TARRYTOWN, N.Y., March 23, 2021 /PRNewswire/ --
REGEN-COV also significantly shortened the duration of
symptoms by 4 days
All doses (8,000 mg, 2,400 mg and 1,200 mg) had similar
efficacy across all endpoints
Companion dose-ranging Phase 2 trial showed significant and
comparable viral reductions for all REGEN-COV doses tested,
including as low as 300 mg
FDA recently updated U.S. EUA fact sheets for all authorized
monoclonal antibody treatments, indicating that REGEN-COV is the
only one to retain potency against key emerging variants
Regeneron will share new data with regulatory authorities
immediately and request that a lower 1,200 mg dose be added to
EUA
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced positive topline results from the largest trial to date
assessing a COVID-19 treatment in infected non-hospitalized
patients (n=4,567). This definitive Phase 3 outcomes trial in
high-risk non-hospitalized COVID-19 patients ("outpatients") met
its primary endpoint, showing the investigational REGEN-COV™
(casirivimab with imdevimab) significantly reduced the risk of
hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71%
(2,400 mg IV) compared to placebo.
"This is a landmark moment in the fight against COVID-19 as this
large well-controlled trial provides conclusive results
demonstrating that REGEN-COV can dramatically reduce the risk of
hospitalization and death in the outpatient setting," said
Suraj Saggar, D.O., trial
investigator and Chief of Infectious Disease at Holy Name Medical
Center in Teaneck, New Jersey.
"With so many people still getting infected, as well as recent data
showing that REGEN-COV addresses emerging variants, these data
underscore the need to rapidly adopt REGEN-COV as standard-of-care
to offer high-risk patients their best chance to reduce serious
consequences like hospitalization or death."
REGEN-COV also met all secondary endpoints in the Phase 3
outcomes trial, including the ability to reduce symptom duration.
In addition, a companion Phase 2 trial showed that even the lowest
doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had
significant viral load reductions over the first 7 study days,
comparable to the 2,400 mg and 1,200 mg IV doses.
"With approximately 60,000 newly diagnosed individuals in the
U.S. every day and 40,000 still in the hospital because of
COVID-19, we are committed to working with the government,
healthcare providers and others to support rapid and widespread
adoption of REGEN-COV in appropriate patients," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer at Regeneron. "We will discuss the new
data with regulatory authorities and request that the 1,200 mg dose
be rapidly added to the U.S. Emergency Use Authorization, in order
for the anticipated REGEN-COV supply to be available to treat even
more patients. These Phase 3 data will also form the basis of a
full Biologics License Application."
TABLE 1: Key
Results from Phase 3 Outpatient Trial1-3
|
|
|
1,200 mg
IV
|
Placebo
|
2,400 mg
IV
|
Placebo
|
n=736
|
n=748
|
n=1,355
|
n=1,341
|
Patients with
³1 COVID-19-related hospitalization or death through day
29
|
Risk
reduction
|
70%
(p=0.0024)
|
71%
(p<0.0001)
|
# of patients with
events
|
7 (1.0%)
|
24 (3.2%)
|
18 (1.3%)
|
62 (4.6%)
|
Time to COVID-19
symptom resolution
|
Median
(days)
|
10
|
14
|
10
|
14
|
Median reduction
(days)
|
4
(p<0.0001)
|
4
(p<0.0001)
|
1.
|
Based on the modified
Full Analysis Set population, which includes all randomized
patients with a positive
SARS-CoV-2 RT-qPCR test from nasopharyngeal swabs at randomization
and ³1 risk factor for severe
COVID-19.
|
2.
|
The formal
hierarchical analysis first evaluated the 2,400 mg dose vs.
concurrent placebo and then
evaluated the 1,200 mg dose vs. concurrent placebo.
|
3.
|
Based on Phase 1/2
analyses showing that the 8,000 mg and 2,400 mg doses were
indistinguishable, the
Phase 3 protocol was amended to compare the 2,400 mg and 1,200 mg
doses vs. placebo, and the 8,000
mg data were converted to a descriptive analysis.
|
A safety assessment was conducted on all available patient data
up to day 169, and identified no new safety signals. Serious
adverse events (SAEs) were largely related to COVID-19 and occurred
in 1.1% of patients in the 1,200 mg group, 1.3% in the 2,400 mg
group and 4.0% in the placebo group. There was 1 death in the 1,200
mg group (n=827), 1 death in the 2,400 mg group (n=1,849) and 5
deaths in the placebo groups (n=1,843).
All patients in this analysis had at least one risk factor,
including obesity (58%), age ³50 years (51%) and cardiovascular
disease, including hypertension (36%). Approximately 35% of
patients were Latino/Hispanic, 5% were Black/African American and
the median age was 50 years (range: 18-96 years).
