TARRYTOWN, N.Y. and
BRIDGEWATER, N.J., Nov. 10, 2015 /PRNewswire/
-- Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) and Sanofi today announced a new post-hoc analysis of
six Phase 3 clinical trials showing that approximately three
quarters (74 percent) of patients reached their pre-specified LDL
cholesterol targets within 8 weeks of adding Praluent®
(alirocumab) Injection 75 mg to their standard-of-care, which
included statins. In the 26 percent of patients whose dose was
increased to 150 mg, most were able to achieve their pre-specified
LDL cholesterol target, with an average additional 14 percent
reduction in LDL cholesterol. The results from this and other
analyses, which evaluated Praluent every two weeks, were presented
at the American Heart Association (AHA) Scientific Sessions in
Orlando, FL.
"In this analysis of patients who required further improvement
of their LDL cholesterol levels, adding Praluent 75 mg to their
standard-of-care allowed the majority of patients to achieve their
LDL cholesterol goals. For those who required further LDL
cholesterol lowering, increasing Praluent to 150 mg provided
additional efficacy," said Harold
Bays, M.D., from the Louisville Metabolic &
Atherosclerosis Research Center,
Kentucky, U.S. "Data such as these provide clinicians
practical insight as to how the two Praluent doses may better allow
patients to achieve their LDL cholesterol goals."
These results are based on a pooled post-hoc analysis of 1,291
patients with high cardiovascular (CV) risk or an inherited form of
high cholesterol (heterozygous familial hypercholesterolemia, or
HeFH) which found 74 percent of patients who added Praluent 75 mg
achieved their LDL cholesterol-lowering goals at week 8, and the
remaining 26 percent had their dose adjusted to 150 mg at week 12.
In other results:
- By week 24, 61 percent of patients who switched to 150 mg
achieved their goal, with a mean additional LDL cholesterol
reduction of 14 percent.
- Comparable adverse event (AE) rates were observed in patients
whose Praluent dose was increased, versus those whose dose was not
(66 percent in both arms in placebo-controlled trials; and 55
percent versus 56 percent respectively in ezetimibe-controlled
trials).
- About the data: The pooled analysis included results
from six Phase 3 ODYSSEY trials where patients added Praluent 75 mg
to standard-of-care, and had their dose adjusted at week 12 to 150
mg if they did not reach their LDL cholesterol goals by week 8.
Cholesterol goals were either less than 70 mg/dL or less than 100
mg/dL, dependent on CV risk. All patients across the six trials
received background statin therapy. In three trials Praluent was
compared to placebo (ODYSSEY FH I, FH II, COMBO I), and in three it
was compared to ezetimibe (ODYSSEY COMBO II, OPTIONS I, OPTIONS
II).
In a separate pooled post-hoc analysis of 3,499 patients,
individuals with diabetes (n=1,051) who initially received Praluent
75 mg or 150 mg every two weeks had a mean percent difference in
LDL cholesterol of 44 percent and 58 percent, respectively, versus
placebo at week 24 (p less than 0.0001). In other results:
- Praluent was generally well tolerated, with the most common
adverse events among people with diabetes being nasopharyngitis (11
percent Praluent, 10 percent placebo) and upper respiratory tract
infection (8 percent Praluent, 9 percent placebo).
- About the data: The pooled analysis included results
from five placebo-controlled trials of individuals with diabetes
(1,051), and without diabetes (2,448) with inadequately controlled
hypercholesterolemia receiving standard-of-care, which included
maximally-tolerated statins. In two of the trials, patients
initially received Praluent 150 mg (ODYSSEY LONG TERM, HIGH FH). In
three of the trials, patients initially received Praluent 75 mg and
had their dose adjusted to 150 mg at week 12 if they required
additional lipid-lowering to meet their LDL cholesterol goals
(ODYSSEY COMBO I, FH I, FH II).
A third post-hoc analysis of 4,974 patients did not find an
increased risk of diabetes-related AEs among those who didn't have
diabetes when they entered the trials, regardless of whether they
were taking Praluent or were in a control group (placebo or
ezetimibe). There was also no evidence that Praluent affected the
incidence of new-onset diabetes or pre-diabetes. The ongoing
ODYSSEY OUTCOMES trial will provide further data on the impact of
Praluent on glycemic measures.
