TARRYTOWN, N.Y., June 16, 2021 /PRNewswire/ --
UK RECOVERY investigators found REGEN-COV reduced risk of
death by 20% in patients hospitalized with COVID-19 who had not
mounted their own immune response (primary outcome for the primary
analysis population)
First trial to demonstrate that any antibody treatment
improved survival in patients hospitalized with COVID-19
Regeneron will share new data with regulatory authorities
immediately and request that the U.S. EUA be expanded to include
appropriate hospitalized patients
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today welcomed positive results from the largest trial
assessing any monoclonal antibody treatment in patients
hospitalized with severe COVID-19. The UK RECOVERY trial found that
adding investigational REGEN-COV™ to usual care reduced the risk of
death by 20% in patients who had not mounted a natural antibody
response on their own against SARS-CoV-2, compared to usual care on
its own.
"These results are very exciting. The hope was that by giving a
combination of antibodies targeting the SARS-CoV-2 virus we would
be able to reduce the worst manifestations of COVID-19," said Sir
Peter Horby, Professor of Emerging
Infectious Diseases in the Nuffield Department of Medicine,
University of Oxford, and Joint Chief
Investigator for the RECOVERY trial. "There was, however, great
uncertainty about the value of antiviral therapies in late-stage
COVID-19 disease. It is wonderful to learn that even in advanced
COVID-19 disease, targeting the virus can reduce mortality in
patients who have failed to mount an antibody response of their
own."
RECOVERY is the first trial large enough to definitively
determine whether REGEN-COV reduces mortality in patients
hospitalized with severe COVID-19. Previous Phase 3 trials in
non-hospitalized COVID-19 patients have shown that REGEN-COV
reduced viral levels, shortened the time to resolution of symptoms
and significantly reduced the risk of hospitalization or death. In
a Phase 1/2 trial in hospitalized patients, REGEN-COV also rapidly
reduced viral levels, with preliminary evidence suggesting that it
lowered the risk of death or receiving mechanical ventilation, with
the benefit driven by patients who entered the trial without having
mounted a natural antibody response of their own (seronegative);
and in the absence of REGEN-COV treatment, seronegative patients
had higher mortality rates than patients who had already mounted
their own immune response (seropositive).
Based on the above Phase 1/2 data, the independently-run
RECOVERY trial prospectively focused on seronegative patients.
Similar to the prior trial, patients in RECOVERY who received usual
care alone had double the mortality rate at day 28 if they were
seronegative (30%) compared to seropositive (15%);
approximately one-third of hospitalized patients were seronegative
(n=3,153), one-half were seropositive (n=5,272) and one-sixth had
unknown serostatus (n=1,360). The mean age of patients for this
comparison was 62 years, and more than 90% received corticosteroids
across all groups.
The primary outcome of RECOVERY showed that adding REGEN-COV
8,000 mg to usual care reduced all-cause mortality by 20% in
seronegative patients (primary analysis population), compared to
usual care alone (24% of patients in the REGEN-COV group died
versus 30% in the usual care group by day 28; rate ratio [RR]:
0.80; 95% confidence interval [CI]: 0.70-0.91; p=0.001). When
combining the larger seropositive group (as well as those with
unknown status) with the seronegative patients, there was no longer
a significant effect on 28-day mortality (overall 20% of patients
in the REGEN-COV group died, versus 21% in the usual care
group; RR: 0.96; 95% CI: 0.86-1.03; p=0.17).
"Definitive Phase 3 trials have now demonstrated that REGEN-COV
can alter the course of COVID-19 infection from prevention, to very
early infection, all the way through to when patients are on a
ventilator in the hospital," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "We are incredibly grateful to the RECOVERY
team, participating investigators and patients for conducting this
in-depth analysis, and hope that the results mean that even more
patients may soon be able to benefit from this life-saving
medicine. We intend to rapidly discuss these results with
regulatory authorities, including in the U.S. where we will ask for
our EUA to be expanded to include appropriate hospitalized
patients."
