Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — ADA 2010 Investor and analyst event
39 slides from Novo Nordisk A/s Class B's conference presentation, Jun 27, 2010
Slide 1: ADA 2010 Investor and analyst event
ADA 2010 Investor and analyst event 27 June 2010 Orlando, Fl
Slide 2: Forward-looking statements
ADA 2010 Investor and analyst event 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 2009 and Form 20-F, both filed with the SEC in February 2010, an
Slide 3: Agenda
ADA 2010 Investor and analyst event Slide no 3 Agenda Time Topic 6.00 pm Welcome Klaus Bülow Davidsen, Head of Investor Relations 6.05 pm Medical need for new insulins Alan Moses, VP and Global CMO 6.15 pm Insulin degludec: molecular structure, MoA & pharmacology Peter Kurtzhals, SVP, Diabetes Resea
Slide 4: Strong emphasis on Victoza and phase 2 data for the new-generation insulins
ADA 2010 Investor and analyst event Slide no 4 Strong emphasis on Victoza® and phase 2 data for the new-generation insulins 59 abstracts accepted at ADA 2010 25 20 15 10 5 0 Victoza® Levemir® NovoRapid® NovoMix® New-gen. Diabetes Other insulins Healthcare
Slide 5: Medical need for new insulins
ADA 2010 Investor and analyst event Slide no 5 Medical need for new insulins Alan Moses, VP & Global CMO
Slide 6: The diabetes epidemic: Global projections for 2010–2030
ADA 2010 Investor and analyst event Slide no 6 The diabetes epidemic: Global projections for 2010–2030 People with diabetes globally 2010: 285 million 2030: 438 million Increase 54% 45.8 37.4 56.1 143.7 53.2 22% 221.7 42% 54% 17.1 33.1 94% 21.6 42.5 97% 18.0 29.6 64% 1.3 1.8 38% Source: Diabetes Atl
Slide 7: Poor glycaemic control in diabetes is a worldwide problem
ADA 2010 Investor and analyst event Slide no 7 Poor glycaemic control in diabetes is a worldwide problem Reported mean HbA1c in T2D patients exceeds local targets in nearly all countries UK The Netherlands 7.0-7.9 7.0-7.6 Germany China 7.5-9.2 8.8 France Japan USA 7.6 8.9-9.4 Italy 7.5-8.6 7.6 India
Slide 8: US data: Despite improved glucose control many with diabetes are still not at target
ADA 2010 Investor and analyst event Slide no 8 US data: Despite improved glucose control many with diabetes are still not at target Share of patients by HbA1c levels 1999-2001 2001-2002 2003-2004 60 Percent of population (%) 50 40 30 20 10 0 <7.0% >9.0% HbA1c levels Source: adapted from Hoerger, T.
Slide 9: Risk of complications increases with HbA1c
ADA 2010 Investor and analyst event Slide no 9 Risk of complications increases with HbA1c Type of complication by HbA1c level Myocardial infarction Microvascular disease 60 Incidence per 1,000 patient years 40 20 0 5 6 7 8 9 10 11 Mean HbA1c (%) Source: Stratton IM, et al. Association of glycaemia w
Slide 10: Benefits of good glycaemic control compromised by more hypoglycaemia
ADA 2010 Investor and analyst event Slide no 10 Benefits of good glycaemic control compromised by more hypoglycaemia Rates of severe hypoglycaemia Intensive treatment group Conventional treatment group 100 Events / 100 patient years 80 60 40 20 0 5 6 7 8 9 10 11 12 13 14 HbA1c (%) during study Sourc
Slide 11: Medical need for improving balance between glycaemic control, hypoglycaemia and convenience
ADA 2010 Investor and analyst event Slide no 11 Medical need for improving balance btw gly- caemic control, hypoglycaemia and convenience Barriers for effective insulin treatment: • Trade-off between optimal glycaemic control and the risk of hypoglycaemia • Lifestyle restriction imposed by insulin r
Slide 12: Insulin degludec: Molecular structure, mode of action and pharmacology
ADA 2010 Investor and analyst event Slide no 12 Insulin degludec: Molecular structure, mode of action and pharmacology Peter Kurtzhals, SVP, Diabetes Research,
Slide 13: Profile of the two new-generation insulins: Degludec and DegludecPlus
ADA 2010 Investor and analyst event Slide no 13 Profile of the two new-generation insulins: Degludec and DegludecPlus DegludecPlus – an ultra-long-acting 8 basal insulin with a bolus boost Glucose infusion rate 6 (mg/kg/min) Degludec – an ultra-long- Rapid acting basal insulin 4 component (insulin a
Slide 14: Molecular structure of Degludec
