PARIS and TARRYTOWN, N.Y., March
10, 2018 /PRNewswire/ -- Sanofi (EURONEXT: SAN) (NYSE:
SNY) and Regeneron Pharmaceuticals, Inc. today announced that
the ODYSSEY OUTCOMES trial met its primary endpoint, showing
Praluent® (alirocumab) Injection significantly reduced
the risk of major adverse cardiovascular events (MACE) in patients
who had suffered a recent acute coronary syndrome (ACS) event such
as a heart attack. Results from the trial will be presented today
during a late-breaker session at the American College of
Cardiology's 67th Annual Scientific Session (ACC.18) in
Orlando, Florida and are available
here.
Key findings include:
- On the primary endpoint, Praluent reduced the overall risk of
MACE by 15% (HR=0.85, CI: 0.78-0.93, p=0.0003). The MACE composite
endpoint includes patients who experienced a heart attack, ischemic
stroke, death from coronary heart disease (CHD), or unstable angina
requiring hospitalization.
- Praluent was also associated with a lower risk of death
overall, known as "all-cause mortality" (HR=0.85; CI: 0.73-0.98,
nominal p=0.026), and there were also numerically fewer CHD deaths
(HR=0.92; CI: 0.76-1.11, p=0.38).
- In a pre-specified analysis, the patients with baseline LDL-C
levels at or above 100 mg/dL experienced a more pronounced effect
from Praluent, reducing their risk of MACE by 24% (HR=0.76, CI:
0.65-0.87). In a post-hoc analysis of this group, Praluent was
associated with a lower risk of death from any cause by 29%
(HR=0.71, CI: 0.56-0.90).
- The analyses described above include the results from 730
patients (8%) in the Praluent group who continued to be assessed in
the Praluent arm despite stopping active Praluent therapy, as
specified in the protocol for patients with persistent LDL-C
readings below 15 mg/dL.
- For those in the Praluent treatment arm, approximately 75% of
patient time was on the 75 mg dose.
- There were no new safety signals in the trial, with injection
site reactions experienced more commonly in the Praluent group
compared to patients on maximally-tolerated statins alone (3.8%
Praluent; 2.1% placebo). There was no difference in neurocognitive
events (1.5% Praluent; 1.8% placebo) or new-onset diabetes (9.6%
Praluent; 10.1% placebo).
"This trial was consistent with
earlier statin trials, showing the greatest benefit in patients
with higher cholesterol levels at baseline," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer, Regeneron. "Many patients who have
survived a recent heart attack or other coronary event are unable
to reach an LDL cholesterol goal of less than 100 mg/dL, and have
an urgent need for new therapeutic options because of their
increased risk of another event. In this trial, such patients who
received Praluent on top of maximally-tolerated statins had
important reductions in their risk."
"Not all patients with heart
disease are the same. Through this trial, we have been able to
identify high-risk patients treated with optimal statins who still
have an urgent need for additional treatment options," said
Elias Zerhouni, M.D., President,
Global R&D, Sanofi. "With nearly 90 percent of the patients in
this trial on high-intensity statins, the data demonstrate that a
precision-medicine approach in the field of cardiovascular disease
may further advance how we better treat high-risk
patients."
Investor Relations Conference Call on ODYSSEY
OUTCOMES
Sanofi and Regeneron will be hosting a conference
call for the financial community on ODYSSEY OUTCOMES. The
conference call will take place on Saturday,
March 10, 2018 (18:00 CET /
12:00 EST / 09:00 PST).
The call will be available on www.sanofi.com and
www.regeneron.com through a webcast.
Conference call numbers are as follows:
United States: +1 (1) 631 570 56 13
France: +33 (0)1 7091 8706
United Kingdom: +44 (0) 207 107
0613
Europe: +41 (0) 58 310 50 00
Other international numbers available here.
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
maximally-tolerated statins. All patients were randomized to
receive Praluent (n=9,462) or a placebo (n=9,462) and were treated
for an average (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 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 lowers LDL-C levels in the blood. The
use of Praluent to reduce the risk of MACE is investigational and
has not been evaluated by any regulatory agency.
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.
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.
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.
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 by physician-scientists for 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, infectious diseases and rare
diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary VelociSuite®
technologies, including VelocImmune® to yield 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.
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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
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Sanofi Media
Relations Contact
Ashleigh
Koss
Tel: +1 (908) 981
8745
mr@sanofi.com
Regeneron Media
Relations Contact
Sarah
Cornhill
Mobile: +1 (917)
297-1522
Sarah.Cornhill@regeneron.com
|
Sanofi Investor
Relations Contact
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
Regeneron Investor
Relations Contact
Manisha Narasimhan,
Ph.D.
Tel: 1 (914)
847-5126
Manisha.Narasimhan@regeneron.com
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Sanofi
Forward-Looking Statements
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contains forward-looking statements as defined in the Private
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Forward-looking statements are statements that are not historical
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Forward-looking statements are generally identified by the words
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believes that the expectations reflected in such forward-looking
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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, 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
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; 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), including the ODYSSEY OUTCOMES
trial discussed in this news release, on the commercial success of
Regeneron's products and product candidates; coverage and
reimbursement determinations by third-party payers, including
Medicare and Medicaid; 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;
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; 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; the
ability of Regeneron to manufacture and manage supply chains for
multiple products and product candidates; 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, Bayer HealthCare LLC, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), to
be canceled or terminated without any further product success
risks; and risks associated with intellectual property of other
parties and pending or future litigation relating thereto,
including the patent litigation proceedings relating to 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 United States Securities and
Exchange Commission, including its Form 10-K for the year ended
December 31, 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)
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SAUS.PRL.18.03.1545
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