Sanofi and Regeneron Announce
18,000-Patient ODYSSEY OUTCOMESTrial of Praluent(®) (alirocumab) Injection Fully
Paris and Tarrytown, New York - November 24, 2015 - Sanofi and Regeneron
Pharmaceuticals, Inc. 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 ODYSSEY 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 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
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 been determined.
In September, the European Commission approved the marketing authorization for
Praluent. In the E.U., 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
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
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information
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
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that could cause actual results and developments to differ materially from those
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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
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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.
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Media Relations Investor Relations
Jack Cox Sébastien Martel
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