TARRYTOWN, N.Y. and
PARIS, Feb.
1, 2022 /PRNewswire/ --
Late-breaking pivotal data show significant disease
improvements in eosinophilic esophagitis and also in chronic
spontaneous urticaria
18 abstracts add to body of evidence that IL-4 and IL-13
pathways inhibited by Dupixent are key drivers of the type 2
inflammation underlying certain diseases, accounting for the impact
of Dupixent in its approved and investigational indications
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced positive Dupixent® (dupilumab) data across
five diseases with underlying type 2 inflammation will be presented
at the American Academy of Allergy, Asthma and Immunology (AAAAI)
Annual Meeting from February 25 to
28.
The five diseases include eosinophilic esophagitis (EoE),
chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis
with nasal polyposis (CRSwNP) and atopic dermatitis. Additionally,
positive results from two Phase 3 trials in a sixth indication,
prurigo nodularis, were recently announced and will be
presented at a separate medical meeting later this year.
Abstracts being presented at the AAAAI meeting have been
published in an online supplement to The Journal of Allergy and
Clinical Immunology and include:
Late-breaking Abstracts
New pivotal data showing
significant disease improvements in EoE and CSU will be presented
for the first time. The use of Dupixent in these diseases is
currently under clinical investigation and its safety and efficacy
have not been fully evaluated by any regulatory authority.
- Oral Presentation L01 (February
26, 2:00-3:15 pm MST):
Dupilumab Significantly Reduces Itch and Hives in Patients with
Chronic Spontaneous Urticaria: Results from a Phase 3 Trial
(LIBERTY-CSU CUPID Study A), Marcus
Maurer
- Oral Presentation L02 (February
26, 2:00-3:15 pm MST):
Dupilumab Improves Clinical and Histologic Aspects of Disease in
Adult and Adolescent Patients with Eosinophilic Esophagitis at Week
24: Results from Part B of the 3-Part LIBERTY EoE TREET Study,
Marc Rothenberg and Evan Dellon
Asthma
New analyses evaluate Dupixent in patients aged
six years and older with moderate-to-severe asthma. These include
analyses in patients characterized by different type 2 inflammatory
biomarkers and comorbidities, as well as those with seasonal
exacerbations.
- Oral Presentation 189 (February
26, 2:00-3:15 pm MST):
Long-Term Efficacy of Dupilumab in Patients with Asthma with and
without Comorbid Chronic Rhinosinusitis/Nasal Polyposis,
Andrew Menzies-Gow
- Oral Presentation 190 (February
26, 2:00-3:15 pm MST):
Efficacy of Dupilumab in the Prevention of Seasonal Exacerbations
in Patients with and without Evidence of an Allergic Asthma
Phenotype, Anju Peters
- Poster 42 (February 26,
9:45-10:45 am MST): Dupilumab
Efficacy in LIBERTY ASTHMA QUEST Patients with Uncontrolled,
Moderate-to-Severe Asthma by Allergen Sensitization Status,
Jonathan Corren
- Poster 50 (February 26,
9:45-10:45 am MST): Efficacy of
Dupilumab in Quadrants of Elevated- vs Low- Type 2 Biomarkers in
Children with Uncontrolled, Moderate-to-Severe Asthma: LIBERTY
ASTHMA VOYAGE, Leonard
Bacharier
- Poster 409 (February 27,
2:00-3:15 pm MST): Dupilumab Improves
Asthma Control, and Allergic Rhinitis-Related Health-Related
Quality of Life in Children with Uncontrolled Persistent Asthma
with Comorbid Allergic Rhinitis, Alessandro
Fiocchi
- Poster 571 (February 28,
9:45-10:45 am MST): Long-Term
Efficacy of Dupilumab in Quadrants of Elevated- vs Low- Type 2
Biomarker Patients with Uncontrolled, Moderate-to-Severe Asthma:
LIBERTY ASTHMA TRAVERSE, Michael
Wechsler
CRSwNP
New analyses assess Dupixent in reducing the
burden of disease for patients with CRSwNP. These include
assessments on the reduction of systemic corticosteroid use and
symptoms, such as loss of sense of smell and nasal congestion, as
well as the increase in days with no symptoms.
