Sanofi and Regeneron Announce Marketing Authorization Application for Dupixent® (dupilumab) Accepted for Review by the EMA
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Marketing Authorization Application for
Dupixent(®) (dupilumab) Accepted for Review by the EMA
Paris, France, and Tarrytown, N.Y. - December 8, 2016 - Sanofi and Regeneron
Pharmaceuticals, Inc. 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 (at)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 Sanofi:
Media Relations Investor Relations
Jack Cox George Grofik
Tel: +33 (0)1 53 77 46 46 Tel: +33 (0)1 53 77 45 45
mr(at)sanofi.com ir(at)sanofi.com
Contacts Regeneron:
Media Relations
Ilana Tabak Investor Relations
Tel: 1 (914) 847-3836 Manisha Narasimhan, Ph.D.
Mobile: +1 (914) 450-6677 Tel: 1 (914) 847-5126
ilana.tabak(at)regeneron.com Manisha.narasimhan(at)regeneron.com
Press release (PDF):
http://hugin.info/152918/R/2062699/773877.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
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