Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — ADA 2012 Novo Nordisk investor and analyst event
34 slides from Novo Nordisk A/s Class B's conference presentation, Jun 10, 2012
Slide 1: ADA 2012 Novo Nordisk investor and analyst event
ADA 2012 Novo Nordisk investor and analyst event ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Philadelphia
Slide 2: Forward-looking statements
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 2 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2011 and Form 20-F, both expected to b
Slide 3: Agenda - update from ADA 2012
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 3 Agenda - update from ADA 2012 Time Topic Welcome 7.05pm Jesper Brandgaard, CFO Challenges associated with insulin treatment 7.10pm Alan Moses, CVP & Global CMO Pharmacokinetics and safety of insulin degludec 7.20pm Peter Kurtzh
Slide 4: Tresiba and Ryzodeg regulatory update
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 4 Tresiba® and Ryzodeg® regulatory update • New drug applications (NDA) submitted to FDA on 29 September 2011 USA • FDA reviews ongoing, PDUFA action date now set for 29 October 2012 • NDAs submitted to EMA on 26 September 2011 E
Slide 5: Strong emphasis on Tresiba - 46 Novo Nordisk abstracts accepted at ADA 2012
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 5 Strong emphasis on Tresiba® (insulin degludec) - 46 Novo Nordisk abstracts accepted at ADA 2012 18 12 11 4 1 Tresiba® Victoza® Levemir® AchieveTM Other healthcare Note: Tresiba® (insulin degludec) is an ultra-long acting basal
Slide 6: Challenges associated with insulin treatment
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 6 Challenges associated with insulin treatment Alan Moses CVP & Global CMO
Slide 7: Poor glycaemic control remains a global problem
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 7 Poor glycaemic control remains a global problem Barriers to optimal insulin treatment1 UK Netherlands • Hypoglycaemia 7.0-7.9 7.5-9.2 Japan USA Germany • Reluctance to inject in public 8.9-9.4 7.5-8.6 France 7.5-9.2 • Fear of r
Slide 8: GAPP2: Treatment compliance and hypoglycaemia is a key obstacle
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 8 GAPP2™: Treatment compliance and hypoglycaemia is a key obstacle for effective insulin treatment in diabetes % Respondents with occasions of non-compliance or self treated hypoglycaemia in last 30 days x Mean # times in the las
Slide 9: Reducing hypoglycaemic events may significantly improve health related quality of life
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 9 Reducing hypoglycaemic events may significantly improve health related quality of life (HRQoL) Estimated HRQoL utility impact of diabetes without and with hypoglycaemia1 HRQoL utility impact per hypoglycaemic event1 Type of Day
Slide 10: Pharmacokinetics and safety of insulin degludec
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 10 Pharmacokinetics and safety of insulin degludec Peter Kurtzhals SVP Diabetes Research
Slide 11: Selected basal insulin structures
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 11 Selected basal insulin structures Insulin degludec Insulin glargine PEG-lispro1 C16 Gly21 Molecular A G Arg31,32 Lys28,Pro29 gGlu structure B K R R K P 20,000 Da PEG -(CH2-CH2-O)- % human insulin sequence 100% ~94% ~96% homolo
Slide 12: Insulin degludec molecular pharmacology similar to human insulin
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 12 Insulin degludec molecular pharmacology similar to human insulin Insulin receptor binding and stimulated effects Insulin degludec characteristics Insulin receptor IGF-1 receptor √ Insulin receptor binding and activation √ IGF-
Slide 13: Receptor interaction and clearance of insulin degludec is similar to human insulin
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 13 Receptor interaction and clearance of insulin degludec is similar to human insulin Insulin Glut4 Insulin receptor Receptor recycled to cellular membrane surface Insulin Glucose Uptake Signaling pH 7.1 Insulin Action pH 5 Pepti
Slide 14: Conceptual action profiles for once-daily basal insulin dosing
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 14 Conceptual action profiles for once-daily basal insulin dosing Source: Heise et al, ADA 2012, Poster 1013
Slide 15: Steady state is reached within 2-3 days with insulin degludec
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 15 Steady state is reached within 2-3 days with insulin degludec Relative insulin degludec serum trough Relative insulin degludec serum trough concentrations in type 1 diabetes concentrations in type 2 diabetes Note: Type 1: Valu
Slide 16: Flat and stable glucose-lowering effect of 200 U/mL insulin degludec
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 16 Flat and stable glucose-lowering effect of 200 U/mL insulin degludec dose formulation Mean 24-hour GIR profile of the two insulin Key characteristics of 200 U/mL degludec formulations at steady state insulin degludec dose form
Slide 17: Safety of insulin degludec confirmed in people with hepatic or renal impairment
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 17 Safety of insulin degludec confirmed in people with hepatic or renal impairment Steady state in subjects with normal hepatic Steady state in subjects with normal renal function or hepatic impairment function or renal impairmen
Slide 18: Insights from longer term clinical trials of insulin degludec
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 18 Insights from longer term clinical trials of insulin degludec Peter Kristensen SVP Global Development
