Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300

AsiaNet 53484

PARIS, June 23, 2013/PRN=KYODO JBN/ --

     - EDITION I demonstrated similar blood sugar control with fewer night-time

       low blood sugar events compared to Lantus(R)-

    - Topline results of EDITION II consistent with EDITION I findings -

    Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the first phase 3

study results (EDITION I) for its investigational new insulin U300 showed

equivalent blood sugar control with fewer night-time low blood sugar events

compared to Lantus(R) (insulin glargine [rDNA origin] injection). The company

also announced topline results of a second Phase 3 study (EDITION II) for

investigational new insulin U300 that also demonstrated similar blood sugar

reduction while fewer patients experienced night-time low blood sugar events

compared with Lantus(R).

    These results are from EDITION I and EDITION II respectively and are part

of the EDITION Phase 3 clinical program evaluating the efficacy and safety of

the investigational new insulin U300 in people with diabetes. The EDITION I

data was presented at the 73rd Scientific Sessions of the American Diabetes

Association.

    "To properly manage diabetes, it is critical to control blood sugar and to

reduce the risk of low blood sugar events, especially at night," said Matthew

Riddle, Professor of Medicine, Division of Endocrinology/Diabetes/Clinical

Nutrition, Oregon Health and Science University, U.S., and Principal

Investigator for the EDITION I study. "I am encouraged by these findings, and

look forward to the results of the full Phase 3 EDITION program, which will

further reveal how this investigational basal insulin may help people living

with diabetes."

    EDITION I

    As the first study of the EDITION Phase 3 program, EDITION I evaluated the

efficacy and safety of investigational new insulin U300, vs. Lantus(R) in

people with type 2 diabetes using basal plus mealtime insulin. In a

multicenter, open-label study 807 people were randomized (1:1) to once daily

evening new insulin U300 (n=404) or Lantus(R) (n=403) while continuing mealtime

insulin. The basal insulin was titrated to achieve fasting plasma glucose of

80-100 mg/dL. Primary endpoint was change in HbA1c from baseline to month 6,

and main secondary endpoint was % of people with at least 1 severe or confirmed

(less than or equal to70 mg/dL) nocturnal hypoglycemic event from month 3 to

month 6.

    EDITION I demonstrated similar reductions in HbA1c (glycated hemoglobin)

from baseline (primary endpoint) between new insulin U300 and Lantus(R) at 6

months [least squares mean change -0.83% (0.06) in both groups; difference

-0.00% (95% CI -0.11 to 0.11)] in people with type 2 diabetes who had

challenging treatment needs (mean age of study participants: 60 years; duration

of type 2 diabetes: 15.8 years; BMI: 36.6 kg/m2; HbA1c: 8.15 %; total insulin

dose: 1.2 U/kg; basal insulin dose: 0.67 U/kg at baseline). In addition,

approximately 40% of study participants with uncontrolled glycemic (blood

sugar) levels despite receiving a combined therapy (oral antidiabetic agents

plus basal and prandial insulins) reached glycemic control (HbA1c ＜7%) at month

6 both in the new insulin U300 (39.6%) and in the Lantus(R) arm (40.9%).

    The investigational new insulin U300 was associated with a 21% reduction in

severe or confirmed nocturnal hypoglycemia (low blood sugar) from month 3 to

month 6. Significantly fewer patients had nocturnal (severe and/or confirmed;

i.e. less than or equal to70 mg/mL) hypoglycemia (low blood sugar) during

months 3 to 6 (pre-specified main secondary endpoint: 36.1% vs. 46.0%; RR 0.79;

p=0.0045) and the occurrence of any nocturnal hypoglycemic event (% of people

with at least one event) during the 6-month study period was lower on new

insulin U300 during the study period compared to the Lantus(R) group (45.3% vs.

59.7%; RR 0.76; 95% CI 0.66 to 0.87). New insulin U300 was well-tolerated in

this study, with no differences in other adverse events observed from Lantus(R).

    The EDITION I abstract is titled: New Insulin Glargine Formulation: Glucose

Control and Hypoglycemia in People with Type 2 Diabetes Using Basal and

Mealtime Insulin (EDITION I) (Riddle, MC et al) [Abstract no. 43-LB]

    EDITION II

    Topline results of EDITION II are consistent with EDITION I findings.

EDITION II demonstrated that investigational new insulin U300 achieved similar

blood sugar reduction while fewer patients experienced night-time low blood

sugar events compared with Lantus(R).

    EDITION II evaluated efficacy and safety of new insulin U300 in a type 2

diabetes population (811 patients) treated with basal insulin plus oral

antidiabetic therapy. The full EDITION II results will be submitted for

presentation at upcoming scientific meetings.

    "There remains a substantial unmet need in people with diabetes taking oral

medication or insulin as many of them do not reach their glycemic goals," said

Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "With the

investigational new insulin U300, we are striving to further enhance the

clinical value of basal insulin, while building on the wealth of evidence of

Lantus(R), the world's most prescribed insulin."

    About investigational new insulin U300

    Investigational new insulin U300 is a new formulation based on the glargine

molecule, the biological entity of Lantus(R), with its well established

efficacy and safety profile. However, new insulin U300 has unique

pharmacokinetic and pharmacodynamic profiles with studies demonstrating it has

even flatter and more prolonged profiles than Lantus(R).[1],[ 2] New insulin

U300 also offers the benefit of a smaller volume of subcutaneous injection

compared with Lantus(R).

    About the EDITION Phase 3 Program

    The EDITION program is a worldwide and comprehensive series of Phase 3

studies evaluating the efficacy and safety of new insulin U300 in broader and

diverse populations of people with diabetes. The full EDITION I (basal +

mealtime insulin) and EDITION II (basal Insulin + oral therapy) results are

expected by the end of this year. Additionally, the following Phase 3 studies

from the EDITION program are ongoing: EDITION III in insulin-naive type 2

diabetes patients , EDITION IV in type 1 diabetes patients, EDITION JP I in

Japanese type 1 diabetes patients (basal + bolus insulin) and EDITION JP II in

Japanese type 2 diabetes patients (basal insulin + oral therapy).

    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 nerve (neuropathy). The global

incidence of diabetes is growing at an alarming rate, with more than 371

million people worldwide living with the condition today.

    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).

    References

    1) Tillner J et al. Euglycemic Clamp Profile of New Insulin Glargine U300

Formulation in Patients With Type 1 Diabetes (T1DM) is Different From Glargine

U100. 73rd Scientific Sessions of the ADA, abstract no. 920-P

   2) Dahmen R et al New Insulin Glargine U300 Formulation Evens and Prolongs

Steady State PK and PD Profiles During Euglycemic Clamp in Patients With Type 1

Diabetes (T1DM)". 73rd Scientific Sessions of the ADA, abstract no. 113-OR

    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

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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

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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.

    Sanofi will host a conference call for the financial community on Monday

June 24, 2013, at 700 AM CST (200 PM Paris Time). The call will include results

from the ongoing EDITION phase 3 program for U300 as well as a status update on

the fixed-ratio combination of insulin glargine and lixisenatide.

    Dial-in numbers and the audio webcast link will be accessible via

http://www.sanofi.com.

    SOURCE: Sanofi Diabetes