ADA 2010 Investor and analyst event Slide no 14 Molecular structure of Degludec 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 C C G G S S H H LL V V E E A A LL Y Y LL V V C C G G E E R R G G F F F F Y Y T T P P K K B chain
Slide 15: The protraction mechanism of Degludec is based on multi-hexamer formation
ADA 2010 Investor and analyst event Slide no 15 The protraction mechanism of Degludec is based on multi-hexamer formation Duration of Action Multi-hexamers Hexamer Monomer Molecular size
Slide 16: Protraction mechanism for Degludec
ADA 2010 Investor and analyst event Slide no 16 Protraction mechanism for Degludec Multi-hexamers Subcutaneous tissue Monomers Capillary membrane Insulin degludec in blood Albumin binding Capillary blood Cell Membrane Insulin Receptors
Slide 17: Insulin degludec provides stable basal insulin coverage with ultra-long duration of action
ADA 2010 Investor and analyst event Slide no 17 Insulin degludec provides stable basal insulin coverage with an ultra-long duration of action Mean serum Degludec concentration-time profile 10,000 Day 1 Day 6 (steady state) Insulin degludec (pmol/l) 1,000 100 0 4 8 12 16 20 24 Time since last injecti
Slide 18: Insulin degludec retains the molecular pharmacology and safety of human insulin
ADA 2010 Investor and analyst event Slide no 18 Insulin degludec retains the molecular pharmacology and safety of human insulin In vitro studies pertaining to insulin degludec molecular safety Parameter k Human Insulin k Degludec (% relative to HI) Insulin receptor binding 100 15 IGF-1 receptor bind
Slide 19: Phase 2 results
ADA 2010 Investor and analyst event Slide no 19 Phase 2 results Mads Krogsgaard Thomsen, EVP & CSO
Slide 20: Design of phase 2 trial: Degludec plus metformin in type 2 diabetes
ADA 2010 Investor and analyst event Slide no 20 Design of phase 2 trial: Degludec plus metformin in type 2 diabetes Alt. formulation of Degludec OD + met Degludec OD + met People with type 2 diabetes (n=236) Degludec 3TW (Mon, Wed, Fri) + met Insulin glargine OD + met -3 0 16 weeks Randomisation All
Slide 21: Baseline characteristics
ADA 2010 Investor and analyst event Slide no 21 Baseline characteristics Degludec Degludec Glargine OD 3TW OD Subjects Randomised (n) 60 62 62 Female/Male (%) 45/55 55/45 40/60 White/Black/Asian (%) 27/18/53 29/13/55 37/6/55 Age (years) 55.3 (±8.7) 54.4 (±8.8) 53.1 (±10.2) Weight (kg) 78.5 (±16.9) 7
Slide 22: Similar glycaemic control over time
ADA 2010 Investor and analyst event Slide no 22 Similar glycaemic control over time Degludec OD Degludec 3TW Glargine OD 9.0 8.5 HbA1c (%) 8.0 7.5 7.4 (0.1) % 7.3 (0.1) % 7.2 (0.1) % 7.0 0 4 8 12 16 Weeks since randomisation Trial: NN1250-1836, Degludec OD and 3TW in type 2 DM. Note: Mean (SEM) for
Slide 23: Participants without confirmed hypoglycaemic episode
ADA 2010 Investor and analyst event Slide no 23 Participants without confirmed hypoglycaemic episode Degludec OD Degludec 3TW Glargine OD 92% 77% 77% Confirmed episode: PG ≤ 56 mg/dl or requiring assistance. The relative rate of hypoglycaemia was estimated by a negative binomial regression model adj
Slide 24: Rate of confirmed hypoglycaemia
ADA 2010 Investor and analyst event Slide no 24 Rate of confirmed hypoglycaemia Degludec OD / Degludec 3TW / Glargine OD Glargine OD Estimated Relative Rate 0.44 [0.15; 1.27] 1.17 [0.46; 2.96] Confirmed episode: PG ≤ 56 mg/dl or requiring assistance. The relative rate of hypoglycaemia was estimated
Slide 25: Hypoglycaemia in type 1 subjects treated with Degludec
ADA 2010 Investor and analyst event Slide no 25 Hypoglycaemia in type 1 subjects treated with Degludec Confirmed nocturnal hypoglycaemia 200 Degludec Glargine Number of events 150 Estimated Relative Rate 0.42 [0.25; 0.69] 100 50 0 0 4 8 12 16 Weeks since randomisation Trial: NN1250-1835, Degludec in
Slide 26: Conclusions from the phase 2 for Degludec
ADA 2010 Investor and analyst event Slide no 26 Conclusions from the phase 2 for Degludec • Degludec OD and 3TW was shown to be well-tolerated, no safety concerns were identified and the compound provided similar glycaemic control to insulin glargine (treat-to-target study) • Fewer patients treated
