Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Investor Day (May 2011)
37 slides from Novo Nordisk A/s Class B's investor day presentation, May 5, 2011
Slide 1: Diabetes treatment tomorrow
Novo Nordisk Capital Markets Day 5 May 2011 Diabetes treatment tomorrow Mads Krogsgaard Thomsen CSO Alan Moses Global CMO
Slide 2: Forward-looking statements
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 2 Forward-looking statements Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company’s Annual Report 2010 and Form 20-F, both expected to be filed with the SEC in February 2011 as we
Slide 3: Treatment therapies for the treatment of type 2 diabetes
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 3 Treatment therapies for the treatment of type 2 diabetes Progression of type 2 diabetes and treatment intensification Diet and exercise Tablets -cell function Insulin GLP-1 Insulin Time
Slide 4: Medications used for the treatment of type 2 diabetes
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 4 Medications used for the treatment of type 2 diabetes Commonly prescribed products for the treatment of type 2 diabetes Hypo- Weight CVD risk Dosing Diabetes co- HbA1C Class morbidity/ change glycaemia change factors (pr. day) contraindication M
Slide 5: Unmet medical need in diabetes today
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 5 Unmet medical need in diabetes today Unmet needs in type 2 diabetes Efficacious medications less likely to induce hypoglycaemia Improved weight loss medications Medications that target complementary disease pathways Importance Improved methods o
Slide 6: Key R&D capabilities in Novo Nordisk
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 6 Key R&D capabilities in Novo Nordisk Rational design Formulation • Amino acid • Half-life extension substitution • Sustained release • Acylation • Liquid • Pegylation • Oral NBE • Modification Expression Delivery systems • Yeast • Pre-filled • E
Slide 7: Novo Nordisk's approach to improving diabetes therapy
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 7 Novo Nordisk’s approach to improving diabetes therapy Novo Nordisk’s diabetes care R&D strategy and key projects Modern insulins Obesity and pre- Once-daily GLP-1 GLP-1/insulin Levemir® diabetes Victoza® Loose combination NovoMix® New class Novo
Slide 8: First phase 3a results indicate encouraging clinical profile of liraglutide in obesity
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 8 First phase 3a results indicate encouraging clinical profile of liraglutide in obesity Obesity R&D strategy Phase 3a programme for liraglutide in obesity Completed: Obesity and pre- Prevention of weight Statistically significant weight diabetes:
Slide 9: Two options for pursuing once-weekly GLP-1
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 9 Two options for pursuing once-weekly GLP-1 either with semaglutide or liraglutide depot GLP-1 R&D strategy Decision on preferred approach expected mid-2012 Once-daily GLP-1 Victoza® Semaglutide Liraglutide depot Once-weekly GLP-1 • New molecule
Slide 10: The phase 3a for IDegLira is expected to begin enrolment in May 2011
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 10 The phase 3a for IDegLira is expected to begin enrolment in May 2011 GLP-1/insulin R&D strategy GLP-1 and insulin combination trials Levemir® and Victoza® 12 months data GLP-1/insulin • Levemir® and Victoza® in loose combination treatment compa
Slide 11: Re-inventing the entire insulin portfolio with three new insulin analogue preparations
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 11 Re-inventing the entire insulin portfolio with three new insulin analogue preparations Insulin R&D strategy Aspirations for inventing new classes of insulins Modern insulins Levemir® Basal insulin NovoMix® To invent an ultra-long-acting basal i
Slide 12: Target profiles for new insulin analogues
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 12 Target profiles for new insulin analogues Action profile of today’s modern insulins Targeted action profiles of future insulins Fast-acting Ultra fast-acting Basal Basal Premix Prandial-Basal 6:00 10:00 14:00 18:00 22:00 2:00 6:00 6:00 10:00 14
Slide 13: Target profiles for new insulin analogues
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 13 Target profiles for new insulin analogues Action profile of today’s modern insulins Targeted action profiles of future insulins Faster onset of action with Fast-acting Ultra fast-acting new ultra fast-acting insulin Basal Basal Premix Prandial-
Slide 14: Hypoglycaemia is a real issue in the treatment of diabetes today