Among seronegative patients in the RECOVERY trial, the median
duration of hospital stay was 4 days shorter in the REGEN-COV group
(13 days versus 17 days), and the proportion of patients discharged
alive by day 28 was greater (64% versus 58%; RR: 1.19; 95% CI:
1.08-1.30). Among the seronegative patients not on invasive
mechanical ventilation at baseline, the risk of progressing to the
composite endpoint of invasive mechanical ventilation or death was
lower among the REGEN-COV group than the usual care group (30%
versus 37%; RR: 0.83; 95% CI: 0.75-0.92). No such benefits were
seen in the overall trial population (combining patients with
negative, positive, or unknown serostatus).
"The RECOVERY trial has shown that in patients who had not made
their own antibodies against SARS-CoV-2, treating them with
REGEN-COV antibodies dramatically reduced their risk of dying or
being on a ventilator, and also shortened how many days they
remained in the hospital," said David
Weinreich, M.D., Executive Vice President, Global Clinical
Development at Regeneron. "The trial was conducted at a time when
most patients had not been fully vaccinated. These results provide
hope to patients who have a poor immune response to either the
vaccine or natural infection, as well as those who are exposed to
variants for whom their existing antibodies might be
sub-optimal."
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.; consequently,
REGEN-COV remains available for use in all 50 states. REGEN-COV
retains potency against variants including P.1 (first identified in
Brazil, now classified by the
World Health Organization [WHO] as Gamma), B.1.351 (first
identified in South Africa, now
classified by the WHO as Beta) and B.1.162.2 (first identified in
India, now classified by the WHO
as Delta). The combined frequency of the P.1 and B.1.351 variants
now exceeds 10% of new COVID-19 diagnoses across eight states
(Arizona, California, Florida, Illinois, Indiana, Massachusetts, Oregon and Washington), and the prevalence of these and
other variants continues to be closely monitored.
Today's data in hospitalized patients follow multiple positive
Phase 3 results earlier this year from Regeneron-sponsored trials
assessing the ability of REGEN-COV to treat outpatients already
infected with SARS-COV-2 (including symptomatic
outpatients and recently infected asymptomatic patients), and
also to prevent infection in close contacts of infected
individuals. REGEN-COV has not been approved by the U.S. Food and
Drug Administration (FDA), but is currently authorized in the
U.S. under an Emergency Use Authorization (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.
This use is 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.
Regeneron is in discussions with the FDA to expand the current
EUA to other populations, including the prevention and hospitalized
patient settings. Later this summer, Regeneron expects to submit a
full Biologics License Application (BLA) for REGEN-COV.
Regeneron is collaborating with Roche to increase global
supply of REGEN-COV. Regeneron is responsible for development and
distribution of the treatment in the U.S., and Roche is primarily
responsible for development and distribution outside the U.S. The
companies 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.
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.
About the Trial
The RECOVERY trial (Randomised
Evaluation of COVid-19 thERapY) was conducted by the registered
clinical trials units in the Nuffield Department of Population
Health in partnership with the Nuffield Department of Medicine. The
trial was supported by a grant to the University of Oxford from UK Research and
Innovation/National Institute for Health
Research (NIHR) and by core funding provided by NIHR
Oxford Biomedical Research Centre, Wellcome, the Bill and
Melinda Gates Foundation, the Department for International
Development, Health Data Research UK, the Medical
Research Council Population Health Research Unit and NIHR
Clinical Trials Unit Support Funding.
Between September 18, 2020 and
May 22, 2021, 9,785 patients
hospitalized with COVID-19 were randomly allocated to receive usual
care plus REGEN-COV (8,000 mg by intravenous infusion) or usual
care alone as part of the RECOVERY trial. Usual care was determined
by individual facilities and clinicians, and could include steroids
and remdesivir. Follow-up is complete for 99% of participants.
