TARRYTOWN, N.Y. and
BRIDGEWATER, N.J., Aug. 25, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced new analyses from Praluent® (alirocumab)
Injection clinical trials will be presented at the European Society
of Cardiology (ESC) Congress 2017, August
26-30 in Barcelona,
Spain.
This year's presentations include results from ODYSSEY APPRISE,
an open-label study in 16 European countries and Canada in patients with severe
hypercholesterolemia at high cardiovascular risk, as well as new
post hoc analyses from the ODYSSEY clinical trial program.
Additionally, an analysis of the risk of atherosclerotic
cardiovascular disease events in a real-world population of
patients with diabetes treated with statins will also be
presented.
Praluent is a human monoclonal antibody targeting PCSK9
(proprotein convertase subtilisin/kexin type 9), which is approved
in more than 50 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
been determined.
Presentations at the ESC Congress 2017 include:
1) Oral Presentation:
- Risk of incident atherosclerotic cardiovascular disease
events by atherogenic lipid levels in a real-world population of
62,428 on-statin individuals with diabetes (Rana)
-
- Abstract # P3097
- Monday, August 28, 11:00am - 11:09am CEST
2) Poster Presentations:
- Open-label ODYSSEY APPRISE study: interim data from the
first 843 patients (Cariou)
-
- Abstract # P1502
- Sunday, August 27, 8:30am - 12:30pm CEST
- Assessment of absolute reductions in LDL-C and other
lipid parameters associated with alirocumab therapy: results from
across the Phase 3 ODYSSEY program (Roth)
-
- Abstract # P1512
- Sunday, August 27, 8:30am - 12:30pm CEST
- Predictive factors for alirocumab dose increase in
patients with hypercholesterolemia and high cardiovascular risk:
from the ODYSSEY COMBO I and II trials (Vallejo-Vaz)
-
- Abstract # P6238
- Tuesday, August 29, 2:00pm - 6:00pm CEST
Additional information on ESC Congress 2017 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-C levels in the
blood.
Praluent is approved in more than 50 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. 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-C
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 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 Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
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 by physician-scientists for nearly 30 years, our
unique ability to repeatedly and consistently translate science
into medicine has led to six FDA-approved treatments and over a
dozen product candidates, all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its unique VelociSuite®
technologies, including VelocImmune® which yields
optimized fully-human antibodies, and ambitious initiatives such as
the Regeneron Genetics Center, 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.
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, risks associated with intellectual property and any related
pending or future litigation and the ultimate outcome of such
litigation, including the patent litigation relating to Praluent,
the uncertainties inherent in research and development, future
clinical data and analysis, including post marketing, unexpected
safety, quality or manufacturing issues, 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 or
Praluent, 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, 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,
2016. 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 commercially 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, including those discussed in this news release (whether
conducted by Regeneron or others and whether mandated or
voluntary), on the commercial success of Regeneron's products and
product candidates, such as Praluent; 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, 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 and its Form 10-Q for the quarterly period ended
June 30, 2017. 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).
Contact Sanofi:
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Mobile: +1 (908)
205-2572
Ashleigh.Koss@sanofi.com
|
|
|
Investor
Relations
George
Grofik
Tel. +33 (0) 1 53 77
45 45
ir@sanofi.com
|
Contact Regeneron:
Media
Relations
Arleen
Goldenberg
Tel: + 1 (914)
847-3456
Mobile: +1 (914)
260-8788
Arleen.Goldenberg@regeneron.com
|
|
|
Investor
Relations
Manisha Narasimhan, Ph.D.
Tel.: +1 (914) 847-5126
manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.