TARRYTOWN, N.Y. and PARIS,
Dec. 8, 2016 /PRNewswire/ --
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the European Medicines Agency (EMA) has
accepted for review the Marketing Authorization Application (MAA)
for Dupixent® (dupilumab) for the treatment of adults with
moderate-to-severe atopic dermatitis (AD) who are candidates for
systemic therapy. The investigational biologic therapy Dupixent
inhibits signaling of IL-4 and IL-13, two key cytokines required
for the type 2 (including Th2) immune response, which is believed
to be a major driver in the pathogenesis of the disease.
The MAA for Dupixent contains data from three Phase 3 pivotal
studies in the global LIBERTY AD program that included more than
2,500 patients. The objective of the studies was to evaluate
Dupixent as monotherapy (SOLO 1 and SOLO 2) and in concomitant
administration with topical corticosteroids (CHRONOS) in adult
patients with moderate-to-severe AD whose disease is not adequately
controlled with topical prescription therapies.
A biologics license application (BLA) for Dupixent was accepted
for Priority Review by the U.S. Food and Drug Administration (FDA)
in September 2016. Per the
Prescription Drug User Fee Act (PDUFA), the target FDA action date
is March 29, 2017. The European
Medicines Agency (EMA) and FDA have conditionally accepted Dupixent
as the trade name for dupilumab.
Dupixent is currently under clinical development and its safety
and efficacy have not been fully evaluated by any regulatory
authority. In addition to AD in adults, Dupixent is being studied
in pediatric AD, asthma, nasal polyposis and eosinophilic
esophagitis. If approved, Dupixent would be commercialized by
Regeneron and Sanofi Genzyme, the specialty care global business
unit of Sanofi.
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 Merial. 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.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
that discovers, invents, develops, manufactures and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, high LDL
cholesterol and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including rheumatoid arthritis, atopic dermatitis, asthma,
pain, cancer and infectious diseases. For additional information
about the company, please visit www.regeneron.com or follow
@Regeneron on Twitter.
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", "would 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 or biological application
that may be filed for 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, 2015. Other than
as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
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 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 adult
patients with moderate-to-severe atopic dermatitis who are
candidates for systemic therapy (including possible regulatory
approval of Dupixent by the European Medicines Agency and the U.S.
Food and Drug Administration discussed in this news release)
and other potential 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 and Bayer HealthCare LLC (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. 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, 2015 and its
Form 10-Q for the quarterly period ended September 30, 2016. 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).
Contacts
Regeneron:
|
|
|
|
Media
Relations
|
Investor
Relations
|
Ilana
Tabak
|
Manisha
Narasimhan, Ph.D.
|
Tel: 1 (914)
847-3836
|
Tel: 1 (914)
847-5126
|
Mobile: +1 (914)
450-6677
|
Manisha.narasimhan@regeneron.com
|
ilana.tabak@regeneron.com
|
|
|
|
Contacts
Sanofi:
|
|
|
|
Media
Relations
|
Investor
Relations
|
Jack
Cox
|
George
Grofik
|
Tel: +33 (0)1 53 77
94 74
|
Tel: +33 (0)1 53 77
45 45
|
jack.cox@sanofi.com
|
ir@sanofi.com
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-marketing-authorization-application-for-dupixent-dupilumab-accepted-for-review-by-the-ema-300375063.html
SOURCE Regeneron Pharmaceuticals, Inc.