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Sanofi announces upcoming launch of MyStar Extra®, the first self- monitoring blood glucose meter with estimated A1c

Geschrieben am 25-09-2013

Paris (ots) -

- CE marks obtained for MyStar Extra® and MyStar SylkFeel® lancing
device, respectively, enabling commercialization in the European
Union

- Scientific data presented at EASD 2013 demonstrate robustness
and accuracy[i],[ii] of estimated A1c algorithm in MyStar Extra®

At the annual meeting of the European Association for the Study of
Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE
: SNY) presented today the innovative blood glucose meter MyStar
Extra®, the first self- monitoring device that provides robust
estimates of the A1c value, a key indicator for long-term glucose
control.[iii],[iv] The hemoglobin A1C (HbA1C) assay has become the
cornerstone for the assessment of diabetes control and A1c test
results are widely used to guide treatment decisions.[v],[vi]
Especially convenient for people starting on insulin or using
insulin, MyStar Extra® is a supportive meter, designed to help people
with diabetes be engaged in their insulin management and treatment
plan.[vii],[viii],[ix]

Scientific data confirm accuracy of A1c estimates

The estimated A1c function of MyStar Extra® is based on a new A1c
estimation method tracking average glycemia from self-monitoring data
stored in the device. Scientific data presented at EASD 2013 show
that the estimation procedure used in MyStar Extra® provides accurate
estimates of the long-term average blood glucose value.1,2 "The major
advantage of this method is that it can work with infrequent
self-monitoring data, for example fasting blood glucose readings and
occasional daily profiles, and still provide reliable estimations
where other techniques could fail. In-silico studies confirmed that
the dynamical estimation procedure of MyStar Extra® tracks accurately
the changes in average glycemia underlying the changes in A1c," said
Dr Boris Kovatchev, Professor at the University of Virginia's School
of Medicine and School of Engineering and Applied Science and
Director of the UVA's Center for Diabetes Technology, on the occasion
of the Sanofi Diabetes press briefing at EASD titled "On the right
track with MyStar Extra®: New blood glucose meter provides estimated
A1c and comprehensive guidance for people with diabetes".

Fasting plasma glucose (FPG) trends and a three-day FPG average
provided

MyStar Extra® is especially convenient for people starting on or
already using insulin as it provides additional blood glucose
information on overall glucose control such as three-, seven- and
thirty-day fasting plasma glucose averages and fasting plasma glucose
trends. The three-day FPG average is an important parameter for
insulin titration.[x] These supportive features may help patients
keep track of how their therapy is working for them so they stay
motivated to achieve their treatment targets for the prevention of
diabetes complications.

Experts agree support and motivation key to improve diabetes self-
care

"People with diabetes need to actively manage their diabetes to
achieve good blood sugar control. Support and guidance through new
technologies in self-monitoring of blood glucose can increase
patients' motivation to stay on track - and motivation is very
important in a chronic disease like diabetes. What's more, several
studies have shown that ongoing feedback of one's A1c may really help
people to see the value of diabetes self-care and ultimately improve
diabetes control", said Dr William Polonsky, Associate Clinical
Professor in Psychiatry at the University of California, San Diego,
and Founder and President of the Behavioral Diabetes Institute.

At the Sanofi press briefing the diabetes experts agreed that
simple illustrations of therapy progress can also contribute to
improved diabetes care and better health outcomes for people with
diabetes, particularly for people starting on or already using
insulin.

"At Sanofi, our aim is to truly understand the needs of people
with diabetes and to provide efficient, simple tools and guidance
that help improve living with and treating diabetes", said Pierre
Chancel, Senior Vice President, Sanofi, Global Diabetes. The upcoming
launches of MyStar Extra® and MyStar SylkFeel® underscore Sanofi's
commitment to provide innovations and integrated solutions to enhance
diabetes self-care."

