TARRYTOWN, N.Y. and
PARIS, April 24, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the European Medicine Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion for the marketing authorization of Kevzara®
(sarilumab), recommending its approval for use in adult patients
with moderately to severely active rheumatoid arthritis. Kevzara is
an investigational human monoclonal antibody directed against the
IL-6 receptor.
The CHMP recommended the use of Kevzara in combination with
methotrexate (MTX) for the treatment of moderately to severely
active RA in adult patients who have responded inadequately to, or
who are intolerant to one or more disease modifying anti-rheumatic
drugs (DMARDs). Kevzara can also be given as monotherapy in cases
of intolerance to MTX or when treatment with MTX is
inappropriate.1 The recommended dose of
Kevzara is 200 mg once every two weeks administered as a
subcutaneous injection. Reduction of dose from 200 mg once every
two weeks to 150 mg once every two weeks is recommended for
management of neutropenia, thrombocytopenia, and liver enzyme
elevations.
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. The CHMP
opinion is based on results from seven Phase 3 trials in the global
SARIL-RA clinical development program, including SARIL-RA-MOBILITY,
SARIL-RA-TARGET and SARIL-RA-MONARCH. These studies incorporate
data from more than 3,300 adults with moderately to severely active
RA who have had an inadequate response or intolerance to one or
more biologic or non-biologic DMARDs.
In Europe, 2.9 million people
suffer from RA, and living with the disease can make everyday life
difficult. 2,3 Symptoms include joint pain,
swelling, stiffness, and fatigue.4
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. Sarilumab is currently under
review in the United States, and
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).
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, 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 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; 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 European
Commission); 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; 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 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, 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:
|
|
|
|
Media
Relations
Ashleigh
Koss
Tel: 1 (908)
981-8745
ashleigh.koss@sanofi.com
|
Investor
Relations
George
Grofik
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
|
1 Kevzara Summary of Product Characteristics
2 National Rheumatoid Arthritis Foundation. "European
Fit to Work report." Available at
http://www.nras.org.uk/european-fit-for-work-report. Last accessed
March 2017.
3 NHS England.
"Rheumatoid arthritis - Living with." Available at:
http://www.nhs.uk/Conditions/Rheumatoid-arthritis/Pages/Living-with.aspx
Last accessed: March 2017
4 Arthritis Research UK. "What are the symptoms of
rheumatoid arthritis?" Available at:
http://www.arthritisresearchuk.org/arthritis-information/conditions/rheumatoid-arthritis/symptoms.aspx
Last accessed: March 2017
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visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-receive-positive-chmp-opinion-for-kevzara-sarilumab-to-treat-adult-patients-with-moderately-to-severely-active-rheumatoid-arthritis-300443951.html
SOURCE Regeneron Pharmaceuticals, Inc.