Pierre Chancel - Sanofi
Pierre Chancel - Sanofi
Pierre Chancel - Sanofi
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Diabetes Roundtable<br />
London – May 26, 2010<br />
<strong>Pierre</strong> <strong>Chancel</strong><br />
Senior Vice President, Global Diabetes Division<br />
1
Forward Looking Statements<br />
This presentation contains forward-looking statements as defined in the Private Securities Litigation<br />
Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical<br />
facts. These statements include projections and estimates and their underlying assumptions,<br />
statements regarding plans, objectives, intentions and expectations with respect to future financial<br />
results, events, operations, services, product development and potential and statements regarding<br />
future performance. Forward-looking statements are generally identified by the words “expects,”<br />
“anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’<br />
management believes that the expectations reflected in such forward-looking statements are<br />
reasonable, investors are cautioned that forward-looking information and statements are subject to<br />
various risks and uncertainties, many of which are difficult to predict and generally beyond the control of<br />
sanofi-aventis, that could cause actual results and developments to differ materially from those<br />
expressed in, or implied or projected by, the forward-looking information and statements. These risks<br />
and uncertainties include among other things, the uncertainties inherent in research and development,<br />
future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as<br />
the FDA or the EMA, regarding whether and when to approve any drug, device or biological application<br />
that may be filed for any such product candidates as well as their decisions regarding labelling and other<br />
matters that could affect the availability or commercial potential of such products candidates, the<br />
absence of guarantee that the products candidates if approved will be commercially successful, the<br />
future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from<br />
external growth opportunities as well as those discussed or identified in the public filings with the SEC<br />
and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary<br />
Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for<br />
the year ended December 31, 2009.<br />
Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or<br />
revise any forward-looking information or statements.<br />
2
New Global Diabetes Division:<br />
Fulfilling sanofi-aventis’ Ambition in Diabetes<br />
Become the 360° partner delivering<br />
best-in-class complete and integrated<br />
solutions to diabetic patients<br />
Become the # 1 global diabetes care<br />
company<br />
Unlock innovation by integrating<br />
New pharmacological targets<br />
Genetic variations and biomarkers<br />
Seamless connectivity between<br />
diagnostics, treatment and monitoring<br />
Integrated structure comprising all key<br />
functions working on diabetes<br />
R&D, Device Development, Medical<br />
Affairs, Commercial Operations and<br />
Business Development<br />
Direct responsibility for 12 markets (U.S.,<br />
France, Germany, UK, Italy, Spain, Brazil,<br />
Mexico, China, Russia, India and Japan)<br />
Headquartered in Frankfurt<br />
R&D center, Device Development<br />
and Insulin Plant<br />
3
<strong>Sanofi</strong>-aventis Currently #2 Diabetes Company (1)<br />
FY2009 sanofi-aventis Diabetes Sales (2) : €3,774m, +19.4% (3)<br />
Diabetes Sales (%)<br />
BRIC-M<br />
Western<br />
Europe<br />
Rest of E.M.<br />
22%<br />
6%<br />
11% 7%<br />
Japan &<br />
