PARIS and TARRYTOWN, N.Y., June
9, 2015 /PRNewswire/ -- Sanofi and Regeneron
Pharmaceuticals, Inc. today announced that the Endocrinologic and
Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and
Drug Administration (FDA) recommended the approval of the
investigational therapy Praluent® (alirocumab)
Injection. The Committee voted 13 to 3 (with no abstentions)
that Sanofi and Regeneron had sufficiently established that the
low-density lipoprotein cholesterol (LDL-C, or bad cholesterol)
lowering benefit of Praluent exceeds its risks to support approval
in one or more patient populations.
"We are pleased with the Committee's recommendation to
approve Praluent. Our clinical trial program focused on patients
with high unmet need in which Praluent delivered
significant reductions in LDL-C on top of statins and
other lipid-lowering therapies," said Elias
Zerhouni, M.D., President, Global R&D, Sanofi. "Our
Phase 3 Praluent development program investigated both a 75 mg and
150 mg dose, providing flexible dosing regimens that can be
tailored to individual patient cholesterol level needs."
The Committee's recommendation was based on Praluent's
benefit-risk profile, following review of efficacy and safety data
from more than 5,000 patients across 10 pivotal Phase 3
double-blind trials ranging from six months to two years. Clinical
data from the ODYSSEY Phase 3 program show consistent, positive
results in reducing LDL-C. Common adverse events that were more
frequently reported in patients treated with Praluent than the
control groups included injection site reaction and pruritus
(itching).
"The discovery of PCSK9 as a powerful regulator of cholesterol
levels and cardiovascular disease was one of the most important
human genetic advances of the last decade," said George Yancopoulos, M.D., Ph.D., Chief
Scientific Officer of Regeneron and President, Regeneron
Laboratories. "Today's outcome brings us one step closer to
translating this genetics-based discovery into a treatment that may
help the many patients in need of additional cholesterol
lowering."
The Advisory Committee's recommendation will be considered by
the FDA in its review of the Biologics License Application (BLA)
for Praluent. The FDA is not bound by the Committee's
recommendation, but takes its advice into consideration when
reviewing investigational medicines. The BLA for Praluent was
accepted for priority review by the FDA with a target action date
of July 24, 2015.
If approved by the FDA, Praluent is expected to be the first
fully human monoclonal antibody targeting PCSK9 (proprotein
convertase subtilisin/kexin type 9) in the U.S. The Marketing
Authorization Application for Praluent in the European Union is
currently under review by the European Medicines Agency (EMA). The
EMA has accepted Praluent as the trade name for alirocumab, and it
has been conditionally accepted by the FDA. The safety and efficacy
of Praluent 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 eye diseases, 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, 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
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; the
likelihood and timing of possible regulatory approval and
commercial launch of Regeneron's late-stage product candidates,
including without limitation Praluent, and the impact of the
recommendation of the Endocrinologic and Metabolic Drugs Advisory
Committee of the U.S. Food and Drug Administration discussed in the
news release on the possible regulatory approval of Praluent;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, 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,
2014 and its Form 10-Q for the quarter ended
March 31, 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.
Contacts
Sanofi:
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Media Relations
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Investor Relations
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Jack Cox
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Sebastien Martel
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Tel: +33 (0) 1 53 77 94 74
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Tel: +33 (0)1 53 77 45 45
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Mobile: +33 (0) 6 78 52 05 36
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IR@sanofi.com
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Jack.Cox@sanofi.com
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Global Communications, PCSK9 Development &
Launch Unit
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Elizabeth Baxter
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Tel: +1 (908) 981-5360
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Mobile: +1 (908)
340-7811
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Elizabeth.Baxter@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
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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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manisha.narasimhan@regeneron.com
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arleen.goldenberg@regeneron.com
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