- Oral Presentation 430 (February
27, 2:05-2:15 pm MST):
Dupilumab Achieves Durable Reduction in Severity of Symptoms Rated
Most Important by Patients with Chronic Rhinosinusitis with Nasal
Polyps, Claire Hopkins
- Oral Presentation 431 (February
27, 2:15-2:25 pm MST):
Dupilumab Improves Objective, Subjective, and Health-Related
Quality of Life Outcomes in Chronic Rhinosinusitis with Nasal
Polyps (CRSwNP), Regardless of BMI ≥30 kg/m2 or Weight ≥90 kg:
Post-hoc Analysis of the SINUS-24 and SINUS-52 Studies,
Seong Cho
- Oral Presentation 432 (February
27, 2:25-2:35 pm
MST): Symptom Free Days in Patients with Severe Chronic
Rhinosinusitis with Nasal Polyps Treated with Dupilumab,
Claus Bachert
- Oral Presentation 434 (February
27, 2:45-2:55 pm
MST): Dupilumab Leads to Reduction of Anosmia in
Patients with Severe Chronic Rhinosinusitis with Nasal Polyps,
Andrew Lane
- Poster 145 (February 26,
9:45-10:45 am MST): EValuating
trEatment RESponses of Dupilumab Versus Omalizumab in Type 2
Patients: The EVEREST Trial, Lucia De Prado
Gomez
- Poster 377 (February 27,
9:45-10:45 am MST): Dupilumab
Reduces Asthma Disease Burden and Recurrent SCS Use in Patients
with CRSwNP and Coexisting Asthma, Mark
Gurnell
EoE
In addition to the late-breaking abstract, a new
analysis assesses the impact of Dupixent treatment on biomarkers of
type 2 inflammation in patients with EoE. The use of Dupixent in
EoE is investigational and has not been approved by any regulatory
authority.
- Oral Presentation 633 (February
28, 9:45-10:45 am MST):
Dupilumab Reduces Biomarkers of Type 2 Inflammation in Adult and
Adolescent Patients with Eosinophilic Esophagitis: Results from
Parts A and C of a Three-Part, Phase 3 LIBERTY EoE TREET Study,
Mark Rothenberg
Atopic Dermatitis
New data from a trial that evaluated
improvements in skin barrier function for adults and adolescents
with moderate-to-severe atopic dermatitis treated with Dupixent, as
well as long-term safety results of Dupixent in adults, will be
shared.
- Poster 29 (February 26,
9:45-10:45 am MST): Dupilumab
Treatment Significantly Improves Skin Barrier Function in Adult and
Adolescent Patients with Moderate to Severe Atopic Dermatitis,
Evgeny Berdyshev
- Poster 30 (February 26,
9:45-10:45 am MST): Safety of
Long-Term Dupilumab Treatment in Adults with Moderate-to-Severe
Atopic Dermatitis up to 172 Weeks: Results from an Open-Label
Extension (OLE) Trial, Andreas
Wollenberg
In addition, results from an observational study highlight the
disease burden of moderate-to-severe atopic dermatitis and unmet
need in children.
- Poster 22 (February 26,
9:45-10:45 am MST): The Patient
Burden of Moderate-to-Severe Atopic Dermatitis (AD) in Children
Aged <12 Years: Results From 732 Patients in the PEDIatric STudy
in Atopic Dermatitis (PEDISTAD) Observational Study, Amy Paller
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 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 350,000
patients have been treated globally.
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-COV® (casirivimab and imdevimab),
Libtayo® (cemiplimab-rwlc), Praluent®
(alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and
odesivimab-ebgn).
Dupilumab Development Program
Dupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. 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.
