TARRYTOWN, N.Y. and
PARIS, July
21, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today announced that the
European Medicine Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) has adopted a positive opinion for the
marketing authorization of Dupixent® (dupilumab),
recommending its approval in Europe for use in adults with
moderate-to-severe atopic dermatitis (AD) who are candidates for
systemic therapy.
AD, a form of eczema, is a chronic inflammatory disease with
symptoms often appearing as a rash on the skin.1,2,3,4
Moderate-to-severe AD is characterized by rashes often covering
much of the body, and can include intense, persistent itching and
skin dryness, cracking, redness, crusting, and oozing.5
Itch is one of the most burdensome symptoms for patients and can be
debilitating. In addition, people with moderate-to-severe AD
experience a high level of disrupted sleep, and increased anxiety
and depression symptoms due to their disease.6
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 AD. If approved, Dupixent will
come in a pre-filled syringe for self-administration by a patient
as a subcutaneous injection every other week after an initial
loading dose.7 Dupxient can be used with or without
topical corticosteroids.
The European Commission (EC) is expected to make a final
decision on the Marketing Authorization Application (MAA) for
Dupixent in the European Union in the coming months. The CHMP
opinion is based on studies from the global LIBERTY AD clinical
trial program, including SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS and
CAFÉ. These studies incorporated data from nearly 3,000 adult
patients with moderate-to-severe AD not adequately controlled with
topical prescription therapies or immunosuppressants such as
cyclosporine, or when those therapies were not advisable.
In the US, Dupixent is approved for the treatment of adults
with moderate-to-severe AD whose disease is not adequately
controlled with topical prescription therapies, or when those
therapies are not advisable. Dupixent can be used with or without
topical corticosteroids.8
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 consistently translate science into medicine has
led to six FDA-approved treatments and over a dozen product
candidates, 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, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary
VelociSuite® technologies, including
VelocImmune® which yields optimized fully-human
antibodies, 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); the impact of the opinion adopted by the European
Medicine Agency's Committee for Medicinal Products for Human Use
discussed in this news release on the European Commission's
decision regarding the Marketing Authorization Application for
Dupixent for use in adults with moderate-to-severe atopic
dermatitis who are candidates for systemic therapy; the likelihood
and timing of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates, such as Dupixent
(including possible regulatory approval of Dupixent in the European
Uninion discussed in this news release and possible regulatory
approval of Dupixent in other jurisdictions and indications);
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 March 31,
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 clinical development of and potential marketing approvals for
the product. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans", "will be" 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, the uncertainties
inherent in research and development of the product, future
clinical data and analysis, including post marketing, decisions by
regulatory authorities, such as the FDA or the EMA, regarding
whether and when to approve the product as well as their
decisions regarding labeling and other matters that could affect
the availability or commercial potential of the product, the
absence of guarantee that the product if approved will be
commercially successful, risks associated with intellectual
property, future litigation, the future approval and commercial
success of therapeutic alternatives, 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: +1 (908)
981-8745
|
Tel: +33 (0) 1 53 77
94 69
|
Ashleigh.koss@sanofi.com
|
ir@sanofi.com
|
References
1 Schneider et al, AAAI 2013, Practice Parameter
Update, page 296
2 Eichenfield et al, AAD 2014, Guidelines of Care for
Atopic Dermatitis, page 118
3 Guideline to treatment, European Dermatology Forum.
http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis.
Accessed December 23, 2016
4 Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis-
all you can do from the outside. Page 19
5 National Institutes of Health (NIH). Handout on
Health: Atopic Dermatitis (A type of eczema) 2013.
http://www.niams.nih.gov/
Health_Info/Atopic_Dermatitis/default.asp. Accessed October 31, 2016.
6 Simpson, E, Bieber, T and Eckert, L, "Patient burden
of moderate to severe atopic dermatitis (AD): Insights from a phase
2b clinical trial of dupilumab in adults," Am Acad Dermatol, pp.
74(3):491-498, 2016.
7 Dupixent Summary of Product Characteristics.
8 Dupixent Prescribing Information 2017.
https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.
Accessed July 2017.
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content:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-receive-positive-chmp-opinion-for-dupixent-dupilumab-to-treat-adult-patients-with-moderate-to-severe-atopic-dermatitis-300492197.html
SOURCE Regeneron Pharmaceuticals, Inc.