New Data Support Flexibility in Timing of Administration for Sanofi's Lyxumia(R)

PR55235

PARIS, Dec. 5 /PRN=KYODO JBN/ --

- Similar glucose lowering effect when once-daily Lyxumia

is administered before breakfast or the main meal -

Sanofi (EURONEXT : SAN and NYSE : SNY) announced today the results of a 24-week

Phase IIIb clinical study showing that Lyxumia(R) (lixisenatide) met the

primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when

administered either before breakfast or the main meal of the day. These results

indicate that lixisenatide can effectively lower blood sugar at either time of

administration.

"Helping patients reach their HbA1c goal is the main objective of type 2

diabetes treatment," said Professor Bo Ahren, Faculty of Medicine, Lund

University, Sweden. "Flexibility in timing of administration is also an

important attribute, especially for injectable diabetes therapies. This study

shows that once-daily lixisenatide meets these criteria, which is significant

for an agent that is prescribed for use in combination with existing treatment

regimens."

The results also showed that a comparable reduction in body weight, regardless

of the meal before which lixisenatide was administered, was achieved. In

addition, gastrointestinal tolerability was comparable regardless of time of

administration, with no cases of severe hypoglycemia in either arm. The data

were shared during an oral presentation at the World Diabetes Congress 2013 in

Melbourne, Australia.

Results of Analysis

The 24-week Phase IIIb study examined 451 patients with type 2 diabetes,

uncontrolled on metformin alone, randomized to lixisenatide either prior to the

main meal or prior to breakfast. Lunch (as defined by questioning patients) was

the main meal of the day for 53% of patients.

The primary endpoint of the study, demonstrating non-inferiority in HbA1c

decrease at 24 weeks from baseline when lixisenatide was injected prior to the

main meal of the day vs. breakfast, was successfully achieved with mean HbA1c

reductions of 0.65% and 0.74% respectively. In addition, 43.6% of patients in

the main meal group and 42.8% in the breakfast group achieved HbA1c below 7%.

The mean change in body weight was -2.6kg in the main meal group and -2.8kg in

the breakfast group. Gastrointestinal tolerability was comparable between the

two groups (nausea 14.7% and 15.5% and vomiting 2.7% and 3.5%, respectively)

and the incidence of symptomatic hypoglycemia was low in both groups, with no

severe cases.

This study abstract is entitled: 'Flexibility in timing of lixisenatide

administration prior to either the main meal of the day or the breakfast in

T2DM patients' (Ahren B, et al. Oral presentation December 5, 2013, 10:45-12:45

[ABS OP-0454]).

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 is approved in Europe 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 also approved in Mexico, Australia, Japan, Brazil, Colombia and

Chile for the treatment of adults with type 2 diabetes. 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 a number of innovative design awards,

including 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, an integrated 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).

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, 2012. 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