Novartis AG · SIX:NOVN
Novartis — Investor Day (January 2004)
23 slides from Novartis's investor day presentation, Jan 22, 2004
Slide 1: Development Pipeline: Delivering Top Performance
Development Pipeline Delivering Top Performance Joerg Reinhardt Head of Pharma Development, Novartis Pharma AG Agenda • Update on clinical profile of key projects • Recent additions further strengthen the pipeline • Conclusion 2 FRESCO 2003 / Joerg Reinhardt / 2004-01-22 / Analysts 1
Slide 2: A Focused Portfolio in Attractive Market Segments
A Focused Portfolio in Attractive Market Segments Phase Business unit/business franchise I II III & Reg Total Nervous system 3 6 5 14 Cardiovascular, metabolism 0 3 7 10 Primary Arthritis, bone, GI1, HRT2 3 7 6 16 care Anti-infectives 1 1 1 3 Respiratory, dermatology 3 4 4 11 Oncology 5 7 5 17 Trans
Slide 3: Zoledronic Acid Shows Potential for Unsurpassed Compliance with Once-a-Year Dose
Zoledronic Acid (Osteoporosis) Shows Potential for “Unsurpassed Compliance” with Once-a-Year Dose • Third-generation bisphosphonate • More potent than currently available bisphosphonates • IV1 formulation for osteoporosis may provide advantages over existing oral products • Well tolerated – lack of
Slide 4: New Promising Results for Zoledronic Acid in Paget's Disease
New Promising Results for Zoledronic Acid in Paget’s Disease Study design: 178 Paget’s Disease 8 weeks’ double-blind treatment patients ≥30 years with serum alkaline phosphatase ≥ 2 x ULN1 Zoledronic acid 5 mg i.v. single injection risedronate (Actonel) 30 mg daily oral Primary endpoint: • ≥75% red
Slide 5: LAF237: Oral DPP4 Inhibitor with Potential for Durable Diabetes Control
10 Highly Innovative Compounds in Attractive Market Segments First in Gold standard Large market Phase class potential potential Zoledronic acid (osteoporosis) III ! ! AAE581 (osteoporosis) II ! ! PTK7871 (cancer) III !2 ! ICL670 (iron overload) III ! ! FTY720 (transplantation) III ! ! ! LDT600 (hep
Slide 6: LAF237 Leads to Dose-Dependent Reductions in HbA1c in Phase II
LAF237 Leads to Dose-Dependent Reductions in HbA1c1 in Mild Diabetics in Phase II Change in HbA1c (%) from mean baseline of 7.7% at 12 weeks Placebo (n=44) 50 mg od (n=40) 100 mg od (n=46) 0.20 0.00 -0.20 -0.20 -0.40 -0.60 -0.56 * -0.68* -0.80 1 Glycosylated Hemoglobin A Source: Study 2203 in drug-n
Slide 7: LAF237 Increases GLP-1 Levels and Decreases Glucagon Levels
LAF237 Increases GLP-1 Levels and Decreases Glucagon Levels in Phase II GLP-1 (pmol/L) Glucagon (pmol/L) 14 120 12 100 p < 0.001 10 80 8 p < 0.001 60 6 40 4 2 20 0 0 -50 0 50 100 150 -50 0 50 100 150 Time (minutes) Time (minutes) Placebo (19) LAF237 (18) Source: Ahren B, et al. Diabetes. 2003;52:A15
Slide 8: LAF237 Phase II Safety and Tolerability; Phase III Program
LAF237 – Phase II Data Suggest a Positive Safety and Tolerability Profile • No difference in nausea or vomiting as compared to placebo • Low incidence of hypoglycemia symptoms • No changes in liver enzymes or increases in creatinine phosphokinase (CPK) • No other laboratory results of concern • No s
Slide 9: SPP100: First in a New Class of Anti-Hypertensives
10 Highly Innovative Compounds in Attractive Market Segments First in Gold standard Large market Phase class potential potential Zoledronic acid (osteoporosis) III ! ! AAE581 (osteoporosis) II ! ! PTK7871 (cancer) III !2 ! ICL670 (iron overload) III ! ! FTY720 (transplantation) III ! ! ! LDT600 (hep
Slide 10: SPP100 Superior to Irbesartan in Phase II
SPP100 – Superior to Irbesartan in Phase II Cuff sitting blood pressure change in hypertensive patients (8 weeks’ treatment) SPP100 150 mg SPP100 300 mg SPP100 600 mg irbesartan 150 mg Placebo (n=130) (n=127) (n=130) (n=129) (n=133) 0 diastolic systolic diastolic systolic -2 -4 -6 -8 -10 * * -12 * *
Slide 11: SPP100 Phase III Program Is on Track
SPP100 Phase III Program Is on Track • Phase III to start in March 2004 • First phase III results expected by Q4 2004 • Submission planned for late 2005/early 2006 21 FRESCO 2003 / Joerg Reinhardt / 2004-01-22 / Analysts Agenda • Update on clinical profile of key projects • Recent additions further
Slide 12: Lucentis: Wet AMD Market Segment Forecast to Grow Strongly
