TARRYTOWN, N.Y. and
PARIS, Feb.
1, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that Health Canada
approved Kevzara™ (sarilumab), an interleukin-6 (IL-6)
receptor antibody, for the treatment of adult patients with
moderately to severely active rheumatoid arthritis (RA) who have
had an inadequate response or intolerance to one or more biologic
or non-biologic Disease-Modifying Anti-Rheumatic Drugs
(DMARDs).1
"With Kevzara, we have a promising new therapy in Canada, which has shown clinically-meaningful
and statistically significant improvements in adult patients with
moderately to severely active rheumatoid arthritis," said Dr.
William Bensen, Clinical Professor
of Rheumatology, Department of Medicine at McMaster University, Ontario, Canada. "Kevzara represents a welcome
new treatment option that works differently from the most commonly
used biologics."
Kevzara is a fully human monoclonal antibody that binds
specifically to both soluble and membrane-bound IL-6 receptors, and
has been shown to inhibit IL-6-mediated signalling through these
receptors.1 Local production of IL-6 by synovial and
endothelial cells in joints affected in chronic inflammatory
disease, such as RA, may play an important role in development of
the inflammatory processes.1
"While there have been advances in the treatment of rheumatoid
arthritis, not all available therapies work for every patient and
there remains an unmet need for new therapeutic options," said
David Meeker, M.D., Executive Vice
President and Head of Sanofi Genzyme. "The approval of Kevzara in
Canada represents an important
advancement in treating adult patients with moderately to severely
active RA."
RA is a systemic inflammatory disease that can affect multiple
joints in the body. In RA, inflammation manifests in the lining of
the joints causing pain, swelling, joint damage and can lead to
deformity. RA impacts 70 million adults worldwide.2,3 In
Canada alone, RA affects
approximately 300,000 people. RA is most common in people between
40 and 60 years old; however, it can occur in adults at any
age.4
The Health Canada approval of Kevzara was based on data from the
global SARIL-RA clinical trial program which includes approximately
2,900 adults with moderately to severely active RA who had an
inadequate response to previous treatment regimens. Kevzara
demonstrated clinically-meaningful improvements, either as
monotherapy or in combination with conventional DMARDs, including
methotrexate, in reducing signs and symptoms, improving physical
function, and inhibiting radiographic progression of structural
damage of RA in approximately 1,743 patients with moderately to
severely active RA.5,6,7,8,9,10 Kevzara should be used
in combination with methotrexate or other traditional DMARDs, or
may be given as monotherapy in cases of intolerance or
contraindication to methotrexate or DMARDs.1 The
recommended dose of Kevzara is 200 mg once every two weeks given as
a subcutaneous injection; dosage can be reduced from 200 mg to 150
mg once every two weeks to help manage certain laboratory
abnormalities.1
Patients treated with Kevzara are at increased risk for
developing serious infections that may lead to hospitalization or
death.1 The most frequent adverse reactions (occurring
in at least 3% of patients treated with Kevzara in combination with
DMARDs) observed with Kevzara in the clinical studies were
neutropenia (6-10%), increased alanine aminotransferase (4-5%),
injection site erythema (3-4%), and upper respiratory tract
infections (3%).1
Kevzara is expected to be available to patients in Canada soon and there will be a patient
support program at the time of product availability. The companies
are committed to helping patients who are prescribed Kevzara gain
access to the medicine and receive the support they may need. In
Canada, Kevzara will be marketed
by Sanofi Genzyme, the specialty care global business unit of
Sanofi. The full Product Monograph in Canada is available here.
Update on U.S. and European Regulatory
Submissions
The resubmission of the sarilumab Biologics
License Application (BLA) to the United States Food
and Drug Administration (FDA) is expected in the first quarter of
2017. This resubmission is subject to successful completion
of an inspection by FDA of Sanofi's Le Trait fill and finish
facility, with an anticipated action date in the second
quarter.
The European Medicines Agency accepted for review the Marketing
Authorization Application for sarilumab in July 2016 and a decision is expected later this
year.
