TARRYTOWN, N.Y. and
PARIS, Jan.
26, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the U.S. Food
and Drug Administration (FDA) has accepted for priority review the
Biologics License Application (BLA) for PraluentTM
(alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the
goal for a priority review is six months, for a target action date
of July 24, 2015. Alirocumab is an
investigational monoclonal antibody targeting PCSK9 (proprotein
convertase subtilisin/kexin type 9) that is intended for the
treatment of patients with hypercholesterolemia.
The BLA for Praluent contains data from more than 5,000
patients, including 10 Phase 3 ODYSSEY trials. Together with
additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY
clinical trial program will include more than 23,500 patients at
more than 2,000 study centers in double-blind, randomized,
placebo-and active-controlled trials ranging from 24 weeks to
approximately 5 years.
Earlier this month, the companies announced that the European
Medicines Agency (EMA) accepted for review the Marketing
Authorization Application for Praluent in the European Union. The
EMA and FDA have conditionally accepted Praluent as the trade name
for alirocumab. The safety and efficacy of alirocumab have not been
fully evaluated by any regulatory authority.
About Sanofi
Sanofi, an integrated 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 eye diseases, colorectal
cancer, and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including hypercholesterolemia, oncology, rheumatoid
arthritis, asthma, and atopic dermatitis. For additional
information about the company, please visit www.regeneron.com.
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, 2013. 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
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"), 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
Praluent™(alirocumab); 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 ODYSSEY global trial program evaluating
Praluent™(alirocumab); the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates, including without limitation
Praluent™(alirocumab); ongoing regulatory obligations and oversight
impacting Regeneron's research and clinical programs and business,
including those relating to patient privacy; 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; 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,
2013 and its Form 10-Q for the quarter ended September 30, 2014. 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.
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
|
Mobile: +33 (0) 6 78 52 05 36
|
IR@sanofi.com
|
Jack.Cox@sanofi.com
|
|
Global Communications, PCSK9 Development &
Launch Unit
|
Elizabeth Baxter
|
Tel: +1 (908) 981 5360
|
Mobile: +1 (908) 340 7811
|
Elizabeth.Baxter@sanofi.com
|
Contacts Regeneron:
Media Relations
|
Investor Relations
|
Arleen Goldenberg
|
Michael Aberman, M.D.
|
Tel: + 1 (914) 847 3456
|
Tel: +1 (914) 847 7799
|
Mobile: +1 (914) 260 8788
|
michael.aberman@regeneron.com
|
arleen.goldenberg@regeneron.com
|
|
|
|
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SOURCE Regeneron Pharmaceuticals, Inc.