TARRYTOWN, N.Y. and
PARIS, Sept. 26, 2016 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced
that the U.S. Food and Drug Administration (FDA) has accepted for
priority review the Biologics License Application (BLA) for
dupilumab for the treatment of adult patients with inadequately
controlled moderate-to-severe atopic dermatitis (AD), a serious,
chronic inflammatory skin disease. The application has been given a
Prescription Drug User Fee Act (PDUFA) target action date of
March 29, 2017. The investigational
antibody therapy dupilumab 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 BLA for dupilumab contains data from three Phase 3 pivotal
studies in the global LIBERTY AD program that included more than
2,500 patients. The goal of the studies was to evaluate dupilumab
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. In 2014, the FDA
granted Breakthrough Therapy designation to dupilumab for the
treatment of adults with moderate-to-severe AD who are not
adequately controlled with topical prescription therapies or for
whom these treatments are not appropriate.
Dupilumab 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 of
Sanofi.
Regeneron and Sanofi will host an Investor Relations Thematic
Conference Call for the financial community focusing on dupilumab
following the late breaking data presentation from two trials
evaluating dupilumab for inadequately controlled moderate-to-severe
AD (SOLO 1 and SOLO 2) at the 25th European Academy
of Dermatology and Venereology (EADV) Congress in Vienna, Austria on Saturday, October 1 at 7:00 am ET/1:00 pm
CET. To access this call, dial (888) 771-4371 (U.S.), 0805
102 604 (France), or 0808 238 9578
(UK). The conference call will include a presentation followed
by a Q&A session.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in diabetes
solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. 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
based in Tarrytown, New York 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, asthma, atopic dermatitis,
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,
the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, 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 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 dupilumab for
the treatment of adult patients with inadequately controlled
moderate-to-severe atopic dermatitis and other potential
indications; unforeseen safety issues and possible liability
resulting from the administration of products and product
candidates in patients, including without limitation dupilumab;
serious complications or side effects in connection with the use of
Regeneron's products and product candidates 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 dupilumab; 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 June 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
94 74
|
Tel: +33 (0) 1 53 77
94 69
|
jack.Cox@sanofi.com
|
ir@sanofi.com
|
|
|
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
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-dupilumab-biologics-license-application-accepted-for-priority-review-by-us-fda-300333529.html
SOURCE Regeneron Pharmaceuticals, Inc.