TARRYTOWN, N.Y. and PARIS, Oct. 28,
2016 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) issued a
Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab, an investigational interleukin-6
receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
The CRL refers to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le
Trait facility in France where sarilumab is filled and finished, one of the last steps in the
manufacturing process. Satisfactory resolution of these deficiencies is required before the BLA can be approved.
Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that
plan. Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns. The CRL does not identify
any concerns relating to the safety or efficacy of sarilumab.
Sanofi and Regeneron remain committed to the development of sarilumab and providing the therapy to RA patients in the U.S. as
quickly as possible. If approved by the FDA, sarilumab 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 cancer, 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 regarding the clinical development of and potential marketing approvals for sarilumab. 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
sarilumab, 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 sarilumab or biological application that may be filed for sarilumab as well
as their decisions regarding labeling and other matters that could affect the availability or commercial potential of sarilumab,
the absence of guarantee that sarilumab 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 impact of the manufacturing deficiencies raised by the U.S. Food and Drug Administration
(the "FDA") and discussed in this new release on the potential FDA approval of sarilumab; the timing and effectiveness of the
corrective measures taken or planned to be taken by Sanofi in response to the Complete Response Letter regarding the biologics
license applications ("BLA") for sarilumab discussed in this news release, as well as Sanofi's ability to resolve the
above-referenced deficiencies timely or at all; 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; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage
product candidates, including without limitation sarilumab (including possible regulatory approval of sarilumab by the FDA based
on the BLA discussed in this news release); 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 Sarilumab; determinations by regulatory and administrative governmental authorities (such
as the FDA) which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and
product candidates, including without limitations sarilumab; 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; 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 (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).
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SOURCE Regeneron Pharmaceuticals, Inc.