Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
for Dupixent® (dupilumab), recommending expanded approval in the
European Union (EU) to treat severe atopic dermatitis in children 6
months to 5 years old who are candidates for systemic therapy. The
European Commission is expected to announce a final decision on the
Dupixent application in the coming months. In June 2022, Dupixent
was approved by the U.S. Food and Drug Administration for children
in this age group.
Atopic dermatitis is a chronic type 2 inflammatory skin disease.
Between 85% and 90% of patients first develop symptoms before 5
years of age, which can often continue through adulthood. Symptoms
include intense, persistent itch and skin lesions that cover much
of the body, resulting in skin dryness, cracking, pain, redness or
darkening, crusting and oozing, which can increase the risk of skin
infection. Severe atopic dermatitis may also significantly impact
the quality of life of young children and their caregivers. Current
treatment options in this age group are primarily topical
corticosteroids (TCS), which can be associated with safety risks
and may impair growth when used long-term.
The positive CHMP opinion is supported by data from a Phase 3
trial in children 6 months to 5 years of age recently published in
The Lancet, which met all primary and secondary endpoints. At 16
weeks, Dupixent plus low-potency TCS improved skin clearance and
reduced overall disease severity compared to TCS alone (the placebo
arm). Dupixent patients also experienced reduced itch and skin pain
as well as improved sleep quality and health-related quality of
life compared to placebo. Long-term data further showed a sustained
improvement in these disease measures up to one year. Safety
results were generally consistent with the known safety profile of
Dupixent in atopic dermatitis. Adverse events more commonly
observed with Dupixent in this atopic dermatitis population
compared to placebo included conjunctivitis and eosinophilia.
The use of Dupixent in infants and young children less than 6
years of age with severe atopic dermatitis is investigational in
the EU and is not yet approved.
About DupixentDupixent, 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 and is not
an immunosuppressant. The Dupixent development program has shown
significant clinical benefit and a decrease in type 2 inflammation
in Phase 3 trials, establishing that IL-4 and IL-13 are key and
central drivers of the type 2 inflammation that plays a major role
in multiple related and often co-morbid diseases. These diseases
include approved indications for Dupixent, such as atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP) and prurigo nodularis, as well as investigational diseases
such as eosinophilic esophagitis (EoE) in the EU.
Dupixent has received regulatory approvals in one or more
countries around the world for use in certain patients with atopic
dermatitis, prurigo nodularis, asthma, CRSwNP or EoE in different
age populations. Dupixent is currently approved for one or more of
these indications in more than 60 countries, including in Europe,
the U.S. and Japan. More than 500,000 patients have been treated
with Dupixent globally.
About Regeneron's VelocImmune
TechnologyRegeneron'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 a
substantial proportion of all original, FDA-approved or authorized
fully human monoclonal antibodies. This includes REGEN-COV®
(casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn).
Dupilumab Development ProgramDupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. To date, dupilumab has been studied across
more than 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 in Phase 3
trials, including pediatric EoE, hand and foot atopic dermatitis,
chronic inducible urticaria-cold, chronic spontaneous urticaria,
chronic pruritus of unknown origin, chronic obstructive pulmonary
disease with evidence of type 2 inflammation, chronic
rhinosinusitis without nasal polyposis, allergic fungal
rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous
pemphigoid. 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
months of age and older with moderate-to-severe eczema (atopic
dermatitis or AD) 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 months 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.
- to treat adults and children 12 years
of age and older, who weigh at least 88 pounds (40 kg), with
eosinophilic esophagitis (EoE). It is not known if DUPIXENT is safe
and effective in children with eosinophilic esophagitis under 12
years of age and who weigh at least 88 pounds (40 kg).
- to treat adults with prurigo
nodularis (PN). It is not known if DUPIXENT is safe and effective
in children with prurigo nodularis under 18 years of age.
IMPORTANT SAFETY INFORMATION
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,
chronic rhinosinusitis with nasal polyposis, eosinophilic
esophagitis, or prurigo nodularis 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:
- Eczema: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, sometimes with blurred vision, cold sores in
your mouth or on your lips, and high count of a certain white blood
cell (eosinophilia).
-
Asthma:
injection site reactions, high count of a certain white blood cell
(eosinophilia), pain in the throat (oropharyngeal pain), 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), gastritis,
joint pain (arthralgia), trouble sleeping (insomnia), and
toothache.
- Eosinophilic
Esophagitis: injection site reactions, upper respiratory
tract infections, cold sores in your mouth or on your lips, and
joint pain (arthralgia).
- Prurigo Nodularis:
eye and eyelid inflammation, including redness, swelling, and
itching, sometimes with blurred vision, herpes virus infections,
common cold symptoms (nasopharyngitis), dizziness, muscle pain, and
diarrhea.
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
http://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 6 months to less 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, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for 35 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 more information, please
visit www.Regeneron.com or follow @Regeneron on
Twitter.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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 or licensees
(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 or licensees (collectively,
“Regeneron’s Product Candidates”) and research and clinical
programs now underway or planned, including without limitation
Dupixent® (dupilumab); the impact of the opinion adopted by the
European Medicines Agency's Committee for Medicinal Products for
Human Use discussed in this press release on the potential approval
by the European Commission of Dupixent to treat severe atopic
dermatitis in children 6 months to 5 years who are candidates for
systemic therapy; 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 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 the potential approval by the European Commission of
Dupixent to treat severe atopic dermatitis in children 6 months to
5 years who are candidates for systemic therapy, as well as
Dupixent for the treatment of including pediatric eosinophilic
esophagitis, hand and foot atopic dermatitis, chronic inducible
urticaria-cold, chronic spontaneous urticaria, chronic pruritus of
unknown origin, chronic obstructive pulmonary disease with evidence
of type 2 inflammation, chronic rhinosinusitis without nasal
polyposis, allergic fungal rhinosinusitis, bullous pemphigoid, and
other potential indications; the ability of Regeneron’s
collaborators, licensees, 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 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
license, collaboration, or supply agreement, including Regeneron’s
agreements with Sanofi and Bayer (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, 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, 2021 and its Form
10-Q for the quarterly period ended September 30, 2022. 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
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Twitter feed (http://twitter.com/regeneron).
Sanofi Disclaimers or 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,
2021. 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
RelationsHannah KwaghTel: +1
914-847-6314hannnah.kwagh@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
|
|
Sanofi
Contacts: |
|
Media
RelationsSally BainTel: +1
617-834-6026sally.bain@sanofi.com |
Investor
RelationsEva Schaefer-JansenTel: +33 7 86
80 56 39eva.schaefer-jansen@sanofi.comArnaud
DelepineTel: +33 (0)6 73 69 36
93arnaud.delepine@sanofi.comCorentine
DriancourtTel: +33 (0)6 40 56 92
21corentine.driancourt@sanofi.comFelix
LauscherTel: +1
908-612-7239felix.lauscher@sanofi.comPriya Nanduri
Tel: +1 617-764-6418priya.nanduri@sanofi.com Nathalie
PhamTel: +33 (0)7 85 93 30 17nathalie.pham@sanofi.com |
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