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Press ReleaseSource: Sanofi (EURONEXT: SAN)
(NYSE: SNY) |
Praluent® (alirocumab) significantly reduced risk of
cardiovascular events in high-risk patients, and was associated
with lower death rate ODYSSEY OUTCOMES trial met its primary
endpoint, demonstrating that high-risk patients who added Praluent®
(alirocumab) to maximally-tolerated statins experienced
significantly fewer major adverse cardiovascular events compared to
those on maximally-tolerated statins alone For the first time,
adding a lipid-lowering therapy to maximally-tolerated statins was
associated with reduced death from any cause More pronounced effect
observed in patients with baseline LDL-C levels at or above 100
mg/dL despite maximally-tolerated statins, who are at high risk of
suffering a future event; in this group, Praluent reduced risk of
major adverse cardiovascular events by 24% and was associated with
a 29% lower risk of death overall In this 18,924-patient, long-term
trial, the safety profile of Praluent was consistent with previous
trials and no new safety issues were observed Paris and
Tarrytown, N.Y. - March 10, 2018 - Sanofi and Regeneron
Pharmaceuticals, Inc. today announced that the ODYSSEY OUTCOMES
trial met its primary endpoint, showing Praluent® (alirocumab)
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 OUTCOMESSanofi 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 13France: +33 (0)1 7091 8706United Kingdom: +44 (0) 207
107 0613Europe: +41 (0) 58 310 50 00Other international numbers
available here. About ODYSSEY OUTCOMESODYSSEY 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 PraluentPraluent 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.About Regeneron Pharmaceuticals, IncRegeneron
(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 SanofiSanofi 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 |
Sanofi Media Relations ContactAshleigh KossTel: +1 (908)
981 8745mr@sanofi.com |
Sanofi Investor Relations ContactGeorge GrofikTel: +33 (0)1
53 77 45 45 ir@sanofi.com |
Regeneron Media Relations ContactSarah CornhillMobile:
+1 (917) 297-1522Sarah.Cornhill@regeneron.com |
Regeneron Investor Relations ContactManisha Narasimhan,
Ph.D.Tel: 1 (914) 847-5126 Manisha.Narasimhan@regeneron.com |
Sanofi Forward-Looking StatementsThis 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
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Forward-looking statements are generally identified by the words
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risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
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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
MediaThis 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);
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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