"Regeneron and Sanofi look forward to resubmitting the U.S. BLA
for Kevzara later this quarter and anticipate a new U.S. action
date in the second quarter of 2017," said Robert Terifay, Executive Vice President,
Commercial, Regeneron. "We are especially grateful for the
commitment of the patients and investigators who participated in
our SARIL-RA clinical program, and have helped to bring this
important new therapy to RA patients."
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).
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.
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 marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans", "looks
forward" 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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, 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 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
who have had an inadequate response or intolerance to one or more
biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs or
other potential indications; the timing and effectiveness of the
corrective measures taken or planned to be taken by Sanofi in
response to the Complete Response Letter from the U.S. Food and
Drug Administration (the "FDA") regarding the biologics license
applications for Kevzara, as well as Sanofi's ability to resolve
the previously identified deficiences timely or at all; 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; the likelihood and
timing of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates, including without
limitation Kevzara (including possible regulatory approval of
Kevzara by the FDA and by the European Medicines Agency);
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 (such as
Kevzara), 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. 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
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Company, including information that may be deemed material to
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routinely posted and is accessible on Regeneron's media and
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(http://newsroom.regeneron.com) and its
Twitter feed
(http://twitter.com/regeneron).
Contacts
Sanofi:
Media
Relations
Ashleigh
Koss
Tel: 1 (908)
981-8745
ashleigh.koss@sanofi.com
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Investor
Relations
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Grofik
Tel: +33 (0) 1 53 77
45 45
IR@sanofi.com
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Contacts
Regeneron:
Media
Relations
Arleen
Goldenberg
Tel: 1 (914)
847-3456
arleen.goldenberg@regeneron.com
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Relations
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Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
1 Kevzara (sarilumab) Product Monograph Health
Canada. January 2017.
2 Gibofsky, A. Overview of Epidemiology,
Pathophysiology, and Diagnosis of Rheumatoid Arthritis. Am J
Manag Care. 2012 Dec;18(13 Suppl):S295-302.
3 United Nations, Department of Economic and Social
Affairs, Population Division (2015). World Population Prospects:
The 2015 Revision, Key Findings and Advance Tables. Working Paper
No. ESA/P/WP.241.
4 The Arthritis Society. Rheumatoid Arthritis. Available
at:
https://arthritis.ca/understand-arthritis/types-of-arthritis/rheumatoid-arthritis.
Last Accessed January 2017.
5 Genovese, MC. Sarilumab Plus Methotrexate in Patients
With Active Rheumatoid Arthritis and Inadequate Response to
Methotrexate: Results of a Phase III Study. Arthritis
Rheumatology. 2015 Jun 67(6):1424-37..
6 Fleischmann, R. Sarilumab and Non-Biologic
Disease-Modifying Antirheumatic Drugs in Patients With Active RA
and Inadequate Response or Intolerance to TNF Inhibitors.
Arthritis Rheumatology. 2016 Nov 10.1002/art.39944..
7 Sanofi. To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In
Patients With Rheumatoid Arthritis (SARIL-RA-EASY). In:
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine
(US). 2000- [cited 28 May 2015].
Available from: https://clinicaltrials.gov/ct2/show/NCT02057250 NLM
Identifier: NCT02057250.
8 Emery P, Rondon J, Garg A, et al. Safety and
tolerability of subcutaneous sarilumab compared to intravenous
tocilizumab in patients with RA. Arthritis Rheumatol.
2015;67(suppl 10): 971..
9 Burmester G, Garg A, van Hoogstraten H, et al.
Sarilumab dose reduction to manage laboratory abnormalities in an
open-label extension study in RA patients. Arthritis
Rheumatol. 2015;67 (suppl 10): 2762..
10 Sanofi. To Evaluate the Immunogenicity and Safety of
Sarilumab Administered as Monotherapy in Patients With Rheumatoid
Arthritis (RA) (SARIL-RA-ONE). In: ClinicalTrials.gov [Internet].
Bethesda (MD): National Library of
Medicine (US). 2000- [cited 28 May
2015].
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SOURCE Regeneron Pharmaceuticals, Inc.