TARRYTOWN, N.Y. and
PARIS, Sept. 28, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced
that the European Commission (EC) has granted marketing
authorization for DUPIXENT® (dupilumab), for use in
adults with moderate-to-severe atopic dermatitis (AD) who are
candidates for systemic therapy.
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, people with
moderate-to-severe atopic dermatitis experience impaired quality of
life, including disrupted sleep, and increased anxiety and
depression symptoms along with their disease.
"People with moderate-to-severe atopic dermatitis can experience
unbearable symptoms that may significantly impact their quality of
life. Many often struggle to control their disease with the
treatment options currently available," said Christine Janus, Chief Executive Officer of the
International Alliance of Dermatology Patient Organizations. "We
support timely access to this important new medication for those
with moderate-to-severe atopic dermatitis to help them control and
provide relief for this life-altering, often severely debilitating,
chronic disease."
DUPIXENT is a human monoclonal antibody that is designed to
specifically inhibit overactive signaling of two key proteins, IL-4
and IL-13, which are believed to be major drivers of the persistent
underlying inflammation in atopic dermatitis, and certain other
allergic or atopic diseases. DUPIXENT will come in a pre-filled
syringe and can be self-administered by a patient as a subcutaneous
injection every other week after an initial loading dose. DUPIXENT
can be used with or without topical corticosteroids.
"This approval of DUPIXENT in Europe demonstrates our approach of bringing
innovative new therapies to those living with the highest unmet
medical need and today's approval represents an important milestone
for people living with moderate-to-severe atopic dermatitis in
Europe," said Elias Zerhouni, M.D., President, Global R&D,
Sanofi. "DUPIXENT targets an underlying cause of atopic dermatitis,
helps clear the skin, manage the persistent debilitating itch, and
improve overall quality of life. We are now focused on quickly
making this important new treatment option available to people
across Europe who live with this
systemic disease."
Following the granting of this marketing authorization, Sanofi
and Regeneron will work with relevant local authorities to make
DUPIXENT available to patients in need in countries across
Europe.
"DUPIXENT represents the culmination of decades of our
scientific research into the biology of allergic diseases such as
moderate-to-severe atopic dermatitis," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer, Regeneron. "We continue to
evaluate the potential of dupilumab in the treatment of atopic
dermatitis in children and adolescents as well as other allergic
inflammatory diseases driven by the IL-4/IL-13 pathway."
DUPIXENT is approved in the U.S. for the treatment of
adults 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.
LIBERTY AD Clinical Program and Results
The approval
of DUPIXENT was based on studies from the global LIBERTY AD
clinical trial program which included nearly 3,000 patients.
LIBERTY AD studies included SOLO 1, SOLO 2, CHRONOS, SOLO-CONTINUE
and CAFÉ. The studies examined the use of DUPIXENT either
alone (SOLO 1, SOLO 2 and SOLO-CONTINUE) or with topical
corticosteroids (CHRONOS or CAFÉ) in moderate-to-severe AD patients
who were inadequately controlled with topical prescription
therapies or immunosuppresants such as cyclosporine, or for whom
those therapies were not advisable. In all these studies, DUPIXENT
alone or with topical corticosteroids met the primary and key
secondary endpoints. The most common adverse events that occurred
at a higher rate than placebo in the DUPIXENT group (> one
percent) included injection site reactions, eye and eye lid
inflammation including redness, swelling, and itching, and cold
sores in the mouth or on the lips.
Dupilumab Program Overview
Dupilumab is currently
being evaluated in a comprehensive development program for AD that
includes studies in children with severe AD (6 months to 11 years
of age) and adolescents with moderate-to-severe AD (12 to 17 years
of age). These potential uses are investigational and the safety
and efficacy have not been fully evaluated nor confirmed by any
regulatory authority.
Dupilumab is also being studied in other inflammatory diseases
that are believed to be driven by the IL-4/IL-13 pathway, including
uncontrolled persistent asthma (Phase 3), nasal polyposis (Phase 3)
and eosinophilic esophagitis (Phase 2). These potential uses are
investigational and the safety and efficacy have not been fully
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.
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 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 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
|
Investor
Relations
|
Arleen
Goldenberg
|
Manisha
Narasimhan, Ph.D.
|
Tel: + 1 (914)
847-3456
|
Tel: +1 (914)
847-5126
|
Mobile: +1 (914)
260-8788
|
Manisha.narasimhan@regeneron.com
|
Arleen.Goldenberg@regeneron.com
|
|
|
|
Contacts
Sanofi:
|
|
Media
Relations
|
Investor
Relations
|
Ashleigh
Koss
|
George
Grofik
|
Tel:
908-981-8745
|
Tel: +33 (0) 1 53 77
94 69
|
ashleigh.koss@sanofi.com
|
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.