Sanofi, Regeneron: 18-Month Results of ODYSSEY LONG TERM Trial with Praluent(TM) (alirocumab) Published in The New England Journal of Medicine
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce 18-Month Results
of ODYSSEY LONG TERM Trial with Praluent (TM) (alirocumab)
Published in The New England Journal of Medicine
- Robust and consistent LDL-C lowering demonstrated with Praluent(TM) in
largest, double-blind, placebo-controlled trial of a PCSK9 inhibitor to date -
- Fewer major cardiovascular events observed with Praluent(TM) in post hoc
analysis -
Paris and Tarrytown, New York - March 15, 2015 - Sanofi and Regeneron
Pharmaceuticals, Inc. today announced that 18-month (78-week) results of a Phase
3 trial of Praluent((TM)) (alirocumab), an investigational therapy, involving
2,341 high risk patients with hypercholesterolemia were published online in The
New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg
every two weeks reduced low-density lipoprotein cholesterol (LDL-C or "bad"
cholesterol) by an additional 62 percent at week 24 when compared to placebo,
the primary efficacy endpoint of the study, with consistent LDL-C lowering
maintained over 78 weeks.
"These results demonstrated the durable efficacy for Praluent when added to
maximally-tolerated statin therapy and further reinforce its generally
consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of
the Prevention Intervention Center, Professor, Departments of Epidemiology &
Medicine, College of Public Health at the University of Iowa. "Additionally, the
post hoc analysis of major cardiovascular events represents an important finding
for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES
trial, which is prospectively evaluating the potential of Praluent to reduce
cardiovascular events."
18-Month (78-Week) Safety and Efficacy Results
ODYSSEY LONG TERM evaluated Praluent 150 mg (n=1,553) every two weeks compared
to placebo (n=788) in patients who were at high cardiovascular (CV) risk and who
were receiving maximally-tolerated statin therapy with or without other lipid-
lowering treatment. The trial included patients with heterozygous familial
hypercholesterolemia (HeFH) (n=276 Praluent, n=139 placebo). Patients received
78 weeks of treatment followed by an eight-week safety assessment. Patients
self-administered a subcutaneous injection every two weeks via a pre-filled
syringe. Key results include:
* At week 24, Praluent reduced LDL-C from baseline by an additional 62 percent
versus placebo (p<0.0001) when added to the current standard of care, which
included maximally-tolerated statins.
* Efficacy remained consistent throughout treatment, and at week 78 there was
a 56 percent reduction from baseline in LDL-C for Praluent versus placebo
(p<0.0001).
* At week 24, 81 percent of patients in the Praluent group achieved their pre-
specified LDL-C goal (either 70 mg/deciliter [mg/dL] or 100 mg/dL depending
on baseline CV risk) compared to 8.5 percent for placebo (p<0.0001).
* Adverse events (AEs) occurred in 81 percent of Praluent and 83 percent of
placebo patients, leading to discontinuation in 7.2 percent and 5.8 percent
of patients, respectively. AEs were similar between groups, apart from
differences in injection site reactions (5.9 percent Praluent, 4.2 percent
placebo), myalgia (5.4 percent Praluent, 2.9 percent placebo),
neurocognitive events (1.2 percent Praluent, 0.5 percent placebo), and
ophthalmological events (2.9 percent Praluent, 1.9 percent placebo). In a
3,759-patient, pooled safety analysis of nine placebo-controlled Praluent
studies to be presented on Monday, rates of skeletal muscle-related and
neurocognitive events were generally balanced between Praluent and placebo.
* At week 78, positively adjudicated pre-specified CV AEs (including
additional CV AEs[1] beyond those in the pre-specified ODYSSEY OUTCOMES
endpoint of 'major adverse cardiac events' described below) occurred in 4.6
percent and 5.1 percent of Praluent and placebo patients, respectively.
* In a post hoc analysis using a pre-specified endpoint that included coronary
heart disease death, myocardial infarction, stroke, or unstable angina
requiring hospitalization, a lower rate of adjudicated major adverse cardiac
events was observed in the Praluent group (27 of 1550 patients, 1.7 percent)
compared with the placebo group (26 of 788 patients, 3.3 percent; hazard
ratio 0.52; 95 percent CI, 0.31 to 0.90; nominal p less than 0.01). The
cumulative incidence curves diverged progressively over time.
