Sanofi and
Regeneron Receive CHMP Positive Opinion for Kevzara®
(sarilumab) to Treat Adult Patients with Moderately to Severely
Active Rheumatoid Arthritis
Paris, France and Tarrytown, New York - April 24,
2017 - Sanofi and Regeneron Pharmaceuticals, Inc. 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.
"Rheumatoid
arthritis is a painful and debilitating disease which impacts
millions of people in Europe, many of whom are still struggling to
find a treatment that works for them," said Elias Zerhouni,
M.D., President, Global R&D, Sanofi. "We
welcome today's positive CHMP opinion for Kevzara, which brings us
one step closer to making this new treatment option available to
patients in Europe."
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 be
given as monotherapy in case 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.1 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.1
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
Press Release (PDF)
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information contained therein.
Source: Sanofi via Globenewswire
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