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 PraluentTM in largest, double-blind,
placebo-controlled trial of a PCSK9 inhibitor to date -
- Fewer major cardiovascular events observed with
PraluentTM in post hoc analysis -
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 64th 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 Jack
Cox Tel: +33 (0) 1 53 77 94 74 Mobile: +33 (0) 6 78 52 05 36
Jack.Cox@sanofi.com Global Communications, PCSK9 Development
& Launch Unit Elizabeth Baxter Tel: +1 (908)
981-5360 Mobile: +1 (908) 340-7811 Elizabeth.Baxter@sanofi.com |
Investor Relations
Sébastien Martel Tel: +33 (0)1 53 77 45 45 IR@sanofi.com
|
Contacts Regeneron:
Media Relations Arleen
Goldenberg Tel: +1 (914) 847-3456 Mobile: +1 (914)
260-8788 arleen.goldenberg@regeneron.com |
Investor Relations
Manisha Narasimhan Tel: +1 (914) 847-5126
manisha.narasimhan@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
HUG#1903633
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