Sanofi to Present New Clinical Data, Including Results From the Investigational New Insulin U300, at the American Diabetes Association 73rd Scientific

Sanofi Diabetes

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Sanofi to Present New Clinical Data, Including Results From the Investigational New Insulin U300, at the American Diabetes Association 73rd Scientific Sessions

PARIS, June 18/PRN=KYODO JBN/ --

    Sanofi (EURONEXT : SAN and NYSE : SNY) announced today that clinical data

highlighting the company's ongoing commitment to advancing diabetes care will

be presented at the American Diabetes Association (ADA) 73rd Scientific

Sessions in Chicago, USA (June 21 - 25, 2013). In total, more than 60

abstracts representing new data sets on Sanofi diabetes drugs, investigational

drugs or medical devices are part of the official scientific program.

    "The American Diabetes Association annual meeting provides an important

opportunity for Sanofi to share significant data with the medical community and

to demonstrate our focus on advancing scientific thinking in the field of

diabetes treatment," said Pierre Chancel, Senior Vice President, Global

Diabetes at Sanofi. "The data being presented further support the company's

leadership in integrated diabetes care and delivering personalized solutions

that directly target the needs of people living with this disease."

    Among the study findings being presented in poster and oral scientific

sessions are the following (abstracts have been posted on the ADA website):

    Investigational new insulin U300

    The EDITION I study compared the efficacy and safety of investigational new

insulin U300 vs. Lantus(R) (insulin glargine) in people with type 2 diabetes

using basal plus mealtime insulin. The EDITION I study is part of a larger

Phase III clinical program.

    

    "New insulin glargine formulation: glucose control and hypoglycemia in

people with type 2 diabetes using basal and mealtime insulin (EDITION I)"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      M. Riddle, Oregon Health and Science University,

Portland,                    

                    USA

    Location:       Poster Hall

    The pharmacodynamic and pharmacokinetic properties of the investigational

new insulin U300 were examined in a double-blind, randomized study in patients

with type 1 diabetes:

  

    "Euglycemic clamp profile of new insulin glargine U300 formulation in

patients with type 1 diabetes (T1DM) is different from glargine U100"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      R. Dahmen, Sanofi, Frankfurt am Main, Germany

    Location:       Poster Hall (also available as an ePoster on the ADA

website

                    after 10 am, June 22)

    

    "New insulin glargine U300 formulation evens and prolongs steady state PK

and PD profiles during euglycemic clamp in patients with type 1 diabetes (T1DM)"

    Embargo lifts:  Saturday, June 22, 1:45 pm CST

    Presenter:      T. Jax, Profil, Neuss, Germany

    Location:       W-375A

    Lyxumia(R) (lixisenatide)*

    Lyxumia(R), the first once-daily prandial GLP-1 receptor agonist, is

approved in the European Union 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(R) data include two analyses investigating its post-prandial

mechanism of action:

    

    "Once-daily lixisenatide as add-on to basal insulin plus or minus OADs in

patients with type 2 diabetes selectively reduces postprandial hyperglycemic

daytime exposure"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      M. Riddle, Oregon Health and Science University, Portland,

                    USA

    Location:       Poster Hall (also available as an ePoster on the ADA

                    website after 10 am, June 22)

    

    "Efficacy of lixisenatide in the GetGoal clinical trial program: pooled

analysis of postprandial metabolic outcomes"

    B. Ahren, Lund University, Sweden. Abstract publication only.

    Further data include analyses of the effects of Lyxumia(R) in combination

with basal insulin on HbA1c, weight gain and symptomatic hypoglycemia in

patients with type 2 diabetes:

    

    "Expanding the basal-plus regimen: basal insulin + lixisenatide is more

likely to achieve the composite outcome of HbA1c <7%, no documented symptomatic

hypoglycemia and no weight gain compared with basal + prandial insulin"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      J. Rosenstock, Dallas Diabetes & Endocrine Center, Texas,

                    USA

    Location:       Poster Hall (also available as an ePoster on the ADA

                    website after 10 am, June 22)

