TARRYTOWN, N.Y. and
PARIS, Nov.
16, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today will present results of
SARIL-RA-MONARCH, a Phase 3 study, which demonstrated the
superiority of investigational sarilumab monotherapy versus
adalimumab (marketed by AbbVie as HUMIRA®) monotherapy
in improving the clinical signs and symptoms in adults with active
rheumatoid arthritis (RA). The results are being presented today at
an oral session during the American College of Rheumatology (ACR)
Annual Meeting in Washington,
DC.
"Approximately 30 percent of people with RA are being treated
with biologic monotherapy largely due to intolerance to
methotrexate," said Dr. Gerd
Burmester, Charité - University Medicine, Berlin, Germany and lead study author. "In the
MONARCH monotherapy study, sarilumab was more effective than
adalimumab, which is one of the most commonly used biologics
today."
SARIL-RA-MONARCH Results
The SARIL-RA-MONARCH study
enrolled 369 adults with active RA who were inadequate responders
to, intolerant of, or inappropriate candidates for methotrexate
(MTX). Patients were randomized to receive either subcutaneous
sarilumab monotherapy (200 mg every 2 weeks) or adalimumab
monotherapy (40 mg every 2 weeks); patients who did not respond
adequately to adalimumab could increase to weekly dosing. Top-line
results were previously announced in March
2016.i
The primary endpoint was change from baseline in DAS28-ESR at 24
weeks, which demonstrated a statistically significant difference in
favor of sarilumab (-3.28 for sarilumab compared to -2.20 for
adalimumab, p less than 0.0001).i DAS28-ESR is a measure
of disease activity in RA, which includes the evaluation of 28
joints in the body for tenderness and swelling, a general health
assessment by the patient, and ESR, a laboratory measure for
inflammation.ii
The study also met other important endpoints including
improvement in American College of Rheumatology (ACR) criteria and
the Health Assessment Questionnaire – Disability Index
(HAQ-DI).i Results included:
- A greater improvement in signs and symptoms of RA with
sarilumab as measured by the proportion of patients achieving a 20
percent improvement in the ACR criteria (ACR20) (72 percent for
sarilumab vs. 58 percent for adalimumab, p less than 0.01). The
proportion of patients achieving ACR50 was also higher with
sarilumab (45 percent for sarilumab vs. 29 percent for adalimumab,
p=0.0017) as well as for ACR70 (23 percent for sarilumab vs. 11
percent for adalimumab, p=0.0036).i
- Rates of DAS28-ESR remission (score<2.6) were higher for
sarilumab vs. adalimumab (26 percent for sarilumab vs. 7 percent
for adalimumab, p less than 0.0001).i
- Improvements in HAQ-DI were observed with sarilumab vs
adalimumab. The change in baseline to week 24 in HAQ-DI for
sarilumab was -0.61 vs. -0.43 for adalimumab
(p=0.0037).i
The study also observed greater numerical response in Clinical
Disease Activity Index (CDAI). The change in baseline to week 24
was -28.9 for sarilumab vs. -25.2 for adalimumab. Higher rates of
CDAI remission were also observed for sarilumab (7 percent) vs.
adalimumab (2 percent).i Adults treated with sarilumab
also experienced greater improvement in functional disability, pain
and fatigue over adults treated with adalimumab. These improvements
included patient-reported outcomes, which were measured by Medical
Outcomes Short Form 36 Health Survey; physician component summary
score (PCS) and mental component summary score (MCS); and
Functional Assessment of Chronic Illness Therapy-Fatigue
(FACIT-F).
The incidence of adverse events (64 percent for both groups),
serious adverse events (5 percent for sarilumab vs. 7 percent for
adalimumab), infections (29 percent for sarilumab vs. 28 percent
for adalimumab), and serious infections (1 percent for both groups)
were generally similar between groups. Neutropenia, which was not
associated with infections, was more common with sarilumab (14
percent for sarilumab vs. 1 percent for adalimumab), as has been
seen in previous studies with IL-6 inhibitors. Injection site
erythema (8 percent sarilumab vs. 3 percent adalimumab) was also
more common with sarilumab.i
The safety and efficacy of sarilumab have not been fully
evaluated by any regulatory authority. If approved, sarilumab will
be marketed by Regeneron and Sanofi Genzyme, the specialty care
global business unit of Sanofi.
