Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
presented late-breaking data from the NOTUS Phase 3 trial
evaluating the investigational use of Dupixent® (dupilumab) as an
add-on maintenance treatment in adults with uncontrolled COPD on
maximal standard-of-care inhaled therapy (nearly all on triple
therapy) and evidence of type 2 inflammation (i.e., blood
eosinophils ≥300 cells per μL). The NOTUS trial confirmed the
positive results demonstrated in the landmark Phase 3 BOREAS trial,
with its data presented at a late-breaking session of the 2024
American Thoracic Society (ATS) International Conference and
simultaneously published in the New England Journal of Medicine
(NEJM).
“In my more than 20 years of practice, there have
been limited advancements for patients struggling with the
debilitating effects of uncontrolled COPD, and too many patients
experience a vicious cycle of exacerbations that can result in loss
of lung function and greatly diminish their quality of life,” said
Surya Bhatt, M.D., MSPH, Professor at the University of Alabama at
Birmingham, Division of Pulmonary, Allergy, and Critical Care
Medicine and a co-principal investigator of the trial. “In NOTUS,
dupilumab reduced exacerbations by a magnitude never seen before
with an investigational biologic in a Phase 3 COPD clinical trial.
These comprehensive results reinforce that, if approved, dupilumab
could provide a first-of-its-kind medical advancement for the COPD
community.”
As presented and published, the NOTUS trial met its
primary and key secondary endpoints. All patients were on
background maximal standard-of-care inhaled therapy (nearly all on
triple therapy). Patients receiving Dupixent (n=470) experienced
the following, compared to placebo (n=465):
- 34% reduction in moderate or severe COPD
exacerbations over 52 weeks (p<0.001), the primary
endpoint.
- More than two times greater
improvement in lung function (pre-bronchodilator FEV1)
from baseline at 12 weeks (139 mL vs. 57 mL; p<0.001), with an
improvement maintained at week 52 (115 mL vs. 54 mL; p=0.018),
secondary endpoints.
- Numerically greater improvements in health-related
quality of life from baseline at 52 weeks, a secondary
endpoint, as defined by patient-reported outcomes
(PRO) in the St. George’s Respiratory Questionnaire (SGRQ).
- Numerically greater reductions in respiratory symptom
severity from baseline to 52 weeks, a secondary endpoint,
as defined by PROs in Evaluating Respiratory Symptoms in COPD
(E-RS).
The safety results were generally consistent with
the known safety profile of Dupixent in its approved indications.
Overall rates of adverse events (AE) were 67% for Dupixent and 66%
for placebo. AEs more commonly observed with Dupixent than placebo
included COVID-19 (9.4% Dupixent, 8.2% placebo), nasopharyngitis
(6.2% Dupixent, 5.2% placebo), and headache (7.5% Dupixent, 6.5%
placebo). AEs more commonly observed with placebo than Dupixent
included COPD (7.8% placebo, 4.9% Dupixent). AEs leading to deaths
were 2.6% for Dupixent and 1.5% for placebo.
Dupixent is currently under Priority Review by the
U.S. Food and Drug Administration as an add-on maintenance
treatment in certain adult patients with uncontrolled COPD with
evidence of type 2 inflammation. The target action date is June 27,
2024. Regulatory submissions are also under review in the European
Union and China, and discussions with other regulatory authorities
around the world are ongoing.
The potential use of Dupixent in COPD is currently
under clinical development, and its safety and efficacy have not
been fully evaluated by any regulatory authority in this
setting.
About COPDCOPD is a respiratory
disease that damages the lungs and causes progressive lung function
decline. Symptoms include persistent cough, breathlessness and
excessive mucus production that may impair the ability to perform
routine daily activities, which may lead to anxiety, depression and
sleep disturbances. 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. In the
U.S., approximately 300,000 people live with uncontrolled COPD with
evidence of type 2 inflammation.
About the Dupixent COPD Phase 3 Trial
ProgramBOREAS and NOTUS are replicate, randomized, Phase
3, double-blind, placebo-controlled trials that evaluated the
efficacy and safety of Dupixent in adults who were current or
former smokers with moderate-to-severe COPD. Patients were aged 40
to 80 years in BOREAS and 40 to 85 years in NOTUS. All 1,874
patients enrolled in BOREAS and NOTUS had evidence of type 2
inflammation, as measured by blood eosinophils ≥300 cells per µL.
Patients with a diagnosis or history of asthma were excluded from
the trials.
During the 52-week treatment period, patients in
BOREAS and NOTUS received Dupixent or placebo every two weeks added
to a maximal standard-of-care inhaled triple therapy of inhaled
corticosteroids (ICS), long-acting beta agonists (LABA), and
long-acting muscarinic antagonists (LAMA). Double maintenance
therapy, which included LABA and LAMA, was allowed if ICS was
contraindicated.
The primary endpoint for BOREAS and NOTUS evaluated
the annualized rate of acute moderate or severe COPD exacerbations.
Moderate exacerbations were defined as those requiring systemic
steroids and/or antibiotics. Severe exacerbations were defined as
those requiring hospitalization; requiring more than a day of
observation in an emergency department or urgent care facility; or
resulting in death. Key secondary endpoints included change from
baseline in lung function (assessed by pre-bronchodilator forced
expiratory volume [FEV1]) at 12 and 52 weeks, change from baseline
at 52 weeks in SGRQ total score compared to placebo, and
safety.
Data from BOREAS were previously published in the
New England Journal of Medicine.
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 two of the 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 portion 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 chronic spontaneous urticaria, 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
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“believe,” “seek,” “estimate,” variations of such words, and
similar expressions are intended to identify such forward-looking
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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) and itepekimab; 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 uncontrolled chronic obstructive pulmonary disease
with evidence of type 2 inflammation as discussed in this press
release (including the impact of the previously disclosed request
by the U.S. Food and Drug Administration to provide additional
analyses regarding sub-populations from the BOREAS and NOTUS
pivotal studies) as well as for the treatment of chronic
spontaneous urticaria, 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 or any
potential regulatory approval of Regeneron’s Products (such as
Dupixent) and Regeneron’s Product Candidates (such as itepekimab);
the ability of Regeneron’s collaborators, licensees, suppliers, or
other third parties (as applicable) to perform manufacturing,
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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 (such as itepekimab) in
patients, including serious complications or side effects in
connection with the use of Regeneron’s Products and Regeneron’s
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and administrative governmental authorities which may delay or
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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
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(or their respective affiliated companies, as applicable) to be
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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
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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.
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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
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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
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Regeneron uses its media and investor relations
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Sanofi Disclaimers or 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
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Forward-looking statements are generally identified by the words
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Regeneron Contacts: |
Media RelationsAnna HodgeTel: +1
914-255-6475Anna.Hodge@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443Vesna.Tosic@regeneron.com |
|
|
Sanofi
Contacts: |
Media
RelationsEvan Berland Tel: + 1
215-432-0234evan.berland@sanofi.comVictor
Rouault Tel: + 33 6 70 93 71
40Victor.Rouault@sanofi.comTimothy Gilbert Tel: +1
516-521-2929Timothy.Gilbert@sanofi.com |
Investor
RelationsThomas Kudsk Larsen Tel: +44
7545 513 693Thomas.Larsen@sanofi.comAlizé
Kaisserian Tel: + 33 (0)6 47 04 12
11Alize.Kaisserian@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.comNathalie
PhamTel: +33 (0)7 85 93 30
17Nathalie.Pham@sanofi.comTarik ElgoutniTel: +1
617-710-3587Tarik.Elgoutni@sanofi.com |
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