TARRYTOWN, N.Y. and
PARIS, Nov.
7, 2018 /PRNewswire/ --
Praluent significantly reduced major adverse cardiovascular
events by 15% (p<0.001)
Praluent was associated with a 15% lower risk of death from
any cause (hazard ratio [HR] 0.85; 95% confidence interval [CI],
0.73 to 0.98)1
Additional analyses, including mortality, to be presented at
upcoming American Heart Association Scientific Sessions,
November 10-12
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the New England Journal of Medicine
(NEJM) has published positive detailed results of the
18,924-patient ODYSSEY OUTCOMES trial.
The trial met its primary endpoint, showing that
Praluent® (alirocumab) Injection significantly reduced
the risk of major adverse cardiovascular events (MACE) in patients
who had suffered an acute coronary syndrome (ACS), which included a
heart attack or unstable angina. MACE occurred in 903 patients
(9.5%) in the Praluent group and in 1,052 patients (11.1%) in the
placebo group (HR 0.85; 95% CI, 0.78 to 0.93; p<0.001).
Death from any cause was less frequent among Praluent-treated
patients. Praluent was associated with a 15% lower risk of death;
death occurred in 334 (3.5%) patients in the Praluent group and 392
(4.1%) patients in the placebo group (HR 0.85; 95% CI, 0.73 to
0.98).1
The NEJM publication also includes results for MACE and
other secondary endpoints including death, according to subgroups
of baseline LDL-C (low-density lipoprotein cholesterol) levels,
which are described in detail in the Supplementary Appendix. The
data showed that patients with higher LDL-C at baseline (at least
100 mg/dL) were at greater risk of MACE, as well as other secondary
endpoints, including death. Moreover, the greater risk-reduction
occurred in this category of patients: in the Praluent group MACE
was reduced by 24% (HR 0.76; 95% CI, 0.65 to 0.87) and death from
any cause was 29% lower (HR 0.71; 95% CI, 0.56 to 0.90) compared to
placebo.2
Adverse events were similar between groups, except for injection
site reactions (Praluent 3.8%, placebo 2.1%).
Results of the ODYSSEY OUTCOMES trial were presented at the
American College of Cardiology's 67th Annual Scientific Session
& Expo in March 2018. Additional
analyses, including of mortality, will be presented later this week
at the American Heart Association Scientific Sessions 2018.
"Despite the use of statins, many patients with coronary heart
disease go on to have recurrent cardiovascular events, underscoring
the need for additional treatment options. This need is
particularly urgent among patients with acute coronary syndrome and
LDL-C levels that remain high, despite best possible application of
statin therapy," said Dr. Gregory G.
Schwartz, M.D., Ph.D., University of
Colorado School of Medicine, Aurora, CO, and co-chair of the trial. "These
data in the New England Journal of Medicine show that adding
alirocumab to intensive or maximum tolerated statin treatment
significantly reduced the risk of future cardiovascular events.
This benefit was heightened among study patients with higher LDL-C
levels at baseline."
The effect of Praluent on cardiovascular morbidity and mortality
is currently being reviewed by regulatory authorities and has not
yet been fully evaluated. Data from the ODYSSEY OUTCOMES trial has
been submitted to regulatory authorities in the European Union and
in the U.S., where the target action date for the Food and Drug
Administration (FDA) decision is April 28,
2019.
ODYSSEY OUTCOMES Trial Design
ODYSSEY OUTCOMES
(n=18,924) assessed the effect of Praluent on the occurrence of
MACE in patients who had experienced an ACS between 1-12 months
(median 2.6 months) before enrolling in the trial, and who were
already on intensive or maximally-tolerated statin treatment.
Patients were randomized to receive Praluent (n=9,462) or placebo
(n=9,462) and were assessed for a median of 2.8 years, with some
patients being treated for up to five years. Approximately 90% of
patients were on a high-intensity statin.
