PARIS and TARRYTOWN, N.Y., Nov.
8, 2015 /PRNewswire/ -- Sanofi and Regeneron
Pharmaceuticals, Inc. today announced results from a pivotal Phase
3 study of sarilumab, an investigational, human antibody against
the IL-6 receptor. The results of the study, SARIL-RA-TARGET, are
being presented today at an oral session during the American
College of Rheumatology (ACR) Annual Meeting in San Francisco, California. The study met both
its co-primary endpoints of improvements in signs and symptoms of
rheumatoid arthritis (RA) and improvements in physical function, as
well as secondary efficacy endpoints.
"Rheumatoid arthritis can be a debilitating disease that has a
significant impact on a patient, and despite the availability of a
wide range of treatments, new agents are still needed to address
unmet patient needs including failure to respond to therapy," said
Dr. Roy Fleischmann, clinical
professor in the Department of Internal Medicine at the
University of Texas Southwestern Medical
Center and lead study author. "These data suggest that
sarilumab, if approved, may be a potential option for patients with
moderate-to-severe RA."
The SARIL-RA-TARGET trial enrolled 546 RA patients who were
inadequate responders or intolerant of TNF-alpha inhibitors
(TNF-IR). Patients 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 non-biologic disease modifying anti-rheumatic drugs
(DMARD) therapy. Top-line results were previously announced in
May 2015.
Both sarilumab groups showed clinically relevant and
statistically significant improvements compared to placebo in both
co-primary endpoints:
- Improvement in physical function at week 12, as measured by
mean change from baseline in the Health Assessment
Questionnaire-Disability Index (HAQ-DI). The HAQ-DI measures
patients' abilities to perform a standard set of daily physical
activities. The change from baseline to week 12 in HAQ-DI was
-0.49, -0.50, and -0.29 in the sarilumab 200 mg (p=0.0004),
sarilumab 150 mg (p=0.0007), and placebo groups, respectively.
- Improvements in signs and symptoms of RA at week 24, as
measured by the proportion of patients achieving an ACR20 response
(ACR20) were 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 (p less than 0.0001).
Secondary efficacy endpoints that will be presented during the
ACR oral session include the following:
- Proportion of patients achieving an ACR50 response at week 24
were 41 percent in the sarilumab 200 mg group, 37 percent in the
sarilumab 150 mg group, and 18 percent in the placebo group (p less
than 0.0001).
- Proportion of patients achieving an ACR70 response at week 24
were 16 percent in the sarilumab 200 mg group (p=0.0056), 20
percent in the sarilumab 150 mg group (p=0.0002), and 7 percent in
the placebo group.
- The mean change from baseline to week 24 in disease activity
score in 28 joints using C-reactive protein (DAS28-CRP), which
evaluates the disease activity of RA, were as follows: -2.82,
-2.35 and -1.38 in the sarilumab 200 mg, sarilumab 150 mg, and
placebo groups, respectively.
- The proportion of patients achieving DAS28-CRP < 2.6 at week
24 were as follows: 29 percent, 25 percent, and 7 percent in
the sarilumab 200 mg, sarilumab 150 mg, and placebo groups,
respectively.
- The change from baseline to week 24 in clinical disease
activity index (CDAI), which also evaluates the disease activity of
RA, were as follows: -30.43, -27.14, and -23.9 in the sarilumab 200
mg, sarilumab 150 mg, and placebo groups, respectively.
- The change from baseline to week 24 in HAQ-DI were as follows:
-0.58, -0.52, and -0.34 in the sarilumab 200 mg, sarilumab 150 mg,
and placebo groups, respectively.
Treatment-emergent adverse events (TEAEs) were more frequent in
the sarilumab groups (65 percent and 66 percent in sarilumab 200 mg
and 150 mg vs 50 percent in placebo respectively). The incidence of
serious adverse events (SAEs) was higher than placebo in the
sarilumab 200 mg group (5 percent vs. 3 percent) and was similar to
placebo in the 150 mg group (3 percent). Infection was the
most frequently reported adverse event (30, 22 and 27 percent in
the 200 mg, 150 mg and placebo groups respectively). Serious
infections occurred in 2 patients in the sarilumab 200 mg group, 1
patient in the sarilumab 150 mg group and 2 patients on placebo.
The most frequent events leading to treatment discontinuation were
infection and neutropenia. Adverse events and laboratory changes
were consistent with observations from the MOBILITY study and with
the mechanism of action of sarilumab.
During the same oral session at ACR, data from the
SARIL-RA-ASCERTAIN/1309 studies will also be presented. In total,
14 abstracts were accepted for presentation at the meeting. This
includes additional abstracts detailing data from the sarilumab
clinical trial program: SARIL-RA-MOBILITY and SARIL-RA-EXTEND.
Sanofi and Regeneron recently submitted a Biologics License
Application (BLA) for sarilumab to the U.S. Food and Drug
Administration (FDA).
Sanofi and Regeneron will host an IR Thematic Conference Call
for the financial community focusing on sarilumab on Monday, Nov. 9 at 7:00
a.m. PT. The conference call will include a
presentation followed by a Q&A session. It will be accessible
through an audio webcast at www.sanofi.com and www.regeneron.com
and also via the following telephone numbers: France, +33 (0) 1 70 77 09 40; UK, +44 (0) 207
107 1613; and USA, +1 855 402
7761.
The investigational agent described above is currently under
clinical development, and its safety and efficacy have not been
evaluated by any regulatory authority.
About Sarilumab
Sarilumab
(REGN88/SAR153191) is a 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.
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 high LDL cholesterol, eye diseases, and a rare
inflammatory condition and has product candidates in development in
other areas of high unmet medical need, including oncology,
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.
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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
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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
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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,
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average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
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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 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 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
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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
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including Medicare and Medicaid; unanticipated
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the ability of Regeneron to meet any of its sales or other
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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 September 30, 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
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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
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Regeneron uses its media and investor relations website and
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investors. Financial and other information about Regeneron is
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(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contacts
Sanofi:
|
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Media
Relations
Jack
Cox
Tel: +33 (0)1 53 77
94 74
jack.cox@sanofi.com
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Investor
Relations
Sebastien
Martel
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
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Contacts
Regeneron:
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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 Sanofi