Slide 19: BEGIN ONCE LONG, a 1-year phase 3 trial in insulin-naive type 2 diabetes
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 19 BEGIN® ONCE LONG (NN1250-3579), a 1-year phase 3 trial in insulin-naïve people with type 2 diabetes Trial design IDeg OD+ metformin ±DPP-4 (n=773) Insulin-naïve patients with type 2 diabetes (n=1030) IGlar OD+ metformin ±DPP-4
Slide 20: Significantly greater reduction in FPG with insulin degludec than insulin glargine
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 20 Significantly greater reduction in FPG with insulin degludec than insulin glargine in NN1250-3579 Change in HbA1c over time Change in FPG over time IDeg OD IDeg OD 9.0 IGlar OD IGlar OD 8.5 FPG (mg/dL) 8.0 HbA1c (%) Treatment
Slide 21: Classification of hypoglycaemia in the phase 3 trials for insulin degludec
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 21 Classification of hypoglycaemia in the phase 3 trials for insulin degludec Suspected hypoglycaemia or routine PG measurement Patient able to treat self? Yes No PG <3.1 mmol/L1 (56 mg/dL) No Yes Not classified as confirmed hypo
Slide 22: Significantly lower risk of nocturnal hypoglycaemia with insulin degludec in NN1250-3579
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 22 Significantly lower risk of nocturnal hypoglycaemia with insulin degludec vs. insulin glargine in NN1250-3579 Hypoglycaemia with insulin degludec Nocturnal hypoglycaemia with insulin compared to insulin glargine degludec compa
Slide 23: Conclusion from trial NN1250-3579
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 23 Conclusion from trial NN1250-3579, a 1-year phase 3 trial in insulin-naïve people with type 2 diabetes Conclusion • Administered once daily in a treat-to-target regimen insulin degludec effectively improved HbA1c in people wit
Slide 24: BEGIN FLEX T1, flexible dosing in type 1 diabetes over 52 weeks
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 24 BEGIN® FLEX T1 (NN1250-3770), flexible dosing in type 1 diabetes over 52 weeks with insulin degludec Trial design Core phase - 26 weeks Extension phase - 26 weeks IDeg OD ‘Flexible’ + IAsp (n=164) IDeg OD ‘Free Flex’ + IAsp (n
Slide 25: Flexible insulin degludec dosing regimen in core phase
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 25 Flexible insulin degludec dosing regimen in core phase - In the extension phase patients were allowed to choose time of dosing Mon Tue Wed Thu Fri Sat Sun 8h 8h morning morning morning 24h evening evening 40h evening evening 4
Slide 26: Flexible dosing provides significantly lower FPG vs. insulin glargine at equal HbA1c
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 26 Flexible dosing with insulin degludec provides significantly lower FPG vs. insulin glargine at equal HbA1c in NN1250-3770 Change in HbA1c over time Change in FPG over time IDeg Free Flex OD + IAsp IDeg Free Flex OD + IAsp IGla
Slide 27: Flexible dosing with less nocturnal hypoglycaemia than insulin glargine in NN1250-3770
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 27 Insulin degludec allows for flexible dosing with less nocturnal hypoglycaemia than insulin glargine in NN1250-3770 Nocturnal hypoglycaemia with insulin degludec compared to insulin glargine Conclusion IDeg Free Flex OD + IAsp
Slide 28: Meta-analyses of insulin degludec
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 28 Meta-analyses of insulin degludec Mads Krogsgaard Thomsen CSO
Slide 29: Prospective pre-specified meta-analysis part of BEGIN phase 3a programme
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 29 Prospective pre-specified meta-analysis part of the BEGIN™ phase 3a trial programme for insulin degludec Insulin degludec once-daily vs. insulin glargine once-daily Type 1 Diabetes Type 2 Diabetes T1 LONG (3583) basal-bolus T2
Slide 30: Meta-analysis shows consistently lower rate of nocturnal hypoglycaemia despite lower FPG
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 30 Meta-analysis shows consistently lower rate of nocturnal hypoglycaemia with insulin degludec despite lower FPG Mean FPG (mg/dL) Trial ID Patients Number randomised (n) Nocturnal hypoglycaemia at end of trial RR IDeg IGlar IDeg
Slide 31: Meta-analysis across type 1 and type 2 trials confirms hypoglycaemic profile
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 31 Meta-analysis across type 1 and type 2 diabetes trials confirms hypoglycaemic profile of insulin degludec Confirmed hypoglycaemia Nocturnal hypoglycaemia Total period Subjects Total period Maintenance period2 Maintenance perio
Slide 32: Meta-analysis shows mental and physical improvements in health status
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 32 Meta-analysis shows mental and physical improvements in health status with insulin degludec vs. insulin glargine SF-36 questionnaire: treatment differences between insulin degludec and insulin glargine in people with type 2 di
Slide 33: Conclusion
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 33 Conclusion • Treatment compliance and impact of hypoglycaemia on health related quality of life are key obstacles for effective insulin treatment of diabetes • The molecular pharmacology of insulin degludec is similar to human
Slide 34: Q&A session
ADA 2012 Novo Nordisk investor and analyst event 10 June 2012 Slide no 34 Q&A session Jesper Brandgaard, CFO Mads Krogsgaard Thomsen, CSO Peter Kurtzhals, SVP Diabetes Research Peter Kristensen, SVP Global Development Alan Moses, CVP & Global CMO
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