2. 2
Sanofi Forward Looking Statements
This presentation 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 labeling 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, 2013. Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.
4. 44
Agenda
Unmet Needs with Diabetes Treatment
● Riccardo Perfetti, MD – Senior Medical Officer, Diabetes
New Clinical Evidence on Toujeo®
● Matthew C. Riddle, Professor of Medicine – Oregon Health & Science University
Sanofi Leading the Basal Insulin Market
● Pierre Chancel – Senior Vice President, Diabetes
Sanofi Expanding its Diabetes Portfolio
● Pierre Chancel – Senior Vice President, Diabetes
Moving Towards Integrated Care
● Pascale Witz – Executive Vice President, Global Divisions & Strategic Development
Q&A Session
Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL; “U300”) is new a basal insulin currently in development for the treatment of people
with diabetes. Toujeo® is the intended trade name for U300. U300 is not currently approved or licensed anywhere in the world.
6. Optimal dose
often not
reached
during initiation
or maintenance
phase1–6
Fear of
hypoglycemia &
insulin-
associated
weight gain
are barriers to
effective insulin
use7–13
High
discontinuation
of basal insulins
during the first
6 months16
50% of
patients on
insulin are still
not at target1–6
Significant
burden of
intra-patient
glucose
variability
in patients15
Hypoglycemia
is a major
contributor to
treatment
discontinuation
/transition14
Unmet
Needs
(1) Steinberg BA et al. Am Heart J 2008, (2) Chan JCN et al. Diabetes Care 2009, (3) Choi YJ et al. Diabetes Care 2009, (4) Banegas JR et al. Eur Heart
J 2011, (5) Vouri SM et al. J Manag Care Pharm 2011, (6) Casagrande SS et al. Diabetes Care 2013, (7) Polonsky WH et al. Diabetes Care 2005, (8)
Funnell MM et al. Clinical Diabetes 2007, (9) Karter AJ et al. Diabetes Care 2010, (10) Khunti K et al. Diabetes Care 2013, (11) Russell-Jones D et al.
Diabetes Obes Metab 2007, (12) Pontiroli AE et al. Diabetes Obes Metab 2011, (13) DAWN2, Diabetes Attitudes, Wishes, and Needs Study, (14) Bron
M et al. Postgrad Med 2012, (15) Skaff M et al. Health Psychol 2009, (16) Quantification of patient adherence to Lantus® treatment initiation, IMS (US,
UK & Germany), 2013 [Market Research]
Unmet Medical Needs Remain a Reality in the
Insulin Space
6
7. As for any Chronic Disease, People with Diabetes Struggle
to Stay on Treatment
Source: Quantification of Patient Adherence to Treatment Initiation (U.S., 2013), IMS
7
Proportion of Patients who Continue With
Initially Prescribed Treatment
% of Patients
Continuing Treatment
at Month 6
% of Patients
Continuing Treatment
at Month 12
0%
25%
50%
75%
100%
0%
25%
50%
75%
100%
8. Patients Fear that Insulin Treatment May Be a Source
of Hypoglycemia, Complexity and Weight Gain
0% 25% 50% 75% 100%
Meant my disease was worsening
Cause hypoglycemia
Have to be on it forever once you start
Represented failure to care of my health
Difficult to integrate insulin injections into my daily routine
Cause weight gain
Injections would be painful
Add restrictions to my eating/sleeping schedule
My diabetes was NOT “severe enough”
Would limit what I can eat
Percent concerned
(1) Source: Insulin glargine satisfaction study, Impact Rx, Dec 2012 (U.S., n=225)
Top 10 Concerns With Insulin Initiation(1)
8
9. Hypoglycemia is a Significant Contributor to Sub-Optimal
Dosing and Discontinuation of Insulin Therapy
9
Patient reluctance to
initiate or comply with
insulin treatment
Hard to maintain routine
(treatment, eating habits);
triggers hypoglycemia
Reduced insulin dose
Sub-optimal insulin dose
lack of efficacy; not
achieving A1c goals
Treatment discontinuation
or switch
Eventual return to
insulin treatment
The drop-off
cycle
Source: Uncontrolled insulin drop-off patients and HCPs – insights regarding insulin drop-off
