PARIS and
TARRYTOWN, N.Y.,
June 11, 2017 /PRNewswire/ -- Sanofi
and Regeneron Pharmaceuticals, Inc. today announced positive
results from two Phase 3b/4 ODYSSEY-DM trials in patients with
diabetes. In the studies, Praluent® (alirocumab), when
administered on top of maximally tolerated doses (MTD) of statins,
significantly reduced low-density lipoprotein cholesterol (LDL-C),
the primary endpoint of the ODYSSEY DM-INSULIN study, and was
superior to usual care in reducing non-high-density lipoprotein
cholesterol (non-HDL-C), the primary endpoint of the ODYSSEY
DM-DYSLIPIDEMIA study. Both studies also found that a majority of
patients reached their lipid goals with Praluent 75 mg every two
weeks, with an overall safety profile comparable to the ODYSSEY
Phase 3 program.
The results were unveiled today as part of the official
symposium of the 77th Scientific Sessions of the
American Diabetes Association (ADA) in San Diego, CA, titled, "Inhibition of PCSK9 in
Dyslipidemia Patients with Diabetes." The data were also featured
in the official ADA Scientific Sessions Advance program.
"Patients with long-standing diabetes, including
insulin-treated patients, are at high risk of cardiovascular
disease," said Lawrence Leiter,
M.D., chair of the ODYSSEY DM Steering Committee and director of
the Lipid Clinic at the Li Ka Shing Knowledge Institute at
St. Michael's Hospital,
University of Toronto, Canada. "The
positive results from ODYSSEY DM-INSULIN provide valuable
information on the efficacy and safety of Praluent in this high
cardiovascular risk group."
Most people with diabetes will develop atherosclerotic
cardiovascular disease (ASCVD). Despite current standard of care,
nearly 70 percent of people age 65 or older with diabetes die from
some form of heart disease, and 16 percent die of
stroke.1
"Mixed dyslipidemia is common in people with type 2
diabetes and further increases CV risk, and yet it is difficult to
treat with available therapies," said Robert Henry, M.D., member of the ODYSSEY DM
Steering Committee and Director of the Center for Metabolic
Research at the VA San Diego Healthcare System. "The results of
ODYSSEY DM-DYSLIPIDEMIA showed that in a real-world setting,
Praluent, on top of maximally tolerated doses of statins,
significantly reduced non-HDL-C, another measure of bad
cholesterol, and was superior to usual care. Praluent may be
another option for physicians who need to further help their
diabetes patients with clinical ASCVD manage their lipid
profiles."
In ODYSSEY DM-INSULIN, patients were randomized to
Praluent 75 mg every two weeks or placebo
in addition to MTD statins. Praluent dose was adjusted at
week 12 to 150 mg every two weeks if their LDL-C was greater than
or equal to 70 mg/dL at week 8. Approximately 80 percent of
patients reached their LDL-C goals with Praluent 75 mg every two
weeks in this study. In ODYSSEY DM-DYSLIPIDEMIA, patients were
randomized to Praluent 75 mg every two weeks or usual care in
addition to MTD statins. Praluent dose was adjusted at week 12 to
150 mg every two weeks if their non-HDL-C was greater than or equal
to 100 mg/dL at week 8. Approximately 64 percent of patients
reached their lipid goals with the Praluent 75 mg dose.
ODYSSEY DM-INSULIN was a randomized, double-blind,
placebo-controlled, parallel-group multicenter study that evaluated
Praluent in 517 people with type 1 and type 2 diabetes on insulin
with high CV risk and hypercholesterolemia who took MTD
statins.2 The primary endpoint was percent change in
calculated LDL-C from baseline to week 24. Results in the type 2
diabetes study population (n=441) were presented at ADA and
showed:
- Praluent in combination with MTD statins reduced LDL-C by
48.2 percent from baseline compared to a 0.8 percent increase for
placebo. The mean difference between the two treatment arms was 49
percent (p<0.0001).
- Treatment with Praluent also improved the overall lipid
profile.
- Overall, Praluent was generally well tolerated. Treatment
emergent adverse events (TEAEs) were similar between the two groups
and no emerging safety findings were identified from the study. The
most frequent TEAEs included nasopharyngitis, myalgia, arthralgia
and cough. There was no new safety signal with the concomitant use
of Praluent and insulin.
- There was no impact on glycemic control as assessed by
fasting plasma glucose (FPG), A1C and glucose lowering treatments
remained stable over time in both treatment groups.
ODYSSEY DM-DYSLIPIDEMIA was a randomized, open-label,
parallel-group, multicenter, multinational study designed to
evaluate the superiority of Praluent versus usual care
in 413 people with type 2 diabetes and mixed dyslipidemia at
high CV risk, not adequately controlled with MTD
statins.3 The primary endpoint was percent change in
non-HDL-C from baseline to week 24. Non-HDL-C is
calculated as total cholesterol minus high-density lipoprotein
cholesterol, and provides a single index of all the potentially
atherogenic, apolipoprotein (apo) B-containing lipoproteins,
including LDL, very-low-density lipoprotein (VLDL),
intermediate-density lipoprotein (IDL), and
lipoprotein(a).
