Novartis AG · SIX:NOVN
Novartis — Investor Day (January 2005)
24 slides from Novartis's investor day presentation, Jan 20, 2005
Slide 1: Key Late Stage Projects
Key Late Stage Projects James Shannon Head of Clinical Development and Medical Affairs Novartis Pharma AG Highly Innovative Compounds in Attractive Market Segments Reflect Depth of Pipeline First-in- Gold standard Large market Phase class potential potential Aclasta1 (osteoporosis) III ! ! AAE581 (o
Slide 2: Highly Innovative Compounds in Attractive Market Segments; The Diabetic Epidemic
Highly Innovative Compounds in Attractive Market Segments Reflect Depth of Pipeline First-in- Gold standard Large market Phase class potential potential Aclasta1 (osteoporosis) III ! ! AAE581 (osteoporosis) II ! ! PTK787 (colorectal cancer) III !2 ! ! ICL670 (iron overload) III ! ! FTY720 (transplan
Slide 3: LAF237 (Phase II): Oral DPP-4 Inhibitor for Durable Diabetes Control
LAF237 (Phase II) Oral DPP-41 Inhibitor for Durable Diabetes Control • First in a highly attractive new class of compounds LAF237 (incretin enhancer) Mixed meal • Effective as monotherapy DPP4 and in combination GLP-13 • Effectively reduces HbA1c2 active • Has the potential for disease modification
Slide 4: Current Treatments for Type 2 Diabetes Have Limitations
Current Treatments for Type 2 Diabetes Have Limitations Sulfonyl- Insulin Metformin Acarbose Thiazolidi- Exenatide ureas nediones Hypoglycemia GI side effects Lactic acidosis Weight gain Edema Need LFT1 monitoring Restricted populations Poor responder rate Nausea Need injection 1 Liver function test
Slide 5: LAF237 is Highly Selective for DPP-4
LAF237 is Highly Selective for DPP-4 • Inhibition of DPP-8 and DPP-9 suggested to result in toxicity in rats characterized by thrombocytopenia, anemia, mortality1 • No evidence of non-specific enzyme inhibition with LAF237 at clinically relevant doses: − LAF237 is ca. 32–250 times more selective for
Slide 6: LAF237 Demonstrates Sustained Efficacy in Metformin-Treated Patients
LAF237 Demonstrates Sustained Efficacy in Metformin-Treated Patients HbA1c (%) LAF237 50 mg OD/Metformin (n=42) Placebo/Metformin (n=29) 8.4 8.0 p<0.025 7.6 7.2 p<0.0001 6.8 -4 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Week Source: Ahrén B. et Al., Diabetes Care 2004 11 FRESCO 2004 / James Shannon / 20
Slide 7: Additional Efficacy when LAF237 is Added to Pioglitazone
Preliminary Data Demonstrate Additional Efficacy when LAF237 is Added to Pioglitazone Glucose levels (mg/dL) Pioglitazone 45 mg OD1 + LAF237 100 mg OD (n=12) 300 Pioglitazone 45 mg OD (n=12) 250 200 150 100 0 2 4 6 8 10 12 14 16 18 Time (hr) 1 Once daily Source: Study LAF237 A2207; study design in a
Slide 8: Selectivity of LAF237 Translates into Good Clinical Safety Profile
Selectivity of LAF237 Translates into Good Clinical Safety Profile LAF237 shown to be generally safe and well tolerated in controlled clinical studies • Phase II core program (n = 434 on LAF237 vs. 170 on placebo) − No differences vs. placebo in SAEs1, AEs2, discontinuations due to AEs, and predefin
Slide 9: SPP100 (Phase IIb/III) – Next Generation in Blood Pressure Control
Highly Innovative Compounds in Attractive Market Segments Reflect Depth of Pipeline First in Gold standard Large market Phase class potential potential Aclasta1 (osteoporosis) III ! ! AAE581 (osteoporosis) II ! ! PTK787 (colorectal cancer) III !2 ! ! ICL670 (iron overload) III ! ! FTY720 (transplant
Slide 10: Unmet Need still Exists in the Growing Hypertension Market Segment
Number of Treated Hypertension Patients Expected to Grow Significantly over the Next 20 Years No. of hypertensive patients (m) in top 7 countries 250 Treated Untreated • Segment value expected to grow 200 from USD 39 bn in 2003 to around USD 150 55 bn in 2008 • More aggressive 100 +75% treatment gui
Slide 11: ACEIs, ARBs and Diuretics Lead to Increased Renin Activity
ACEIs, ARBs and Diuretics Alone or in Combination Lead to Increased Renin Activity Angiotensin ogen Diuretic ↑ Renin Volume activity depletion ACE- independent pathways Angiotensin I Compensatory feedback mechanisms ACE ACEI ARB Angiotensin I Harmful effects Receptor Angiotensin II Potential harmful
Slide 12: The Importance of Renin – Association Between Renin and Cardiorenal Disease
The Importance of Renin – Association Between Renin and Cardiorenal Disease • Plasma renin activity (PRA) is independently and directly associated with the occurrence of cardiovascular disease in the hypertensive patient − A 25% increase in the incidence of myocardial infarction for every 2 ng/mL/h