- About the data: The pooled analysis included results
from 10 Phase 3 ODYSSEY trials of patients with inadequately
controlled hypercholesterolemia, ranging from 24 to 78 weeks
(ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II,
OPTIONS I, OPTIONS II, MONO, ALTERNATIVE). In total, 1,526 (31
percent) had a medical history of diabetes upon entering the
trials, 1,969 (40 percent) were identified as having pre-diabetes,
and 1,479 (30 percent) did not have diabetes (e.g., had a normal
concentration of glucose in the blood).
About Praluent
In July, the companies announced that Praluent was approved for
use in the U.S. Praluent is a PCSK9 (proprotein convertase
subtilisin/kexin type 9) inhibitor indicated as adjunct to diet and
maximally tolerated statin therapy for the treatment of adults with
HeFH or clinical atherosclerotic CV disease, who require additional
lowering of LDL cholesterol. The effect of Praluent on CV morbidity
and mortality has not been determined.
In September, the European Commission approved the marketing
authorization for Praluent. In the E.U., 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-cholesterol 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 yet been determined.
IMPORTANT SAFETY INFORMATION FOR U.S.
PRALUENT is contraindicated in patients with a history of a
serious hypersensitivity reaction to PRALUENT. Reactions have
included hypersensitivity vasculitis and hypersensitivity reactions
requiring hospitalization.
Hypersensitivity reactions (e.g., pruritus, rash, urticaria),
including some serious events (e.g., hypersensitivity vasculitis
and hypersensitivity reactions requiring hospitalization), have
been reported with PRALUENT treatment. If signs or symptoms of
serious allergic reactions occur, discontinue treatment with
PRALUENT, treat according to the standard of care, and monitor
until signs and symptoms resolve.
The most commonly occurring adverse reactions (>5% of
patients treated with PRALUENT and occurring more frequently than
with placebo) are nasopharyngitis, injection site reactions, and
influenza.
Local injection site reactions including erythema/redness,
itching, swelling, and pain/tenderness were reported more
frequently in patients treated with PRALUENT (7.2% versus 5.1% for
PRALUENT and placebo, respectively). Few patients discontinued
treatment because of these reactions (0.2% versus 0.4% for PRALUENT
and placebo, respectively), but patients receiving PRALUENT had a
greater number of injection site reactions, had more reports of
associated symptoms, and had reactions of longer average duration
than patients receiving placebo.
Neurocognitive events were reported in 0.8% of patients treated
with PRALUENT and 0.7% of patients treated with placebo. Confusion
or memory impairment were reported more frequently by those treated
with PRALUENT (0.2% for each) than in those treated with placebo
(<0.1% for each).
Liver-related disorders (primarily related to abnormalities in
liver enzymes) were reported in 2.5% of patients treated with
PRALUENT and 1.8% of patients treated with placebo, leading to
treatment discontinuation in 0.4% and 0.2% of patients,
respectively. Increases in serum transaminases to greater than 3
times the upper limit of normal occurred in 1.7% of patients
treated with PRALUENT and 1.4% of patients treated with
placebo.
The most common adverse reactions leading to treatment
discontinuation in patients treated with PRALUENT were allergic
reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively)
and elevated liver enzymes (0.3% versus <0.1%).
PRALUENT is a human monoclonal antibody. As with all therapeutic
proteins, there is a potential for immunogenicity with
PRALUENT.
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 has core strengths in diabetes solutions, human vaccines,
innovative drugs, consumer healthcare, emerging markets, animal
health and 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 high LDL cholesterol, eye diseases, and a rare
inflammatory condition and has product candidates in development in
other areas of high unmet medical need, including oncology,
rheumatoid arthritis, asthma, atopic dermatitis, pain, and
infectious diseases. 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, 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 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; 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 evaluating Praluent; 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 prospectively assessing the
potential of Praluent to demonstrate cardiovascular benefit);
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 (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
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 and its Form 10-Q for the quarterly period ended
September 30, 2015. 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).
Contacts Sanofi:
Media
Relations
Carrie Brown Tel: +1 (908) 981-6486
Carrie.Brown@sanofi.com
|
Global
Communications, PCSK9 Development & Launch Unit
Elizabeth
Baxter
Mobile (onsite at
AHA): +1 (908)
340-7811
Elizabeth.Baxter@sanofi.com
|
Contacts Regeneron:
Media Relations
Arleen
Goldenberg
Tel: + 1 (914)
847-3456
Mobile: +1 (914)
260-8788
arleen.goldenberg@regeneron.com
|
|
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SOURCE Regeneron Pharmaceuticals, Inc.