TARRYTOWN, N.Y. and
PARIS, Oct.
16, 2018 /PRNewswire/ --
Dupixent significantly reduced nasal polyp size, nasal
congestion severity and need for systemic corticosteroids and/or
surgery
Dupixent has now demonstrated positive late-stage results in
three Type 2 or allergic inflammatory diseases: atopic dermatitis,
asthma and chronic rhinosinusitis with nasal polyps
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that both pivotal Phase 3 placebo-controlled trials
evaluating Dupixent® (dupilumab) in adults with
inadequately-controlled chronic rhinosinusitis with nasal polyps
("CRSwNP"), met all their primary and secondary endpoints.
On the co-primary endpoints for both trials at 24 weeks,
patients treated with Dupixent added to a standard-of-care
corticosteroid nasal spray experienced a 51% and 57% improvement in
their nasal congestion/obstruction severity compared to a 15% and
19% improvement with nasal spray alone ("placebo") (-1.25 and -1.34
for Dupixent compared to -0.38 and -0.45 for placebo, on a 0-3
scale). Dupixent-treated patients had a 27% and 33% reduction in
their nasal polyps score compared to a 4% and 7% increase for
placebo (-1.71 and -1.89 for Dupixent compared to 0.10 and 0.17 for
placebo, on a 0-8 scale that measures bilateral polyps size by
endoscopy). Dupixent also met all secondary endpoints in both
trials, including demonstrating a significant reduction in the need
for systemic corticosteroids or surgery, and improvements in smell
and chronic rhinosinusitis symptoms. In a pre-specified group of
patients with comorbid asthma, Dupixent significantly improved lung
function and asthma control (p < 0.0001 for all primary and
secondary endpoints in both trials). Dupixent blocks the IL-4 and
IL-13 signaling pathways.
"Dupixent has now demonstrated significant late-stage efficacy
in three Type 2 or allergic inflammatory diseases, indicating that
IL-4 and IL-13 are required drivers of Type 2 or allergic
inflammation in general. With these data, Dupixent has now been
shown to address this inflammation across the complete airway,
which manifests in the upper respiratory tract as polyps and
congestion, and in the lower airway as asthma," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "We look forward to U.S.
regulatory action on our moderate-to-severe asthma application
later this month, and we are continuing our development program in
additional Type 2 or allergic inflammatory diseases with high unmet
need including pediatric asthma, pediatric and adolescent atopic
dermatitis, eosinophilic esophagitis, and food and environmental
allergies."
CRSwNP is a chronic disease in which Type 2 or allergic
inflammation causes polyps that obstruct the sinus and nasal
passages, leading to severe congestion, nasal discharge, facial
pain or pressure, and reduced sense of smell and taste. Persistent
symptoms of CRSwNP have a substantial adverse impact on patients'
health-related quality of life. Current treatments are limited and
include intranasal corticosteroids, oral corticosteroids and
surgery, with high recurrence rates after treatment. Among the
patients involved in the two Phase 3 Dupixent trials, more than
half had previously undergone surgery for their nasal polyps and
nearly three-quarters had used systemic corticosteroids within the
past two years.
"Living with inadequately controlled nasal polyps carries a
heavy burden with patients experiencing pain, nasal discharge,
difficulty breathing and the inability to smell. The standard of
care, which includes the use of oral and intranasal
corticosteroids, often alongside surgery, has not changed for
decades," said John Reed, M.D.,
Executive Vice President, Global Head of Research & Development
at Sanofi. "For the first time, we have Phase 3 data showing that a
biologic can help address the underlying Type 2 or allergic
inflammation that causes chronic rhinosinusitis with nasal polyps
and we look forward to working with regulatory authorities around
the world to make Dupixent an option for people living with this
chronic condition."
The rates of adverse events were generally similar across
Dupixent and placebo, and no new or unexpected side effects related
to Dupixent were observed. The rates of conjunctivitis were: 1.4%
Dupixent versus 0.8% placebo in SINUS-24; 2.7% Dupixent every two
weeks and 2.0% Dupixent every two/four weeks versus 1.3% placebo in
SINUS-52. Overall rates of serious adverse events were lower with
Dupixent: 4.2% Dupixent versus 14.4% placebo in SINUS-24; 5.4%
Dupixent every two weeks and 6.8% Dupixent every two/four weeks
versus 10.0% placebo in SINUS-52.