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 14 In multiple ways, hypoglycaemia is a real issue in the treatment of diabetes today Hypoglycaemia limits glycaemic control Glucose control and hypoglycaemia trade-off • Impact of hypoglycaemia • Medical risk factors Hypoglycaemic events • Loss o
Slide 15: Engineering insulin to achieve desired PK/PD profile: insulin degludec
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 15 Engineering insulin to achieve desired PK/PD profile: insulin degludec LysB29Nε-hexadecandioyl-γ-Glu desB30 human insulin s s G G II V V E E Q Q C C C C T T S S II C C S S LL Y Y Q Q LL E E N N Y Y C C N N A chain s s s s F F V V N N Q Q H H LL
Slide 16: Degludec designed with a novel, protracted and stable absorption mechanism
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 16 Degludec has been designed with a novel, protracted and stable absorption mechanism Insulin degludec Insulin degludec is a basal insulin under development that forms soluble multi-hexamers upon sub-cutaneous injection, 1 resulting in a depot fr
Slide 17: Slow absorption designed to produce ultra-long and flat action profile
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 17 The slow absorption mechanism was designed to produce an ultra-long and flat action profile in man Ultra-long and steady action profile over time at steady-state 3 Glucose infusion rate (GIR) (mg/kg/min) 2 1 Clamp run-in 0 0 4 8 12 16 20 24 Tim
Slide 18: Clinical data demonstrate very predictable profile with very limited variability
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 18 Clinical data demonstrate very predictable profile with very limited variability Degludec and insulin glargine: PK/PD model of hour-to-hour variability Degludec Insulin glargine Glucose infusion rate (GIR) Increasing risk of hypoglycaemia (mg/k
Slide 19: Phase 3a programme BEGIN: Degludec tested across insulin treatment regimens
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 19 In phase 3a programme BEGINTM, Degludec was tested across the spectrum of insulin treatment regimens BEGINTM Phase 3a programme 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 3582: 12 mth vs. IGlar, T2 - BB, N=1006 • Largest clinical insulin programm
Slide 20: All three 52 week trials showed significant improvement in nocturnal hypoglycaemia
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 20 All three 52 week trials demonstrated a statistically significant improvement in nocturnal hypoglycaemia BEGINTM Degludec versus insulin glargine 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 Blood glucose Hypoglycaemia reduction 3582: 12 mth vs. IG
Slide 21: Degludec U200 pen device can reduce injection volume
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 21 Phase 3a trial demonstrated that patients using the Degludec U200 pen device can reduce injection volume BEGINTM Degludec U200 versus insulin glargine 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 Injection volume reduced by 50% based on twice the i
Slide 22: Flexible dosing trial data indicate Degludec can be dosed at any time
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 22 Flexible dosing trial data indicate that Degludec can be dosed at any time on any day BEGINTM Degludec flexible dosing versus insulin glargine 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 3582: 12 mth vs. IGlar, T2 - BB, N=1006 Dosing intervals wit
Slide 23: Development in nocturnal hypoglycaemia in trial 3579
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 23 Development in nocturnal hypoglycaemia in trial 3579; the largest phase 3a trial BEGINTM Nocturnal confirmed hypoglycaemia over time (weeks) 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 insulin degludec insulin glargine Nocturnal hypoglycaemia 3582
Slide 24: Degludec phase 3a hypoglycaemia meta-analysis
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 24 Degludec phase 3a hypoglycaemia meta-analysis BEGINTM Objective of meta-analysis 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 3582: 12 mth vs. IGlar, T2 - BB, N=1006 • Objective: 3583 : 12 mth vs. IGlar, T1 - BB, N=629 • To investigate rate of trea
Slide 25: Meta-analysis shows significant reduction in overall and nocturnal hypoglycaemia
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 25 Meta-analysis shows statistically significant reduction in overall and nocturnal hypoglycaemia vs. insulin glargine BEGINTM Degludec versus insulin glargine in type 1 and type 2 diabetes 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 3582: 12 mth vs.
