Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted
for Review by US FDA
Paris, France and Tarrytown, New York - January 8, 2016 - Sanofi and Regeneron
Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the Biologics License Application (BLA) for
sarilumab. Per the Prescription Drug User Fee Act (PDUFA), the target action
date is Oct. 30, 2016. Sarilumab is an investigational, human monoclonal
antibody directed against the IL-6 receptor that is intended for the treatment
of patients with active, moderate-to-severe rheumatoid arthritis (RA).[1] IL-6
is the most abundant cytokine in the serum and synovial fluid of patients with
RA and levels correlate with both disease activity and joint destruction. [2]
The BLA for sarilumab contains data from approximately 2,500 adults with active,
moderate-to-severe RA who had an inadequate response to previous treatment
regimens, including seven studies from the global SARIL-RA Phase 3 program.
The goal of the ongoing global clinical development program is to evaluate the
safety and efficacy of subcutaneous sarilumab, either as monotherapy or in
combination with conventional disease-modifying anti-rheumatic drugs (DMARDs),
including methotrexate (MTX), in reducing the signs and symptoms and inhibiting
the radiographic progression of RA.[3][4][5][6][7][8][9]
The safety and efficacy of sarilumab have not been fully 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
diabetes solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and 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
(at)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 initiatives 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; 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, such as sarilumab (including possible
regulatory approval of sarilumab by the U.S. Food and Drug Administration based
on the Biologics License Application discussed in this news release);
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; 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; 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
Jack Cox Sébastien Martel
Tel: +33 (0)1 53 77 94 74 Tel.: +33 (0)1 53 77 45 45
jack.cox(at)sanofi.com ir(at)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(at)regeneron.com
arleen.goldenberg(at)regeneron.com
--------------------------------------------------------------------------------
[1] Huizinga TWJ, Fleischmann RM, Jasson M, et al. "Sarilumab, a fully human
monoclonal antibody against IL-6Ralpha in patients with rheumatoid arthritis and
an inadequate response to methotrexate: efficacy and safety results from the
randomized SARIL-RA-MOBILITY Part A trial." Annals of Rheumatic Diseases
2014; 73(9): 1626-1634.
[2] Dayer JM, et al. Rheumatology (Oxford). 2010;49(1):15-24. 3. Rose-John S, et
al. J Leukoc Biol. 2006;80(2):227-236.
[3] Sanofi. Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in
Rheumatoid Arthritis Patients (RA-MOBILITY). In: ClinicalTrials.gov [Internet].
Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015].
Available from: https://clinicaltrials.gov/show/NCT01061736 NLM Identifier:
NCT01061736.
[4] Sanofi. To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs
In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy
(SARIL-RA-TARGET). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National
Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: NLM
Identifier: https://clinicaltrials.gov/ct2/show/NCT01709578 NCT01709578.
[5] 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.
[6] Sanofi. To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added
to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of
Anti-TNF Therapy (SARIL-RA-ASCERTAIN). In: ClinicalTrials.gov [Internet].
Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015].
Available from: https://clinicaltrials.gov/show/NCT01768572 NLM Identifier:
NCT01768572.
[7] Sanofi. Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients
(RA-EXTEND). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library
of Medicine (US). 2000- [cited 28 May 2015]. Available from:
https://clinicaltrials.gov/show/NCT01146652 NLM Identifier: NCT01146652.
[8] 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]. Available from:
https://clinicaltrials.gov/ct2/show/NCT02121210 NLM Identifier: NCT02121210.
[9] Sanofi. Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in
Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH). In: ClinicalTrials.gov
[Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28
May 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT02332590 NLM
Identifier: NCT02332590.
Press release:
http://hugin.info/152918/R/1977254/723983.pdf
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Source: Sanofi via GlobeNewswire
[HUG#1977254]
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Datum: 08.01.2016 - 07:00 Uhr
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