About RA
RA is a chronic inflammatory autoimmune
disease, which carries substantial patient burden.iii,iv
In RA, the immune system attacks the tissues of the joints, causing
inflammation, pain, and eventually joint damage and
disability.iii,iv RA affects
approximately 1.3 million Americans, with nearly 75 percent being
women.iii,v It most often strikes people
between 30 and 60 years old; however, it can occur in adults at any
age.vi
About Sarilumab
Sarilumab is a human monoclonal
antibody directed against the IL-6 receptor that inhibits the
inflammatory activity in RA mediated by the IL-6 signaling pathway.
IL-6 is the most abundant cytokine in the serum and synovial fluid
of patients with RA, and levels of IL-6 correlate with both disease
activity and joint
destruction. vii,viii,ix,x,xi,xii,xiii,xiv,xv
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 Merial. 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 and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including rheumatoid arthritis, atopic dermatitis, 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
sarilumab. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans", "would 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 sarilumab, 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 sarilumab or biological application
that may be filed for sarilumab as well as their decisions
regarding labeling and other matters that could affect the
availability or commercial potential of sarilumab, the absence of
guarantee that sarilumab 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, 2015. 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 impact of the
previously disclosed manufacturing deficiencies raised by the U.S.
Food and Drug Administration (the "FDA") on the potential FDA
approval of sarilumab; 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; the likelihood and
timing of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates, including without
limitation sarilumab; 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 sarilumab; determinations by regulatory and administrative
governmental authorities (such as the FDA) which may delay or
restrict Regeneron's ability to continue to develop or
commercialize Regeneron's products and product candidates,
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; competing drugs and product candidates
that may be superior to Regeneron's products and product
candidates, such as sarilumab; 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 (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. 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, 2015 and its Form 10-Q for the
quarterly period ended September 30,
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:
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|
|
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Media
Relations
|
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Jack
Cox
|
Investor Relations
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Tel: +33 (0)1 53 77
94 74
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Sébastien Martel
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jack.cox@sanofi.com
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Tel.: +33 (0)1 53 77 45 45
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ir@sanofi.com
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Contacts
Regeneron:
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Media Relations
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Investor Relations
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Arleen
Goldenberg
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Manisha Narasimhan, Ph.D.
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Tel: 1 (914)
847-3456
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Tel: 1 (914) 847-5126
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Mobile: +1 (914)
260-8788
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i Burmester G. et al.#3321 Efficacy and
Safety of Sarilumab Versus Adalimumab in a Phase 3, Randomized,
Double-blind, Monotherapy Study in Patients With Active Rheumatoid
Arthritis With Intolerance or Inadequate Response to
Methotrexate. Arthritis Rheumatol. 2016; 68 (suppl 10).
ii Arthritis Foundation. "Measuring Disease Activity in
Rheumatoid Arthritis."
http://www.arthritis.org/living-with-arthritis/life-stages/remission/measuring-disease-activity.php.
Last accessed October 2016.
iii American College of Rheumatology. "Rheumatoid
Arthritis." Available at:
http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis.
Last accessed: August 2016
iv Mayo Clinic. "Rheumatoid Arthritis." Available at
http://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/basics/definition/con-20014868.
Last accessed July 2016.
v Centers for Disease Control. "Rheumatoid Arthritis."
Available at http://www.cdc.gov/arthritis/basics/rheumatoid.htm.
Last accessed October 2016.
vi Arthritis Foundation. "What is Rheumatoid Arthritis?"
Available at
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoidarthritis.php.
Last accessed October 2016.
vii Wong PK, et al. Arthritis Rheum.
2006;54(1):158-168.
viii de Hooge AS, et al. Am J Pathol.
2000;157(6):2081-2091.
ix Nakamura I, et al. J Rheumatol.
2009;36(2):459-460.
x Van Leeuwen MA, et al. Ann Rheum Dis.
1995;54(1):33-38.
xi Hashizume M, et al. Rheumatology (Oxford).
2008;47(11):1635-1640.
xii Maggio M, et al. J Gerontol A Biol Sci Med Sci.
2006;61(6):575-584.
xiii Ducreux J, et al. Arthritis Rheumatol.
2014;66(1):15-23.
xiv Garnero P, et al. Arthritis Rheum.
2010;62(1):33-43.
xv Ishimi Y, et al. J Immunol.
1990;145(10):3297-3303.
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SOURCE Regeneron Pharmaceuticals, Inc.