TARRYTOWN, N.Y., May 3, 2021 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
positive Phase 3 data from trials evaluating two Regeneron
medicines will be featured at the 2021 American Thoracic Society
International Conference (ATS 2021)
in the Breaking News: Clinical Trial Results in Pulmonary
Medicine Scientific Symposium on May 17, 2021. The data selected for presentation
in this session represent late-breaking information on leading
clinical trials in pulmonary and critical care medicine. It
includes positive results from two Regeneron pivotal Phase 3
trials, the first evaluating REGEN–COV™
(casirivimab with imdevimab) in high-risk non-hospitalized patients
(outpatients) with mild-to-moderate COVID-19, and the second
evaluating Dupixent® (dupilumab) in children as young as
6 years with uncontrolled moderate-to-severe asthma. These uses for
both medicines are investigational.
"We work every day to push the boundaries of science to improve
patient lives, and are pleased to see two of our medicines
recognized at ATS as leading data that could potentially impact the
COVID-19 and asthma landscape," said David
Weinreich, M.D., Executive Vice President and Head of Global
Clinical Development at Regeneron. "We pride ourselves on quickly
and consistently translating science to medicine, and as part of
this process, it is particularly important to present our data in
peer-reviewed settings. We are moving rapidly to publish these
significant results in peer-reviewed journals."
REGEN–COV is an investigational antibody cocktail authorized for
emergency use in the U.S. for patients with mild-to-moderate
COVID-19 who are at high-risk of severe disease or hospitalization,
and is strongly recommended by the National Institute of Health
COVID-19 Treatments Guidelines for these patients. REGEN–COV
continues to be studied in the outpatient (symptomatic and
asymptomatic infections), prevention and certain hospitalized
COVID-19 patient settings.
In addition to the pivotal Phase 3 results in children as young
as 6 years, Dupixent data being presented at ATS 2021 also include results from a two-year
open-label extension trial on the ability of Dupixent to reduce and
eliminate long-term oral corticosteroid use in adults and
simultaneously improve patient-reported, health-related quality of
life outcomes in adults and adolescents with asthma. Regeneron will
also present data from the largest clinical trial to date
demonstrating rapid and significant symptom improvement in patients
with chronic rhinosinusitis with nasal polyps (CRSwNP). This
includes results across several key measures including sense of
smell, and in adults with or without coexisting respiratory
diseases such as asthma, allergic rhinitis and aspirin-exacerbated
respiratory disease. Safety results from these trials were
generally consistent with the known safety profile of Dupixent in
its approved indications.
Presentations at ATS 2021
(May 14-19)
B007: Breaking
News: Clinical Trial Results in Pulmonary
Medicine Scientific Symposium
May 17, 2021 | 10:00 am-11:30 am EDT
- Casirivimab with Imdevimab, a Cocktail of Two Antibodies
Against SARS-CoV-2, in the Outpatient Setting: Phase 3 Efficacy and
Safety Results, Julie
Philley
- Efficacy and Safety of Dupilumab in Children With Uncontrolled
Moderate-to-Severe Asthma, Leonard
Bacharier
Dupixent Data Presentations
Data evaluating Dupixent
efficacy, safety, and long-term clinical and health-related quality
of life outcomes will be also presented:
Adult and adolescent asthma, including long-term
outcomes
- Abstract #A1204: Dupilumab Efficacy and Safety in
Children With Uncontrolled Moderate-to-Severe Asthma: The Phase 3
VOYAGE Study, Leonard Bacharier
-
- Oral Presentation Session: D007 Advances in Asthma Therapies,
Wednesday, May 19, 10:00 am-11:30 am EDT
- Abstract #A1201: Long-Term Dupilumab Treatment in
Moderate-to-Severe Asthma With Type 2 Inflammation: Open Label
LIBERTY ASTHMA TRAVERSE Study, Michael
Wechsler
-
- Oral Presentation Session: D007 Advances in Asthma Therapies,
Wednesday, May 19, 10:00 am-11:30 am EDT
- Abstract #A1441: Assessment of Long-Term Maintenance of
OCS Reduction and Efficacy in the Dupilumab LIBERTY ASTHMA TRAVERSE
Extension Study, Lawrence Sher
- Abstract #A1452: Dupilumab Shows Sustained Efficacy and
Improvements in Asthma Control and Health-Related Quality of Life
in Patients With Moderate-to-Severe Asthma: LIBERTY ASTHMA
TRAVERSE, Michael Wechsler
- Abstract #A1446: Dupilumab Efficacy in Patients With
Moderate-to-Severe Type 2 Asthma With and Without Elevated Blood
Neutrophils, Eugene Bleecker
- Abstract #A1460: Long-Term 3-Year Efficacy of Dupilumab
in QUEST Patients Enrolled in LIBERTY ASTHMA TRAVERSE, Albert Papi
- Abstract #A1443: Long-term Exacerbations and Lung
Function Assessment in LIBERTY ASTHMA TRAVERSE Stratified by Lung
Function Improvements at the End of Parent Study, Nicola Hanania
- Abstract #A1444: Dupilumab Provides Rapid and Sustained