The pivotal Phase 3 trials, known as SINUS-24 (n=276) and
SINUS-52 (n=448), had the same co-primary endpoints, which were
change from baseline in nasal congestion/ obstruction severity
based on the patient's daily morning assessment, and change from
baseline in nasal polyposis score (a measure of polyp size) after
24 weeks, as assessed by nasal endoscopy. An additional co-primary
endpoint in Japan and a key
secondary endpoint in other countries was change from baseline in
sinus opacification, as assessed by computed tomography scan. The
trials were randomized double-blind, placebo-controlled trials
evaluating Dupixent when added to the corticosteroid mometasone
furoate nasal spray (MFNS), compared to MFNS alone. The trials
enrolled patients who were 18 years or older with bilateral nasal
polyps who, despite treatment with systemic corticosteroids in the
previous two years or history of surgery, continued to have ongoing
moderate or severe symptoms of nasal congestion, blockage, loss of
smell or nasal discharge. Consistent with the overlap seen among
patients with Type 2 or allergic inflammatory diseases, more than
three-quarters also suffered from other conditions, including
asthma (approximately 59 percent), allergic rhinitis (approximately
58 percent) and NSAID-exacerbated respiratory disease
(approximately 28 percent). Patients with co-morbid asthma and
CRSwNP tend to have more severe disease.
Detailed results from these trials will be submitted for
presentation at future medical meetings and will form part of the
companies' regulatory submissions. The safety and efficacy of
Dupixent in CRSwNP is investigational and has not been evaluated by
any regulatory authority.
Dupilumab Development Program
In addition to its
approved indication in adults with uncontrolled moderate-to-severe
atopic dermatitis, Regeneron and Sanofi are also studying dupilumab
in a broad range of clinical development programs for diseases
driven by allergic or Type 2 inflammation, including asthma (under
regulatory review), pediatric asthma (Phase 3), pediatric atopic
dermatitis (Phase 3), adolescent atopic dermatitis (Phase 3),
eosinophilic esophagitis (Phase 3), grass allergy (Phase 2) and
peanut allergy (Phase 2). A future trial is planned for chronic
obstructive pulmonary disease. Dupixent is also being studied in
combination with REGN-3500, which targets IL-33. These potential
uses are investigational and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab was discovered
using Regeneron's proprietary VelocImmune®
technology that yields optimized fully human antibodies, and is
being jointly developed by Regeneron and Sanofi under a global
collaboration agreement.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
INDICATION
In the U.S., Dupixent is used to treat
adult patients 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.
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
- have asthma
- 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 have asthma and 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. Stop using Dupixent and go to the
nearest hospital emergency room if you get any of the following
symptoms: fever, general ill feeling, swollen lymph nodes, hives,
itching, 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.
The most common side effects include injection site
reactions, eye and eyelid inflammation, including redness, swelling
and itching, and cold sores in your mouth or on your
lips.
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 may report side effects
to FDA at 1-800-FDA-1088.
Use Dupixent exactly as prescribed. 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.
Please click here for the full Prescribing Information. The
patient information is available here.
About Regeneron
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, neuromuscular diseases,
infectious diseases 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
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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
inadequately-controlled chronic rhinosinusitis with nasal polyps,
pediatric and adolescent atopic dermatitis, asthma, pediatric
asthma, eosinophilic esophagitis, grass allergy, food allergy
(including peanut), chronic obstructive pulmonary disease, and
other potential indications; 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; 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; 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; competing drugs and product candidates that
may be superior to Regeneron's products and product candidates;
uncertainty of market acceptance and commercial success of
Regeneron's products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
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manufacture and manage supply chains for multiple products and
product candidates; the ability of Regeneron's collaborators,
suppliers, or other third parties to perform filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's products and product candidates; 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; 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
proceedings relating to EYLEA® (aflibercept) Injection,
Dupixent, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such litigation 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-Q for the quarterly period ended
June 30, 2018. 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 Securitie 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
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generally beyond the control of Sanofi, that could cause actual
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things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
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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
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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,
2017. 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:
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Relations
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Mirza
Tel.: +1
914-847-3422
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Relations
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Narasimhan, Ph.D.
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Sanofi
Contacts:
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45 45
ir@sanofi.com
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