TARRYTOWN, N.Y. and
CAMBRIDGE, Mass., Sept. 20, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that The Lancet has
published detailed positive results from two Phase 3 trials
evaluating the safety and efficacy of
Dupixent® (dupilumab) in adults with
recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP)
despite previous treatment with surgery and/or systemic
corticosteroids.
Results published in
The Lancet demonstrated that adding
Dupixent to the standard-of-care corticosteroid nasal spray reduced
nasal polyp size and nasal congestion severity (co-primary
endpoints). Dupixent also reduced chronic sinus disease associated
with nasal polyps and improved sense of smell.
In addition to the results of the primary endpoints of these
trials, the publication included a pre-specified pooled analysis
that showed Dupixent significantly reduced systemic corticosteroid
use by 74% and the need for sino-nasal surgery by 83% compared to
placebo. Given that these patients frequently also suffer from
asthma, the trials prospectively studied the effect of Dupixent on
a subgroup of patients with a history of asthma, and found
significant improvements in asthma control and lung function.
"The results published in
The Lancet show that Dupixent improved all
disease measures of chronic rhinosinusitis with nasal polyps in the
trials," said Claus Bachert, M.D.,
Professor and Head of Clinics of the Department of
Otorhinolaryngology at Ghent
University and principal investigator of the trials. "In patients
with CRSwNP who have a history of asthma, Dupixent was also
effective in improving asthma symptoms, lung function and
asthma control, as well as upper airway outcomes. This is important
news for these patients as they often suffer from high disease
burden and are not controlled by standard treatment."
CRSwNP is a chronic disease of the upper airway that obstructs
the sinuses and nasal passages. It can lead to breathing
difficulties, nasal congestion and discharge, reduced or loss of
sense of smell and taste, and facial pressure. Many patients with
CRSwNP have other type 2 inflammatory diseases like asthma, and
these patients often have more severe asthma and are often more
difficult to treat. These co-morbid diseases can lead to an
increased risk of asthma attacks, high symptom burden and a
substantial adverse impact on health-related quality of life. In
the Dupixent CRSwNP trials, 59% of patients also had asthma.
The Lancet publication provides data on key
endpoints from 724 patients involved in LIBERTY NP SINUS-24 and
LIBERTY NP SINUS-52, which evaluated Dupixent 300 mg every two
weeks with standard-of-care mometasone furoate nasal spray (MFNS)
compared to placebo injection plus MFNS. These data were
presented earlier this year at the 2019 Annual Meeting of the
American Academy of Allergy, Asthma & Immunology (AAAAI).
In data reviewed by the U.S. Food and Drug Administration
(FDA), adverse reactions that occurred in at least 2% of
Dupixent patients and greater than placebo were injection site
reactions (6% Dupixent, 4% placebo), conjunctivitis (2% Dupixent,
1% placebo), arthralgia (3% Dupixent, 2% placebo) and gastritis (2%
Dupixent, 1% placebo).
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins. Data from Dupixent clinical trials have shown that IL-4
and IL-13 are key drivers of the type 2 inflammation that plays a
major role in CRSwNP as well as asthma and atopic
dermatitis.
Dupixent is approved in the U.S. for use with other medicines to
treat CRSwNP in adults whose disease is not controlled, and is
currently under regulatory review for these patients in the EU and
Japan. In addition, Dupixent is
approved for use in specific patients with moderate-to-severe
atopic dermatitis, and certain patients with asthma in a number of
other countries around the world, including the EU, U.S. and
Japan.
Dupilumab Development Program
In addition to the currently approved indications, Regeneron and
Sanofi are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and
other type 2 inflammation, including pediatric asthma (6
to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months
to 5 years of age, Phase 2/3 and 6 to 11 years of age, Phase 3),
eosinophilic esophagitis (Phase 2/3), chronic obstructive pulmonary
disease (Phase 3) and food and environmental allergies (Phase 2).
Dupilumab is also being studied in combination with REGN3500
(SAR440340), which targets IL-33.
These potential uses are investigational and the safety and
efficacy have not been evaluated by any regulatory authority.
Dupilumab and REGN3500 were invented using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully human antibodies, and are being jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat people 12 years of age and older with
moderate-to-severe atopic dermatitis (eczema) 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 12
years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in people aged 12 years 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 12 years of
age.
- with other medicines to treat chronic rhinosinusitis with nasal
polyposis 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.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
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 taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- 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. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
DUPIXENT can cause serious side
effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- 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, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, and
cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), and high count of a certain white blood cell
(eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
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. DUPIXENT is an injection
given under the skin (subcutaneous injection). If your healthcare
provider decides that you or a caregiver can give DUPIXENT
injections, you or your caregiver should receive training on the
right way to prepare and inject DUPIXENT. Do not try to
inject DUPIXENT until you have been shown the right way by your
healthcare provider. In children 12 years of age and older, it is
recommended that DUPIXENT be administered by or under supervision
of an adult.
Please see full Prescribing
Information including Patient Information.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved treatments and numerous
product candidates in development, 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, infectious diseases,
pain and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the
millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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 Regeneron's products, product candidates, and
research and clinical programs now underway or planned, including
without limitation Dupixent® (dupilumab) Injection; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's late-stage product candidates and
new indications for marketed products, such as dupilumab for the
treatment of pediatric asthma and pediatric atopic dermatitis,
eosinophilic esophagitis, chronic obstructive pulmonary disease,
food and environmental allergies, and other potential indications
(as well as in combination with REGN3500); unforeseen safety issues
resulting from the administration of products and product
candidates (such as dupilumab) in patients, including serious
complications or side effects in connection with the use of
Regeneron's product candidates in clinical trials; ongoing
regulatory obligations and oversight impacting Regeneron's marketed
products (such as Dupixent), research and clinical programs, and
business, including those relating to patient privacy;
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
product candidates, including without limitation dupilumab; the
availability and extent of reimbursement of the Company's products
(such as Dupixent) 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; uncertainty of market acceptance
and commercial success of Regeneron's products and product
candidates (such as Dupixent) and the impact of studies (whether
conducted by Regeneron or others and whether mandated or voluntary)
on the commercial success of any such products and product
candidates; competing drugs and product candidates that may be
superior to Regeneron's products and product candidates; the extent
to which the results from the research and development programs
conducted by Regeneron or its collaborators may be replicated in
other studies and lead to therapeutic applications; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; 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 or collaboration agreement,
including Regeneron's agreements with Sanofi, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; 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, Dupixent, and Praluent®
(alirocumab) Injection, the ultimate outcome of any such
proceedings, 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, 2018
and its Form 10-Q for the quarterly period ended June 30, 2019. 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 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
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
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 absence of guarantee that
the product will 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
conditions, as well as those risks 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,
2018. 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
Sharon
Chen
Tel: +1 (914)
847-1546
Sharon.Chen@regeneron.com
|
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
|
|
Sanofi
Contacts:
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Ashleigh.Koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.