Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the Ministry of Health, Labor and Welfare (MHLW) in
Japan has granted marketing and manufacturing authorization for
Dupixent® (dupilumab) for the treatment of chronic spontaneous
urticaria (CSU) in people aged 12 years and older whose disease is
not adequately controlled with existing therapy. Japan is the first
country to approve Dupixent for CSU, emphasizing the value of
Dupixent as a novel treatment option to manage this disease in
patients with unmet needs.
CSU is a chronic inflammatory skin disease driven in part by
type 2 inflammation, which causes sudden and debilitating hives and
persistent itch. CSU is typically treated with histamine-1 (H1)
antihistamines, medicines that target H1 receptors on cells to
control symptoms of urticaria. However, the disease remains
uncontrolled despite antihistamine treatment in many patients, some
of whom are left with limited alternative treatment options. These
individuals continue to experience symptoms that can be
debilitating and significantly impact their quality of life.
Approximately 110,000 people aged 12 years and older suffer from
uncontrolled moderate-to-severe CSU in Japan, for which there are
currently limited treatments.
The Japanese approval is based primarily on data from Study A of
the LIBERTY-CUPID clinical trial program evaluating Dupixent as an
add-on therapy to standard-of-care H1 antihistamines compared to
antihistamines alone (placebo) in 138 patients with CSU who
remained symptomatic despite antihistamine use and were not
previously treated with omalizumab. This study met the primary and
all key secondary endpoints. Patients taking Dupixent added to
standard-of-care antihistamines experienced a significant reduction
in itch severity compared to standard of care alone at 24 weeks.
The safety profile of Dupixent in CSU was generally consistent with
the known safety of Dupixent in its approved dermatological
indications.
In addition to CSU, Dupixent is approved in Japan in certain
patients with atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyposis (CRSwNP), and prurigo nodularis.
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, CRSwNP, prurigo nodularis and eosinophilic
esophagitis (EoE).
Dupixent has received regulatory approvals in one or more
countries around the world for use in certain patients with atopic
dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and CSU in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Japan, Europe and the U.S. More than 800,000 patients are being
treated with Dupixent globally.
The potential use of Dupixent in CSU is under clinical
development in additional countries around the world, and its
safety and efficacy have not been fully evaluated by any regulatory
authority outside of Japan.
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 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), Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
Dupilumab Development Program Dupilumab 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 chronic pruritus of unknown origin, chronic
obstructive pulmonary disease (COPD) with evidence of type 2
inflammation, 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 1 year of age and older with
eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15
kg). It is not known if DUPIXENT is safe and effective in children
with eosinophilic esophagitis under 1 year of age, or who weigh
less than 33 pounds (15 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, dry eye, 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 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 RegeneronRegeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for over 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and 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, 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 about Regeneron, please visit
www.Regeneron.com or follow Regeneron on LinkedIn.
About Sanofi We 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 nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, “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) for the treatment of
chronic spontaneous urticaria (“CSU”); 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), such as the studies discussed or
referenced in this press release, on any of the foregoing
(including whether the results of any such studies will be deemed
sufficient for regulatory approval of Dupixent for the treatment of
CSU by regulatory agencies of other countries); 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 chronic
pruritus of unknown origin, chronic obstructive pulmonary disease
with evidence of type 2 inflammation, bullous pemphigoid, and other
potential indications, as well as potential regulatory approval of
Dupixent for the treatment in CSU by regulatory agencies of other
countries; 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 (such as potential
regulatory approval of Dupixent for the treatment in CSU in other
countries); 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; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; 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), 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,
2023. 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
(https://investor.regeneron.com) and its LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
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 pandemics or other global crises may 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. 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, 2022. 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 Ilana YellenTel: +1
914-330-9618Ilana.Yellen@regeneron.comSanofi
Contacts: Media
Relations Sally Bain Tel: +1
617-834-6026 Sally.Bain@sanofi.com Evan
Berland Tel: +1 215 432 0234Evan.Berland@sanofi.com
Victor RouaultTel: + 33 6 70 93 71
40Victor.Rouault@sanofi.com |
Investor
Relations Vesna Tosic Tel: +1
914-847-5443 Vesna.Tosic@regeneron.com Investor
Relations Eva
Schaefer-Jansen Tel: +33 7 86 80 56
39 Eva.Schaefer-Jansen@sanofi.com Arnaud
Delepine Tel: +33 (0)6 73 69 36
93 Arnaud.Delepine@sanofi.com Corentine
Driancourt Tel: +33 (0)6 40 56 92
21 Corentine.Driancourt@sanofi.com Felix
Lauscher Tel: +1
908-612-7239 Felix.Lauscher@sanofi.com Tarik
Elgoutni Tel: +1
617-710-3587 Tarik.Elgoutni@sanofi.comNathalie
Pham Tel: +33 (0)7 85 93 30
17 Nathalie.Pham@sanofi.com |
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