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Sanofi Announces the CE Mark for JuniorSTAR®, a New Half-Unit Insulin Reusable Pen for People with Type 1 Diabetes

Geschrieben am 26-09-2013

Paris (ots/PRNewswire) -

Sanofi announced today at the 49th Annual Meeting of the European
Association for the Study of Diabetes (EASD), Barcelona, the CE Mark
of JuniorSTAR(R), a new halfunit insulin reusable pen that can be
used with Lantus(R) (insulin glargine), Apidra(R) (insulin glulisine)
or Insuman(R) (recombinant human insulin). Delivering from 1 to 30
units per injection, JuniorSTAR(R) is an easy-to-use lightweight pen
with a large dose display and a single-step dial back that does not
leak insulin. JuniorSTAR(R) has been developed and is manufactured by
Sanofi's partner Haselmeier GmbH, Stuttgart, Germany.

"Everyone deserves high-quality care while learning to manage
their diabetes, for the best chances in life," said Pierre Chancel,
Senior Vice President, Global Diabetes, Sanofi. "With JuniorSTAR(R),
we aim to meet the needs of type 1 patients worldwide, specifically
the younger ones, who need an easy-to-use pen device. This is a
welcome addition to our comprehensive portfolio of established
insulins, which leads the way in personalized diabetes care."

Half-unit dose increment pens provide flexibility to achieve
target insulin doses especially in young patients with diabetes.
JuniorSTAR(R) has been tested by people with type 1 diabetes (6 to 18
years old), parents and nurses in a non-comparative survey with 167
insulin pen users from five European countries[1]:


- 81% of patients/parents and 86% of nurses agreed it is easy to carry on a
daily basis, due to its light weight (approximately 34 grams)
- 98% of patients/parents and 94% of nurses agreed it is easy to read due to its
large dose display and legible numbers
- Additionally, 91% of patients/parents and 89% of nurses agreed that dialling
back was easy due to its single-step dial back, a feature that avoids insulin leakage
- Overall, 93% of survey participants agreed on its ease of use.


A rising number of people with type 1 diabetes are being diagnosed
worldwide at an increasingly younger age[2]. People with diabetes
deserve the best support to meet their needs and Sanofi is committed
to providing efficient and simplified care to lighten the lives of
young people living with type 1 diabetes with a comprehensive
treatment portfolio, which includes established insulins, optimized
insulin pens, innovative blood glucose monitoring systems and
tailored patient support.

JuniorSTAR(R) meets the new ISO 11608-1 2012 standard, passed all
requirements for robustness and dose accuracy, and is in three
different colors (blue, red and silver) for flexibility and insulin
differentiation.

JuniorSTAR(R) is expected to become available in Europe during
2014.

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.[2]

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 and in New
York .

About Haselmeier

Haselmeier is a leading designer and manufacturer of pen and
auto-injection systems. The Company's devices feature unique
function, design and technology and are marketed by leading
pharmaceutical and biotechnology companies around the world. For more
information please visit http://www.haselmeier.com.

References:


1) Klonoff D et al., Evaluation of the JuniorSTAR(R) half-unit insulin pen
in young people with type 1 diabetes - user perspectives. European Endocrinology.
2013; 9(2):82-5.
2) International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: 2012
update. Brussels, Belgium, 2011. http://www.idf.org/diabetesatlas (accessed: June,
2013)


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.

ots Originaltext: Sanofi Diabetes
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Corporate Media Relations: Jack Cox, Tel.: +33-1-53-77-45-02,
jack.cox@sanofi.com ; Investor Relations: Sébastien Martel, Tel.:
+33-1-53-77-45-45, ir@sanofi.com ; Global Diabetes Division
Communications,
Tilmann Kiessling, Tel.: +49-172-615-9291,
tilmann.kiessling@sanofi.com ;
Marketing Haselmeier GmbH : Nadia Di Secli, Tel.: +41-44-250-52-40,
n.secli@haselmeier.com


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