Sanofi and Regeneron Announce Kevzara® (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Kevzara(®) (sarilumab) Biologics License
Application Resubmission Accepted for Review by US FDA
- New action date for Kevzara U.S. BLA is May 22, 2017 -
Paris, France and Tarrytown, New York - April 28, 2017 - Sanofi and Regeneron
Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration
has accepted the resubmission of Biologics License Application for Kevzara(®)
(sarilumab) as a Class I response with a two month review timeline. Per the
Prescription Drug User Fee Act (PDUFA), the new target action date is May
22, 2017. Kevzara is an investigational human monoclonal antibody directed
against the IL-6 receptor being evaluated 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 disease modifying
antirheumatic drugs (DMARDs), such as methotrexate.[1]
The companies recently received a positive opinion for Kevzara from the European
Medicine Agency's Committee for Medicinal Products for Human Use, and the
European Commission is expected to make a final decision on the Marketing
Authorization Application for Kevzara in the European Union in the coming
months. In Canada, Kevzara is approved for use in adult patients with moderately
to severely active RA who have had an inadequate response or intolerance to one
or more biologic or non-biologic DMARDs. The companies are also seeking
approvals in a number of other countries globally.
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, atopic dermatitis and a rare
inflammatory condition and has product candidates in development in other areas
of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer
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 regarding the clinical development of and potential
marketing approvals for the product. Forward-looking statements are generally
identified by the words "expects", "anticipates", "believes", "intends",
"estimates", "plans", "will 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 the product, 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
the product as well as their decisions regarding labeling and other matters
that could affect the availability or commercial potential of the product, the
absence of guarantee that the product 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, 2016. 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 or other potential
indications; the likelihood and timing of possible regulatory approval and
commercial launch of Regeneron's late-stage product candidates, such as Kevzara
(including possible regulatory approval of Kevzara by the U.S. Food and Drug
Administration based on the Biologics License Application discussed in this news
release); the impact of the opinion adopted by the European Medicine Agency's
Committee for Medicinal Products for Human Use discussed in this news release on
the European Commission's decision regarding the Marketing Authorization
Application for Kevzara in the European Union; 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;
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, 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; the ability of Regeneron's
collaborators, suppliers, or other third parties to perform filling, finishing,
packaging, labelling, distribution, and other steps related to Regeneron's
products and product candidates; 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, Bayer HealthCare LLC,
and Teva Pharmaceutical Industries Ltd. (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, including without
limitation the patent litigation relating to Praluent(®) (alirocumab) Injection,
the permanent injunction granted by the United States District Court for the
District of Delaware that, if upheld on appeal, would prohibit Regeneron and
Sanofi from marketing, selling, or commercially manufacturing Praluent in the
United States, the outcome of any appeals regarding such injunction, the
ultimate outcome of such litigation, and the impact any of the foregoing may
have on Regeneron's business, prospects, operating results, and financial
condition. 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, 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:
Media Relations Investor Relations
Ashleigh Koss George Grofik
Tel: 1 (908) 981-8745 Tel.: +33 (0)1 53 77 45 45
ashleigh.koss(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] Kevzara (sarilumab) Prescribing Information. May 2017
Press release:
http://hugin.info/152918/R/2099975/795914.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 28.04.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 538991
Anzahl Zeichen: 12958
contact information:
Town:
PARIS
Kategorie:
Business News
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