Findings from previous S-A research – LOLA assessment of uncontrolled patients
The
drop-off cycle
4
5
6 2
3
1
10. Emotional and Economic Burden
Reported events associated with
hypoglycemia in prior 12 months (%)(1)
Substantial Cost Burden to the Healthcare System
Associated with Hypoglycemia
10
3% 4%
55%
49%
10%
Hospitalization ED visit
Consulted
HCP ≥1
Consulted
HCP ≤5
Sick leave
from work
ED: Emergency department; HCP: Healthcare professional
(1) Willis WD et al. Expert Rev Pharmacoecon Outcomes Res. 2013;13:123-130 and European online survey (n=1,848)
(2) Ward A et al. J Med Econ, Vol. 17, No. 3, 2014, 176–183
Complication
Estimated Costs
Per Patient
Hypoglycemia
requiring
hospitalization
$16,478
Hypoglycemia
requiring ED visit
$1,331
Cost Impact of Hypoglycemia is High
Estimated direct medical costs
per patient per episode(2)
~1/3 of patients
very worried
about
hypoglycemia
11. Many People with Diabetes are Still Not at A1c Goal
despite Treatment
11
47% 47%
53% 53%
2013
(437)
2013
(2215)
Controlled (<=7%) Uncontrolled (>7%)
All T1D
Patients
All T2D
Diabetes
Source: Adelphi Real World Diabetes Disease Specific Programme (DSP) X, 2013
Base: All US diabetic patients where doctor has stated most recent HbA1c (random sample).
“All patients” are treated patients and must be on an OAD, GLP-1 or insulin
12. Diabetes Is Associated with
Micro and Macrovascular Complications
12
Microvascular Complications Macrovascular Complications
Diabetic Retinopathy
Leading cause of
blindness in working-age
adults
Diabetic Nephropathy
Leading cause of end-stage
renal disease
Heart Disease
Leading cause of
mortality in patients with
Type 2 diabetes
Peripheral
Vascular Disease
Leading cause of
non-traumatic lower-
extremity amputations
Diabetic Neuropathy
Leading cause of diabetic
foot syndrome and non-
traumatic lower-extremity
amputations
Stroke
25% of all ischemic
strokes are due to
diabetes alone or with
hypertension
(1) Endocrinol Metab Clin 1996;25:243 - 254 (DCC Trial)
(2) Diabetes Care Publish Ahead of Print, published online March 6, 2013
Risk of complications and HbA1c(1)
HbA1C(%)
RelativeRiskin%
1
3
5
7
9
11
13
15
6 7 8 9 10 11 12
Retinopathy
Nephropathy
Microalbuminuria
Neuropathy
25% to 45% of diabetes-attributed medical expenditures
spent treating complications of diabetes(2)
13. New Clinical Evidence on Toujeo®
13
Matthew C. Riddle, Professor of Medicine
Oregon Health & Science University
Toujeo® is the intended trade name for the investigational product insulin glargine 300 U/ml.
14. Toujeo® Provides More Constant Absorption of Glargine
after Subcutaneous Injection
14
Three-fold more concentrated formulation of glargine
Reduced volume (1/3) and reduced surface area (1/2)
of subcutaneous depot
Slower and more constant rate of absorption
Schematic illustration
Toujeo®
15. Toujeo® Has a Flatter and More Prolonged PK/PD Profile
than Lantus®
15
Flatter PK Profile More Prolonged PD Profile
Dahmen R et al, 2013 ADA, abstract 113-OR (euglycemic clamp study in T1D in steady state)
PK/PD: Pharmacokinetic/Pharmacodynamic
0 6 12 18 24 30 36
0
1
2
3
4
5
DOSE 0.4 U.kg-1
U300
U100
GIR-mg.kg-1
.min-1
TIME - hour
Glucose Infusion Rate
0 6 12 18 24 30 36
0
5
10
15
20
25
30
LLOQ 5.02 µU.mL-1
SC INJECTION
INSULIN-µU.mL-1
TIME - hour
U100 0.4 U.kg-1
U300 0.4 U.kg-1
LOESS 0.15
Toujeo®
Lantus®
Serum Insulin Glargine Concentration
Toujeo®
Lantus®
16. EDITION: A Comprehensive Phase III Program
Testing Toujeo® in Different Diabetes Populations
16
Study Population Intervention
Data
Released
EDITION 1 Type 2 Basal + mealtime insulin √
EDITION 2 Type 2 Basal + oral therapy √
EDITION 3 Type 2 Insulin naïve √
EDITION 4 Type 1 Basal + mealtime insulin √
EDITION JP 1 Type 1 Basal + bolus insulin √
EDITION JP 2 Type 2 Basal + oral therapy √
Toujeo® vs.
