Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia(r) (lixisenatide)
March 19 2015 - 02:11AM
Sanofi announced today top-line results of the Phase IIIb ELIXA
cardiovascular outcomes study, which compared lixisenatide to
placebo in a high-risk population of adults with type 2 diabetes
evaluating cardiovascular safety. The study showed that
lixisenatide was non-inferior, although not superior, to placebo
for cardiovascular safety.
ELIXA full results will be presented Monday,
June 8, 2015, at the American Diabetes Association 75th Scientific
Sessions in Boston by the ELIXA steering committee, chaired by Dr.
Marc Pfeffer. The results will also be included in the U.S. New
Drug Application of lixisenatide, which is on track to be
resubmitted to the U.S. Food and Drug Administration in the
third-quarter of 2015. Lixisenatide is not approved in the United
States.
"The completion of the ELIXA study is a
significant milestone for lixisenatide, which is the first GLP-1
receptor agonist with long-term cardiovascular safety data in
people with diabetes who have high cardiovascular risk," said Dr.
Elias Zerhouni, President, Global R&D at Sanofi. "Sanofi looks
forward to submitting the results to health authorities
worldwide."
About ELIXA ELIXA (Evaluation of
Cardiovascular Outcomes in Patients With Type 2 Diabetes After
Acute Coronary Syndrome During Treatment With Lixisenatide) is the
first event-driven cardiovascular outcomes study to provide data
for a glucagon-like peptide-1 receptor agonist (GLP-1 RA). ELIXA
was a randomized, double-blind, parallel group trial designed to
evaluate cardiovascular risk, comparing lixisenatide to placebo in
a high-risk population of adults with type 2 diabetes. More than
6,000 adults with type 2 diabetes and high CV risk (i.e., patients
who have recently experienced a spontaneous acute coronary syndrome
event) participated in the trial. The composite primary endpoint,
which was evaluated for non-inferiority and superiority, comprised
cardiovascular (CV) death, non-fatal myocardial infarction,
non-fatal stroke, or hospitalization for unstable angina. The
global ELIXA study started in June 2010 and was completed in
2015.
About Lixisenatide Lixisenatide is a
once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1
RA) for the treatment of adult 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.
Lixisenatide was in-licensed from Zealand Pharma
A/S (NASDAQ OMX Copenhagen: ZEAL), 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. Lixisenatide is currently approved in over 50
countries worldwide for the treatment of adults with type 2
diabetes, with commercial launches in some European countries,
Japan, Brazil, Mexico and other markets. Lyxumia is the proprietary
name approved by the European Medicines Agency and other health
authorities for the GLP-1 RA lixisenatide. The proprietary name in
the U.S. is under consideration.
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 injectable, inhaled 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 Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).
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.
Contacts:
Media Relations Jack Cox Tel.: + (33) 1 53 77 46 46
mr@sanofi.com |
Investor Relations
Sébastien Martel Tel.: + (33) 1 53 77 45 45 ir@sanofi.com |
Global
Diabetes Communications Philip McNamara Tel.: +1 908 981 5497
philip.mcnamara@sanofi.com |
U.S.
Diabetes Communications Susan Brooks Office: +1 (0) 908 981
6566 Mobile: +1 (0) 201 572 49 94 susan.brooks@sanofi.com |
Press release (PDF)
http://hugin.info/152918/R/1904474/677490.pdf
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