Slide 26: Basal-only therapy meta-analysis shows significant reduction in hypoglycaemia
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 26 In basal-only insulin therapy, the meta-analysis indicates a statistically significant reduction in hypoglycaemia BEGINTM Type 2 diabetes basal only therapy vs. insulin glargine 3579: 12 mth vs. IGlar, T2 - BOT, N=1030 3582: 12 mth vs. IGlar, T
Slide 27: Conclusion on clinical results of Degludec
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 27 Conclusion on clinical results of Degludec • Highly effective glycaemic control • Better fasting blood glucose control than observed with insulin glargine • Lower rates of hypoglycaemia • Statistically significant in meta-analyses for both tota
Slide 28: Action profile of the prandial-basal insulin DegludecPlus
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 28 Action profile of the prandial-basal insulin DegludecPlus Action profile of DegludecPlus and NovoMix®30 10 Glucose Infusion Rate (GIR) 8 (mg/kg/min) 6 NovoMix® 30 4 DegludecPlus 2 0 0 4 8 12 16 20 24 Time since injection (hours) Note: People wi
Slide 29: Phase 3a programme for DegludecPlus demonstrates clear benefits over premix insulin
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 29 The phase 3a programme for DegludecPlus demonstrates clear benefits over premix insulin BOOSTTM DegludecPlus versus NovoMix® 30 in type 2 diabetes 3590: 6 mth vs. IGlar, OD, T2, N=529 Blood glucose Hypoglycaemia reduction 3592: 6 mth vs. BIAsp,
Slide 30: Conclusion on clinical results of DegludecPlus
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 30 Conclusion on clinical results of DegludecPlus • Highly effective glycaemic control • Lower fasting blood glucose control • Lower rates of hypoglycaemia • Statistically significant for both nocturnal and total vs. premix administered twice-dail
Slide 31: Commercial strategy for Degludec and DegludecPlus
Novo Nordisk Capital Markets Day 5 May 2011 Commercial strategy for Degludec and DegludecPlus Jakob Riis SVP Global Marketing
Slide 32: Insulin is often under-utilised resulting in poorly controlled patients
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 32 Insulin is often under-utilised resulting in poorly controlled patients • Despite numerous insulin therapies currently being available, a large proportion of people with diabetes under treatment are still unable to reach guideline recommended H
Slide 33: Degludec and DegludecPlus designed to challenge established treatment standards
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 33 Degludec and DegludecPlus have been designed to challenge established treatment standards Designed to challenge standards of Degludec Ultra long acting basal basal insulin treatment by providing an ultra-long basal insulin Designed to challenge
Slide 34: Degludec potential to support easier insulin initiation
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 34 Degludec has the potential to support easier insulin initiation by dealing with important unmet needs Degludec has been designed to provide: • physicians with a treatment that offers efficacious glycaemic control with a very low risk of hypogly
Slide 35: The cost and burden of minor hypoglycemia
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 35 The cost and burden of “minor” hypoglycemia Reduced well Reduced Increased being productivity treatment cost “You actually wake up and you just feel like you’ve been hit by a brick because you feel that ill. And sometimes I can’t go to work the
Slide 36: Hypoglycemia associated with acute CV events
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 36 Hypoglycemia associated with acute CV events Patients with hypoglycaemic events had a 79% higher risk of acute cardiovascular events Source: Stephen S. Johnson et al. Evidence Linking Hypoglycemic Events to an Increased Risk of Acute Cardiovasc
Slide 37: Preparing for world class launches
Novo Nordisk Capital Markets Day 5 May 2011 Slide no 37 Preparing for world class launches • Following a successful launch of Victoza®, Novo Nordisk is well prepared for yet another world class launch • Once approved, the Degludec launch will build on Victoza® learnings with a clear ambition of furt