TARRYTOWN, N.Y., July 30, 2021 /PRNewswire/ --
Expanded authorization enables use of REGEN-COV for
post-exposure prophylaxis in certain people exposed to a
SARS-CoV-2 infected individual, or who are at high risk of exposure
to an infected individual in an institutional setting
Supported by pivotal Phase 3 data showing 81% reduced risk of
symptomatic infections in close contacts of SARS-CoV-2 infected
individuals
Only COVID-19 antibody therapy currently available across the
U.S. for both treatment and post-exposure prophylaxis; REGEN-COV
retains potency against variants of concern
Use of REGEN-COV across the U.S. is rapidly increasing to
address ongoing outbreaks
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that the U.S. Food and Drug Administration (FDA) updated
the Emergency Use Authorization (EUA) for the investigational
COVID-19 antibody cocktail REGEN-COV™ (casirivimab and imdevimab).
The authorization now includes post-exposure prophylaxis in people
at high risk for progression to severe COVID-19, who are not fully
vaccinated or are not expected to mount an adequate response to
vaccination, and have been exposed to a SARS-CoV-2 infected
individual, or who are at high risk of exposure to an infected
individual because of infection occurring in the same institutional
setting (such as in nursing homes or prisons).
In those who require repeat dosing for ongoing exposure,
REGEN-COV can also now be administered monthly. This new indication
in people aged 12 and older is in addition to the previously
granted authorization to treat non-hospitalized patients. REGEN-COV
is not a substitute for vaccination against COVID-19, and is not
authorized for pre-exposure prophylaxis to prevent COVID-19.
"Today's FDA authorization enables certain people at high risk
of developing severe COVID-19 infection to access REGEN-COV if they
have been exposed to the virus – the first time an antibody
treatment has been authorized for this purpose," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "With this
authorization, the FDA specifically highlights the needs of
immunocompromised people, including those taking immunosuppressive
medicines, who may not mount an adequate response to vaccination,
who are exposed to a person with COVID-19 or are in an
institutional setting and are at high risk of exposure because of
infection occurring in the same setting. Today's FDA decision to
expand the use of REGEN-COV in post-exposure settings is a very
helpful step, and we continue to work with the FDA as it undertakes
its review of REGEN-COV in a broader group of people including in a
pre-exposure prophylactic setting for people who are
immunocompromised, and in patients hospitalized due to
COVID-19."
Experts estimate that approximately 3% of the U.S. population
may not respond fully to COVID-19 vaccination because of
immunocompromising conditions or immunosuppressive medicines. This
includes people receiving chemotherapy, people with hematologic
cancers such as chronic lymphocytic leukemia, people receiving stem
cells or hemodialysis, people who have received organ transplants,
and/or people taking certain medications that might blunt immune
response (e.g., mycophenolate, rituximab, azathioprine, anti-CD20
monoclonal antibodies, Bruton tyrosine kinase inhibitors). This
authorization enables these groups to use REGEN-COV to prevent
infection in post-exposure and certain institutional settings.
Under the EUA for post-exposure prophylaxis, REGEN-COV can be
administered by subcutaneous injection or intravenous infusion. For
people who aren't expected to mount an adequate immune response to
vaccination and who have an ongoing exposure to SARS-CoV-2 for more
than four weeks, the initial 1,200 mg dose can be followed by
subsequent repeat dosing of REGEN-COV 600 mg once every four weeks,
for the duration of ongoing exposure.
REGEN-COV has not been approved by the FDA, but is currently
authorized 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.
Multiple analyses, including a recent publication in
Cell, have shown that REGEN-COV retains potency against the
main variants of concern circulating within the U.S., including
Delta (B.1.617.2; first identified in India), Gamma (P.1; first identified in
Brazil) and Beta (B.1.351; first
identified in South Africa).
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.
The development and manufacturing of REGEN-COV have been funded
in part with federal funds from the Biomedical Advanced Research
and Development Authority (BARDA), part of the U.S. Department of
Health and Human Services' Office of the Assistant Secretary for
Preparedness and Response, under OT number: HHSO100201700020C.