Dose-ranging Virology Trial
A companion dose-ranging
Phase 2 trial of 803 outpatient COVID-19 patients was conducted to
evaluate the antiviral effect of several different REGEN-COV doses
(IV: 2,400 mg, 1,200 mg, 600 mg and 300 mg; SC: 1,200 mg and 600
mg). All tested doses met the primary endpoint, rapidly and
significantly reducing patients' viral load (log10
copies/mL) compared to placebo (p£0.001). Each dose demonstrated
similar efficacy, including the lowest doses tested (IV: 300 mg;
SC: 600 mg).
"These encouraging results confirm the rapid and significant
antiviral effects of REGEN-COV, even at much lower and subcutaneous
doses," said David Weinreich, M.D.,
Executive Vice President and Head of Global Clinical Development at
Regeneron. "We are grateful to all patients and investigators who
participated in these and other ongoing REGEN-COV trials. We will
share both our Phase 3 outcomes data and our Phase 2 virology data
with regulatory authorities to discuss next steps, including the
possibility of utilizing lower doses and more convenient
subcutaneous administration."
Detailed results from both trials will be shared with regulatory
authorities and submitted for peer review as soon as possible.
REGEN-COV continues to be evaluated in clinical trials in multiple
settings for COVID-19: in non-hospitalized and certain hospitalized
patients, including the open-label RECOVERY trial of hospitalized
patients in the UK, and a trial for the prevention of COVID-19 in
household contacts of infected individuals. As of March 2021, more than 25,000 people have
participated in clinical trials involving REGEN-COV.
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.
FDA Updates to Fact Sheets
To address SARS-CoV-2
variants, last week the U.S. Food and Drug Administration
(FDA) authorized revisions to the fact sheets for monoclonal
antibodies currently under emergency use authorization (EUA). The
REGEN-COV fact sheet (see table below), notes that it retains
potency against the main variants of concern known to be
circulating within the U.S. In contrast, multiple variant strains
had reduced susceptibility to the other two FDA-authorized
monoclonal antibodies (fact sheets are available here and
here).
TABLE 2:
Pseudovirus Neutralization Data for SARS-CoV-2 Variant
Substitutions with casirivimab and imdevimab
Together
|
Lineage with Spike
Protein
Substitution
|
Key Substitutions
Tested
|
Fold Reduction
in
Susceptibility
|
B.1.1.7 (UK
origin)
|
N501Ya
|
no
changec
|
B.1.351 (South Africa
origin)
|
K417N, E484K,
N501Yb
|
no
changec
|
P.1 (Brazil
origin)
|
K417T +
E484K
|
no
changec
|
B.1.427/B.1.429
(California origin)
|
L452R
|
no
changec
|
B.1.526 (New York
origin)d
|
E484K
|
no
changec
|
a.
|
Pseudovirus
expressing the entire variant spike protein was tested. The
following changes from wild-type
spike protein are found in the variant: del69-70, del145, N501Y,
A570D, D614G, P681H, T716I, S982A,
D1118H.
|
b.
|
Pseudovirus
expressing the entire variant spike protein was tested. The
following changes from wild-type
spike protein are found in the variant: D80Y, D215Y, del241-243,
K417N, E484K, N501Y, D614G, A701V.
|
c.
|
No change: <
2-fold reduction in susceptibility.
|
d.
|
Not all isolates of
the New York lineage harbor the E484K substitution (as of February
2021).
|
Supply and Distribution Update
REGEN-COV is available
throughout the U.S. without restriction – information on
availability in your area is available from the Department of
Health and Human Services and the National Infusion Center
Association.
Regeneron anticipates recording approximately $260 million in REGEN-COV U.S. net product
sales to the U.S. government in the first quarter of 2021,
representing final deliveries from the initial agreement with the
U.S. government. Sales under the second U.S. government agreement
are now expected to begin in the second quarter of 2021. The
company expected to provide approximately 750,000 doses at the
2,400 mg dose level, but now anticipates being able to provide
approximately 1.25 million doses if the 1,200 mg dose is added to
the EUA. Due to the pandemic, many organizations are currently
utilizing the same limited manufacturing resources including
external fill and finish capacity, and this may impact the timing
of final delivery of doses. The government is obligated to purchase
all finished doses supplied by June 30,
2021, up to 1.25 million doses total, and may accept doses
after this date at its discretion.
Roche, which is responsible for REGEN-COV outside the U.S.,
continues to work with the European Medicines Agency, governments
and other health authorities across the globe to bring this
antibody cocktail to as many patients as possible.
About the REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab with 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 issued by the FDA, REGEN-COV is currently
available in the U.S. to treat mild-to-moderate COVID-19 in adults,
as well as in pediatric patients at least 12 years of age and
weighing at least 40 kg, who have received positive results of
direct SARS-CoV-2 viral testing and are at high risk for
progressing to severe COVID-19 and/or hospitalization.
