TARRYTOWN, N.Y. and
PARIS, Sept. 16, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced positive results from the Phase 3 CAFÉ study of
DUPIXENT® (dupilumab) in adults with moderate-to-severe
atopic dermatitis (AD) who are inadequately controlled with or are
intolerant to the broad immunosuppressant drug cyclosporine A
(CSA), or when this treatment is medically inadvisable. In the
study, DUPIXENT with topical corticosteroids (TCS) significantly
improved measures of overall disease severity, skin clearing,
itching, and patient reported quality of life measures. CSA is
approved for the treatment of AD in most European countries and
Japan; it is not approved in the
U.S. for this use. The results of this study are being presented at
the European Academy of Dermatology and Venereology (EADV) Congress
in Geneva, Switzerland.
The primary endpoint of the study was the proportion of patients
that achieved a 75 percent or greater improvement in the Eczema
Area and Severity Index (EASI-75) score at 16 weeks from baseline.
EASI is a tool used to measure the extent and severity of the
disease. Fifty-nine percent of patients who received DUPIXENT
weekly with TCS, and 63 percent of patients who received DUPIXENT
every two weeks with TCS achieved EASI-75, compared to 30 percent
of those patients who received placebo with TCS (p less than
0.0001). The mean percent change improvement in EASI from baseline
at 16 weeks (a secondary endpoint) was 78 percent and 80 percent
for patients who received DUPIXENT weekly or every two weeks with
TCS, respectively, compared to 47 percent for those who received
placebo plus TCS (p less than 0.0001).
"In moderate-to-severe atopic dermatitis, some patients stop
cyclosporine therapy due to intolerance or lack of efficacy, or are
not candidates because of other medical conditions or
contraindicated medications," said Dr. Marjolein De Bruin-Weller, Dermatologist,
National Expertise Center for Atopic Dermatitis, University Medical
Center Utrecht. "In the CAFÉ study, DUPIXENT with topical
corticosteroids significantly improved overall measures of disease
severity including lesions, itch, quality of life measures and
symptoms of anxiety and depression in these patients. The safety
profile in this study was consistent with three previous positive
DUPIXENT Phase 3 studies in moderate-to-severe atopic
dermatitis."
Other secondary endpoints of the study included measures of the
impact of DUPIXENT on the persistent itch caused by the disease,
quality of life measures, and symptoms of anxiety and depression.
The results for these secondary endpoints at 16 weeks include:
- The mean percent improvement from baseline in the intensity of
patient-reported itch, as measured by the pruritus Numerical Rating
Scale (NRS), was 52 percent and 54 percent in patients who received
DUPIXENT weekly or every two weeks with TCS, respectively, compared
to 25 percent for those who received placebo plus TCS (p less than
0.0001).
- The proportion of patients with a greater than or equal to
four-point improvement from baseline in aspects of patient quality
of life, as measured by the Dermatology Life Quality Index (DLQI),
was 78 percent and 88 percent in patients who received DUPIXENT
weekly or every two weeks with TCS, respectively, compared to 44
percent of those who received placebo plus TCS (p less than
0.0001).
- The proportion of patients with a greater than or equal to
four-point improvement from baseline in the severity of their AD,
as measured by the Patient Oriented Eczema Measure (POEM), a tool
that quantifies the illness as experienced by the patients, was 76
percent and 83 percent in patients who received DUPIXENT weekly or
every two weeks with TCS, respectively, compared to 42 percent for
those who received placebo plus TCS (p less than 0.0001).
No new adverse events were reported in the study. The proportion
of patients reporting an adverse event was similar among the
treatment arms. Conjunctivitis was more frequent in patients who
received DUPIXENT with TCS, with 16 percent and 28 percent reported
in patients who received DUPIXENT weekly or every two weeks with
TCS, respectively, compared to 11 percent for patients who received
placebo with TCS. Injection site reactions were reported in 11
percent and 4 percent among patients who received DUPIXENT with TCS
weekly or every two weeks, respectively, compared to 5 percent for
patients who received placebo with TCS. Skin infections were
reported in 4 percent and 2 percent among patients who received
DUPIXENT weekly or every two weeks with TCS, respectively, compared
to 8 percent for patients who received placebo with TCS.
