CAMBRIDGE, Mass. and
TARRYTOWN, N.Y., Feb. 27, 2017 /PRNewswire/ -- Sanofi and
Regeneron Pharmaceuticals, Inc. today announced that detailed
results from the Phase 3 CHRONOS study will be presented as a
late-breaking abstract at this year's Annual Meeting of the
American Academy of Dermatology (AAD). The CHRONOS study evaluated
the use of investigational DUPIXENT for one year with topical
corticosteroids versus topical corticosteroids alone for adults
living with uncontrolled moderate-to-severe atopic dermatitis (AD).
Additionally, interim safety and efficacy data will be presented
from a Phase 3 long-term open-label study of DUPIXENT monotherapy
for uncontrolled moderate-to-severe AD at the Annual Meeting of the
American Academy of Asthma, Allergy, and Immunology (AAAAI).
Moderate-to-severe AD is a life-long chronic inflammatory
disease. Despite currently available therapies, there still remains
an unmet need for treatment to help those adults struggling
to manage their moderate to severe AD.
Important company-supported presentations and posters
include:
Annual Meeting of the American Academy of Dermatology (AAD)
in Orlando, Fla., March 3 – 7, 2017
- Abstract #5267: Long-Term Management of Moderate-To-Severe
Atopic Dermatitis (AD) with Dupilumab up to 1 Year with Concomitant
Topical Corticosteroids (TCS): a Randomized, Placebo-Controlled
Phase 3 Trial (CHRONOS)
Evaluation of efficacy and safety
of long-term treatment with dupilumab plus concomitant topical
corticosteroids in moderate-to-severe AD
Andrew
Blauvelt, M.D., President of Oregon Medical Research Center,
Portland, OR, USA
- Abstract #5279: Pharmacokinetics, Safety and Efficacy of
Dupilumab in a Pediatric Population with Moderate-to-Severe Atopic
Dermatitis: Results from an Open-Label Phase 2a Trial
Evaluation of the safety, efficacy
and pharmacokinetics of dupilumab in pediatric patients with
moderate-to-severe AD
Michael J.
Cork, M.D., Professor of Dermatology, University of
Sheffield, Sheffield, United Kingdom
- Abstract #5541: Real-World Disease Burden in U.S. Adults
with Moderate-to-Severe Atopic Dermatitis Eligible for Treatment
with Systemic Immunosuppressants
Analysis of immunosuppressant use
among moderate-to-severe AD adult patients eligible for
immunosuppressant therapy and to compare the real-world disease
burden, including AD disease control, between patients treated with
immunosuppressants and patients eligible for but not treated with
immunosuppressants
April
Armstrong, M.D., Associate Professor of Clinical
Dermatology, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA
- Abstract #5523: Real-World Utilization Patterns of Systemic
Immunosuppressants among U.S. Adult Patients with Atopic
Dermatitis
Analysis of real-world systemic
immunosuppressant utilization patterns and adverse events in AD
patients
April
Armstrong, MD, Associate Professor of Clinical Dermatology,
Keck School of Medicine at the University of
Southern California, Los Angeles,
CA, USA
Annual Meeting of the American Academy of Asthma, Allergy,
and Immunology (AAAAI) in Atlanta,
Ga., March 3 – 6, 2017
- Abstract #L21: Long-Term Safety and Efficacy of Open-Label
Dupilumab in Patients with Moderate-to-Severe Atopic
Dermatitis
Evaluation of efficacy and safety
of long-term treatment with dupilumab in adults with uncontrolled
moderate-to-severe AD
Prof. Mette Deleuran, Department of Dermatology,
Aarhus University Hospital, Aarhus,
Denmark
The DUPIXENT Biologics License Application (BLA) was accepted
for Priority Review by the U.S. Food and Drug Administration (FDA)
with a target action date of March 29,
2017. The FDA granted DUPIXENT Breakthrough Therapy
designation in uncontrolled moderate-to-severe atopic dermatitis in
2014. 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. If approved, dupilumab would be commercialized by
Regeneron and Sanofi Genzyme, the specialty care global business
unit of Sanofi.
About Atopic Dermatitis
AD is the most common form of
eczema and is characterized by unpredictable flare-ups. It is a
chronic inflammatory disease with symptoms often appearing on the
skin. Moderate-to-severe AD is characterized by rashes and can
include intense, persistent and debilitating itching, skin dryness,
cracking, redness, crusting, and oozing. Itch is one of the most
burdensome symptoms for patients and can be debilitating.
It's estimated that approximately 300,000 people in the United States are living with uncontrolled
moderate-to-severe AD and despite their current treatment, are most
in need of new treatment options. Despite currently available
therapies, there still remains an unmet need for treatment that
helps those adults struggling to manage their moderate-to-severe
AD.
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.
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 and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
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, the uncertainties inherent in research and development,
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 any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic
conditions, the impact of cost containment initiatives and
subsequent changes thereto, the average number of shares
outstanding as well as those 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
uncontrolled moderate-to-severe atopic dermatitis (including
possible regulatory approval of Dupixent by the U.S. Food and Drug
Administration and the European Medicines Agency) 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, 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. 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
Ashley
Koss
Tel:
908-981-8745
ashley.koss@sanofi.com
Carrie
Brown
Tel:
908-981-6486
Carrie.brown@sanofi.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
Contacts
Regeneron:
Media
Relations
Ilana
Tabak
Tel: 1 (914)
847-3836
Mobile: +1 (914)
450-6677
ilana.tabak@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
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SOURCE Sanofi