REGEN-COV is currently authorized and available in a 2,400 mg IV
dose, with infusion times as short as 20 minutes. The criteria for
'high-risk' patients are described in the Fact Sheet for
Healthcare Providers. 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.
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.
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 co-Founder, 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-COVTM (casirivimab with 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
Authorized Emergency Use
REGEN-COV, (casirivimab with
imdevimab 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 progressing to severe
COVID-19 and/or hospitalization. [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 with 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
High-risk is defined
as patients who meet at least one of the following criteria:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- Are ≥55 years of age AND have
-
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory
disease.
- Are 12 – 17 years of age AND have
-
- BMI ≥85th percentile for their age and gender based on CDC
growth charts,
https://www.cdc.gov/growthcharts/clinical_charts.htm,OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders (e.g., cerebral palsy), OR
- a medical-related technological dependence, for example,
tracheostomy, gastrostomy, or positive pressure ventilation (not
related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease
that requires daily medication for control.
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
with 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: There is a potential for serious
hypersensitivity reaction, including anaphylaxis, 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. Infusion-related reactions
have been observed with administration of REGEN-COV.
-
- 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, dizziness, fatigue and diaphoresis.
If an infusion-related reaction occurs, consider slowing or
stopping the infusion and administer appropriate medications and/or
supportive care.
- 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:
- Serious adverse events (SAEs) were reported in 4 (1.6%)
patients in REGEN-COV 2,400 mg group, 2 (0.8%) patients in
REGEN-COV 8,000 mg group and 6 (2.3%) patients in the placebo
group. None of the SAEs were considered to be related to study
drug. SAEs that were reported as Grade 3 or 4 adverse events were
pneumonia, hyperglycemia, nausea and vomiting (2,400 mg REGEN-COV),
intestinal obstruction and dyspnea (8,000 mg REGEN-COV) and
COVID-19, pneumonia and hypoxia (placebo). REGEN-COV is
not authorized at the 8,000 mg dose (4,000 mg casirivimab and
4,000 mg imdevimab).
- One anaphylactic reaction was reported in the clinical program.
The event began within 1 hour of completion of the infusion, and
required treatment including epinephrine. The event resolved.
Infusion-related reactions, of Grade 2 or higher severity, were
reported in 4 subjects (1.5%) in the 8,000 mg (4,000 mg casirivimab
and 4,000 mg imdevimab) arm. These infusion-related reactions
events were moderate in severity; and include pyrexia, chills,
urticaria, pruritus, abdominal pain, and flushing. One
infusion-related reaction (nausea) was reported in the placebo arm
and none were reported in the 2,400 mg (1,200 mg casirivimab and
1,200 mg imdevimab) arm. In two subjects receiving the 8,000 mg
dose of REGEN-COV, the infusion-related reactions (urticaria,
pruritus, flushing, pyrexia, shortness of breath, chest tightness,
nausea, vomiting) resulted in permanent discontinuation of the
infusion. All events resolved.
Patient Monitoring Recommendations: Clinically monitor
patients during infusion and observe patients for at least 1 hour
after infusion is complete.
Use in Specific Populations:
- Pregnancy: There is currently limited clinical
experience in the use of REGEN-COV in COVID-19 patients who are
pregnant. REGEN-COV therapy should be used during pregnancy only if
the potential benefit justifies the potential risk for the mother
and the fetus.
- Lactation: There is currently no clinical
experience in use of REGEN-COV in COVID-19 patients who are
breastfeeding. 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, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world. For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
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 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 and research and clinical programs now underway or
planned, including without limitation the development program
relating to REGEN-COVTM (casirivimab with 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) and new indications for Regeneron's Products;
whether the 1,200 mg dose of REGEN-COV will be added the EUA for
REGEN-COV based on the data discussed in this press release or
otherwise; the amount of net product sales of REGEN-COV under
Regeneron's agreements with the U.S. government and timing of
recognition of any such sales; 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 (including REGEN-COV) and the impact of the
foregoing on Regeneron's ability to supply its Products and 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 product candidates (such as REGEN-COV) in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and product candidates in clinical
trials; 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) (including the study discussed in this press
release) on any potential regulatory approval (including with
respect to REGEN-COV) and/or the commercial success of Regeneron's
Products and product candidates; 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, 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 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 REGEN-COV, 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. 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).
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
media@regeneron.com
|
Investor
Relations
Vesna
Tosic
investor@regeneron.com
|
View original
content:http://www.prnewswire.com/news-releases/phase-3-trial-shows-regen-cov-casirivimab-with-imdevimab-antibody-cocktail-reduced-hospitalization-or-death-by-70-in-non-hospitalized-covid-19-patients-301253401.html
SOURCE Regeneron Pharmaceuticals, Inc.