* ODYSSEY LONG TERM was not designed to evaluate CV outcomes. The number of CV
events seen in the post hoc analysis was relatively small, which limits the
ability to draw conclusions on the effects of Praluent on CV events. The
ongoing ODYSSEY OUTCOMES trial will evaluate the CV benefits of Praluent in
approximately 18,000 patients over 5 years.
Praluent ACC.15 Presentation Highlights
* Positive results from the ODYSSEY CHOICE I and CHOICE II trials, which
evaluated monthly dosing of Praluent 300 mg and Praluent 150 mg, were
presented at the American College of Cardiology's 64(th) Annual Scientific
Sessions & Expo (ACC.15), in San Diego. The full poster presentation is
available on Regeneron's website here.
* On Monday, investigators will present a pooled analysis of AEs from five
Phase 3 and four Phase 2 double-blind, placebo-controlled trials exploring
multiple Praluent doses and regimens involving 3,759 patients with
hypercholesterolemia who also received statins. These slides will be
available on Monday on Regeneron's website.
Praluent is an investigational fully human monoclonal antibody targeting PCSK9
(proprotein convertase subtilisin/kexin type 9). Earlier this year, Regeneron
and Sanofi announced that the Biologics License Application (BLA) for Praluent
was accepted for priority review by the U.S. Food and Drug Administration (FDA).
Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review
is six months, for a target action date of July 24, 2015. Additionally, the
European Medicines Agency (EMA) accepted for review the Marketing Authorization
Application for Praluent in the European Union. The EMA and FDA have
conditionally accepted Praluent as the trade name for alirocumab. The safety and
efficacy of Praluent have not been fully evaluated by any regulatory authority.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, consumer healthcare, emerging
markets, animal health and the new Genzyme. 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
based in Tarrytown, New York that discovers, invents, develops, manufactures,
and commercializes medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, and a rare inflammatory
condition and has product candidates in development in other areas of high unmet
medical need, including hypercholesterolemia, oncology, rheumatoid arthritis,
asthma, and atopic dermatitis. For additional information about the company,
please visit www.regeneron.com.
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, the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact of cost
containment policies 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, 2014.
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
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"), 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(TM)(alirocumab); 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, such as the ODYSSEY global trial program
evaluating Praluent; the likelihood and timing of possible regulatory approval
and commercial launch of Regeneron's late-stage product candidates, including
without limitation Praluent; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products, 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; 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; 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; the potential for any license or collaboration
agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare
LLC, to be cancelled or terminated without any further product success; and
risks associated with intellectual property of other parties and pending or
future litigation relating thereto. 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, 2014. 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.
Contacts Sanofi:
Media Relations Investor Relations
Jack Cox Sébastien Martel
Tel: +33 (0) 1 53 77 94 74 Tel: +33 (0)1 53 77 45 45
Mobile: +33 (0) 6 78 52 05 36 IR(at)sanofi.com
Jack.Cox(at)sanofi.com
Global Communications, PCSK9 Development & Launch
Unit
Elizabeth Baxter
Tel: +1 (908) 981-5360
Mobile: +1 (908) 340-7811
Elizabeth.Baxter(at)sanofi.com
Contacts Regeneron:
Media Relations Investor Relations
Arleen Goldenberg Manisha Narasimhan
Tel: +1 (914) 847-3456 Tel: +1 (914) 847-5126
Mobile: +1 (914) 260-8788 manisha.narasimhan(at)regeneron.com
arleen.goldenberg(at)regeneron.com
--------------------------------------------------------------------------------
[1] CV adverse events defined as CHD death including unknown cause, non-fatal
MI, fatal and non-fatal ischemic stroke, unstable angina requiring
hospitalization, congestive heart failure requiring hospitalization and
ischemia-driven coronary revascularization procedure.
Press release (PDF):
http://hugin.info/152918/R/1903633/677022.pdf
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Source: Sanofi via GlobeNewswire
[HUG#1903633]
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Datum: 15.03.2015 - 15:59 Uhr
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News-ID 378513
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