TARRYTOWN, New York and
PARIS, Nov.
24, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today announced that the
companies have completed enrollment in the global Phase 3 ODYSSEY
OUTCOMES trial, which is prospectively evaluating the potential
cardiovascular (CV) benefits of Praluent® (alirocumab)
Injection after an acute coronary syndrome (ACS). The
18,000-patient OUTCOMES trial is expected to be completed in
2017.
ODYSSEY OUTCOMES is designed to determine whether the addition
of Praluent to intensive statin therapy reduces major adverse
cardiac events among patients who had previously experienced an
ACS, such as a heart attack or unstable angina. The primary
endpoint evaluates the time to first occurrence of coronary heart
disease death, acute myocardial infarction, hospitalization for
unstable angina, or fatal and non-fatal ischemic stroke. Patients
with recent ACS were selected as the study population because they
face a higher risk of recurrent events than patients with stable
cardiovascular disease.
Praluent is currently approved in the U.S. and EU to reduce bad
(LDL) cholesterol in some patients with significant unmet need,
including those with established cardiovascular disease, or an
inherited form of high cholesterol, called heterozygous familial
hypercholesterolemia (HeFH). The effect of Praluent on CV morbidity
and mortality has not yet been determined.
The global ODYSSEY program includes 16 Phase 3 trials conducted
at more than 2,000 study centers, around the world, and once
complete will evaluate more than 25,000 patients. Data from this
program helped form one of the most comprehensive data sets ever
used for the initial regulatory filing of a cholesterol-lowering
therapy. In completed trials, Praluent reduced LDL cholesterol by
up to an additional 62 percent versus placebo, and was generally
well-tolerated with an acceptable safety profile.
The ODYSSEY OUTCOMES trial design was published in the
American Heart Journal in November
2014.
About Praluent
In July, the companies announced that
Praluent was approved for use in the U.S. Praluent is a PCSK9
(proprotein convertase subtilisin/kexin type 9) inhibitor indicated
as adjunct to diet and maximally tolerated statin therapy for the
treatment of adults with HeFH or clinical atherosclerotic CVD, who
require additional lowering of LDL cholesterol. The effect of
Praluent on CV morbidity and mortality has not yet been
determined.
In September, the European Commission approved the marketing
authorization for Praluent. In the EU Praluent is approved for the
treatment of adult patients with primary hypercholesterolemia (HeFH
and non-familial) or mixed dyslipidemia as an adjunct to diet:
a) in combination with a statin, or statin with other
lipid-lowering therapies in patients unable to reach their LDL
cholesterol goals with the maximally-tolerated statin or b)
alone or in combination with other lipid-lowering therapies for
patients who are statin intolerant, or for whom a statin is
contraindicated. The effect of Praluent on CV morbidity and
mortality has not yet been determined.
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions.
Important Safety Information for U.S.
Do not
use PRALUENT if you are allergic to alirocumab or to any of the
ingredients in PRALUENT.
Before you start using PRALUENT, tell your healthcare provider
about all your medical conditions, including allergies, and if you
are pregnant or plan to become pregnant or if you are breastfeeding
or plan to breastfeed.
Tell your healthcare provider or pharmacist about any
prescription and over-the-counter medicines you are taking or plan
to take, including natural or herbal remedies.
PRALUENT can cause serious side effects, including allergic
reactions that can be severe and require treatment in a hospital.
Call your healthcare provider or go to the nearest hospital
emergency room right away if you have any symptoms of an allergic
reaction including a severe rash, redness, severe itching, a
swollen face, or trouble breathing.
The most common side effects of PRALUENT include: redness,
itching, swelling, or pain/tenderness at the injection site,
symptoms of the common cold, and flu or flu-like symptoms. Tell
your healthcare provider if you have any side effect that bothers
you or that does not go away.
Talk to your doctor about the right way to prepare and give
yourself a PRALUENT injection and follow the "Instructions for Use"
that comes with Praluent.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing
Information
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 @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 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 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
Praluent® (alirocumab) Injection; unforeseen safety
issues and possible liability resulting from the administration of
products (including without limitation Praluent) and product
candidates in patients; serious complications or side effects in
connection with the use of Regeneron's products and product
candidates in clinical trials, such as the ODYSSEY OUTCOMES trial
evaluating Praluent discussed in this news release; ongoing
regulatory obligations and oversight impacting Regeneron's marketed
products (such as Praluent), research and clinical programs, and
business, including those relating to the enrollment, completion,
and meeting of the relevant endpoints of post-approval studies
(such as the ODYSSEY OUTCOMES trial discussed in this news release
prospectively assessing the potential of Praluent to demonstrate
cardiovascular benefit); 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; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's late-stage product candidates and new
indications for marketed products; 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
quarterly period 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
|
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
|
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
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-18000-patient-odyssey-outcomes-trial-of-praluent-injection-fully-enrolled-300183674.html
SOURCE Regeneron Pharmaceuticals, Inc.