Dupixent(®) late-breaking data from NOTUS confirmatory phase 3 COPD study
presented at ATS and published in NEJM

  * NOTUS results confirm landmark data from the phase 3 BOREAS study and show
    Dupixent significantly reduced exacerbations by 34% and improved lung

function, compared to placebo, in uncontrolled chronic obstructive pulmonary

    disease (COPD) with evidence of type 2 inflammation
  * Data support the potential of Dupixent as the first new treatment approach
    in more than a decade and first-ever targeted therapy for COPD

Paris and Tarrytown, N.Y. May 20, 2024. Late-breaking data were presented from
the NOTUS phase 3 study 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 ?L). The
NOTUS study confirmed the positive results demonstrated in the landmark phase 3
BOREAS study, 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)
(https://www.nejm.org/doi/full/10.1056/NEJMoa2401304).
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 study
"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. In NOTUS, dupilumab reduced exacerbations by a magnitude never seen before with an investigational biologic in a phase 3 COPD clinical study. 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 study 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=300 cells per µL. Patients with a diagnosis or history of

asthma were excluded from the studies.
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 also published
(https://www.nejm.org/doi/full/10.1056/NEJMoa2303951) in the New England Journal
of Medicine.
About Sanofi and Regeneron's COPD Clinical Research Program
Sanofi and Regeneron 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 studies
currently enrolling, and its safety and efficacy have not been evaluated by any
regulatory authority.
About Dupixent
Dupixent 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 studies,
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.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global
collaboration agreement. To date, dupilumab has been studied across more than
60 clinical studies involving more than 10,000 patients with various chronic
diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are
studying dupilumab in a broad range of diseases driven by type 2 inflammation or
other allergic processes in phase 3 studies, 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.
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 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 (http://www.Regeneron.com)
or follow Regeneron on LinkedIn (https://www.linkedin.com/company/regeneron-
pharmaceuticals/mycompany/verification/), Instagram
(https://www.globenewswire.com/Tracker?data=-
XtT1o6G7EigQMncM_SeYchLdX_OvUrCTtP9HB1GAb170uZuSeUKFHWCbo_N8Km95XNY0XYkvADtY11Xu
tdjBNskRyB_00fxtA51SN4QeHc=), Facebook
(https://www.globenewswire.com/Tracker?data=yXrfehBs7EJlB3buMp5ba2MNRrTu4tokCBwl
dVSrdKiP5XLl3T1MvBemR1dSRE9AUyvlb2aulHjXHjNkAzesP6k1rXvZX524jO8D2dcHPnY=) or X
(https://www.globenewswire.com/Tracker?data=yLHTtnyw42HvbARrj9jqYOtUSjB-
B0ANvqff-9jf0AeUwhP2tJ4M10Ao2pC6JZ2PyFr8yDZmP9bN23TsBW-c3g==).
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 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
Sanofi Media Relations
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com
(mailto:evan.berland@sanofi.com)
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
(mailto:victor.rouault@sanofi.com)
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com
(http://invalid.uri)
Sanofi Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
(mailto:thomas.larsen@sanofi.com)
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
(mailto:alize.kaisserian@sanofi.com)
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
(mailto:arnaud.delepine@sanofi.com)
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
(mailto:corentine.driancourt@sanofi.com)
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
(mailto:felix.lauscher@sanofi.com)
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
(mailto:nathalie.pham@sanofi.com)
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com
(mailto:Tarik.Elgoutni@sanofi.com)
Regeneron Media Relations
Anna Hodge | +1 914 255 6475| Anna.Hodge@regeneron.com
(mailto:Anna.Hodge@regeneron.com)
Regeneron Investor Relations
Vesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com
(mailto:vesna.tosic@regeneron.com)
Sanofi 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, 2023. Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information or
statements.
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) 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, 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
(such as itepekimab) 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).
Â