The trial involved many thousands of doctors, nurses,
pharmacists, and research administrators at 176 hospitals across
the whole of the UK, supported by staff at the NIHR Clinical
Research Network, NHS DigiTrials, Public Health
England, Department of Health & Social Care, the Intensive Care
National Audit & Research Centre, Public Health Scotland, the
Secure Anonymised Information Linkage at University of
Swansea, and the NHS in
England, Scotland, Wales and Northern Ireland.
About the REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab and imdevimab) is a cocktail of two monoclonal
antibodies (also known as REGN10933 and REGN10987) 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 Science.
Under an EUA, REGEN-COV is available throughout the U.S. –
information on availability in your area is available from the
Department of Health and Human Services and the National Infusion
Center Association. REGEN-COV can be administered by intravenous
infusion (as short as 20 minutes) or by subcutaneous injection
(four injections), which is an alternative when intravenous
infusion is not feasible and would lead to a delay in treatment. It
is now authorized as a co-formulated single vial, or in individual
vials to be administered together.
In the U.S., REGEN-COV is not authorized 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.
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 USE AND IMPORTANT SAFETY
INFORMATION
REGEN-COV, (casirivimab and imdevimab)
co-formulated product and REGEN-COV (casirivimab and imdevimab)
supplied as individual vials to be administered together, 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.
[see Limitations of Authorized Use]
- REGEN-COV has not been approved, but has been authorized for
emergency use by FDA
- This use is 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
Limitations of Authorized Use
- REGEN-COV (casirivimab and imdevimab) 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
- Benefit of treatment with REGEN-COV has not been observed in
patients hospitalized due to 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
Definition of High Risk Patients
The following
medical conditions or other factors may place adults and pediatric
patients (age 12-17 years and weighing at least 40 kg) at higher
risk for progression to severe COVID-19:
- Older age (for example, age ≥65 years of age)
- Obesity or being overweight (for example, BMI >25
kg/m2, or if age 12-17, have BMI ≥85th percentile for
their age and gender based on CDC growth charts,
https://www.cdc.gov/growthcharts/clinical_charts.htm)
- Pregnancy
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or
hypertension
- Chronic lung diseases (for example, chronic obstructive
pulmonary disease, asthma [moderate-to-severe], interstitial lung
disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or
other conditions that confer medical complexity (for example,
genetic or metabolic syndromes and severe congenital
anomalies)
- Having a medical-related technological dependence (for example,
tracheostomy, gastrostomy, or positive pressure ventilation (not
related to COVID 19))
Other medical conditions or factors (for example, race or
ethnicity) may also place individual patients at high risk for
progression to severe COVID-19 and authorization of REGEN-COV under
the EUA is not limited to the medical conditions or factors listed
above.
For additional information on medical conditions and factors
associated with increased risk for progression to severe COVID, see
the CDC website:
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
Healthcare providers should consider the benefit-risk for an
individual patient.
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
- 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, arrythmia (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,
arrythmia (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: Benefit of treatment
with REGEN-COV has not been observed in patients hospitalized
due to 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:
-
- In a pooled phase 1/2/3 analysis of COV-2067, 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
- Overall, in Phase 1/2/3, 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
- The safety with subcutaneous administration is based on
analysis from HV-2093, a randomized double-blind,
placebo-controlled trial evaluating the safety and pharmacokinetic
profile in healthy volunteer adult subjects. Subjects were
randomized 3:1 to REGEN-COV (n=729) or placebo
(n=240). Injection site reactions were observed in 12% and 4%
of subjects following single dose administration in the casirivimab
and imdevimab, and placebo arms respectively; the remaining safety
findings with subcutaneous administration in the casirivimab and
imdevimab arm were similar to the safety findings observed with
intravenous administration in COV-2067
- 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; 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 Application
planned to be filed with the FDA and referenced in this press
release) 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); whether the EUA for REGEN-COV will be
expanded for use for appropriate hospitalized patients (based on
the results of the UK RECOVERY trial discussed in this press
release or otherwise) and/or in the prevention setting; 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 (http://twitter.com/regeneron).
Contacts:
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Media
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Tammy
Allen
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Investor
Relations
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Tosic
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