TARRYTOWN, N.Y. and
BRIDGEWATER, N.J., March 13, 2019 /PRNewswire/ --
Sub-analyses from ODYSSEY OUTCOMES trial, including featured
clinical research, provide new Praluent insights
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced that four new sub-analyses from the
Praluent® (alirocumab) ODYSSEY OUTCOMES cardiovascular
(CV) outcomes trial will be presented at the American College of
Cardiology's 68th Annual Scientific Session (ACC.19), held
March 16-18, in New Orleans, LA.
The sub-analyses from the 18,924-patient ODYSSEY OUTCOMES trial
include:
- A Featured Clinical Research presentation that evaluates the
impact of lowering lipoprotein(a) [Lp(a)] with Praluent on total CV
events, independent of low-density lipoprotein cholesterol (LDL-C)
reduction. Elevated Lp(a), an inherited lipid disorder, is
associated with increased risk of atherosclerosis and CV
disease.
- An oral presentation that shows Praluent treatment was
associated with larger reductions in the risk of major adverse CV
events (MACE) and death in patients with polyvascular disease,
compared to those without. Polyvascular disease is defined as
having an acute coronary syndrome (ACS), plus either concurrent
peripheral artery disease or cerebrovascular disease, or
both.
Regeneron and Sanofi presentations at ACC.19 from the ODYSSEY
clinical trial program and other trials include the following three
oral presentations and five poster presentations:
Praluent Featured Clinical Research Session III
- Lipoprotein(a) Lowering by Alirocumab Contributes to Total
Events Reduction Independent of Low-Density Lipoprotein Cholesterol
in the ODYSSEY OUTCOMES Trial (Vera A.
Bittner)
Monday, March 18, 2:30-2:40 PM CT
Other Praluent Oral Presentations
- Post-Acute Coronary Syndrome Patients with Polyvascular
Disease Derive Large Absolute Benefit from Alirocumab: ODYSSEY
OUTCOMES (J. Wouter Jukema)
Sunday, March 17, 8:12-8:22 AM CT
- Reduction of Type 1 and Type 2 Myocardial Infarctions in
Patients Treated with Alirocumab: Insights from the ODYSSEY
Trial (Harvey D. White)
Monday, March 18, 8:51-9:01 AM CT
Praluent Poster Presentations
- Patients with Acute Coronary Syndrome, Elevated Atherogenic
Lipoproteins, and Prior Coronary Artery Bypass Grafting Derive
Large Absolute Benefit from Alirocumab: Insights from the ODYSSEY
OUTCOMES Trial (Shaun G.
Goodman)
Monday, March 18, 10:15-10:25 AM CT
Additional Analyses of Interest
- Statin Therapy in Patients with Cerebrovascular Disease vs.
Coronary Artery Disease: Insights from the PALM
Registry (Ying Xian)
Saturday, March 16, 10:00-10:45 AM CT
- Long-term Residual Risk and Predictors of Cardiovascular
Disease in Individuals Taking Statins for Primary Prevention:
Insights from the Cartagene Study (Maxime Robert-Halabi)
Saturday, March 16, 3:45-4:30 PM
CT
- Practice-Level Variation in Statin Use and LDL-C Control in
the United States: Results from the Patient and Provider
Assessment of Lipid Management (PALM) Registry (Michele Nanna)
Sunday, March 17, 12:30-12:40 PM CT
- Patient Perceptions and Management of Cholesterol Among
Individuals with or without Diabetes in Community Practice: Results
from the PALM Registry (Angela Lowenstern)
Sunday, March 17, 1:30-1:40 PM CT
About ODYSSEY OUTCOMES
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 a 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.
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® (alirocumab)
Injection 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 was
developed by Regeneron and Sanofi under a global collaboration
agreement and 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, Brazil and the 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 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.
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;
uncertainty of market acceptance and commercial success of
Regeneron's products (such as Praluent) and product candidates and
the impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), including the ODYSSEY OUTCOMES
trial discussed in this press release, on the commercial success of
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; 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; 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; 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 (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's products and product candidates; 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; risks associated with intellectual
property of other parties and pending or future litigation relating
thereto, including without limitation the patent litigation and
other proceedings relating to Praluent, EYLEA®
(aflibercept) Injection, and Dupixent® (dupilumab)
Injection, the ultimate outcome of any such proceedings, and the
impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition; and 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. 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-K for the
year ended December 31, 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:
|
Sanofi
Contacts:
|
|
|
Media
Relations Sarah
Cornhill Tel: +1 (914)
847-5018 sarah.cornhill@regeneron.com
|
Media
Relations Nicolas Kressmann
Tel: +1 (732) 532-5318
nicolas.kressmann@sanofi.com
|
|
|
Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
mark.hudson@regeneron.com
|
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.