TARRYTOWN, N.Y. and
PARIS, April 28, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced
that the U.S. Food and Drug Administration has accepted the
resubmission of the Biologics License Application for Kevzara
(sarilumab) as a Class I response with a two month review timeline.
Per the Prescription Drug User Fee Act (PDUFA), the new target
action date is May 22, 2017. Kevzara
is an investigational human monoclonal antibody directed against
the IL-6 receptor being evaluated for the treatment of adult
patients with moderately to severely active rheumatoid arthritis
(RA) who have had an inadequate response or intolerance to one or
more disease modifying antirheumatic drugs (DMARDs), such as
methotrexate.
The companies recently received a positive opinion for Kevzara
from the European Medicine Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP), and the European Commission (EC) is
expected to make a final decision on the Marketing Authorization
Application (MAA) for Kevzara in the European Union in the coming
months. In Canada, Kevzara is
approved for use in adult patients with moderately to severely
active RA who have had an inadequate response or intolerance to one
or more biologic or non-biologic DMARDs. The companies are also
seeking approvals in a number of other countries globally.
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).
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, atopic dermatitis and a rare inflammatory condition
and has product candidates in development in other areas of high
unmet medical need, including rheumatoid arthritis, 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", "will 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 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,
2016. 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
Kevzara® (sarilumab) for the treatment of adult patients
with moderately to severely active rheumatoid arthritis or other
potential indications; the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates, such as Kevzara (including possible regulatory
approval of Kevzara by the U.S. Food and Drug Administration based
on the Biologics License Application discussed in this news
release); the impact of the opinion adopted by the European
Medicine Agency's Committee for Medicinal Products for Human Use
discussed in this news release on the European Commission's
decision regarding the Marketing Authorization Application for
Kevzara in the European Union; 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 Kevzara; 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 Kevzara;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, research and clinical programs, and business,
including those relating to patient privacy; 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, including without
limitation Kevzara; the ability of Regeneron's collaborators,
suppliers, or other third parties to perform filling, finishing,
packaging, labelling, distribution, and other steps related to
Regeneron's products and product candidates; coverage and
reimbursement determinations by third-party payers, including
Medicare and Medicaid; 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 HealthCare LLC, 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 commercially 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:
|
|
|
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Media
Relations
|
Investor
Relations
|
Ashleigh
Koss
|
George
Grofik
|
Tel: 1 (908)
981-8745
|
Tel: +33 (0)1 53 77
45 45
|
ashleigh.koss@sanofi.com
|
ir@sanofi.com
|
|
|
Contacts
Regeneron:
|
|
|
|
Media
Relations
|
Investor
Relations
|
Arleen
Goldenberg
|
Manisha Narasimhan,
Ph.D.
|
Tel: 1 (914)
847-3456
|
Tel: 1 (914)
847-5126
|
Mobile: +1 (914)
260-8788
|
Manisha.narasimhan@regeneron.com
|
arleen.goldenberg@regeneron.com
|
|
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visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-kevzara-sarilumab-biologics-license-application-resubmission-accepted-for-review-by-us-fda-300447685.html
SOURCE Regeneron Pharmaceuticals, Inc.