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 StatementsThis
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 MediaThis 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
RelationsAshleigh Koss Tel: 1 (908)
981-8745ashleigh.koss@sanofi.com |
Investor
RelationsGeorge GrofikTel.: +33 (0)1 53 77 45
45ir@sanofi.com |
Contacts Regeneron: Media
RelationsArleen GoldenbergTel: 1 (914) 847-3456Mobile: +1 (914)
260-8788arleen.goldenberg@regeneron.com |
Investor
RelationsManisha 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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