Slide 27: Design of phase 2 trial: DegludecPlus + metformin in type 2 diabetes
ADA 2010 Investor and analyst event Slide no 27 Design of phase 2 trial: DegludecPlus + metformin in type 2 diabetes Alt. formulation OD + met People with type 2 diabetes DegludecPlus OD + met (n=178) Insulin glargine OD + met -3 0 16 weeks Randomisation All endpoints Discont. OADs Titrate met Trial
Slide 28: Similar glycaemic control after 16 weeks
ADA 2010 Investor and analyst event Slide no 28 Similar glycaemic control after 16 weeks DegludecPlus Glargine 9.0 8.5 HbA1c (%) 8.0 7.5 7.1 (0.2) % 7.0 7.0 (0.1) % 6.5 0 4 8 12 16 Weeks since randomization Trial: NN5401-1791, DegludecPlus OD in type 2 DM. Note: Mean (SEM) for all randomized subject
Slide 29: Similar profiles with additional post-dinner control with DegludecPlus
ADA 2010 Investor and analyst event Slide no 29 Similar profiles with additional post-dinner control with DegludecPlus 30 29 2h PG increment (mg/dl) 280 DegludecPlus Glargine 20 240 SMPG (mg/dl) 10 200 Week 0 2 0 160 Week 16 120 am h t e t r er ch st as as ne nc im fa nn un 0 kf kf in lu dt ak :0 di
Slide 30: A stable and flat nocturnal profile with DegludecPlus at week 16
ADA 2010 Investor and analyst event Slide no 30 A stable and flat nocturnal profile with DegludecPlus at week 16 DegludecPlus Glargine 9.0 162 Interstitial glucose (mmol/l) Interstitial glucose (mg/dl) 8.5 153 8.0 144 7.5 135 7.0 126 6.5 117 6.0 108 0 0 24:00 01:00 02:00 03:00 04:00 05:00 06:00 Cloc
Slide 31: Hypoglycaemic episodes
ADA 2010 Investor and analyst event Slide no 31 Hypoglycaemic episodes DegludecPlus Glargine N E N E All confirmed episodes 13 20 9 12 Nocturnal 1 1 3 3 No severe hypoglycaemia observed (requiring assistance) Confirmed episode: PG ≤ 56 mg/dl or requiring assistance. Nocturnal episode: confirmed epis
Slide 32: Conclusions from phase 2 for DegludecPlus
ADA 2010 Investor and analyst event Slide no 32 Conclusions from phase 2 for DegludecPlus • DegludecPlus OD was well-tolerated and no safety concerns were identified • A trend toward greater HbA1c reductions for DegludecPlus OD vs. insulin glargine OD* was observed • End-of-trial mean daily insulin
Slide 33: Phase 3 programme
ADA 2010 Investor and analyst event Slide no 33 Phase 3 programme Mads Krogsgaard Thomsen, EVP & CSO
Slide 34: BEGIN and BOOST are designed to explore Degludec and DegludecPlus in broad settings
ADA 2010 Investor and analyst event Slide no 34 BEGIN™ and BOOST™ are designed to explore Degludec and DegludecPlus in broad settings Insulin initiation Insulin intensification Degludec OD + NovoRapid® TID vs. BEGIN™ T1 glargine OD + NovoRapid® TID Degludec OD vs. sitagliptin T2 Degludec OD + NovoRa
Slide 35: Recruitment now completed for the BEGIN and BOOST phase 3a programmes
ADA 2010 Investor and analyst event Slide no 35 Recruitment now completed for the BEGINTM and BOOSTTM phase 3a programmes Estimated timeline for patient treatment for clinical programme NN1250-3579: 12 mth vs. IGlar in T2 (N=984) NN1250-3582: 12 mth vs. IGlar in T2 (N=984) NN1250-3583 : 12 mth vs. I
Slide 36: Q&A session
ADA 2010 Investor and analyst event Slide no 36 Q&A session Mads Krogsgaard Thomsen, EVP and CSO Peter Kurtzhals, SVP, Diabetes Research Alan Moses, VP and Global CMO Klaus Bülow Davidsen, Head of IR
Slide 37: Appendix
ADA 2010 Investor and analyst event Slide no 37 Appendix Rate of hypoglycaemia in type 1 and type 2 diabetes
Slide 38: Reduced risk of hypoglycaemia in type 1 diabetes with modern insulins
ADA 2010 Investor and analyst event Slide no 38 Reduced risk of hypoglycaemia in type 1 diabetes with modern insulins Insulin detemir NPH insulin 60 Hypoglycaemic events 50 per patient year 40 30 20 10 6 7 8 9 10 11 HbA1c Source: Heller and Kim, Insulin Detemir Reduces Hypoglycemic Risk at Comparabl
Slide 39: Reduced risk of hypoglycaemia in type 2 diabetes with modern insulins
ADA 2010 Investor and analyst event Slide no 39 Reduced risk of hypoglycaemia in type 2 diabetes with modern insulins Insulin detemir NPH insulin 16 Hypoglycaemic events 14 per patient year 12 10 8 6 4 2 5 6 7 8 9 10 HbA1c Source: Kolendorf and Kim, Lower Risk of Hypoglycemia at Each Level of Glycem