Novartis AG · SIX:NOVN
Novartis — Investor Day (January 2006)
34 slides from Novartis's investor day presentation, Jan 19, 2006
Slide 1: Development Pipeline 2006 – Filings for Key Projects
Development Pipeline 2006 Filings for Key Projects James Shannon Head of Pharma Development Novartis Pharma AG The following information contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “will” or
Slide 2: Agenda; 2005 – A Successful Year for Development
Agenda • Overview 2005 • New data from key projects • Outlook 2006 3 FRESCO 2005 / James Shannon / 2006-01-19 / Analyst 2005 – A Successful Year for Development • Good progress of key projects • Eight significant approvals, including two high priority reviews • Ten filings, including two NMEs1 • Exc
Slide 3: Good Progress of Key Projects
Good Progress of Key Projects Phase Progress New Data ICL670 (Exjade®; iron overload) Filed1 + + Telbivudine (hepatitis B) Filed (US) + + Galvus®2 (type 2 diabetes) III + + Rasilez®2 (hypertension) III + + Aclasta® (osteoporosis) III + PTK787 (colorectal cancer) III – – FTY720 (MS) II/III + + QAB149
Slide 4: Galvus (vildagliptin) Is the First-In-Class Islet Enhancer for T2DM
Galvus® (vildagliptin) Is the First-In-Class ‘Islet Enhancer’ for the Treatment of T2DM1 • First-in-class islet enhancer, LAF237 increases activity of GLP-12 and GIP3 H O N HO N • Strong Phase III results in N monotherapy and combinations • Potential for disease modification Mixed meal based on beta
Slide 5: 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 6: Galvus Is a Strong Add-on Treatment to Glimepiride and Metformin
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 7: 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 8: Overview of Filings, Timing of Study Starts and Expected Data for Galvus
Overview of Filings, Timing of Study Starts 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 dura
Slide 9: Rasilez (aliskiren) – Next Generation in Blood Pressure Control
Rasilez® (aliskiren) – Next Generation in Blood Pressure and Vascular Disease Control • First oral renin inhibitor for hypertension Renin • Efficacious in monotherapy and excellent candidate for combination therapy • Potential for improved end-organ protection via control of plasma renin activity •
Slide 10: Rasilez Offers Superior Efficacy Compared to Ramipril
Rasilez® (aliskiren) Offers Superior Efficacy Compared to ramipril in Systolic Blood Pressure… Mean change in systolic blood pressure from baseline at endpoint (week 8) mmHg ramipril Rasilez® Rasilez® / ramipril 10 mg 300 mg 300/10 0 -10.0 -11.0 n = 459 -12.0 -12.0 -13.0 -14.0 n = 282 -15.0 -14.7 -1
Slide 11: Rasilez Shows Promise for Mono- and Combination Therapy
Rasilez® Provides Significant BP Reduction when Added to amlodipine with Reduced Incidence of Edema Mean change in blood pressure from baseline at week 6 mmHg amlodipine amlodipine Rasilez®1 150 mg 5 mg 10 mg + amlodipine 5 mg n=180 n=178 n=187 0 dia dia sys sys sys dia -4 -5 −4.8 −5.0 -6 -7 -8 −8.0
Slide 12: Overview of Filings, Timing of Study Starts and Expected Data for Rasilez
Overview of Filings, Timing of Study Starts and Expected Data for Rasilez® (aliskiren) Large outcome studies (start) Primary Long term outcome data prevention available: 2011 and beyond Post-MI1 combination Secondary therapy prevention 2005 2006 2007 2008 Filing in US Filing in EU Surrogate outcome
Slide 13: Exforge – A Dual Combination Product
Exforge (valsartan / amlodipine) – A Dual Combination Product of the Most Prescribed Antihypertensives • Exforge development was successfully completed − Clinical program included over 5 000 patients • Systolic blood pressure reduction up to 36 mmHg1 • Diastolic blood pressure reduction up to 29 mmH