Regeneron is collaborating with Roche to increase global
supply of the antibody cocktail, 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 the Clinical Data Supporting the EUA
Extension
The REGEN-COV EUA for post-exposure prophylaxis is
based on data from multiple groups.
A pivotal Phase 3 trial jointly run with the National Institute
of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), assessed REGEN-COV for
post-exposure prophylaxis of COVID-19 in household contacts of
individuals infected with SARS-CoV-2 (index case). REGEN-COV was
found to:
- Reduce the risk of symptomatic infections by 81% in
those who were not infected when they entered the trial
(p<0.0001).
-
- There were 1,505 participants (753 REGEN-COV, 752 placebo) who
were not infected (seronegative with a negative PCR test) when they
entered the trial.
- In a post-hoc analysis in the subgroup of participants who met
the criteria for high risk for progression to severe COVID-19 (570
REGEN-COV, 567 placebo), there was a 76% risk reduction in COVID-19
with REGEN-COV treatment compared to placebo (p<0.0001).
- Adverse events were reported in 20% (265/1,311) of REGEN-COV
participants and 29% (379/1,306) of placebo participants. Injection
site reactions (all mild to moderate) occurred in 4% (55) of
REGEN-COV participants and 2% (19) of placebo participants.
Hypersensitivity reactions occurred in 0.2% (2) of REGEN-COV
participants, all of which were mild in severity.
- Reduced the risk of symptomatic infections by 62% in a
broader group of asymptomatic participants, regardless of infection
status, based on a post-hoc analysis (p<0.0001).
-
- There were 2,378 participants who were asymptomatic when they
entered the trial, regardless of serology (1,201 REGEN-COV, 1,177
placebo).
- Adverse events for uninfected individuals are reported above,
and for infected individuals (n=311) were reported in 34% (52/155)
of REGEN-COV participants and 48% (75/156) of placebo participants.
Injection site reactions (all mild to moderate) occurred in 4% (6)
of REGEN-COV participants and 1% (1) of placebo participants. There
were no cases of hypersensitivity reaction.
An additional double-blind, placebo-controlled Phase 1 trial
evaluated the safety, pharmacokinetic and immunogenicity of
repeated doses of REGEN-COV 1,200 mg (n=729) compared to placebo
(n=240), administered subcutaneously in healthy adults every 4
weeks for 24 weeks. During the 28-day assessment period, adverse
events were reported in 52% (380) of REGEN-COV participants and 46%
(111) of placebo participants. Injection site reactions occurred in
12% and 4% of participants following a single dose of REGEN-COV and
placebo, respectively; and with repeat dosing injection site
reactions occurred in 35% (252) of REGEN-COV participants and 16%
(38) of placebo participants. Hypersensitivity reactions occurred
in 1% (8) of REGEN-COV participants, all of which were mild to
moderate.
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 is currently available via emergency or temporary
pandemic use authorizations in more than 20 countries, including in
the U.S., European Union, India,
Switzerland and Canada, and is also fully approved in
Japan.
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.
In the U.S., for post-exposure prophylaxis use REGEN-COV 1,200
mg (600 mg casirivimab and 600 mg imdevimab) can be administered by
subcutaneous injection (4 injections), or by intravenous infusion
(as short as 20 minutes). It is available as a co-formulated single
vial, or in individual vials to be administered together. For
people who aren't expected to mount an adequate immune response to
vaccination and who have an ongoing exposure to SARS-CoV-2 for more
than four weeks, the initial 1,200 mg dose can be followed by
subsequent repeat dosing of REGEN-COV 600 mg once every four weeks,
for the duration of ongoing exposure.
In addition to post-exposure prophylaxis, in November 2020 the FDA authorized
REGEN-COV in the U.S. under an EUA to treat mild-to-moderate
COVID-19 in adults and pediatric patients (12 years of age and
older weighing ≥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.
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 COVID-19 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 use 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 infusion 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; 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 the EUA for REGEN-COV will be expanded for
use for chronic pre-exposure prophylaxis in appropriate
populations; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's Product
Candidates (such as REGEN-COV) 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, including the impact of recommendations,
guidelines, or 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 (such as REGEN-COV);
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), 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 March 31, 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
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SOURCE Regeneron Pharmaceuticals, Inc.