TARRYTOWN, N.Y. and
PARIS, Sept. 21, 2021 /PRNewswire/ --
More than 30 presentations reinforce the role of Dupixent in
targeting IL-4 and IL-13, key drivers of the type 2 inflammation
underlying atopic dermatitis in children, adolescents and
adults
Results provide insight into the clinical and real-world
experience of Dupixent on disease measures including itch, disease
severity, sleep, and anxiety
Dupixent presentations include longest duration of data for
any biologic medicine in adults with moderate-to-severe atopic
dermatitis, with results up to 3.5 years
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that new Dupixent® (dupilumab) analyses in
patients as young as six years old with moderate-to-severe atopic
dermatitis will be presented at the 14th World Congress
of Pediatric Dermatology Annual Congress (WCPD) from September 22-25 and the 30th European
Academy of Dermatology and Venereology Congress (EADV) from
September 29-October 2.
"Moderate-to-severe atopic dermatitis can severely affect people
from infancy into adulthood, often causing a lifetime of
debilitating symptoms like intense itch, skin lesions covering much
of the body, impaired mental well-being and an increased risk of
skin infections," said Bola Akinlade, M.D., Vice President,
Clinical Sciences, Immunology and Inflammation at Regeneron. "Our
broad portfolio of data at WCPD and EADV helps provide much-needed
insight into the long-term effects of the disease, as well as the
impact of Dupixent on physical symptoms and quality of life
measures through different stages of life."
Notable Dupixent presentations include long-term efficacy and
safety data showing the impact of Dupixent on signs and symptoms of
moderate-to-severe atopic dermatitis in children, adolescents and
adults. More than 30 presentations highlight Dupixent results on
skin lesions, itch and skin infections, as well as sleep and
health-related quality of life, for patients and their families,
such as in adults with a history of mental health disorders and in
children with anxiety and depression. Real-world evidence will also
be presented from observational registries and claims databases
across multiple geographies.
Disease burden data to be presented at EADV include results from
the Atopic Dermatitis Global Adolescent and Pediatric survey on how
patients, caregivers and physicians view the full impact of
moderate-to-severe atopic dermatitis, based on findings from more
than 3,900 people across 13 countries. Data will also be shared
from the Quality of Care in AD Initiative, which
documents best practices from 32 atopic dermatitis centers across
the world, focused on the value of patient education and
communication.
Data to be presented at WCPD 2021
Clinical Efficacy and Safety of Dupixent in Atopic
Dermatitis
- Oral presentation (September 24,
3:40-3:50 pm BST):
-
- #SP42 Long-Term Efficacy and Safety Data for Dupilumab in a
Phase 3, Open-Label Extension Trial (LIBERTY AD PED-OLE) in
Patients Aged ≥ 6 to < 12 Years With Uncontrolled,
Moderate-to-Severe Atopic Dermatitis (AD), Michael Cork
- Poster #P22: Efficacy and Safety of Dupilumab for up to 1 Year
in a Phase 3 Open-Label Extension (OLE) Trial (LIBERTY AD PED-OLE)
in Adolescents With Uncontrolled, Moderate-to-Severe Atopic
Dermatitis (AD), Andrew
Blauvelt
- Poster #P23: 52-Week Laboratory Safety Findings From an
Open-Label Extension (OLE) Study of Dupilumab in Adolescent
Patients With Atopic Dermatitis (LIBERTY AD PED-OLE), Michael Cork
- Poster #P33: Dupilumab Improved Itch in Children Aged 6–11
Years With Severe Atopic Dermatitis: Analysis From the LIBERTY AD
PEDS Trial, Gil Yosipovitch
- Poster #P35: IGAxBSA: An Alternative to EASI in Assessing
Disease Severity and Response in Pediatric Patients With
Moderate-to-Severe Atopic Dermatitis, Amy
Paller
- Poster #P36: Dupilumab Induces Rapid and Sustained Improvement
in Clinical Signs in Children With Severe Atopic Dermatitis,
Amy Paller
- Poster #P38: Dupilumab Significantly Improves All POEM
Components in Children Aged ≥6 to <12 Years With Severe Atopic
Dermatitis, Andreas Wollenberg
- Poster #P40: Efficacy and Safety of Dupilumab in Children Aged
≥ 6 to < 18 Years With a History of Infection (LIBERTY AD PEDS,
LIBERTY AD ADOL), Michael Cork
- Poster #P41: Dupilumab in Children Aged ≥6 to <12 Years
Promotes Rapid and Sustained Improvement in Clinical Signs of
Atopic Dermatitis (LIBERTY AD PEDS), Amy
Paller
- Poster #P44: Dupilumab in Children Aged ≥6–<12 Years
Significantly Improves Signs and Symptoms of Atopic Dermatitis
Assessed by SCORAD, Sébastien Barbarot
Quality of Life Data in Atopic Dermatitis for
Dupixent
- Poster #P30: Dupilumab Induces Clinically Meaningful
Improvement in Symptoms of Anxiety and Depression in Children With
Severe Atopic Dermatitis, Elaine