- Praluent was superior to usual care in lowering non-HDL
cholesterol (37.3 percent and 4.7 percent for the usual care arm).
The mean difference between the two treatment arms was 32.5 percent
(p<0.0001).
- Praluent in combination with MTD reduced measured LDL-C
by 43.3 percent from baseline compared to a 0.3 percent increase
for usual care (p<0.0001).
- Treatment with Praluent also improved the overall lipid
profile.
- Praluent was generally well-tolerated. The
most frequent TEAEs included urinary tract infection, diarrhea, and
nasopharyngitis.
- There was no impact on glycemic control observed as
assessed by fasting plasma glucose (FPG), A1C and glucose lowering
treatments remained stable over time in both treatment
groups.
In the previously reported results from the ODYSSEY LONG
TERM study in which all patients were treated with Praluent 150 mg
on top of MTD statins, Praluent reduced LDL-C by 60 percent from
baseline in patients with diabetes (n=545) at week
24.4
The recommended starting dose of Praluent is 75 mg
administered subcutaneously every 2 weeks, or alternatively 300 mg
every 4 weeks (monthly) for patients who prefer less frequent
dosing. The majority of patients taking Praluent achieve sufficient
LDL-C reduction with the 75 mg dose. If the LDL-C response is
inadequate, the dosage may be adjusted to the maximum dosage of 150
mg administered every 2 weeks.
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
results in lower LDL-C levels in the blood.
Praluent is approved in more than 50 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 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.
The effect of Praluent on CV morbidity and mortality has not yet
been determined. ODYSSEY OUTCOMES is prospectively evaluating the
effect of Praluent on the occurrence of CV events in approximately
18,000 patients who have experienced an acute coronary
syndrome.
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.
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 Sanofi
Sanofi, a global
healthcare leader, discovers, develops and distributes therapeutic
solutions focused on patients' needs. Sanofi is organized into five
global business units: Diabetes and Cardiovascular, General
Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and
Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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 the past 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, and
infectious and rare diseases.
Regeneron is accelerating and improving the traditional
drug development process through its unique VelociSuite®
technologies 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.
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 regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related litigation and the ultimate
outcome of such litigation, and volatile economic conditions, as
well as those risks 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, 2016.
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, risks associated with
intellectual property of other parties and pending or future
litigation relating thereto, including the patent litigation
relating to Praluent® (alirocumab) Injection, the
permanent injunction granted by the United States District Court
for the District of Delaware that,
if upheld on appeal, would prohibit Regeneron and Sanofi from
marketing, selling, or commercially manufacturing Praluent in
the United States, the outcome of
any appeals regarding such injunction, the ultimate outcome of such
litigation, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition; 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; 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 prospectively assessing the
potential of Praluent to demonstrate cardiovascular benefit;
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); 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; and 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 cancelled or terminated without
any further product success. 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,
2016 and its Form 10-Q for the quarterly period ended
March 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).
Contact
Sanofi:
|
|
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Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
Mobile: +1 (908)
205-2572
Ashleigh.Koss@sanofi.com
|
Mai Tran
Tel: +33 1 5377 46
46
Mobile: +33 6 87 05
17 80
mr@sanofi.com
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Investor
Relations
George
Grofik
Tel. +33 (0) 1 53 77
45 45
ir@sanofi.com
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Contact
Regeneron:
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Media
Relations
Arleen
Goldenberg
Tel: + 1 (914)
847-3456
Mobile: +1 (914)
260-8788
Arleen.Goldenberg@regeneron.com
|
Investor
Relations
Manisha Narasimhan,
Ph.D.
Tel: 1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
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References:
- American Heart Association Cardiovascular Disease and
Diabetes. April 2017.
http://www.heart.org/HEARTORG/Conditions/More/Diabetes/WhyDiabetesMatters/Cardiovascular-Disease-Diabetes_UCM_313865_Article.jsp/#.WRXYVFXyvIU.
Accessed June 2017.
- Cariou B., Leiter LA,
Müller‑Wieland D, et al. Efficacy
and safety of alirocumab in insulin-treated patients with type 1 or
type 2 diabetes and high cardiovascular risk: Rationale and design
of the ODYSSEY DM–INSULIN trial. Diabetes
Metab (2017),
http://www.diabet-metabolism.com/article/S1262-3636(17)30008-3/fulltext.
- Müller‑Wieland, Leiter LA,
Cariou B, et al. Design and rationale of the ODYSSEY
DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of
alirocumab in individuals with type 2 diabetes and mixed
dyslipidaemia at high cardiovascular risk. Cardiovasc
Diabetol (2017);16:70, DOI
10.1186/s12933-017-0552-4.
- Colhoun HM, Ginsberg HN, Leiter LA, et al. Efficacy and
safety of alirocumab in individuals with diabetes: analyses from
the ODYSSEY LONG TERM study. Diabetologia (2015);58 (Suppl
1):S79-S80.
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