Sanofi to Present New Clinical Data at American Diabetes Association 74th Scientific Sessions
Sanofi to Present New Clinical Data at American Diabetes Association 74th Scientific Sessions
PR57011
PARIS, France, June 11 /PRN=KYODO JBN/ --
- New results for Toujeo(R)(insulin glargine [rDNA origin] injection, 300
U/mL; "U300") from EDITION I/II/III meta-analysis, EDITION III, IV, JP 1 and JP
2 studies are among over 65 abstracts to be presented -
Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that new data on U300,
Lyxumia(R) (lixisenatide) and Lantus(R) will be presented at the American
Diabetes Association (ADA) 74th Scientific Sessions in San Francisco, June
13,'17. Abstracts are available on the ADA website
[http://professional.diabetes.org/Congress_Display.aspx?TYP=9&CID=93229 ].
Eight abstracts from the EDITION Phase III program for U300 will be
presented. The worldwide and comprehensive EDITION program evaluated, in broad
and diverse populations of people with diabetes, the efficacy and safety of
U300 vs. Lantus(R). Following presentation of EDITION I[1] and II[2] results in
2013, a meta-analysis of EDITION I/II/III; full results from the other four
studies in the EDITION program; and year one results from EDITION I and II
showing the first longer-term data for U300, will be presented at ADA 2014.
More than 55 additional abstracts from across the Sanofi Diabetes portfolio
will also be presented. Data highlights from lixisenatide, the fixed-ratio
combination of lixisenatide and Lantus(R), Lantus(R), and the TEENs study are
listed below.
Data highlights
- Abstract # 90-LB: New Insulin Glargine 300 U/mL: Glycemic Control and
Hypoglycemia in a Meta-analysis of Phase 3a EDITION Clinical Trials in
People with T2DM
- Abstract # 68-OR: New Insulin Glargine 300 U/mL: Glycemic Control and
Hypoglycemia in Insulin Naive People with T2DM (EDITION 3)
- Abstract # 80-LB: Glycemic Control and Hypoglycemia with New Insulin
Glargine 300U/mL in People with T1DM (EDITION 4)
- Abstract # 88-LB: New Insulin Glargine 300 U/mL: Glycemic Control and
Hypoglycemia in Japanese People with T1DM (EDITION JP 1)
- Abstract # 94-LB: Glycemic Control and Hypoglycemia in Japanese People
with T2DM Receiving New Insulin Glargine 300 U/mL in Combination with
OADs (EDITION JP 2)
- Abstract # 81-LB: Sustained Glycemic Control and Less Hypoglycemia with
New Insulin Glargine 300 U/mL Compared with 100 U/mL: 1-Year Results in
People with T2DM Using Basal + Mealtime Insulin (EDITION 1)
- Abstract # 93-LB: Less Nocturnal Hypoglycemia and Weight Gain with New
Insulin Glargine 300 U/mL Compared with 100 U/mL: 1-Year Results in
People with T2DM Using Basal Insulin with OADs (EDITION 2)
- Abstract # 892-P: Low Within- and Between-Day Variability in Exposure to
New Insulin Glargine 300 U/mL
- Abstract # 919-P: New Insulin Glargine 300 U/mL: Efficacy and Safety of
Adaptable vs. Fixed Dosing Intervals in People with T2DM
Data highlights
16 abstracts (including 1 publication-only) will be presented on
lixisenatide, including:
- Abstract # 1017-P: Effect of Lixisenatide vs. Liraglutide on Glycemic
Control, Gastric Emptying, and Safety Parameters in Optimized Insulin
Glargine T2DM plus or minus Metformin
- Abstract # 118-LB: Effectiveness of Lixisenatide Before Breakfast or the
Main Meal Using CGM with AGP Analysis
2 abstracts will be presented on the fixed-ratio combination of
lixisenatide and Lantus(R), including:
- Abstract # 332-OR: Benefits of a Fixed-Ratio Formulation of Once-Daily
Insulin Glargine/Lixisenatide (LixiLan) vs. Glargine in Type 2 Diabetes
(T2DM) Inadequately Controlled on Metformin
27 abstracts will be presented on Lantus(R), including:
- Abstract # 6-LB: Enhanced Prediction of Cardiovascular Events By Adding
Novel Biomarkers to Clinical Risk Factors in the ORIGIN Trial
3 abstracts for the first global presentation of the TEENs study results
will be presented, including:
- Abstract # 32-OR: Global Assessment of Factors Associated with Target
Glycemic Control in Youth with Type 1 Diabetes (T1D): the TEENs Study
About Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL)
Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL; "U300") is a
new basal insulin currently in development for the treatment of people with
diabetes mellitus. U300 has a pharmacokinetic and pharmacodynamic profile with
studies demonstrating it is smoother and more prolonged than Lantus(R).[3-6]
Toujeo(R) is the intended trade name for U300. U300 is not currently approved
or licensed anywhere in the world.