Slide 13: SPP100 Showed Superiority to Irbesartan in a Phase II Trial
SPP100 Showed Superiority to Irbesartan in a Phase II Clinical Trial 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
Slide 14: Study 2203 Confirms the Blood Pressure Lowering Effect of SPP100
Study 2203 Confirms the Blood Pressure Lowering Effect of SPP100 Cuff sitting blood pressure change in hypertensive patients (8 weeks treatment) SPP100 300 mg SPP100 300 mg Valsartan 320 mg Placebo (n=130) (n=130) Placebo (n=177) (n=175) (n=60) 0 diastolic diastolic diastolic systolic systolic systo
Slide 15: Combination of SPP100 and Valsartan Gives Additional Diastolic Lowering
Combination of SPP100 and Valsartan Gives Additional Diastolic Blood Pressure Lowering Diastolic blood pressure reduction 75 80 150 160 300 320 mmHg n=177 mg mg n=179 n=58 n=60 mg mg n=178 n=59 n=60 mg mg n=175 n=60 n=58 -6 -7 -8 -9 -10 -11 -12 Placebo * * SPP 100 * * -13 Valsartan * Combination * -
Slide 16: SPP100 – First in New Class of Renin-inhibiting Anti-hypertensive Drugs
SPP100 – First in New Class of Renin-inhibiting Anti-hypertensive Drugs • SPP100 is first in a new class of anti-hypertensive agents − 10 years after ARB launch • SPP100 is the first renin inhibitor in Phase III • SPP100 has shown comparable efficacy and safety to ARBs • SPP100 has − Potential for i
Slide 17: QAB149 (Phase II): Once-a-Day Control in Airways Diseases
Highly Innovative Compounds in Attractive Market Segments Reflect Depth of Pipeline First in Gold standard Large market Phase class potential potential Aclasta1 (osteoporosis) III ! ! AAE581 (osteoporosis) II ! ! PTK787 (colorectal cancer) III !2 ! ! ICL670 (iron overload) III ! ! FTY720 (transplant
Slide 18: Market Segment Outlook – Strong Growth Potential for Bronchodilation
Market Segment Outlook – Strong Growth Potential for Bronchodilation • Strong market segment Global bronchodilator1 sales growth: +10.7% CAGR USD 9.4 bn in 2004 • Single agent products will COPD 38% retain substantial share, in 62% Asthma both asthma & COPD USD 17.2 bn in 2010 • Fixed dose combinati
Slide 19: Dose Ranging Trial Design for QAB149 Certihaler in Asthma and COPD
Dose Ranging Trial Design for QAB149 Certihaler in Asthma and COPD • Asthma patient population A2216: adult and adolescent asthmatics on steroids with stable persistent asthma (n=436) • COPD patient population B2205: adult (age >40) COPD patients with moderate to severe disease (n=635) • Design: ran
Slide 20: QAB149 Shows Rapid Onset of Action in COPD and True 24-hour Control
QAB149 Shows Rapid Onset of Action in COPD and True 24-hour Control Percentage predicted FEV1 70 65 60 55 50 400 µg Certihaler (n=110) 200 µg Certihaler (n=105) 100 µg Certihaler (n=105) 50 µg Certihaler (n=103) Placebo (n=107) 0 0 5 10 15 30 1 2 3 4 8 12 22 23 24 Minutes Hours Time post dose Source
Slide 21: QAB149 – The First Once-Daily Beta-2 Agonist with 24-hour Bronchodilation
QAB149 – The First Once-Daily Beta-2 Agonist with 24-hour Bronchodilation for Asthma and COPD • Effective 24-hour bronchodilator control after single dose • Rapid onset • Good safety with once-daily dosing • Safety confirmed at high doses • Safety profile similar to placebo • Potential new gold stan
Slide 22: Strong Newsflow in 2005; Conclusions
Strong Newsflow in 2005 Regulatory Data Submissions decisions • ICL670 Phase III • ICL670 chronic iron • Focalin™ XR (US) overload • LAF237 Phase III • Aclasta2 Paget’s disease • PTK787 colorectal (US & EU) • SPP100 Phase Ilb/III cancer1 • Zelnorm® IBS (EU) • PTK787 Phase III • LDT600 hepatitis B •
Slide 23: Appendix: Type 2 Diabetes Mellitus – A Global Epidemic
Appendix 45 FRESCO 2004 / James Shannon / 2005-01-20 / Analysts Type 2 Diabetes Mellitus (T2DM) A Global Epidemic Prevalence of diabetes worldwide 1995 m people 2000 Current prevalence for all 2030 types of diabetes: 140 ∼171 m people worldwide: 120 • European Union 3-9% 100 diabetes prevalence, ∼19
Slide 24: Design of Study LAF237 A2207 with Pioglitazone
Design of Study LAF237 A2207 with Pioglitazone • Design: A double-blind, randomized, crossover, three period, placebo controlled trial • Patient population: Type 2 diabetics (n=12), HbA1c 7-11% • Dosage regimen: LAF237 100 mg OD1 and Pioglitazone 45 mg OD • Treatment periods: Run-in Pioglitazone 45