Siegfried
- Poster #P37: Dupilumab Treatment Improves Sleep in Children
Aged ≥ 6 to < 12 Years With Severe Atopic Dermatitis,
Danielle Marcoux
- Poster #P46: Dupilumab Improves Family Quality of Life in
Children Aged 6–11 Years With Severe Atopic Dermatitis (LIBERTY AD
PEDS), Amy Paller
Dupixent Use and Vaccination
- Poster #P120: Dupilumab and Live-Attenuated Vaccines:
Experience With Prior Dupilumab Use and Yellow Fever Vaccine in
Patients With Severe Asthma From Brazil, Michael Wechsler
Abstracts presenting research on the burden of atopic dermatitis
include:
- Poster #P29: Pediatric Patients With Atopic Dermatitis (AD)
Have a High Burden of Atopic Comorbidities: Results From a Large
Worldwide Survey, Jonathan
Silverberg
Data to be presented at EADV 2021
Long-Term Efficacy and Safety of Dupixent in Atopic
Dermatitis
- Oral Presentation (September 30,
10:00-11:00 am CEST):
-
- #2008 Long-Term Efficacy of Dupilumab in Adults With
Moderate-to-Severe Atopic Dermatitis: Results From an Open-Label
Extension Trial up to 172 Weeks, Lisa
Beck
- Poster #P0258: Dupilumab Provides Long-Term Improvement in
Pruritus in Children With Severe Atopic Dermatitis, and Adolescents
and Adults With Moderate-to-Severe Atopic Dermatitis, Amy Paller
- Poster #P0723: Patient Well-Being and Perception of Treatment
Effect With Long-Term Dupilumab Monotherapy in Adults With
Moderate-to-Severe Atopic Dermatitis, Eric
Simpson
- Poster #P0726: Safety of Long-Term Dupilumab Treatment in
Adults With Moderate-to-Severe Atopic Dermatitis: Results From an
Open-Label Extension Trial up to 172 Weeks, Andreas Wollenberg
- Poster #P0727: Dupilumab Provides Long-Term Efficacy Over 2.5
Years in Adults With Moderate-to-Severe Atopic Dermatitis,
Lisa Beck
- Poster #P0729: Dupilumab Monotherapy Provides Long-Term Control
and Prevents Flares in Adults With Moderate-to-Severe Atopic
Dermatitis Optimally Responding at Week 16, Andreas Wollenberg
Quality of Life Data for Dupixent in Atopic
Dermatitis
- Poster #P0239: Dupilumab Improves Family Quality of Life in
Children Aged 6-11 Years With Severe Atopic Dermatitis: An Analysis
From the Phase 3 LIBERTY AD PEDS Trial, Amy
Paller
- Poster #P0252: Dupilumab Provides Long-Term Improvement of
Sleep Loss in Children, Adolescents, and Adults With Atopic
Dermatitis, Lisa Beck
- Poster #P0722: Dupilumab Monotherapy Provides Long-Term
Improvement in Quality of Life in Adults With Moderate-to-Severe
Atopic Dermatitis Optimally Responding at Week 16, Carlos
Ferrándiz
Additional Efficacy and Safety Analyses of Dupixent in Atopic
Dermatitis
- Poster #P0230: Dupilumab Treatment in Adult Patients Is
Efficacious Regardless of Age at Atopic Dermatitis Onset,
Jonathan Silverberg
- Poster #P0231: Dupilumab in Children Aged ≥ 6 to < 12 Years
Promotes Rapid Improvement in Clinical Signs of Atopic Dermatitis,
Amy Paller
- Poster #P0251: Infections in Dupilumab Pediatric Clinical
Trials in Atopic Dermatitis — A Pooled Analysis, Amy Paller
- Poster #P0255: Dupilumab Significantly Improves Treatment
Response in Children With Severe Atopic Dermatitis From the
Patient's Perspective and by Clinical Assessments of Signs,
Symptoms, and Quality of Life: Results From the LIBERTY AD PEDS
Phase 3 Clinical Trial, Stephan
Weidinger
- Poster #P0256: Dupilumab Treatment Is Efficacious in Adult
Atopic Dermatitis Patients Independent of History of Mental Health
Disorders: A Post Hoc Analysis of Pooled Phase 3 Trials,
Jonathan Silverberg
- Poster #P0260: Dupilumab Treatment Is Efficacious in Adult
Atopic Dermatitis Patients Regardless of History of Infection: A
Pooled Analysis of Four Phase 3 Trials, Andreas Wollenberg
- Poster #P0733: Dupilumab Monotherapy Provides 1 Year Sustained
Response in Adults With Moderate-to-Severe Atopic Dermatitis
Optimally Responding at Week 16, With No Need of Concomitant
Topical Steroids, Margitta Worm
Real-World Analyses
- Poster #P0257: Improvement in Disease Severity and Quality of
Life in Patients With Atopic Dermatitis Treated With Dupilumab for
up to 18 Months: Real-World Data From the PROSE Registry, Jerry
Bagel
- Poster #P0259: Use of Systemic Therapies in Adults With Atopic
Dermatitis: 18-Month Results From the European Prospective
Observational Study in Patients Eligible for Systemic Therapy for
Atopic Dermatitis (EUROSTAD), Marjolein De
Bruin-Weller
- Poster #P0272: Real-World Use of Dupilumab Among Adults With
Atopic Dermatitis and Its Impact on Healthcare Utilization in
Japan, Ken
Igawa
Abstracts presenting research on patient education,
health-related quality of life and burden of disease in atopic
dermatitis include:
- Poster #P0208: The Importance of Patient Education and
Communication: Results from the Atopic Dermatitis Quality of Care
Initiative, Eric Simpson