Today’s focus will be on Type 2 Diabetes
17. Pooled Analysis of EDITION Phase III Trials
in Type 2 Diabetes (T2D)(1)
17
Baseline characteristics Toujeo® Lantus®
Age (years) 58.7 58.5
BMI (kg/m2) 34.7 34.8
Duration of diabetes (years) 12.7 12.6
A1c (%) 8.31 8.32
n=1,249
Screening period
Up to 2 weeks
Qualifying visit:
7% ≤ A1c ≤10%
7% ≤ A1c ≤10%
7% ≤ A1c ≤11%
Concomitant glucose-lowering therapyR
T2D
patient
(≥18 years old) Toujeo®
Lantus®
n=1,247
Evaluation
of
endpoints
at 6 months
FPG target: 80-100 mg/dL (4.4-5.6 mmol/L)
Basal insulin dose adjusted once weekly
Concomitant glucose-lowering therapy
EDITION 1 + Mealtime insulin + Met
EDITION 2 + Met + OADs(3)
EDITION 3 + Met + OADs(4)
Glucose-lowering therapy at screening:
EDITION 1: Basal(2) + mealtime insulin + OADs
2: Basal(2) + OADs
3: Insulin naïve + OADs
Met: metformin OAD: oral antihyperglycemic drug FPG: Fasting plasma glucose
(1) Ritzel R et al, 2014 ADA, abstract 90-LB
(2) Total daily dose Lantus® ≥42 U (or equivalent dose of NPH) (3) Use of sulfonylureas were prohibited within 2 months prior to screening and
during the study (4) Except sulfonylureas, glinides and other OADs not approved for use with insulin
Titration period Maintenance phase
18. 7.00%
7.20%
7.40%
7.60%
7.80%
8.00%
8.20%
8.40%
0 1 2 3 4 5 6 7 8
8.4%
8.2%
8.0%
7.0%
7.2%
7.4%
7.6%
7.8%
Baseline Week 12 Month 6
Toujeo® was as Effective as Lantus® in Improving
Glycemic Control(1)
18
Mean A1c (%) from Baseline
A1c(%)Mean±SE
LS mean difference
between groups (95% CI)
0.00 (-0.08 to 0.07)
Lantus®
Toujeo®
(1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB
LS: Last square
19. (1) Confirmed: ≤70 mg/dL (≤3.9 mmol/L)
(2) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB
With Toujeo® -- Lower Rates of Confirmed(1) or Severe
Hypoglycemic Events(2)
Event Rate Per Patient-Year
Across The 6-Month Study Period
Cumulative Mean Number of
Events Per Patient
Any Time
(24 h)
Nocturnal
(00:00-05:59)
19
0
1
2
3
2 4 6 8 10 12 14 16 18 20 22 24 26 28
0
2
4
6
8
10
2 4 6 8 10 12 14 16 18 20 22 24 26 28
Week
15.22
3.06
17.73
2.10
= Statistically significant
Week
Lantus®
Toujeo®
Lantus®
Toujeo®
Lantus® Toujeo®
-14%
-31%
RR: 0.69 (0.57 to 0.84)
p=0.0002
RR: 0.86 ( 077 to 0.97)
p=0.0116
20. With Toujeo® -- Fewer Patients Experienced Confirmed
or Severe Hypoglycemia across Study Periods(1)
20
0%
10%
20%
30%
40%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Nocturnal (00:00-05:59)Any Time of Day (24 h)
Baseline
to Week 8
Week 9
to Month 6
Baseline
to Month 6
Baseline
to Week 8
Week 9
to Month 6
Percentage of Patients Reporting
≥1 Event ≤ 70 mg/dL (3.9 mmol/L)
Baseline
to Month 6
RR: 0.91
(0.87 to 0.96)
RR: 0.83
(0.77 to 0.89)
RR: 0.75
(0.68 to 0.83)
RR: 0.69
(0.58 to 0.81)
RR: 0.92
(0.86 to 0.98) RR: 0.80
(0.71 to 0.91)
Lantus® Toujeo®
(1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB
-9%
-25%
= Statistically significant
21. 21
0%
5%
10%
15%
20%
25%
0%
10%
20%
30%
40%
50%
Baseline
to Week 8
Week 9
to Month 6
Baseline
to Month 6
Baseline
to Week 8
Week 9
to Month 6
Baseline
to Month 6
RR: 0.81
(0.72 to 0.90)
RR: 0.78
(0.66 to 0.93)
RR: 0.73
(0.59 to 0.81)
RR: 0.73
(0.53 to 1.02)
RR: 0.87
(0.76 to 1.01)
RR: 0.76
(0.58 to 0.99)
Lantus®
Toujeo®
Any Time of Day (24 h) Nocturnal (00:00-05:59)
Percentage of Patients Reporting
≥1 Event ≤ 54 mg/dL (3.0 mmol/L)
With Toujeo® -- Fewer Patients Experienced Confirmed
or Severe Hypoglycemia across Study Periods(1)
-19%
-27%