A total of 325 patients in Europe were randomized into three treatment
groups in the 16-week study to receive either DUPIXENT 300 mg
weekly with TCS, DUPIXENT 300 mg every two weeks with TCS or
placebo with TCS.
About DUPIXENT (dupilumab)
DUPIXENT is a human monoclonal antibody that is designed to
simultaneously inhibit overactive signaling of IL-4 and IL-13
cytokines. In addition to moderate-to-severe atopic dermatitis,
Sanofi and Regeneron are studying dupilumab in a broad range of
clinical development programs including uncontrolled persistent
asthma (phase 3), nasal polyps (phase 3) and eosinophilic
esophagitis (phase 2). 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.
In March 2017, the U.S. Food and
Drug Administration (FDA) approved DUPIXENT® (dupilumab)
in the U.S. for the treatment of adults with moderate-to-severe
atopic dermatitis whose disease is not adequately controlled with
topical prescription therapies, or when those therapies are not
advisable. DUPIXENT is given as one, 300 mg injection under the
skin (subcutaneous injection) every 2 weeks after an initial
loading dose (600 mg). The European Commission (EC) is expected to
adopt a final decision on the Marketing Authorization Application
(MAA) for DUPIXENT in the European Union, following the Committee
for Medicinal Products for Human Use (CHMP) adopting a positive
opinion on July 21, 2017.
About Atopic Dermatitis
Atopic dermatitis, a form of
eczema, is a chronic inflammatory disease with symptoms often
appearing as a rash on the skin. Moderate-to-severe atopic
dermatitis is characterized by rashes often covering much of the
body, and can include intense, persistent itching and skin dryness,
cracking, redness, crusting, and oozing. Itch is one of the most
burdensome symptoms for patients and can be debilitating. In
addition, patients with moderate-to-severe atopic dermatitis
experience a substantial burden of disease, including skin lesions,
intense pruritus, and impact on quality of life components, such as
sleep and symptoms of anxiety and depression.
IMPORTANT SAFETY INFORMATION for U.S.
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 Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for nearly 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to six FDA-approved treatments and over a
dozen product candidates in development, all of which were
homegrown in our laboratories. Our medicines and pipeline are
designed to help patients with eye disease, heart disease, allergic
and inflammatory diseases, pain, cancer, and infectious and rare
diseases.
Regeneron is accelerating and improving the traditional drug
development process through its unique
VelociSuite® technologies and ambitious
initiatives such as The Regeneron Genetics Center, 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, a global healthcare
leader, discovers, develops and distributes therapeutic solutions
focused on patients' needs. Sanofi is organized into five global
business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
Regeneron Forward-Looking Statements and Use of Digital
Media
This news 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 Dupixent for the treatment of
uncontrolled moderate-to-severe atopic dermatitis in the European
Union and other potential jurisdictions, as well as other potential
indications; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in later studies and lead to therapeutic
applications; unforeseen safety issues and possible liability
resulting from the administration of products and product
candidates in patients, including without limitation Dupixent;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates (such as Dupixent) in
clinical trials; coverage and reimbursement determinations by
third-party payers, including Medicare, Medicaid, and pharmacy
benefit management companies; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products, research and
clinical programs, and business, including those relating to the
enrollment, completion, and meeting of the relevant endpoints of
post-approval studies; 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, such as Dupixent;
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 products and product candidates;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its sales or other
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 relating to Praluent®
(alirocumab) Injection, the permanent injunction granted by the
United States District Court for the District of Delaware that, if upheld on appeal, would
prohibit Regeneron and Sanofi from marketing, selling, or
manufacturing Praluent in the United
States, the outcome of any appeals regarding such
injunction, the ultimate outcome of such litigation, 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 United States Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the
quarterly period ended June 30, 2017.
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,
2016. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts
Regeneron:
Media
Relations
Ilana
Tabak
Tel: 1 (914)
847-3836
Mobile: +1 (914)
450-6677
ilana.tabak@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
|
|
Contacts
Sanofi:
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.