MACE, the primary endpoint, was a composite of death from
coronary heart disease, nonfatal myocardial infarction, fatal or
nonfatal ischemic stroke, or unstable angina requiring
hospitalization.
The trial was designed to maintain patients' LDL-C levels
between 25-50 mg/dL, using two different doses of Praluent (75 mg
and 150 mg). Praluent-treated patients started the trial on 75 mg
every 2 weeks and switched to 150 mg every 2 weeks if their LDL-C
levels remained above 50 mg/dL (n=2,615). Some patients who
switched to 150 mg switched back to 75 mg if their LDL-C fell below
25 mg/dL (n=805), and patients who experienced two consecutive
LDL-C measurements below 15 mg/dL while on the 75 mg dose (n=730)
stopped active Praluent therapy for the remainder of the trial.
About Praluent
Praluent inhibits the binding of PCSK9
(proprotein convertase subtilisin/kexin type 9) to the LDL receptor
and thereby increases the number of available LDL receptors on the
surface of liver cells to clear LDL, which lowers LDL-C levels in
the blood. Praluent is being developed by Regeneron and Sanofi
under a global collaboration agreement and was invented by
Regeneron using the company's proprietary
VelocImmune® technology that yields optimized
fully-human monoclonal antibodies.
Praluent is approved in more than 60 countries worldwide,
including the U.S., Japan,
Canada, Switzerland, Mexico and Brazil, as well as the European Union (EU). In
the U.S., Praluent is approved for use as an adjunct to diet and
maximally tolerated statin therapy for the treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD) who require
additional lowering of LDL-C. The effect of Praluent on
cardiovascular morbidity and mortality has not been determined.
Important Safety Information for the 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.
(1) Analyses for the death
endpoints in the overall study fell outside of the statistical
hierarchy; and in accordance with recently-implemented NEJM
policies, the hazard ratio (HR) and its confidence interval (CI)
were published, but no P-values were reported.
(2) Analyses of the death
endpoint based on baseline LDL-C levels was not included in the
statistical hierarchy; and in accordance with recently-implemented
NEJM policies, the hazard ratio (HR) and its confidence interval
(CI) were published, but no P-values were reported.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Regeneron Forward-Looking Statements and Use of Digital
Media
This press 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; 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, such as the potential regulatory
approval of the update to the prescribing information for Praluent
referenced in this press release; whether the proposed
update to the prescribing information for Praluent referenced in
this press release will be acceptable to the relevant regulatory
authorities and result in any changes to such prescribing
information; 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
extent to which the results from the research and development
programs conducted by Regeneron or its collaborators may be
replicated in other studies and lead to therapeutic applications;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products (such as Praluent), 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, including without limitation
Praluent; 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; the ability of Regeneron's collaborators,
suppliers, or other third parties to perform filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's products and product candidates; the availability and
extent of reimbursement of the Company's products (such as
Praluent) from third-party payers, including private payer
healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its 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, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), 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, including without limitation the patent litigation
proceedings relating to EYLEA® (aflibercept) Injection,
Dupixent® (dupilumab) Injection, and Praluent, the
ultimate outcome of any such litigation proceedings, and the impact
any of the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-Q for the quarterly period ended
September 30, 2018. 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).
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,
Sanofi's ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances,
risks associated with intellectual property and any related pending
or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic conditions, the impact of cost containment
initiatives 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,
2017. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
Tel: +1 (914)
847-5018
Sarah.Cornhill@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.Narasimhan@regeneron.com
|
Sanofi
Contacts:
Media
Relations
Ashleigh
Koss
Tel: +1 (908) 981
8745
Ashleigh.Koss@sanofi.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
View original
content:http://www.prnewswire.com/news-releases/new-england-journal-of-medicine-publishes-positive-detailed-results-from-praluent-alirocumab-injection-cardiovascular-outcomes-trial-300746075.html
SOURCE Regeneron Pharmaceuticals, Inc.