The CE marks were obtained by AgaMatrix Inc. for MyStar Extra® and
HTL-STREFA S.A. for MyStar SylkFeel®, respectively, the legal
manufacturers of the devices and Sanofi's partners in the development
of these products. MyStar SylkFeel® is a new lancing device that
provides easy to use and gentle lancing with no vibration so it is
less painful for people with diabetes to perform blood sugar testing.
In addition, adjustable penetration depths and a safety ejector allow
for convenient and safe testing.[xi]

Now approved in Europe, MyStar Extra® and the new lancing device
MyStar SylkFeel® will be available in selected European countries
starting in the last quarter of 2013. They will complement the new
MyStar® portfolio of Sanofi, combining devices, services and guidance
for simple and effective diabetes management.

About Diabetes

Diabetes is a chronic disease that occurs as type 1 diabetes,
which is an autoimmune disease characterized by the lack of insulin
(the hormone that regulates blood glucose concentrations) production
by the pancreas, and type 2, a metabolic disorder in which there are
two main biological defects: a deficient production of insulin and
reduced ability of the body to respond to the insulin being produced.
Type 1 and type 2 diabetes are characterized by an increase in blood
glucose concentrations (hyperglycemia). Over time, uncontrolled
hyperglycemia leads to the macrovascular and microvascular
complications of diabetes. Macrovascular complications, which affect
the large blood vessels, include heart attack, stroke and peripheral
vascular disease. Microvascular complications affect the small blood
vessels of the eyes (retinopathy), kidney (nephropathy) and nerves
(neuropathy). The global incidence of diabetes is growing at an
alarming rate, with more than 371 million people worldwide living
with the condition today.[xii]

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 and diversified 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. 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.

References:

[i] Kovatchev B, Flacke F, Sieber J, Breton M "Accuracy of Dynamical
Real-Time Estimation of A1c Using Routine Self-Monitoring Blood
Glucose (SMBG) Data." Poster presented at EASD 2013.

[ii] Breton M, Flacke F, Sieber J, Kovatchev B "Robustness of
Dynamical Real-Time Estimation of A1c Using Routine Self-Monitoring
of Blood Glucose (SMBG) Data." Poster presented at EASD 2013.

[iii] The Diabetes Control and Complications Trial Research Group.
The effect of intensive treatment of diabetes on the development and
progression of long-term complications in insulin-dependent diabetes
mellitus. N Engl J Med. 1993; 329: 977-86.

[iv] UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-
glucose control with sulphonylureas or insulin compared with
conventional treatment and risk of complications in patients with
type 2 diabetes (UKPDS 33). The Lancet. 1998; 352: 837-53.

[v] American Diabetes Association. Standards of medical care in
diabetes. Diabetes Care. 2010; 33:S 11-61.

[vi] UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-
glucose control with sulphonylureas or insulin compared with
conventional treatment and risk of complications in patients with
type 2 diabetes (UKPDS 33). The Lancet. 1998; 352: 837-53.


[vii] Data on file: MyStar Extra(TM) Blood Glucose Monitoring System
Owner?s Guide.


[viii] Cagliero E, et al. Immediate feedback of HbA1c levels improves
glycemic control in type 1 and insulin-treated type 2 diabetic
patients. Diabetes Care 1999;22:1785?1789.


[ix] Fisher WA et al. What Primary Care Providers Can Do to Address
Barriers to Self-Monitoring of Blood Glucose. Clinical Diabetes
2013;31(1):34-42.


[x] Nathan DM, et al. Medical management of hyperglycaemia in type 2
diabetes mellitus: a consensus algorithm for the initiation and
adjustment of therapy. Diabetologia 2009;52(1):17?30.

[xi] Data on file: HTL-Strefa S.A. 2013.

[xii] International Diabetes Federation. IDF Diabetes Atlas, 5th edn.
Brussels, Belgium: International Diabetes Federation, 2011.
http://www.idf.org/diabetesatlas (Accessed: August 13, 2013).



Contacts:
Media Relations:
Jack Cox
Tel.: + (33) 1 53 77 45 02
mr@sanofi.com

Milena Saleh
Tel.: + (49) 173 68 96 040
Milena.Saleh@sanofi.com

Investor Relations:
Sébastien Martel
Tel.: + (33) 1 53 77 45 45
ir@sanofi.com


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