Aus/NZ<br />
54%<br />
(1) IMS Midas 2009 (in value)<br />
(2) Diabetes Brands: Lantus® + Apidra® + Amaryl® + Insuman®<br />
(3) Growth at constant exchange rates<br />
North<br />
America<br />
Diabetes Sales (€m)<br />
5,000<br />
4,000<br />
3,000<br />
2,000<br />
1,000<br />
0<br />
39%<br />
61%<br />
25%<br />
75%<br />
2006 2009<br />
sanofi-aventis Novo Nordisk<br />
4
Growth Rate and Unmet Needs in Diabetes<br />
Make it an Attractive Market<br />
Disease Burden is Expected to Increase<br />
Dramatically (1) (in million patients)<br />
285<br />
120<br />
21<br />
27<br />
118<br />
+54%<br />
+62%<br />
+17%<br />
+34%<br />
+56%<br />
438<br />
193<br />
24<br />
36<br />
185<br />
2010 2030<br />
RoW<br />
EU Top 5<br />
U.S.<br />
BRIC-M<br />
Most Diabetes Patients in China<br />
Remain Untreated (2) (in million patients)<br />
Diabetes<br />
patients<br />
Diagnosed<br />
patients<br />
Treated<br />
patients<br />
Insulin<br />
treated<br />
(1) IDF International Diabetes Atlas, 4th edition, 2009 (2) Chinese Center for Disease Control, October 2007 (3) Wenying Yang et al, NEJM, vol 36, 1090-1101, March 25, 2010<br />
12<br />
10<br />
2<br />
40<br />
92 (3)<br />
5
Diabetes Management Offers Multiple Opportunities<br />
with a Patient-Centric Approach<br />
Patient<br />
education<br />
Nutrition<br />
Disease management<br />
Services<br />
Oral therapies<br />
Socio<br />
Economic<br />
factors<br />
Genetic<br />
profile<br />
Environment<br />
&<br />
Family<br />
Treatments<br />
Attitudes &<br />
behaviors<br />
Co<br />
morbidities<br />
Insulins and other injectables<br />
Self monitoring<br />
Devices<br />
Pens,<br />
connectivity with<br />
blood glucose<br />
monitoring,<br />
telemedicine<br />
Pumps – Closed loop<br />
Regenerative medicines<br />
6
Lantus ® Has Changed the Way Physicians Treat<br />
Diabetes<br />
Lantus ® has driven switch from<br />
premix insulins and NPH<br />
ADA/EASD have recognized<br />
basal insulin as “most effective”<br />
to treat to HbA1c target (1)<br />
Advantages of Lantus ®<br />
Greater number of subjects at<br />
goal with 1 injection (2)<br />
Lower insulin dose (3)<br />
Lower cost (4)<br />
Superior efficacy in real life<br />
setting (5)<br />
(1) Diabetes Care 2009; 32(1) (2) Heller - Clinical Therapeutics 2009; 31(10) : 2086-97 / Rosenstock - Diabetologia 2008; 51(3): 408-16<br />
(3) Rosenstock - Diabetologia 2008; 51(3): 408-16/ IQWIG report 2009 / Dailey - Diabetes 2009; 58:A128<br />
(4) Evans - Diabetes 2009 (5) Blonde - Diabetes 2009; 58:A137 6) IMS MIDAS, International Units, Q4 2009<br />
IU bn<br />
Select Insulin Market Share, U.S (6)<br />
80<br />
60<br />
40<br />
20<br />
0<br />
2002 2005 2009<br />
Lantus® detemir Premix NPH<br />
Lant us®<br />
7
The ORIGIN Study could Potentially further Change the<br />
Landscape of Type 2 Diabetes Treatment<br />
Patients at high CV<br />
risk and IFG, IGT,<br />
newly detected or<br />
established diabetes<br />
(on 0 or 1 oral agent)<br />
R<br />
12,600 patients 40 countries Results in 2012<br />
Other agents for<br />
glycemic control<br />
Endpoints:<br />
CV morbidity/mortality<br />
All cause mortality<br />
Risk of diabetic microvascular<br />
outcomes<br />
Rate of progression of IFG or<br />
IGT to type 2 diabetes<br />
Can early use of Lantus ® reduce CV events in early/pre-diabetic<br />
patients more than standard glycemic care?<br />
8
Entering the GLP-1 Arena with Lixisenatide<br />
Advantages of a GLP-1 agonist (acting<br />
on postprandial glucose level) vs. short<br />
acting or premix insulins<br />
Better weight management<br />
Lower risk of hypoglycemia<br />
Reduced # of daily injections vs. basal<br />
bolus approach<br />