About Lyxumia(R) (lixisenatide)
Lyxumia(R) (lixisenatide) is a once-daily prandial glucagon-like peptide-1
receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes
mellitus. GLP-1 is a naturally-occurring peptide hormone that is released
within minutes after eating a meal. It is known to suppress glucagon secretion
from pancreatic alpha cells and stimulate glucose-dependent insulin secretion
by pancreatic beta cells.
Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen:
ZEAL), http://www.zealandpharma.com and was approved in Europe in 2013 for the
treatment of adults with type 2 diabetes mellitus to achieve glycemic control
in combination with oral glucose-lowering medicinal products and/or basal
insulin when these, together with diet and exercise, do not provide adequate
glycemic control. Lyxumia is currently approved in over 40 countries worldwide
for the treatment of adults with type 2 diabetes, with commercial launches in
Europe, Japan, Mexico and other markets. Sanofi plans to resubmit the New Drug
Application for lixisenatide in the United States in 2015, after completion
of the ELIXA cardiovascular outcomes study. Lyxumia is the proprietary name
approved by the European Medicines Agency and other health authorities for the
GLP-1 RA lixisenatide.
The Lyxumia pen is the winner of the Good Design Award 2012 and the iF
Product Design Award. The variant of the Lyxumia pen used in Japan won the Good
Design Award (G Mark) 2013.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by
delivering innovative, integrated and personalized solutions. Driven by
valuable insights that come from listening to and engaging with people living
with diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services, and devices including blood glucose monitoring systems.
Sanofi markets both injectable and oral medications for people with type 1 or
type 2 diabetes.
About Sanofi
Sanofi, a 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).
References
1) Riddle M, et al. New insulin glargine formulation: glucose control and
hypoglycaemia in people with type 2 diabetes using basal and mealtime
insulin (EDITION I). Diabetologia. 2013;56 (Suppl 1):A220.
2) Yki-Jarvinen et al. An investigational new insulin U300: glucose control
and hypoglycemia in people with type 2 diabetes on basal insulin and
OADs (EDITION II). Abstract at World Diabetes Congress 2013. Oral
presentation OP0075 Abstract.
3) Dahmen R et al New Insulin Glargine U300 Formulation Evens and Prolongs
Steady State PK and PD Profiles During Euglycemic Clamp in Patients With
Type 1 Diabetes (T1DM). 73rd Scientific Sessions of the ADA, abstract
no. 113-OR.
4) Tillner J, et al. Euglycaemic single dose clamp profile of new insulin
glargine formulation in subjects with type 1 diabetes is flat and
prolonged. Diabetologia. 2013;56 (Suppl 1):A1033.
5) Jax T, et al. New insulin glargine formulation has a flat and prolonged
steady state profile in subjects with type 1 diabetes. Diabetologia.
2013;56 (Suppl 1):A1029.
6) Shiramoto M, et al. Single dose of new insulin glargine Gla-300
formulation has a flatter and prolonged PK/PD profile than Gla-100 in
Japanese subjects with type 1 diabetes. Diabetologia. 2013;56 (Suppl
1):A1031.
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
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Sanofi's management believes that the expectations reflected in such
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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,
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therapeutic alternatives, the Group's ability to benefit from external growth
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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, 2013. Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information or
statements.
SOURCE: Sanofi Diabetes
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