healthcare Providers for
criteria for identifying high risk individuals
SARS-CoV-2 Viral Variants
Circulating SARS-CoV-2 viral variants may be associated with
resistance to monoclonal antibodies. Healthcare providers should
review the Antiviral Resistance information in Section 15 of the
Fact Sheet for details regarding specific variants and resistance,
and refer to the CDC website
(https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html)
as well as information from state and local health authorities
regarding reports of viral variants of importance in their region
to guide treatment decisions
Important Safety Information
REGEN-COV (casirivimab and imdevimab) is an unapproved
investigational therapy, and there are limited clinical data
available. Serious and unexpected adverse events may occur that
have not been previously reported with REGEN-COV
use
- Contraindication:
REGEN-COV is contraindicated in
individuals with previous severe hypersensitivity reactions,
including anaphylaxis, to REGEN-COV
- Warnings and Precautions:
-
- Hypersensitivity Including Anaphylaxis and Infusion-Related
Reactions: Serious hypersensitivity reactions, including
anaphylaxis, have been observed with administration of REGEN-COV.
If signs or symptoms of a clinically significant hypersensitivity
reaction or anaphylaxis occur, immediately discontinue
administration and initiate appropriate medications and/or
supportive therapy. Hypersensitivity reactions occurring more than
24 hours after the infusion have also been reported with the use of
REGEN-COV under EUA. Infusion-related reactions, occurring during
the infusion and up to 24 hours after the infusion, have been
observed with administration of REGEN-COV. These reactions may be
severe or life threatening
-
- Signs and symptoms of infusion-related reactions may
include: fever, difficulty breathing, reduced oxygen
saturation, chills, nausea, arrhythmia (e.g., atrial fibrillation,
tachycardia, bradycardia), chest pain or discomfort, weakness,
altered mental status, headache, bronchospasm, hypotension,
hypertension, angioedema, throat irritation, rash including
urticaria, pruritus, myalgia, vasovagal reactions (e.g.,
pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider
slowing or stopping the infusion and administer appropriate
medications and/or supportive care if an infusion-related reaction
occurs
- Clinical Worsening After REGEN-COV
Administration: Clinical worsening of COVID-19 after
administration of REGEN-COV has been reported and may include signs
or symptoms of fever, hypoxia or increased respiratory difficulty,
arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia),
fatigue, and altered mental status. Some of these events required
hospitalization. It is not known if these events were related to
REGEN-COV use or were due to progression of COVID-19
- Limitations of Benefit and Potential for Risk in Patients
with Severe COVID-19: Monoclonal antibodies, such as
REGEN-COV, may be associated with worse clinical outcomes when
administered to hospitalized patients with COVID-19 requiring
high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is
not authorized for use in patients who are hospitalized due to
COVID-19, OR who require oxygen therapy due to COVID-19, OR who
require an increase in baseline oxygen flow rate due to COVID-19 in
those on chronic oxygen therapy due to underlying
non-COVID-19–related comorbidity
- Adverse Reactions:
-
- COV-2067 (Treatment): Infusion-related reactions
(adverse event assessed as causally related by the investigator) of
grade 2 or higher severity have been observed in 10/4,206 (0.2%) of
those who received REGEN-COV at the authorized dose or a higher
dose. Three subjects receiving the 8,000 mg dose of REGEN-COV, and
one subject receiving the 1,200 mg casirivimab and 1,200 mg
imdevimab, had infusion-related reactions (urticaria, pruritus,
flushing, pyrexia, shortness of breath, chest tightness, nausea,
vomiting, rash) which resulted in permanent discontinuation of the
infusion. All events resolved. Anaphylactic reactions have been
reported in the clinical program in subjects receiving REGEN-COV.
