TARRYTOWN, N.Y. and
PARIS, Jan.
8, 2016 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (REGN) and Sanofi today announced that
the U.S. Food and Drug Administration (FDA) has accepted for review
the Biologics License Application (BLA) for sarilumab. Per the
Prescription Drug User Fee Act (PDUFA), the target action date is
October 30, 2016. Sarilumab is an
investigational, human monoclonal antibody directed against the
IL-6 receptor that is intended for the treatment of patients with
active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the
most abundant cytokine in the serum and synovial fluid of patients
with RA and levels correlate with both disease activity and joint
destruction.
The BLA for sarilumab contains data from approximately 2,500
adults with active, moderate-to-severe RA who had an inadequate
response to previous treatment regimens, including seven studies
from the global SARIL-RA Phase 3 program.
The goal of the ongoing global clinical development program is
to evaluate the safety and efficacy of subcutaneous sarilumab,
either as monotherapy or in combination with conventional
disease-modifying anti-rheumatic drugs (DMARDs), including
methotrexate (MTX), in reducing the signs and symptoms and
inhibiting the radiographic progression of RA.
The safety and efficacy of sarilumab have not been fully
evaluated by any regulatory authority.
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).
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 high LDL cholesterol, eye
diseases, and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including oncology, rheumatoid arthritis, asthma, atopic
dermatitis, pain, 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, 2014. 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 sarilumab;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, research and clinical programs, and business,
including those relating to patient privacy; unforeseen safety
issues resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials, such as the SARIL-RA clinical
development program; the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates, including without limitation sarilumab;
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; 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; coverage and reimbursement
determinations by third-party payers,
including Medicare and Medicaid; 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, 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, 2014 and its Form 10-Q for the quarter
ended September 30, 2015. 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
Jack
Cox
Tel: +33 (0)1 53 77
94 74
jack.cox@sanofi.com
|
Investor
Relations
Sebastien
Martel
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
Contacts
Regeneron:
Media
Relations
Arleen
Goldenberg
Tel: 1 (914)
847-3456
Mobile: +1 (914)
260-8788
arleen.goldenberg@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.