Strong rationale for combination with<br />
Lantus ®<br />
Lantus ® the only true 24h basal insulin<br />
Variable dose of insulin possible with<br />
fixed dose of GLP-1<br />
Patients with Good Fasting<br />
Control but with Abnormal<br />
Postprandial Glycemia<br />
Blood glucose<br />
Breakfast Lunch Dinner<br />
Good fasting control achieved<br />
9
Lixisenatide Once-Daily: 1 st Step to a Unique<br />
Combination with Lantus ®<br />
GETGOAL phase III now fully enrolled<br />
9 studies with >4,500 patients<br />
GETGOAL- MONO (1) meets trial endpoints<br />
Significant HbA1c reduction vs. placebo<br />
46.5 to 52.2% of patients achieving HbA1c<br />
A Growing R&D Portfolio in Diabetes Division<br />
to Expand via External Innovation<br />
R&D Portfolio – Diabetes Division<br />
Phase I Phase II Phase III<br />
lixisenatide + Lantus®<br />
GLP-1 agonist + insulin glargine<br />
Type 2 diabetes<br />
SAR236553 (2)<br />
Anti-PCSK9 mAb<br />
Hypercholesterolemia<br />
PN2034 (1)<br />
Insulin sensitizer<br />
Type 2 diabetes<br />
SAR161271<br />
Very long –acting insulin analog<br />
Diabetes<br />
lixisenatide (AVE0010)<br />
GLP-1 agonist<br />
Type 2 diabetes<br />
Lantus®<br />
insulin glargine<br />
Reduction in CV<br />
morbidity & mortality<br />
Anticipated R&D Newsflow in 2010 – Diabetes Timing<br />
Anti-PCSK9 monoclonal antibody – PoC data Initial data released<br />
Lixisenatide in Type 2 diabetes – Phase III monotherapy data presentation EASD 2010<br />
Lixisenatide + Lantus ® in Type 2 diabetes – Start of Phase III trial Q4 2010<br />
PN 2034 – Start of Phase IIb By end 2010<br />
Pancreate TM (Regenerative approach) – Start of clinical development By end 2010<br />
(1) Partnership with Wellstat (2) Partnership with Regeneron (3) Partnershup with Cure DM<br />
11
Demonstrated Ability to Build Innovative<br />
and Competitive Device Solutions<br />
Strong in-house development<br />
and industrialization capabilities<br />
Device center of excellence in<br />
Frankfurt<br />
Two award-winning devices<br />
developed and marketed within<br />
3 years<br />
Devices accounting for ~50% of<br />
Lantus ® sales<br />
Full range of device solutions<br />
under development for marketed<br />
and R&D products<br />
(1) IMS NPA January 2010<br />
IU bn<br />
SoloSTAR ® Drives U.S. Volumes<br />
Lantus® U.S. Units by Method of Delivery (1)<br />
9<br />
8<br />
7<br />
6<br />
5<br />
4<br />
3<br />
2<br />
1<br />
0<br />
Q4 2005<br />
Q1 2006<br />
Q2 2006<br />
Q3 2006<br />
Q4 2006<br />
Q1 2007<br />
Q2 2007<br />
Q3 2007<br />
Q4 2007<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Cartridge Vial SoloSTAR®<br />
Q3 2009<br />
Q4 2009<br />
12
Redefining Diabetes Treatment through<br />
a Set of Integrated Solution<br />
Patient Safety<br />
(1) Partnership with AgaMatrix<br />
High<br />
accuracy<br />
Values that matter<br />
Linked to<br />
mobile<br />
technology<br />
State-of-the art<br />
Features<br />
& Services<br />
Attractive<br />
design<br />
Self monitoring<br />
Linked to<br />
insulin use<br />
First BGM devices (1) expected to be marketed before end 2010<br />
Better Outcomes<br />
13
<strong>Sanofi</strong>-aventis – Poised for Growth in Diabetes<br />
The diabetes epidemic presents health care and economic<br />
challenges<br />
Diabetes is one of the largest business opportunities in the<br />
healthcare space and a growth platform for sanofi-aventis<br />
<strong>Sanofi</strong>-aventis is well positioned with concrete steps forward<br />
fulfilling our vision to deliver tailored and integrated solutions<br />
to patients and healthcare providers<br />
Our ambition is to become the #1 global diabetes care company<br />
14