TARRYTOWN, N.Y. and
PARIS, July
24, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today announced that the European
Medicine Agency's (EMA's) Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion for the marketing
authorization of Praluent® (alirocumab), recommending
its approval for use in certain adult patients with
hypercholesterolemia. Praluent is an investigational fully human
monoclonal antibody targeting PCSK9 (proprotein convertase
subtilisin/kexin type 9).
"We are very pleased to receive a positive opinion from the CHMP
for Praluent, and look forward to bringing Praluent to those in
greatest need across Europe," said
Elias Zerhouni, M.D., President,
Global R&D, Sanofi. "Despite statins and other lipid-lowering
therapies, many patients are unable to reach their LDL cholesterol
goals, and may benefit from new therapeutic options such as
Praluent."
The CHMP recommended Praluent in both a 75 mg and 150 mg dose be
approved for the treatment of adult patients with primary
hypercholesterolemia (heterozygous familial hypercholesterolemia
[HeFH] and non-familial) or mixed dyslipidemia as an adjunct to
diet: a) in patients unable to reach their low density
lipoprotein cholesterol (LDL-C) goals with a maximally-tolerated
statin, Praluent would be used in combination with a statin, with
or without other lipid-lowering therapies; and b) for
patients who are statin intolerant, or for whom a statin is
contraindicated, Praluent would be used alone or in combination
with other lipid-lowering therapies. The effect of Praluent on
cardiovascular morbidity and mortality has not been determined. The
most common adverse reactions were injection site reactions, upper
respiratory tract signs and symptoms, and pruritus.
The European Commission (EC) is expected to make a final
decision on the Marketing Authorization Application for Praluent in
the European Union in late September. The CHMP opinion was based on
the benefit-risk profile of Praluent, 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.
"In our clinical trial program, Praluent significantly reduced
LDL cholesterol among patients with high unmet needs, including
those with high or very high cardiovascular risk and those with an
inherited form of high cholesterol called familial
hypercholesterolemia," said George D.
Yancopoulos, M.D., Ph.D., Chief Scientific Officer of
Regeneron and President, Regeneron Laboratories. "In these trials,
patients received Praluent as a single subcutaneous injection once
every two weeks using either a 75 mg or 150 mg dose, providing
flexible dosing options that can be tailored to an individual's
cholesterol lowering needs."
The U.S. Food and Drug Administration has set a target action
date of July 24 for the Biologics
License Application (BLA) of Praluent. The safety and efficacy of
Praluent have not been fully evaluated by any other 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, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's late-stage product candidates,
including without limitation Praluent; the impact of the opinion
adopted by the European Medicine Agency's Committee for Medicinal
Products for Human Use discussed in the news release on the
European Commission's decision regarding the Marketing
Authorization Application for Praluent in the European Union, as
well as the previously reported recommendation of the
Endocrinologic and Metabolic Drugs Advisory Committee of the U.S.
Food and Drug Administration (the "FDA") on the possible regulatory
approval of Praluent by the FDA; 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
|
Investor
Relations
|
Jack
Cox
|
Sebastien
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
|
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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
|
Arleen
Goldenberg
|
Manisha
Narasimhan, Ph.D.
|
Tel: +1 (914)
847-3456
|
Tel: +1 (914)
847-5126
|
Mobile: +1 (914)
260-8788
|
manisha.narasimhan@regeneron.com
|
arleen.goldenberg@regeneron.com
|
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visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-chmp-recommends-european-approval-of-praluent-alirocumab-for-the-treatment-of-hypercholesterolemia-300118312.html
SOURCE Regeneron Pharmaceuticals, Inc.