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
recommending the approval of Dupixent® (dupilumab) in the European
Union (EU) as an add-on maintenance treatment in adults with
uncontrolled chronic obstructive pulmonary disease (COPD)
characterized by raised blood eosinophils. The European Commission
is expected to announce a final decision on the Dupixent
application in the coming months.
COPD is a respiratory disease that damages the lungs and causes
progressive lung function decline, and is the fourth leading cause
of death worldwide. Symptoms include persistent cough, excessive
mucus production and shortness of breath that may impair the
ability to perform routine daily activities, which may lead to
sleep disturbances, anxiety and depression. COPD is also associated
with a significant health and economic burden due to recurrent
acute exacerbations that require systemic corticosteroid treatment
and/or lead to hospitalization. Smoking and exposure to noxious
particles are key risk factors for COPD, but even individuals who
quit smoking can still develop or continue having the disease.
There have been no new treatment approaches approved for more than
a decade.
The positive CHMP opinion is supported by data from the landmark
BOREAS and NOTUS Phase 3 trials that evaluated the efficacy and
safety of Dupixent in adults with uncontrolled COPD with evidence
of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL).
All patients were on background maximal standard-of-care inhaled
therapy (nearly all on triple therapy). The primary endpoint was
met in both trials, showing Dupixent significantly reduced
annualized moderate or severe acute COPD exacerbations by up to 34%
compared to placebo. Dupixent rapidly and significantly improved
lung function compared to placebo, with improvements sustained at
52 weeks. Additionally, Dupixent improved health-related quality of
life at 52 weeks (statistically significant in BOREAS and nominally
significant in NOTUS) as assessed by the St. George’s Respiratory
Questionnaire (SGRQ).
Safety results in both trials were generally consistent with the
known safety profile of Dupixent in its approved indications.
Adverse events more commonly observed with Dupixent (≥5%) compared
to placebo in either trial were back pain, COVID-19, diarrhea,
headache and nasopharyngitis.
Submissions are also under review with regulatory authorities
around the world, including in the U.S. and China. Earlier this
year, the U.S. Food and Drug Administration (FDA) accepted for
Priority Review the supplemental Biologics License Application for
Dupixent as an add-on maintenance treatment in certain adult
patients with uncontrolled COPD. The target action date is
September 27, 2024.
The use of Dupixent in COPD is investigational and is not yet
approved by global regulatory authorities.
About Regeneron and Sanofi’s COPD Clinical Research
ProgramRegeneron and Sanofi are motivated to transform the
treatment paradigm of COPD by examining the role different types of
inflammation play in the disease progression through the
investigation of two potentially first-in-class biologics, Dupixent
and itepekimab.
Dupixent inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and the program focuses on a
specific population of people with evidence of type 2 inflammation.
Itepekimab is a fully human monoclonal antibody that binds to and
inhibits interleukin-33 (IL-33), an initiator and amplifier of
broad inflammation in COPD.
Itepekimab is currently under clinical investigation, with two
Phase 3 trials currently enrolling, and its safety and efficacy
have not been evaluated by any regulatory authority.
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.
Dupixent has received regulatory approvals in more than 60
countries in one or more indications including certain patients
with atopic dermatitis, asthma, chronic rhinosinusitis with nasal
polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo
nodularis and chronic spontaneous urticaria (CSU) in different age
populations. More than 850,000 patients are being 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), Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
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 chronic pruritus of unknown origin, chronic
obstructive pulmonary disease 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 by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to numerous approved treatments and product
candidates in development, most 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, neurological
diseases, hematologic conditions, infectious diseases, and rare
diseases.
Regeneron pushes the boundaries of scientific discovery
and accelerates drug development using our proprietary
technologies, such as VelociSuite®, which produces optimized fully
human antibodies and new classes of bispecific antibodies. We are
shaping the next frontier of medicine with data-powered insights
from the Regeneron Genetics Center® and pioneering genetic medicine
platforms, enabling us to identify innovative targets and
complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook or X.
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 the world, 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
MediaThis 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); 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
adults with uncontrolled chronic obstructive pulmonary disease
(“COPD”) characterized by raised blood eosinophils; 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 COPD as
discussed in this press release as well as for the treatment of
chronic pruritus of unknown origin, bullous pemphigoid, 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; 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; 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
(including the pending civil proceedings initiated or joined by the
U.S. Department of Justice and the U.S. Attorney's Office for the
District of Massachusetts), 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 and its Form 10-Q for the quarterly
period ended March 31, 2024. 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 Forward-Looking StatementsThis 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, 2023. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
All trademarks mentioned in this press release are
protected.
Regeneron Contacts:Media
RelationsHannah KwaghTel: +1
914-847-6314Hannah.kwagh@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443Vesna.Tosic@regeneron.com |
|
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Sanofi Contacts:Media
RelationsSandrine GuendoulTel: + 33 6 25
09 14 25Sandrine.Guendoul@sanofi.comEvan Berland
Tel: + 1 215-432-0234evan.berland@sanofi.comVictor
RouaultTel: + 33 6 70 93 71
40Victor.Rouault@sanofi.comTimothy Gilbert Tel: +1
516-521-2929Timothy.Gilbert@sanofi.com |
Investor RelationsThomas Kudsk
LarsenTel: +44 7545 513
693Thomas.Larsen@sanofi.comAlizé KaisserianTel:
+33 6 47 04 12 11Alize.Kaisserian@sanofi.comArnaud
DelepineTel: +33 6 73 69 36
93Arnaud.Delepine@sanofi.comCorentine
DriancourtTel: +33 6 40 56 92
21Corentine.Driancourt@sanofi.comFelix
LauscherTel: +1
908-612-7239Felix.Lauscher@sanofi.comTarik
ElgoutniTel: +1
617-710-3587Tarik.Elgoutni@sanofi.comNathalie
PhamTel: +33 7 85 93 30 17Nathalie.Pham@sanofi.com |
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