Novartis AG · SIX:NOVN
Novartis — Citigroup Global Healthcare Conference 2006
21 slides from Novartis's conference presentation, Feb 28, 2006
Slide 1: Citigroup Global Healthcare Conference
Citigroup Global Healthcare Conference February 28, 2006 Mathias Hukkelhoven, Ph.D. Senior Vice President / Global Head, Drug Regulatory Affairs The following information contains certain forward-looking statements relating to the Company business, which can be identified by the use of forward-looki
Slide 2: Agenda; 2005 – Another Record Year for Group
Agenda • 2005 Results • Pipeline: 2005 achievements • New data from key projects − Galvus®1 (vildagliptin) − Rasilez®1 (aliskiren) − Exforge1 (valsartan / amlodipine) − FTY720 (fingolimod) • Outlook 1 Trade name pending regulatory approval 3 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 2005 –
Slide 3: Strong Pharma Net Sales Expansion; 8 of Top 10 Products Growing
Strong Pharma Net Sales Expansion Full year 2005 Growth in % vs. 2004 USD m USD LC Net sales 20 262 10 9 Operating income 6 014 12 Return on sales 29.7% +0.7%-point Employees at year-end 49 308 4 Global market share up from 3.83 to 3.91%1 1 IMS 29 Countries Nov YTD 2005 5 Citibank HC Conference – M.
Slide 4: Key Pharma Messages 2005
Key Pharma Messages 2005 • Dynamic sales growth ahead of market • Top ranked sales force in all key markets1 • Improved operating income margin • Positive newsflow on key compounds • Top rated pipeline 1 Overall Reps quality in key markets for Cardiovascular prescribers in 2005; Japan ranked #3 Inte
Slide 5: 2005 – A Successful Year in Clinical Development
2005 – A Successful Year in Clinical Development Strong data Key approvals • Rasilez®1 – aliskiren • Aclasta® Paget’s (EU) • Galvus®1 – vildagliptin • Diovan® post-MI5 • Exjade® • Diovan® CHF6 (EU) • FTY720 MS2 • Exjade® • Lucentis™3 • Femara® early adjuvant (US) • Telbivudine4 • Femara® extended ad
Slide 6: Galvus Is Highly Efficacious as Mono- and Combination Therapy
Agenda • 2005 Results • Pipeline: 2005 achievements • New data from key projects − Galvus®1 (vildagliptin) − Rasilez®1 (aliskiren) − Exforge1 (valsartan / amlodipine) − FTY720 (fingolimod) • Outlook 11 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 Galvus® (vildagliptin) Is Highly Efficacious a
Slide 7: Galvus Is Effective as Once-A-Day Treatment
Galvus® (vildagliptin) Is Effective as Once-A-Day Treatment Change in HbA1c (%) Mean HbA1c reduction from baseline at 24 weeks (7.5%–11%) 0.0 -0.1 -0.2 -0.3 -0.3 -0.4 -0.5 -0.6 -0.7 -0.8 -0.78 -0.79 -0.9 * * -0.88 Galvus® 50 mg qd (n=104) -1.0 † Galvus® 50 mg bid (n= 90) *P=0.006; † P=0.001 vs. plac
Slide 8: Galvus Is a Strong Add-on Treatment to glimepiride
Galvus® (vildagliptin) Is a Strong Add-on Treatment to glimepiride Mean HbA1c (%) glim1 & Galvus® 50 mg qd (n=132) glim & Galvus® 50 mg bid (n=132) 9.0 glim & placebo (n= 144) 8.8 8.6 8.4 8.2 8.0 * * 7.8 0 -4 0 4 8 12 16 20 24 Time (weeks of treatment) 1 glimepiride 4 mg qd * P<0.001 difference vs.