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 atopic dermatitis (6 months to 5 years of age, Phase 3),
eosinophilic esophagitis (Phase 3), prurigo nodularis (Phase 3),
chronic spontaneous urticaria (Phase 3), chronic rhinosinusitis
without nasal polyposis (Phase 3), chronic obstructive pulmonary
disease with evidence of type 2 inflammation (Phase 3), bullous
pemphigoid (Phase 3), chronic inducible urticaria-cold (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.
U.S. Indications
DUPIXENT is
a prescription medicine used:
- to treat adults and children 6 years of age 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
adults and children 6 years of age 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 6 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" right before and during treatment with
DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
-
- A pregnancy registry for women who take DUPIXENT during
pregnancy collects information about the health of you and your
baby. To enroll or get more information 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. DUPIXENT can cause allergic reactions
that can sometimes be severe. Stop using DUPIXENT and tell your
healthcare provider or get emergency help right away if you get any
of the following signs or symptoms: breathing problems or wheezing,
swelling of the face, lips, mouth, tongue or throat, fainting,
dizziness, feeling lightheaded, fast pulse, fever, hives, joint
pain, general ill feeling, itching, skin rash, swollen lymph nodes,
nausea or vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision, such as blurred vision. Your healthcare provider may send
you to an ophthalmologist for an exam if needed.
- 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, chest pain, worsening shortness of breath, a
feeling of pins and needles or numbness of your arms or legs, or
persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have
had trouble walking or moving due to their joint symptoms, and in
some cases needed to be hospitalized. Tell your healthcare provider
about any new or worsening joint symptoms. Your healthcare provider
may stop DUPIXENT if you develop joint symptoms
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, and cold sores in your mouth or on
your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), high count of a certain white blood cell
(eosinophilia), and parasitic (helminth) infections.
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, sometimes with blurred vision, 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 by your healthcare provider.
It's an injection given under the skin (subcutaneous injection).
Your healthcare provider will decide if you or your caregiver can
inject DUPIXENT. Do not try to prepare and inject DUPIXENT
until you or your caregiver have been trained by your healthcare
provider. In children 12 years of age and older, it's recommended
DUPIXENT be administered by or under supervision of an adult. In
children under 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
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Regeneron and/or its collaborators or licensees (collectively,
"Regeneron's Products"), and the global economy; the nature,
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Regeneron's Products and product candidates being developed by
Regeneron and/or its collaborators or licensees (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 atopic dermatitis, eosinophilic esophagitis,
prurigo nodularis, chronic spontaneous urticaria, chronic
rhinosinusitis without nasal polyposis, chronic obstructive
pulmonary disease with evidence of type 2 inflammation, bullous
pemphigoid, chronic inducible urticaria-cold, allergic fungal
rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut
allergy, and other potential indications; uncertainty of the
utilization, market acceptance, and commercial success of
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of the foregoing or any potential regulatory approval of
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Candidates; the ability of Regeneron's collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
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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 or licensees 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
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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-COV® (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 September 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
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Regeneron uses its media and investor relations website and
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routinely posted and is accessible on Regeneron's media and
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Sanofi Forward-Looking Statements
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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
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Forward-looking statements are generally identified by the words
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generally beyond the control of Sanofi, that could cause actual
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Regeneron
Contacts:
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Media
Relations
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Investor
Relations
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Sharon
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Vesna
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Tel: +1
914-847-5443
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Sharon.Chen@regeneron.com
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Vesna.Tosic@regeneron.com
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Sanofi
Contacts:
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Media
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Investor
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Sally
Bain
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781-264-1091
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Paris
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Sally.Bain@sanofi.com
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Eva
Schaefer-Jansen
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Arnaud
Delepine
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Nathalie
Pham
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Sanofi Investor
Relations – Contact
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North
America
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Felix
Lauscher
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Sanofi IR main
line:
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Tel: +33 (0)1 53 77
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investor.relations@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.