TARRYTOWN, N.Y. and
PARIS, Nov.
8, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi 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 less than 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, November 9 at 7:00
a.m. PDT. 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).5 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.
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 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 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 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
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
|
Investor Relations
|
Carrie Brown
|
Sebastien Martel
|
Tel: +1 (908) 981-6486
|
Tel: +33 (0)1 53 77 45 45
|
Mobile: +1 (908)
247-6006
|
IR@sanofi.com
|
Carrie.Brown@sanofi.com
|
|
|
|
Contacts
Regeneron:
|
|
|
|
Media Relations
|
Investor
Relations
|
Arleen Goldenberg
|
Manisha Narasimhan, Ph.D.
|
Tel: +1 (914) 847-3456
|
Tel: +1 (914) 847-5126
|
Mobile: +1 (914) 260-8788
|
manisha.narasimhan@regeneron.com
|
arleen.goldenberg@regeneron.com
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-present-results-from-pivotal-phase-3-study-of-sarilumab-at-american-college-of-rheumatology-annual-meeting-300174459.html
SOURCE Regeneron Pharmaceuticals, Inc.