- Poster #P0254: Relative Importance of Distinct Aspects of
Quality of Life for Patients Aged 6–11 and 12–17 Years Old With
Atopic Dermatitis, Caregivers, and Physicians (AD-GAP),
Stephan Weidinger
- Poster #P0271: Prevalence and Characteristics of Prurigo
Nodules in Adults With Moderate-to-Severe Atopic Dermatitis in
Japan: Results From a 2-Year
Observational Study, Yoko
Kataoka
About Dupixent
Dupixent, which was invented using
Regeneron's proprietary VelocImmune® technology,
is a fully human monoclonal antibody that inhibits the signaling of
the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
Dupixent is not an immunosuppressant and does not require lab
monitoring. IL-4 and IL-13 are key and central drivers of the type
2 inflammation that plays a major role in atopic dermatitis, asthma
and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved in the U.S., Europe, Japan
and other countries around the world for use in specific patients
with moderate-to-severe atopic dermatitis, as well as certain
patients with asthma or CRSwNP in different age populations.
Dupixent is also approved in one or more of these indications in
more than 60 countries around the world and more than 300,000
patients have been treated globally.
Dupilumab Development Program
To date, dupilumab has
been studied across 60 clinical trials involving more than 10,000
patients with various chronic diseases driven in part by type 2
inflammation.
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 peanut allergy (Phase 2). These
potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy 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.
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 or authorized
fully human monoclonal antibodies currently available. This
includes Dupixent, REGEN-COVTM (casirivimab and
imdevimab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and InmazebTM
(atoltivimab, maftivimab, and odesivimab-ebgn).
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.
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.
About Sanofi
Sanofi is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100
countries, Sanofi is transforming scientific innovation
into healthcare solutions around the globe.
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 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 Dupixent® (dupilumab); the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's Product Candidates 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, allergic bronchopulmonary aspergillosis, peanut
allergy, and other potential indications; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron's Products and Regeneron's Product Candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), including the studies discussed or
referenced in this press release, on any of the foregoing or any
potential regulatory approval of Regeneron's Products and
Regeneron's Product Candidates; 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; the ability of Regeneron to manage
supply chains for multiple products and product candidates; safety
issues resulting from the administration of Regeneron's Products
(such as Dupixent) and Regeneron's Product Candidates 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 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 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), 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-COVTM
(casirivimab and imdevimab)), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations, the ultimate outcome of any such proceedings
and investigations, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the U.S. Securities
and Exchange Commission, including its Form 10-K for the year ended
December 31, 2020 and its Form 10-Q
for the quarterly period ended June 30,
2021. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed
(http://twitter.com/regeneron).
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31, 2020. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
|
|
|
|
Media
Relations Hannah
Kwagh Tel: +1
914-847-6314 Hannah.Kwagh@regeneron.com
|
Investor
Relations Vesna
Tosic Tel: +1
914-847-5443 Vesna.Tosic@regeneron.com
|
|
|
Sanofi
Contacts:
|
|
|
|
Media
Relations Sally
Bain Tel: +1
781-264-1091 Sally.Bain@sanofi.com
|
Investor
Relations Sanofi
Investor Relations – Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Nathalie Pham
|
|
|
|
Sanofi Investor
Relations – Contacts North America Felix Lauscher
|
|
|
|
Sanofi IR main
line: Tel: +33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
|
View original
content:https://www.prnewswire.com/news-releases/new-dupixent-dupilumab-data-in-patients-as-young-as-six-years-old-with-moderate-to-severe-atopic-dermatitis-to-be-presented-at-wcpd-and-eadv-301381058.html
SOURCE Regeneron Pharmaceuticals, Inc.