Slide 9: Galvus Shows Good Cardiovascular Safety Profile
Galvus® (vildagliptin) Shows Good Cardiovascular Safety Profile • Overall cardiac adverse events − Incidence 2.4%, lower than metformin and similar to placebo • Hypertension − Adverse events reports for hypertension low (3.4%), lower than for metformin and similar to placebo − No propensity in subgr
Slide 10: Overview of Filings and Expected Data for Galvus
Overview of Filings and Expected Data for Galvus® (vildagliptin) Durability Prevention Disease modification Prevention and outcome data available: 2009 and beyond T2DM Prevention of prevention CVM1 risk 2005 2006 2007 2008 2009 2010 2011 2012 Durability Combo prediabetes durability Filing in US Fili
Slide 11: Data Confirms Excellent Efficacy and Safety Profile of Rasilez
Data Confirms Excellent Efficacy and Safety Profile of Rasilez® (aliskiren) Previously disclosed study data showed • Consistent blood pressure lowering in the double digit range at 300 mg dose • Safe and well tolerated up to 300 mg a day • Additive BP-lowering effects in combination with the diureti
Slide 12: …And in Diastolic Blood Pressure
…And in Diastolic Blood Pressure Mean change in diastolic blood pressure from baseline at endpoint (week 8) mmHg ramipril Rasilez® Rasilez® / ramipril 10 mg 300 mg 300/10 0 -10.0 n = 278 -11.0 -10.7 n = 282 -11.3 -12.0 Non-inferior n = 277 -13.0 -12.8 p = 0.04 p = 0.004 Source: Study 2307 23 Citiban
Slide 13: Rasilez Shows Promise for Mono- and Combination Therapy
Rasilez® (aliskiren) Shows Promise for Mono- and Combination Therapy • New data available confirms attractive profile for Rasilez® − Strong efficacy in monotherapy vs. ACE1 inhibitor − Superior blood pressure lowering in combination with hydrochlorothiazide, ACE inhibitor and calcium channel blocker
Slide 14: Exforge – A Dual Combination Product
Agenda • 2005 Results • Pipeline: 2005 achievements • New data from key projects − Galvus® (vildagliptin) − Rasilez® (aliskiren) − Exforge (valsartan / amlodipine) − FTY720 (fingolimod) • Outlook 27 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 Exforge (valsartan / amlodipine) – A Dual Combina
Slide 15: FTY720 in Multiple Sclerosis – Strong Efficacy Maintained Over 12 Months
Agenda • 2005 Results • Pipeline: 2005 achievements • New data from key projects − Galvus® (vildagliptin) − Rasilez® (aliskiren) − Exforge (valsartan / amlodipine) − FTY720 (fingolimod) • Outlook 29 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 FTY720 in Multiple Sclerosis – Strong Efficacy Ma
Slide 16: FTY720 – Reduced Relapse Rate over 12 Months
FTY720 – Reduced Relapse Rate over 12 Months Confirms MRI Findings Time to first confirmed relapse1 Proportion relapse-free 1.0 Core phase Extension phase 0.9 0.8 FTY720 5 mg FTY720 1.25 mg 0.7 Placebo / FTY720 1.25 mg Placebo Placebo / FTY720 5 mg 0.6 re-randomized to FTY720 0.5 0 Time to 1st confi
Slide 17: FTY720 Multiple Sclerosis Program Progresses into Phase III
FTY720 Multiple Sclerosis Program Progresses into Phase III1 • Study results confirm the potential of FTY720 to become a first-in-class oral treatment for multiple sclerosis • EU health authorities approved start of Phase III in Sweden, UK and Belgium • First patients started in Phase III study in J
Slide 18: Strong Newsflow Continues in 2006
Agenda • 2005 Results • Pipeline: 2005 achievements • New data from key projects − Galvus® (vildagliptin) − Rasilez® (aliskiren) − Exforge (valsartan / amlodipine) − FTY720 (fingolimod) • Outlook 35 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 Strong Newsflow Continues in 2006 Regulatory Data
Slide 19: Conclusions
Conclusions • Strong progress in key projects in 2005 • Sustained high R&D productivity • 2006 will be a year of multiple filings for key products 37 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 38 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 19
Slide 20: Backup: Planned Filings 2006 to ≥ 2009
Backup 39 Citibank HC Conference – M. Hukkelhoven 28 Feb 2006 Planned Filings 2006 to ≥ 2009 2006 2007 2008 ≥ 2009 Galvus® LIC477 (US) QAB149 AAE581 AEE788 Diabetes Bipolar disorder Asthma, COPD Osteoporosis Solid tumors LucentisTM(EU) AMN107 EPO906 LDC300 XBD173 AMD1 CML2 Solid tumors Hepatitis B A
Slide 21: Latest Data Show Even Better than Expected Therapeutic Benefit
Latest Data Show Even Better than Expected Therapeutic Benefit • Clear advantage in overall survival vs. Interferon + Ara-C therapy1 • 93% survival without progression to advanced disease after 54 months of Glivec® as first-line therapy and 90% overall survival2 • Less than 1% of patients progress t
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