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.
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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SOURCE Regeneron Pharmaceuticals, Inc.