(1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB = Statistically significant
22. Less Weight Gain was Observed with Toujeo®
than with Lantus®(1)
22
Mean Change From Baseline in Weight (kg) by Visit
-0,50
0,00
0,50
1,001.0
0.5
0
-0,5
Mean difference between
groups (95% CI)
-0.28kg (−0.55 to 0.01)
p=0.039
WeightChange(kg)Mean±SE
Adverse Events
Both treatments were
generally well tolerated
with similar rates of AEs
Lantus®
Toujeo®
Mean dose 0.76 UI/kg/day
Mean dose 0.85UI/kg/day
(1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB
LOV: last on-treatment value defined as the last measurement made prior to or on the day of the last investigational product intake
during the main 6-month on-treatment period.
= Statistically significant
23. 23
0
2
4
6
8
10
12
14
16
0 2 4 6 8 10 12 14 16 18 20 22 24 26
0
1
2
3
4
5
0 2 4 6 8 10 12 14 16 18 20 22 24 26
Cumulative Mean Number of
Events Per Patient
Any Time
(24 h)
Nocturnal
(00:00-05:59)
Week
Week
Lantus®
Toujeo®
Lantus®
Toujeo®
Event Rate Per Patient-Year
Across The 6-Month Study Period
10.48
4.98
16.52
2.18
Lantus® Toujeo®
-36%
-55%
RR: 0.45 (0.21 to 0.96)
RR: 0.64 (0.43 to 0.96)
(1) Confirmed: ≤70 mg/dL (≤3.9 mmol/L)
(2) Terauchi Y et al. 2014 ADA, abstract 94-LB
= Statistically significant
EDITION JP 2 -- Lower Rates of Confirmed(1) or Severe
Hypoglycemic Events(2)
24. New Clinical Evidence on Toujeo®
24
● A pooled analysis of 6-month data from EDITION 1, 2 and 3(1) demonstrated,
compared with Lantus®
● Comparable glycemic control
● Less hypoglycemia, especially at night, and consistently in the first 8 weeks as well as from
8 weeks to 6 months
● Limited weight effect
● EDITION JP 2(2), in T2D Japanese patients uncontrolled on basal insulin, also
showed significantly less hypoglycemia with Toujeo®
● Over one year of treatment in EDITION 1
(3)
and 2
(4)
, Toujeo®
provided sustained
glycemic control with a lower risk of hypoglycemia compared with Lantus®
● A sub-study
(5)
of EDITION 1 and 2 demonstrated no untoward effects of occasionally
adapting dosing intervals by ±3 hours
(1) Ritzel R et al, 2014 ADA, abstract 90-LB
(2) Terauchi Y et al. 2014 ADA, abstract 94-LB (4) Yki-Järvinen H 2014 ADA, abstract 93-LB
(3) Riddle MC et al 2014 ADA, abstract 81-LB (5) Riddle MC et al 2014 ADA, abstract 919-P
Summary
25. Conclusion
25
● Toujeo® is as effective as Lantus® in controlling glucose in T2D
● Lower risk of hypoglycemia with Toujeo® was consistently found both
early and late after intensification of treatment, in different populations,
and when timing of injections was flexible
● These findings support the potential of Toujeo® to further enhance
the clinical value of basal insulin
Toujeo®
in T2D
26. Sanofi Leading
the Basal Insulin Market
26
Pierre Chancel
Senior Vice President, Diabetes, Sanofi
27. 27
Global Treatment Paradigm Shift Towards Basal Insulin
Breakdown By Insulin Type
Market Share (%)
2003 - 2013 Worldwide Insulin Market Development (Value)
47.8%
Source: Market share data from IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved
31.8%
48.9%
36.1%
17.1%
32.1%
34.0%
0%
10%
20%
30%
40%
50%
60%
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
% of Sales
Basal Premix SAI
28. Basal Insulin New Gold Standard in All Regions
28
2003 – 2013 Insulin Market by Insulin Type (Value)
Market Share (%)
+ 23% + 24%
+ 8%
- 1%
+ 3%
+ 1%
+ 4%
+ 0%
+ 7%
+ 14%
+ 15%
35.9%
51.3%
29.6%
11.3%
34.5%
37.4%
0%
10%
20%
30%
40%
50%
60%