Exacerbation Protection in Patients With Uncontrolled,
Moderate-to-Severe Type 2 Inflammatory Asthma Enrolled in the
LIBERTY ASTHMA QUEST Study, Jonathan
Corren
Adult CRSwNP efficacy and safety
- Abstract #A1340: Efficacy of Dupilumab in Patients With
Chronic Rhinosinusitis With Nasal Polyps and Allergic Rhinitis,
Anju T. Peters
- Abstract #A1345: Rapid and Sustained Effects of
Dupilumab in Patients with Severe Chronic Rhinosinusitis with Nasal
Polyps: Analysis of the SINUS-24 and SINUS-52 Phase 3 Trials,
Peter W. Hellings
- Abstract #A1343: Association between Dupilumab Effect on
Nasal Polyp Score and Biomarkers of Type 2 Inflammation in Patients
With Chronic Rhinosinusitis With Nasal Polyps in the Phase 3
SINUS-24 and SINUS-52 Trials, Claus
Bachert
- Abstract #A1341: Dupilumab Provides Early and Durable
Alleviation of Symptoms in Patients with Chronic Rhinosinusitis
with Nasal Polyps: Results from the SINUS-24 and SINUS-52 Phase 3
Trials, Philippe Gevaert
Real-world data in asthma
- Abstract #A1449: The RAPID Registry: A Global Real-World
Cohort of Patients Receiving Dupilumab for the Treatment of
Moderate-to-Severe Asthma, Neal
Jain
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.
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.
Under an Emergency Use Authorization (EUA) issued by the
U.S. Food and Drug Administration (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
has not been approved by FDA but has been authorized for emergency
use. 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.
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.
Under this 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.
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 Dupixent
Dupixent is a fully human monoclonal
antibody that inhibits the signaling of the interleukin-4 (IL-4)
and interleukin-13 (IL-13) pathways and is not an
immunosuppressant. It was invented using Regeneron's proprietary
VelocImmune technology. IL-4 and IL-13 are key and central
drivers of the type 2 inflammation that plays a major role in
asthma, CRSwNP, atopic dermatitis, and eosinophilic
esophagitis.
Dupixent is approved in the U.S. to treat patients aged 6 years
and older with moderate-to-severe atopic dermatitis that is not
well controlled with prescription therapies used on the skin
(topical), or who cannot use topical therapies; for use with other
asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
patients aged 12 years and older whose asthma is not controlled
with their current asthma medicines; and for use with other
medicines for the maintenance treatment of CRSwNP in adults whose
disease is not controlled.
Outside of the U.S., Dupixent is approved for specific patients
with moderate-to-severe atopic dermatitis and certain patients with
asthma in a number of other countries around the world, including
those in the European Union (EU) and Japan. Dupixent is also approved in the EU and
Japan to treat certain adults with
severe CRSwNP. Across all approved indications globally, more than
260,000 patients have been treated with Dupixent.
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–COV™ (casirivimab
with imdevimab), Dupixent® (dupilumab),
Libtayo® (cemiplimab-rwlc), Praluent®
(alirocumab), Kevzara® (sarilumab), Evkeeza™
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and
odesivimab-ebgn).
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven by type 2 inflammation.
In addition to the currently approved indications, Regeneron and
Sanofi are studying dupilumab in a broad range of diseases driven
by type 2 inflammation or other allergic processes, including
pediatric asthma (6 to 11 years of age, Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid
(Phase 3), prurigo nodularis (Phase 3), chronic spontaneous
urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3),
chronic rhinosinusitis without nasal polyposis (Phase 3), allergic
fungal rhinosinusitis (Phase 3), allergic bronchopulmonary
aspergillosis (Phase 3) and food allergies (Phase 2). These
potential uses are under clinical investigation, and the safety and
efficacy of dupilumab in these conditions have not been fully
evaluated by any regulatory authority. Dupilumab is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
U.S. INDICATIONS
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years and older with moderate-to-severe
atopic dermatitis (eczema) that is not well controlled with
prescription therapies used on the skin (topical), or who cannot
use topical therapies. DUPIXENT can be used with or without topical
corticosteroids. It is not known if DUPIXENT is safe and effective
in children with atopic dermatitis under 6 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
people aged 12 years and older whose asthma is not controlled with
their current asthma medicines. DUPIXENT helps prevent severe
asthma attacks (exacerbations) and can improve your breathing.