Wet AMD1 A Market Segment Forecast to Grow Strongly Sales (USD m) • ~480 000 new cases of wet AMD 1 600 1 500 diagnosed worldwide each year 1 400 • Visudyne® is the only currently approved pharmacological 1 200 treatment for wet AMD 1 000 • Launch of anti-VEGF2 compounds 800 will drive market segmen
Slide 13: Phase II Results Are Very Encouraging; Phase III Trials in Progress
Phase II Results Are Very Encouraging Lucentis™ visual acuity changes at 6 months in % of subjects 100 • 64 wet AMD patients randomized to monthly 80 38 intravitreal injections of 53 Lucentis™ or usual care 60 • Lucentis™ was well tolerated 40 • Biological activity seen in both 62 predominantly clas
Slide 14: Gimatecan: A Promising Topoisomerase I Inhibitor
Gimatecan A Promising Topoisomerase I Inhibitor Topoisomerase I market segment is large and growing steadily USD m 1 000 900 800 Gimatecan shows promise 700 • Novel topoisomerase I inhibitor 600 • Third generation camptothecin 500 derivative 400 300 • Orally active 200 • Excellent preclinical data 1
Slide 15: Gimatecan Phase I Efficacy; AKU517 for Gastrointestinal Ulcers
Gimatecan Shows Encouraging Efficacy in Phase I • 132 patients treated in phase I • 7 confirmed partial responses – including 5 with prior taxane failure − Several different cancers • 6 minor responses in glioma • Phase II studies in progress (colorectal cancer, breast) 29 FRESCO 2003 / Joerg Reinha
Slide 16: AKU517: A Potential New Treatment for Gastrointestinal Disorders
AKU517 – A Potential New Treatment for Gastrointestinal Disorders • First phase I trial started in October 2003 • Preclinical data and mechanism of action predict a fast onset of action and potent sustained acid supression • Phase II dose-finding studies planned to start in H2 2004 − Placebo and act
Slide 17: Development Pipeline: Productivity, Innovation and Focus
Development Pipeline Productivity, Innovation and Focus Key development projects Major products Major additions in registration LAF237 Major approvals to pipeline in SPP100 in 2003 2003 Diovan® ICL670 Xolair® (VALIANT) AKU517 PTK787 Certican® Enablex™ LDT600 FTY720 myfortic® Foradil® LDC300 LDT600 S
Slide 18: Appendix: Planned Filings 2004-2007
Appendix Planned Filings 2004–2007 2004 2005 2006 ≥ 2007 Zelmac® (EU) ICL670 LAF237 QAB149 EPO906 IBS Iron overload Diabetes Asthma, COPD Cancer SOM230 PKC412 NKS104 LAQ824 Xolair® (EU) Cancer AML Dyslipidemia Cancer Femara® FTY720 Lucentis SAB378 XAA296 Extended adj. Transplantation AMD Chronic pai
Slide 19: A Focused Portfolio; Optimally Exploit Potential of Projects
A Focused Portfolio in Attractive Market Segments Phase Business unit/business franchise I II III & Reg Total Nervous system 3 6 5 14 Cardiovascular, metabolism 0 3 7 10 Primary Arthritis, bone, GI1, HRT2 3 7 6 16 care Anti-infectives 1 1 1 3 Respiratory, dermatology 3 4 4 11 Oncology 5 7 5 17 Trans
Slide 20: Nervous System; Cardiovascular and Metabolic Diseases
Nervous System Phase I Phase II Phase III Registration AAG561 TCH346 Iloperidone Anxiety/depression ALS Schizophrenia AEP924 AMP397 Trileptal® NP Depression Epilepsy Diab. neurop. pain XBD173 SAB378 Focalin LA Anxiety Chronic pain LIC477D Exelon® Bipolar disorder non-Alzh. dementia TCH346 Exelon® TD
Slide 21: Arthritis, Bone, GI, HRT; Respiratory and Dermatology
Arthritis, Bone Diseases, GastroIntestinal, HRT Phase I Phase II Phase III Registration ABN912 AAE581 Prexige® Enablex® Rheumatoid arthritis Osteoporosis RA, OA & pain Overactive bladder AKU517 RGN303 Zelmac®(EU) Zelnorm® GERD Rheumatoid arthritis IBS Chronic constipation Prexige® Zelmac® Zoledronic
Slide 22: Oncology; Infectious Diseases
Oncology Phase I Phase II Phase III Registration LAQ824 EPO906 ICL670 Zometa® (J) Hypercalcemia of Solid & liquid tumors Solid tumors Chronic iron overload malignancy XAA296 PKC412 PTK787 Solid tumors AML Solid tumors LBH589 SOM230 Femara® Early adjuvant Solid & liquid tumors Acromegaly/GEP tumors b
Slide 23: Transplantation; Ophthalmology
Transplantation Phase II Phase III Registration FTY720 myfortic® Transplantation Transplantation Certican® (US) Transplantation NME LCM 45 FRESCO 2003 / Joerg Reinhardt / 2004-01-22 / Analysts Ophthalmology Phase II Phase III Registration PIR335 Lucentis™ Myopia AMD Elidel® Visudyne® (US) Ophtha ind