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
% of Sales
Basal Premix SAI
29.9%
47.7%
36.9%
16.3%
33.2%
36.0%
0%
10%
20%
30%
40%
50%
60%
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
% of Sales
Basal Premix SAI
30.1%
42.7%
48.2%
37.8%
21.7%
19.5%
0%
10%
20%
30%
40%
50%
60%
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
% of Sales
Basal Premix SAI
25.1%
44.2%45.1%
23.0%
29.8% 32.8%
0%
10%
20%
30%
40%
50%
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
% of Sales
Basal Premix SAI
Japan/Can/Aus/NZEmerging Markets(2)
U.S. Western Europe(1)
(1) France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland,
Finland, Norway, Iceland, Denmark (2) World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand
Source: Market share data from Source IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved
29. 29
Sanofi has a Strong Position in the Basal Market,
the Fastest Growing Insulin Segment
Breakdown By Insulin Type
Market Share (%)
Growth vs. Prior Year (%)
Basal Breakdown By Brand
Market Share (%)
Growth vs. Prior Year (%)
2013 Worldwide Insulin Market Breakdown (Value)
47.8%
18.3%
SAI: Short-Acting Insulins NPH: Neutral Protamine Hagedorn
Source: Market share data from IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved
Basal
48.9%
+ 21.5 %
SAI
34.0%
+18.0 %
Premix
17.1%
+ 7.3 %
69.3%
+ 22.9 %
Levemir®
20.6%
+27.4 %
Tresiba®
0.2% NPH
9.9%
+1.8%
Lantus®
30. Basal Insulins Constitute the Leading and Fastest
Growing Insulin Segment Across All Geographies
30
2013 Insulin Market Breakdown by Insulin Type (Value)
Market Share (%)
Growth vs. Prior Year (%)
U.S.
Emerging Markets
17%
- 5%
12%
+ 7%
50%
+ 24%
47%
+ 5%
42%
+ 12%
38%
+ 10%
Source: Market share data from Source IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved
51.3%
+28.8%
37.4%
+24.1%
11.3%
+12.0%
47.7%
+5.0%
36.0%
+3.7%
16.3%
- 3.7%
42.7%
+17.3%
19.5%
+17.8%
37.8%
+11.7% 44.2%
+11.0%
32.8%
+4.3%
23%
-6.6%
Western Europe
Japan/Can/Aus/NZ
Premix
Basal
SAI
31. 60.8%
+7.4%
24.8%
+5.6%
14.1%
- 5.9%
0.2%
69.0%
+14.7%
17.6%
+ 2.4%
11.3%
-11.0%
2.1%
Lantus® as a Well-established Position on the Basal
Market in all Geographies
31
2013 Basal Insulin Market Breakdown by Brand(Value)
Market Share (%)
Growth vs. Prior Year (%)
12%
+ 7%
50%
+ 24%
Source: Market share data from Source IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved
74.4%
+28.9%
20.8%
+41.1%
4.9%
-6.5%
56.3%
+16.1%
16.3 %
+17.1%
27.3 %
+19.4%
0.1%
U.S.
Emerging Markets
Western Europe
Japan/Can/Aus/NZNPH
Lantus®
Levemir®
Tresiba®
32. Patients Initiating or Using Basal Insulin Therapy
Represent a Large Pool of Diabetic Patients
32
Existing Basal
Insulin users
~14m patients
(80% T2D)
>50% uncontrolled
Insulin naïve
patients starting
Basal Insulin
~4m patients
START WITH SWITCH TO
STAY ON
Patient numbers: Company estimates based on various sources – 11 main markets (U.S. Top 5 EU, Japan, and BRIC countries)
Toujeo is the intended trade name for the investigational product insulin glargine U300/ml
33. Toujeo®: New Generation Basal Insulin
to Improve Patient Care
33
● The basal insulin market is large and
growing
● Patients initiating or using basal insulin
therapy represent a broad pool of
diabetics with unmet needs
● Toujeo® offers a competitive profile
● Sanofi uniquely positioned to sustain a
strong foothold in diabetes with Toujeo®
and other new product opportunities
● EMA evaluation of
application recently started
● NDA submitted in the U.S.