Slide 14: FTY720 in Multiple Sclerosis – Strong Efficacy Maintained Over 12 Months
FTY720 in Multiple Sclerosis – Strong Efficacy Maintained Over 12 Months MRI1 – Proportion of patients free of Gd2-enhancing (lesions by visit) % Lesion-free patients FTY720 1.25 mg (n=92) FTY720 5 mg (n=93) Placebo / FTY 1.25 mg (n=40) Placebo / FTY 5 mg (n=43) 100 90 89% 83% 80 83% 70 73% 60 50 Pl
Slide 15: Good Safety Profile of FTY720; Program Progresses into Phase III
Good Safety Profile of FTY720 in Multiple Sclerosis • FTY720 was safe and well tolerated over 12 months, no unexpected adverse events as compared to 6-months interim analysis • No confirmed cases of macular edema to date in the MS population • No confirmed cases of PML1 to date • All patients contin
Slide 16: Overview of Filings, Timing of Study Starts and Expected Data for FTY720
Overview of Filings, Timing of Study Starts and Expected Data for FTY720 Start of 2-year double-blind pivotal trial in RRMS1 comparing FTY720 1.25 mg & US Filing 0.5 mg doses with placebo 2005 2006 2007 2008 2009 Start of 1-year active 18 Month Phase II to be comparator trial in RRMS presented at AA
Slide 17: Strong Newsflow Continues in 2006
Agenda • Overview 2005 • New data from key projects • Outlook 2006 33 FRESCO 2005 / James Shannon / 2006-01-19 / Analyst Strong Newsflow Continues in 2006 Regulatory Data Submissions Decisions • Rasilez® Phase III • Rasilez® hypertension • Aclasta® Paget’s disease (US) • Galvus® Phase III • Galvus®
Slide 18: Planned Filings 2006 to ≥ 2009
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 Anxiety Rasilez® PTK7873 LBH589 VNP489 SAB378 Hypertension Colo
Slide 19: Eight Significant Approvals in 2005
Appendix 37 FRESCO 2005 / James Shannon / 2006-01-19 / Analyst Eight Significant Approvals, Including Two High Priority Reviews in 2005 Approvals Xolair® Severe allergic asthma EU Diovan® Post-MI risk reduction US & EU Diovan® Treatment of CHF1 EU Femara® Extended adjuvant treatment of breast EU (MR
Slide 20: Ten Filings in 2005; Focused Portfolio in Attractive Market Segments
Ten Filings, Including Two New Molecular Entities in 2005 Submissions Femara® Early adjuvant treatment of breast cancer US & EU Co-Diovan® High strength EU Comtan® Parkinson’s disease Japan Certican™ Heart transplantation Japan Exelon® Dementia in Parkinson’s disease EU Diovan® 320 Hypertension EU G
Slide 21: Study 2301 – Galvus Once-A-Day vs. Twice-A-Day
Galvus® (vildagliptin) Study 2301 – Galvus® (vildagliptin) as Once-A-Day vs. Twice-A-Day Therapy Objective: Superior HbA1c reduction of Galvus® vs. placebo Target population: Drug naïve T2DM; HbA1c 7.5%–11% Galvus® 50 mg qd Galvus® 50 mg qd n=104 Galvus® 50 mg bid Galvus® 50 mg bid n=90 n1=380 Drug
Slide 22: Study 2327 and Study 2305 – Galvus Designs
Study 2327 – Galvus® (vildagliptin) vs. rosiglitazone Objective: HbA1c reduction with vildagliptin is not inferior to rosiglitazone Target population: Drug naïve T2DM; HbA1c 7.5%–11% Galvus® 50 mg bid Galvus® 50 mg bid n=459 n1=697 Drug naïve rosi2 8 mg qd rosi 8 mg qd n=238 Extension 2 weeks 24 wee
Slide 23: Study 2303 – Galvus as Add-on to Metformin
Study 2303 – Galvus® (vildagliptin) as Add-on to metformin, the Intended Target Population Objective: Superior HbA1c reduction with Galvus® and metformin vs. metformin monotherapy Target population: T2DM on maximal dose of met; HbA1c 7.5%–11% Galvus® 50 mg qd + met Galvus® 50 mg qd + met n=143 n1=41
Slide 24: Study 2307 and 2305 – Rasilez Study Designs
Study 2307 – Rasilez® (aliskiren) vs. and in Combination with ramipril in Hypertensive Patients with Diabetes Randomized, double-blind, parallel group, dose escalation study in 837 patients with hypertension and diabetes Rasilez® 150 mg Rasilez® 300 mg n=282 Wash-out Placebo ramipril 5 mg ramipril 1