    "Meta-analysis of randomized controlled trials of lixisenatide as add-on to

basal insulin in patients with type 2 diabetes mellitus"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      B. Charbonnel, University of Nantes, France

    Location:       Poster Hall (also available as an ePoster on the ADA

                    website after 10 am, June 22)

    ORIGIN (Outcome Reduction with Initial Glargine INtervention)[1]

    ORIGIN is a unique, seven-year landmark cardiovascular (CV) outcomes trial,

evaluating Lantus(R) vs. standard care in over 12,500 individuals who are at

high CV risk with pre-diabetes or early type 2 diabetes mellitus. Spanning 40

countries worldwide, it is the world's longest and largest randomized clinical

trial of its type in this population, and the first to formally evaluate the

effects of insulin on CV outcomes.

    Results from a new sub-analysis of ORIGIN will be presented:

    

    "Cancer outcomes in patients with dysglycemia on basal insulin: results of

the ORIGIN trial"

    Embargo lifts:  Monday, June 24, 8 am CST

    Presenter:      LJ. Bordeleau, McMaster University, Ontario, Canada

    Location:       S-103B

    ATLAS (Asian Treat to Target Lantus(R) Study)

    The ATLAS study compared the effectiveness of a patient-led vs.

physician-led initiation of Lantus(R) in 552 patients with type 2 diabetes in

Asia and Russia. Due to the specific challenges faced by people living with

diabetes in Asia, this study investigated whether self-adjustment of insulin in

this population is similarly effective at lowering blood glucose levels as it

is in Western diabetes patients.

    Data from ATLAS includes:

    

    "Asian Treat to Target Lantus Study (ATLAS): a 24 week randomized,

multinational study"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      S. Garg, University of Colorado Health Sciences Center,

                    Denver, Colorado, USA

    Location:       Poster Hall

    "Evaluating the patient experience in the Asian Treat to Target Lantus

Study (ATLAS): a 24-week randomized, multinational study"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      N. Freemantle, University College London, UK

    Location:       Poster Hall

    BGStar(R)

    Now available in 14 countries across four continents, our intuitive blood

glucose monitoring (BGM) devices BGStar(R) and iBGStar(R) form a key part of

our comprehensive patient-centric portfolio and are at the heart of our

integrated approach to diabetes.

    Key BGStar(R) data show that the performance of our self-monitoring BGM

device achieves similar system accuracy as point of care testing systems for

professional use:

    

    "Evaluating system accuracy of blood glucose monitoring systems for point

of care testing"

    Embargo lifts:  Saturday, June 22, 10 am CST

    Presenter:      G. Freckmann, Institut fuer Diabetes-Technologie

                    Forschungs- und Entwicklungsgesellschaft mbH an der

                    Universitat Ulm, Germany

    Location:       Poster Hall (also available as an ePoster on the ADA

                    website after 10 am, June 22)

    Sanofi will host a conference call for the financial community during the

upcoming ADA 73rd Scientific Sessions. The call will include results from the

ongoing EDITION Phase III program for the company's investigational new insulin

U300 as well as a status update on the fixed-ratio combination of insulin

glargine and lixisenatide.

    The conference call will take place on Monday June 24, 2013, at 7 am CST (2

pm CET). Dial-in numbers and the audio webcast link will be accessible via

http://www.sanofi.com

    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, 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).

    Footnote

    *Lixisenatide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), was

in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL),

http://www.zealandpharma.com, and is approved in Europe, Mexico and Australia

for the treatment of patients with type 2 diabetes mellitus. Lyxumia is the

proprietary name approved by the EMA, Australia and Mexico, and submitted to

other health authorities for the GLP-1 RA lixisenatide. The proprietary name

for lixisenatide in the United States is under consideration.

    References

    1. Gerstein H (ORIGIN Trail Investigators) et al. Basal Insulin and

Cardiovascular and Other Outcomes in Dysglycemia. New England Journal of

Medicine 2012; 367: 319-328.

    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 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

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