Sanofi and Regeneron Announce Positive Results from First Dedicated Studies Evaluating Praluent® (alirocumab) in Individuals with Diabetes and Hypercholesterolemia
(Thomson Reuters ONE) -
Sanofi and Regeneron Announce Positive Results from First Dedicated Studies
Evaluating Praluent(®) (alirocumab) in Individuals with Diabetes and
Hypercholesterolemia
- Data presented at the 77(th) Scientific Sessions of the American Diabetes
Association (ADA) -
Paris, France and Tarrytown, N.Y., June 11, 2017 - 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 77(th)
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 (at)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:
Media Relations Mai Tran
Ashleigh Koss Tel: +33 1 5377 46 46
Tel: +1 (908) 981-8745 Mobile: +33 6 87 05 17 80
Mobile: +1 (908) 205-2572 mr(at)sanofi.com
Ashleigh.Koss(at)sanofi.com
Investor Relations
George Grofik
Tel. +33 (0) 1 53 77 45 45
ir(at)sanofi.com
Contact Regeneron:
Media Relations Investor Relations
Arleen Goldenberg Manisha Narasimhan, Ph.D.
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
References:
1. American Heart Association Cardiovascular Disease and Diabetes. April 2017.
http://www.heart.org/HEARTORG/Conditions/More/Diabetes/WhyDiabetesMatters/Ca
rdiovascular-Disease-Diabetes_UCM_313865_Article.jsp/#.WRXYVFXyvIU. Accessed
June 2017.
2. 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.
3. 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.
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.
Press release (PDF):
http://hugin.info/152918/R/2112332/803404.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 11.06.2017 - 17:01 Uhr
Sprache: Deutsch
News-ID 547290
Anzahl Zeichen: 23697
contact information:
Town:
PARIS
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 418 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Sanofi and Regeneron Announce Positive Results from First Dedicated Studies Evaluating Praluent® (alirocumab) in Individuals with Diabetes and Hypercholesterolemia"
steht unter der journalistisch-redaktionellen Verantwortung von
Sanofi (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