DUPIXENT may also help reduce the amount of oral corticosteroids
you need while preventing severe asthma attacks and improving your
breathing. DUPIXENT is not used to treat sudden breathing problems.
It is not known if DUPIXENT is safe and effective in children with
asthma under 12 years of age.
- with other medicines for the maintenance treatment of chronic
rhinosinusitis with nasal polyposis (CRSwNP) in adults whose
disease is not controlled. It is not known if DUPIXENT is safe and
effective in children with chronic rhinosinusitis with nasal
polyposis under 18 years of age.
IMPORTANT SAFETY INFORMATION FOR U.S.
PATIENTS
Do not use if
you are allergic to dupilumab or to any of
the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
-
- There is a pregnancy exposure registry for women who take
DUPIXENT during pregnancy to collect information about the health
of you and your baby. Your healthcare provider can enroll you or
you may enroll yourself. To get more information about the registry
call 1–877-311-8972 or go to
https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all
the medicines you take, including prescription and over-the-counter medicines, vitamins
and herbal supplements.
Especially tell your healthcare provider if you are taking oral,
topical, or inhaled corticosteroid medicines; have asthma and use
an asthma medicine; or have atopic dermatitis or CRSwNP, and also
have asthma. Do not change or stop your corticosteroid
medicine or other asthma medicine without talking to your
healthcare provider. This may cause other symptoms that were
controlled by the corticosteroid medicine or other asthma medicine
to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- Inflammation of your blood vessels. Rarely, this can
happen in people with asthma who receive DUPIXENT. This may happen
in people who also take a steroid medicine by mouth that is being
stopped or the dose is being lowered. It is not known whether this
is caused by DUPIXENT. Tell your healthcare provider right away if
you have: rash, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects by indication are as
follows:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, and
cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), and high count of a certain white blood cell
(eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
Tell your healthcare provider if
you have any side
effect that bothers you or that does not go away.
These are not all the possible
side effects of DUPIXENT.
Call your doctor for medical
advice about side
effects. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. Your healthcare provider
will tell you how much DUPIXENT to inject and how often to inject
it. DUPIXENT is an injection given under the skin (subcutaneous
injection). If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver
should receive training on the right way to prepare and inject
DUPIXENT. Do not try to inject DUPIXENT until you have been
shown the right way by your healthcare provider. In children 12
years of age and older, it is recommended that DUPIXENT be
administered by or under supervision of an adult. In children
younger than 12 years of age, DUPIXENT should be given by a
caregiver.
Please see accompanying full Prescribing Information including Patient Information.
REGEN–COV 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, 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, 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 and research and clinical programs now underway or
planned, including without limitation the development programs
relating to REGEN–COVTM (casirivimab with imdevimab)
antibody cocktail and Dupixent® (dupilumab); 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, such as Dupixent
for the treatment of pediatric asthma, chronic obstructive
pulmonary disease with evidence of type 2 inflammation, pediatric
atopic dermatitis, eosinophilic esophagitis, bullous pemphigoid,
prurigo nodularis, chronic spontaneous urticaria, chronic inducible
urticaria-cold, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, food allergies, and other potential
indications; uncertainty of the utilization, market
acceptance, and commercial success of Regeneron's Products and
product candidates, including the impact of recommendations,
guidelines (including the National Institutes of Health COVID-19
Treatment Guidelines referenced in this press release), 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 product candidates (such as
REGEN–COV); whether the 1,200 mg subcutaneous dose of
REGEN–COV will be included in the EUA for REGEN–COV based on the
data referenced in this press release or otherwise; 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 and Dupixent) in patients, including serious
complications or side effects in connection with the use of
Regeneron's Products and 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
product candidates, including without limitation REGEN–COV and
Dupixent; 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,
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
Hannah
Kwagh
Tel:
+1 914-847-6314
Hannah.Kwagh@regeneron.com
|
Investor
Relations
Mark
Hudson
Tel: +1
914-847-3482
Mark.Hudson@regeneron.com
|
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content:http://www.prnewswire.com/news-releases/ats-2021-breaking-news-session-to-feature-pivotal-data-on-regencov-casirivimab-with-imdevimab-and-dupixent-dupilumab-301281713.html
SOURCE Regeneron Pharmaceuticals, Inc.