TARRYTOWN, N.Y. and
BRIDGEWATER, N.J., March 7, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced new
Phase 3 data from the Praluent® (alirocumab) Injection
clinical trial program will be presented at the American College of
Cardiology Scientific Sessions (ACC.17), March 17-19, 2017 in Washington, D.C.
Key data include presentations on the effects of Praluent across
several patient subsets such as diabetes, heterozygous familial
hypercholesterolemia (HeFH), and atherosclerotic cardiovascular
disease (ASCVD) and post-hoc analyses on the effect of Praluent on
major cardiovascular events (MACE). Additionally, a safety update
utilizing real-world data from the Praluent open-label extension
trial will be presented.
Praluent is a human monoclonal antibody targeting PCSK9
(proprotein convertase subtilisin/kexin type 9), which is approved
in approximately 40 countries worldwide, including the U.S.,
Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). The effect
of Praluent on cardiovascular (CV) morbidity and mortality has not
yet been determined.
Sanofi and Regeneron data will be presented throughout ACC.17
during the following sessions of note:
1) MODERATED POSTER
PRESENTATIONS
- The PCSK9 revolution: new insights into evaluation and
treatment
- Alirocumab efficacy and safety in patients with
hypercholesterolemia and with or without clinical atherosclerotic
cardiovascular disease: Pooled analysis of 10 ODYSSEY randomized
trials (Jones)
- Abstract #1133M-03
- Friday, March 17, 10:00 –
10:10 a.m. ET
- Alirocumab treatment in a real world setting: Safety update
from an open-label treatment extension to the ODYSSEY program for
patients with heterozygous familial hypercholesterolemia (Guyton)
- Abstract #1133M-07
- Friday, March 17, 10:30 –
10:40 a.m. ET
- Impact of statin intolerance rates on ezetimibe and/or PCSK9
inhibitor use for meeting low-density lipoprotein goals in a
real-world cohort with atherosclerotic cardiovascular disease
(Cannon)
- Abstract #1133M-13
- Friday, March 17, 11:15 –
11:25 a.m. ET
- A randomized, double-blind, placebo-controlled, parallel group
study to evaluate the efficacy and safety of alirocumab in high
cardiovascular risk patients with hypercholesterolemia not
adequately controlled with their lipid-modifying therapy in
South Korea and Taiwan (Koh)
- Abstract #1133M-15
- Friday, March 17, 11:30 –
11:40 a.m. ET
- The intersection of diabetes and atherosclerotic
cardiovascular disease (ASCVD)
- Alirocumab safety in individuals with and without diabetes
mellitus: Pooled data from 14 ODYSSEY trials (Leiter)
- Abstract #1222M-07
- Saturday, March 18, 1:00 –
1:10 p.m. ET
2) POSTER PRESENTATIONS
- Advances in cholesterol measurement and management
- Efficacy and safety of the PCSK9 inhibitor alirocumab 300 mg
every 4 weeks in individuals with type 2 diabetes on maximally
tolerated statin therapy (Muller-Wieland)
- Abstract #1106-055
- Friday, March 17, 10:00 –
10:45 a.m. ET
- Traditional and novel factors used to assess the risk of,
and used for the treatment of, coronary artery disease (CAD)
- Lower on-treatment low-density lipoprotein cholesterol is
associated with lower cardiovascular risk in very high risk
patients with atherosclerotic cardiovascular disease: analyses from
the ODYSSEY trials (Ray)
- Abstract # 1126-316
- Friday, March 17, 10:00 –
10:45 a.m. ET
- Advances in lipid management
- Alirocumab reduces major cardiovascular events in individuals
with atherosclerotic cardiovascular disease: a post-hoc analysis of
ODYSSEY LONG TERM (Robinson)
- Abstract #1203-305
- Saturday, March 18, 9:45 –
10:30 a.m. ET
- Use of high-intensity statin therapy post-acute coronary
syndrome in the ongoing ODYSSEY OUTCOMES trial of alirocumab, a
proprotein convertase subtilisin/kexin type 9 monoclonal antibody,
versus placebo: Interim baseline data (Goodman)
- Abstract #1203-307
- Saturday, March 18, 9:45 –
10:30 a.m. ET
- Cardiac arrest, diabetes, and other high risk features of
patients with acute coronary syndrome (ACS)
- Lower on-treatment low-density lipoprotein cholesterol is
associated with lower cardiovascular risk in women: Analyses from
the ODYSSEY trials of alirocumab versus control (Vallejo-Vaz)
- Abstract #1204-331
- Saturday, March 18, 9:45 –
10:30 a.m. ET
Additional information on ACC.17 is available on the congress
website.
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, which results in lower LDL cholesterol
levels in the blood. Praluent is the only PCSK9 inhibitor available
in two dosages with two levels of efficacy (75 mg and 150 mg),
allowing physicians to select the dose based on a patient's LDL
cholesterol lowering needs.
Praluent is approved in approximately 40 countries worldwide,
including the U.S., Japan,
Canada, Switzerland, Mexico, Brazil and the European Union (EU). In the
U.S., Praluent is approved for use as adjunct to diet and maximally
tolerated statin therapy for the treatment of adults with HeFH or
clinical atherosclerotic CV disease, who require additional
lowering of LDL cholesterol. 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. ODYSSEY OUTCOMES is prospectively evaluating the
effect of Praluent on the occurrence of CV events in approximately
18,000 patients who have experienced an acute coronary
syndrome.
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 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 Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. 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
that discovers, invents, develops, manufactures and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, high
LDL-cholesterol, and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including rheumatoid arthritis, asthma, atopic dermatitis,
pain, cancer 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,
Sanofi's ability to benefit from external growth opportunities
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, 2015.
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, risks associated with
intellectual property of other parties and pending or future
litigation relating thereto, including the patent litigation
relating to Praluent® (alirocumab) Injection, the
permanent injunction granted by the United States District Court
for the District of Delaware that,
if upheld on appeal, would prohibit Regeneron and Sanofi from
marketing, selling, or manufacturing Praluent in the United States, the outcome of any appeals
regarding such injunction, the ultimate outcome of such litigation,
and the impact any of the foregoing may have on Regeneron's
business, prospects, operating results, and financial
condition; 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; 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 prospectively assessing the
potential of Praluent to demonstrate cardiovascular benefit;
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); 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; and the potential for any
license or collaboration agreement, including Regeneron's
agreements with Sanofi and Bayer HealthCare LLC, 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 United States Securities and Exchange Commission, including its
Form 10-K for the year ended December 31,
2016. 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
Ashleigh Koss
Tel: +1
(908) 981-8745
ashleigh.koss@sanofi.com
Contacts Regeneron:
Arleen
Goldenberg
Tel: + 1 (914)
847-3456
Mobile: +1 (914)
260-8788
arleen.goldenberg@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.