● Submission in Japan
planned in H2 2014
● Phase IIIb/IV plan and
patient support program
Next Steps Conclusion
35. ®
New Data(1) Reinforces That Not All GLP-1
Receptor Agonists Are the Same
35
PPG Levels at Baseline and Week 8(1)
● More pronounced PPG-lowering
effect of lixisenatide vs. liraglutide,
as add-on to Lantus®(1)
● Lyxumia® launch status
● Commercially available in UK,
Spain, Italy, Japan and Mexico
● ELIXA CV outcome trial on track
● Results expected in H1 2015
● U.S. submission planned in
summer 2015
*p<0.0001 for change vs. baseline
†p<0.0001 for change with lixisenatide vs liraglutide
(1) PPG (post-prandial glucose) lowering effect evaluated after a test-meal - Meier JJ et al, 2014 ADA, Poster 1017-P
Treatment groups
Day -1 / Before treatment
(full lines)
Week 8
(dotted lines)
36. : Combining Insulin Glargine With Lixisenatide
in a Single Daily Injection
36
● Phase III program initiated in Q1 2014
● LixiLan-O study in patients insufficiently
controlled on OADs (1,125 patients)
● LixiLan-L study in patients not at goal
on basal insulin (700 patients)
● >90% of study sites initiated
● Potential to be the first combination
of [Basal Insulin + GLP-1] in a single
daily injection marketed in the U.S.
● Targeted FDA submission could be as
early as end of 2015
Patients
Uncontrolled
with basal
therapy
~4m patients
Patients
Not at Target
on OAD
~5.5m
patients
Number of patients estimated for the U.S. (2017 projections based on internal model adapted from Adelphi)
1st injectable
drug
Basal
Intensification
U.S. Target Populations of T2D Patients
for
37. New Insulin Lispro (SAR342434)
Progressing to Phase III Development in H2 2014
37
● Complementary to Sanofi Diabetes
portfolio aiming at offering patients
complete solutions for better outcomes
● Phase I completed
● Similar activity and exposure
demonstrated to Humalog®(1)
● Phase III program to recruit ~1,000
patients
● Leading rapid-acting insulin
among U.S. T1D pump users(2)
Phase III study
in T1D Patients
vs. Humalog®
Phase III study
in T2D Patients
vs. Humalog®
Insulin lispro is marketed by Eli Lilly and Company as Humalog®
(1) Using the euglycemic clamp technique in subjects with Type 1 Diabetes (data on file)
(2) Sourced from www.insulin-pumpers.org (June 2, 2014) T1D: Type 1 Diabetes
Insulin Lispro Structure
LysB28
ProB29
38. Moving Towards Integrated Care
38
Pascale Witz
Executive Vice President, Global Divisions &
Strategic Development
39. No single product or service can satisfy the market demand
for simple, complete solutions that provide better outcomes
39
Integrated Care: Tremendous Potential to Improve
Patients’ Lives
● Increase adherence
to products
● Better patient experience
● Improved outcome
● Cost control
TOMORROWTODAY
40. Working to Improve the Journey of People with Diabetes
40
®
Integrated Care
BGM Drug Delivery
Digital
Heath Drugs
Patient
Support
MyStar
Care®
LixiLan and Toujeo® are under development. These products are not approved or licensed anywhere in the world.
41. Global Strategic Alliance between Sanofi and
Medtronic Supports Broader Strategy(1)
● Leader in insulin pumps and
continuous glucose monitoring
● Drug delivery technology
● Miniaturization
● Implantable devices
● Leader in insulin management
● Deep clinical and medical expertise
● Regulatory and market access
● Leading portfolio of
pharmaceuticals
Structured as open innovation model,
leveraging complementary strengths of both companies
Initial focus on novel drug-device combinations and
care management services
41
(1) Sanofi and Medtronic announced on June 14, 2014 that they have signed a memorandum of understanding to enter into global strategic alliance
in diabetes.