Slide 25: FTY720 – Planned MS Phase III Pivotal Studies
FTY720 FTY720 – Planned MS Phase III Pivotal Studies D2301 – 2-year double-blind pivotal trial in relapsing-remitting MS FTY720 0.5 mg daily n∼360 FTY720 1.25 mg daily n∼360 Placebo n∼360 Primary endpoint: Relapse rate and disability progression after 2 years D2302 – 1-year active comparator trial i
Slide 26: Telbivudine – Specific Inhibitor of Hepatitis B Virus
Telbivudine Telbivudine – Specific Inhibitor of Hepatitis B Virus • Hepatitis B is the most common severe chronic viral infection in the world O CH 3 HN • 10th leading cause of death worldwide with 1.2 m deaths per year O N OH O • Responsible for up to 80% of the world's primary liver cancer OH • Ch
Slide 27: The GLOBE Study Compares Telbivudine to Lamivudine
The GLOBE Study Compares telbivudine to Current Standard lamivudine Study participants: 1 367 patients with chronic hepatitis B (clinical history and baseline biopsy) telbivudine n=680 lamivudine n=687 Randomization Primary analysis Final analysis (1:1) Week 52 (AASLD 2005) Week 104 1 year 1 year 53
Slide 28: GLOBE Study Demonstrates High Efficacy and Good Safety of Telbivudine
Telbivudine Eliminates HBV1 DNA Faster than lamivudine in HBeAg-negative Patients HBV DNA: Maintained PCR non-detectable Percent of patients 100 90 88% * telbivudine 80 71% 70 lamivudine 60 50 40 30 * p < 0.0001 vs. lamivudine 20 10 0 Week 0 1 4 8 12 16 20 24 28 32 36 40 44 48 52 55 FRESCO 2005 / Ja
Slide 29: Over Half of Development Projects Are New Molecular Entities
Pipeline Over Half of Development Projects Are New Molecular Entities 75 projects (end 2005) 40% LCM = 30 projects NME = 45 projects 60% 58 FRESCO 2005 / James Shannon / 2006-01-19 / Analyst 29
Slide 30: Pipeline Under Constant Review; 22 Projects Added
Pipeline Under Constant Review and Renewal 80 5 70 22 60 17 50 40 75 75 30 20 10 0 Jan 2005 Approvals & Terminations New projects End Dec 2005 launches 59 FRESCO 2005 / James Shannon / 2006-01-19 / Analyst 22 Projects Have Been Added to the Portfolio… 25 New projects • AFQ056 anxiety 20 5 • AIN457 r
Slide 31: 22 Projects Have Left the Portfolio; Cardiovascular and Metabolic Diseases
... and 22 Projects Have Left the Portfolio 25 Major approvals / launches • Diovan® VALIANT 20 5 • Diovan® congestive heart failure (EU) • Femara® extended adjuvant breast cancer 15 • Focalin™ XR • Xolair® asthma 22 On hold / terminated 10 17 • AEP924 depression • QAK423 Asthma & 5 • AFG495 osteopor
Slide 32: Oncology and Hematology; Neuroscience
Oncology and Hematology Phase I Phase II Phase III Registration LBH589 LBQ707 EPO906 Exjade® (EU) Solid & liquid tumors Solid tumors Solid tumors Chronic iron overload AEE788 AMN107 PTK7872 Femara® (EU) CML Colorectal cancer Early adjuvant Solid tumors breast cancer ABJ879 PKC412 Glivec®3 Glivec®3 A
Slide 33: Respiratory and Dermatology; Infectious Diseases, Transplantation
Respiratory and Dermatology Phase I Phase II Phase III Registration ABN912 QAB149 Lamisil® Foradil® Asthma & COPD Asthma / COPD Tinea capitis Certihaler™ QAP642 NVA237 Asthma COPD QAE397 Asthma QAT370 Asthma ACZ885 COPD Foradil Mometasone ® Asthma, COPD NME LCM 65 FRESCO 2005 / James Shannon / 2006-
Slide 34: Ophthalmics; Arthritis, Bone Diseases, Gastrointestinal
Ophthalmics Phase I Phase II Phase III Registration RKI983 Elidel® OPC759 Glaucoma Dry eye (rebamipide) Dry Eye PTK787 Lucentis® (EU) AMD AMD Visudyne® (US) Occult AMD Sandostatin® LAR® Diabetic retinopathy NME LCM 67 FRESCO 2005 / James Shannon / 2006-01-19 / Analyst Arthritis, Bone Diseases, Gastr