The events began within 1 hour of completion of the infusion, and
in at least one case required treatment including epinephrine. The
events resolved
- COV-2069 (Post-exposure prophylaxis): In subjects
who were SARS-CoV-2 negative at baseline (Cohort A), injection site
reactions (all grade 1 and 2) occurred in 55 subjects (4%) in the
REGEN-COV group and 19 subjects (2%) in the placebo group. The most
common signs and symptoms of injection site reactions which
occurred in at least 1% of subjects in the REGEN-COV group were
erythema and pruritus. Hypersensitivity reactions occurred in
2 subjects (0.2%) in the REGEN-COV group and all hypersensitivity
reactions were grade 1 in severity. In subjects who were SARS-CoV-2
positive at baseline (Cohort B), injection site reactions, all of
which were grade 1 or 2, occurred in 6 subjects (4%) in the
REGEN-COV group and 1 subject (1%) in the placebo group. The most
common signs and symptoms of injection site reactions which
occurred in at least 1% of subjects in the REGEN-COV group were
ecchymosis and erythema
- COV-2093 (Subcutaneous Dosing): Injection site
reactions occurred in 12% and 4% of subjects following single dose
administration in the REGEN-COV and placebo groups, respectively.
Remaining safety finding following subcutaneous administration in
the REGEN-COV group were similar to the safety findings observed
with intravenous administration in COV-2067. With repeat dosing,
injection site reactions occurred in 252 subjects (35%) in the
REGEN-COV group and 38 subjects (16%) in the placebo group; all
injection site reactions were grade 1 or 2 in severity.
Hypersensitivity reactions occurred in 8 subjects (1%) in the
REGEN-COV group; and all hypersensitivity reactions were grade 1 or
2 in severity. There were no cases of anaphylaxis
- Patient Monitoring Recommendations: Clinically monitor
patients during dose administration and observe patients for at
least 1 hour after intravenous infusion or subcutaneous dosing is
complete
- Use in Specific Populations:
-
- Pregnancy: There are insufficient data to evaluate
a drug-associated risk of major birth defects, miscarriage, or
adverse maternal or fetal outcomes. REGEN-COV should only be used
during pregnancy if the potential benefit outweighs the potential
risk for the mother and the fetus
- Lactation: There are no available data on the
presence of casirivimab and/or imdevimab in human milk or animal
milk, the effects on the breastfed infant, or the effects of the
drug on milk production. The development and health benefits of
breastfeeding should be considered along with the mother's clinical
need for REGEN-COV and any potential adverse effects on the
breastfed child from REGEN-COV or from the underlying maternal
condition
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 nine
FDA-approved treatments and numerous product candidates in
development, almost 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, 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 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 or otherwise commercialized 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 product candidates being developed by Regeneron and/or
its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation the development program relating to
the REGEN-COVTM (casirivimab and imdevimab) antibody
cocktail; the utilization, market acceptance, and commercial
success of Regeneron's Products and Regeneron's Product Candidates
(such as REGEN-COV), including the impact of recommendations,
guidelines, or studies (whether conducted by Regeneron or others
and whether mandated or voluntary), such as the study discussed in
this press release, on any of the foregoing or any potential
regulatory approval of Regeneron's Products and Regeneron's
Product Candidates; how long the Emergency Use Authorization
("EUA") granted by the U.S. Food and Drug
Administration (the "FDA") for REGEN-COV will remain in effect
and whether the EUA is revoked by the FDA based on its
determination that the underlying health emergency no longer exists
or warrants such authorization or other reasons; whether, based on
the data discussed in this press release or otherwise, the EUA for
REGEN-COV will be expanded to include treatment of certain patients
hospitalized due to COVID-19 infection; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's Product Candidates (such as REGEN-COV, including based
on the Biologics License Applications filed or planned to be filed
with the FDA and referenced in this press release) and new
indications for Regeneron's Products; 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
Regeneron's Product Candidates (including REGEN-COV) and the impact
of the foregoing on Regeneron's ability to supply Regeneron's
Products and Regeneron's Product Candidates (including REGEN-COV);
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 (such as REGEN-COV) 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, including without
limitation REGEN-COV; 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; 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; 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, Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), as well as Regeneron's collaboration
with Roche relating to the casirivimab and imdevimab antibody
cocktail (known as REGEN-COV in the
United States and Ronapreve™ in other countries) and its
REGEN-COV supply agreement with the U.S. government referenced in
this press release, to be cancelled or terminated; 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),
Praluent® (alirocumab), and REGEN-COV), 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, 2020 and its Form 10-Q for the
quarterly period ended June 30, 2021. 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
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contacts:
Media Relations
Tammy
Allen
media@regeneron.com
Investor Relations
Vesna
Tosic
investor@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.