TARRYTOWN, N.Y. and
PARIS, May
21, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi announced today that a Phase 3 study of
sarilumab, an investigational, fully human IL-6 receptor antibody,
met its co-primary efficacy endpoints of a greater improvement in
signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and
physical function at 12 weeks, compared to placebo. The study,
called SARIL-RA-TARGET, evaluated the efficacy and safety of two
subcutaneous sarilumab doses versus placebo, added to non-biologic
disease modifying anti-rheumatic drugs (DMARD) therapy in RA
patients who were inadequate responders to or intolerant of
TNF-alpha inhibitors (TNF-IR).
The SARIL-RA-TARGET trial enrolled 546 TNF-IR patients who were
randomized to one of three treatment groups self-administered
subcutaneously (SC) every other week (Q2W): sarilumab 200
milligrams (mg), sarilumab 150 mg, or placebo, in addition to DMARD
therapy. Both sarilumab groups showed clinically relevant and
statistically significant improvements compared to the placebo
group in both co-primary endpoints (p greater than 0.001):
(1) Improvement in signs and symptoms of RA at 24 weeks, as
measured by the American College of Rheumatology score of 20
percent improvement (ACR20), were as follows: 61 percent in the
sarilumab 200 mg group; 56 percent in the sarilumab 150 mg group;
and 34 percent in the placebo group, all in combination with DMARD
therapy.
(2) Improvement in physical function, as measured by change from
baseline in the Health Assessment Question-Disability Index
(HAQ-DI) at week 12.
The most frequently reported adverse events included infections
(30, 22 and 27 percent in the 200 mg, 150 mg and placebo groups
respectively) and injection site reactions (8, 7, 1 percent in the
200 mg, 150 mg and placebo groups respectively). Serious infections
were uncommon (1, 0.6 and 1 percent in the 200 mg, 150 mg and
placebo groups respectively). Reduction in neutrophil count was the
most common lab abnormality. No unexpected safety findings were
observed.
Two additional trials from the Phase 3 program, SARIL-RA-EASY
and SARIL-RA-ASCERTAIN, also met their primary endpoints:
- SARIL-RA-EASY enrolled 217 patients and was designed to
evaluate the technical performance and usability of the sarilumab
autoinjector device. There were no product technical failures with
the autoinjector, the primary endpoint of the study.
- SARIL-RA-ASCERTAIN was a 202 patient safety calibrator study,
designed to assess the safety of two subcutaneous doses of
sarilumab and tocilizumab infusion in combination with DMARDs in
patients with RA who were TNF-IR. There were no clinically
meaningful differences between the treatment groups in serious
adverse events and serious infections.
Detailed results from all three SARIL-RA trials will be
presented at future medical congresses.
About Sarilumab
Sarilumab (REGN88/SAR153191) is
the first fully human monoclonal antibody directed against the IL-6
receptor (IL-6R). Sarilumab binds with high affinity to the
IL-6 receptor. It blocks the binding of IL-6 to its receptor
and interrupts the resultant cytokine-mediated inflammatory
signaling. Sarilumab was developed using Regeneron's
VelocImmune® antibody technology.
The investigational agent described above is currently under
clinical development, and its safety and efficacy have not been
evaluated by any regulatory authority.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi has core strengths in the field of healthcare with seven
growth platforms: diabetes solutions, human vaccines, innovative
drugs, consumer healthcare, emerging markets, animal health and the
new Genzyme. 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 based in Tarrytown, New
York that discovers, invents, develops, manufactures, and
commercializes medicines for the treatment of serious medical
conditions. Regeneron commercializes medicines for eye
diseases and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including hypercholesterolemia, oncology, rheumatoid
arthritis, asthma, and atopic dermatitis. For additional
information about the company, please
visit www.regeneron.com.
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 and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" 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, 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 any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies and subsequent changes thereto, the
average number of shares outstanding as well as those 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, 2014. 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
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"), 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 sarilumab;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, research and clinical programs, and business,
including those relating to patient privacy; 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 the SARIL-RA clinical
development program; the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates, including without limitation sarilumab;
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; 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, 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, 2014 and its Form 10-Q for the quarter
ended March 31, 2015. 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.
Contacts
Sanofi:
|
Media
Relations
Jack
Cox
Tel: +33 (0) 1 53 77
94 74
Mobile: +33 (0) 6 78
52 05 36
Jack.Cox@sanofi.com
|
Investor
Relations
Sébastien
Martel
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
|
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SOURCE Regeneron Pharmaceuticals, Inc.