Novartis Ag · SIX:NOVN
Novartis — ASCO 2004
28 slides from Novartis's conference presentation, Jun 6, 2004
Slide 1: Novartis Oncology: Intelligent Innovation
Novartis Oncology: Intelligent Innovation David Epstein President, Novartis Oncology 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 "expect", or by discuss
Slide 2: Several Key Trends are Shaping the Future of Cancer Therapy
Several Key Trends are Shaping the Future of Cancer Therapy Ç Use of targeted therapies Novartis Novartis Oncology’s Oncology’s goal: goal: Create Create an an Intelligent Intelligent Development Development program, program, Ç Role of genomic integrating integrating these these trends trends to to
Slide 3: Strong Rx Lift Post MA-17 Extended Adjuvant Publication
Strong Rx Lift Post MA-17 Extended Adjuvant Publication Weekly Femara® TRx, US in ’000s 12 11 MA-17 published 10 9 8 TRx + 86% 7 6 5 4 3 03-Jan 07-Feb 14-Mar 18-Apr 23-May 27-Jun 01-Aug 05-Sep 10-Oct 14-Nov 19-Dec 23-Jan 27-Feb 2-Apr 7-May Source: IMS NPA Weekly 6 ASCO 2004 / D. Epstein / June 7, 20
Slide 4: Driving Strong Market Share Increases
Driving Strong Market Share Increases US Volume Market Share1 of AIs Percent 80% 70% 60% Femara Q1 04 50% Results, Global 40% Sales (USD) Growth (LC) 30% $78M 30% 20% 10% 0% Aug Sep Oct Nov Dec Jan Feb Mar Apr Arimidex Femara Aromasin 1 Aromatase Inhibitor market defined as Arimidex, Aromasin, and F
Slide 5: Femara: Clinical Superiority Throughout Breast Cancer Therapy
Femara®: Clinical Superiority Throughout Breast Cancer Therapy Demonstrated Superiority vs. Standard of Care Early Breast Cancer Advanced Breast Cancer Neo- Early Extended 1st line 2nd line adj. Adjuvant Adjuvant BIG 1-98 Filed (Q2 04) Anastrozole Exemestane (switch) 9 ASCO 2004 / D. Epstein / June
Slide 6: Early Adjuvant Trial with Over 8000 Patients Awaiting Results
Early Adjuvant Trial with Over 8000 Patients Awaiting Results Breast International Group 1-98 Study (BIG 1-98) Randomization End 2004 (following tumor resection) Data Unblinded Femara® n=2 442 tamoxifen n=2 443 tamoxifen Femara® n=1 525 Femara® tamoxifen n=1 525 0 2 5 years 1998 Trial initiated 11 A
Slide 7: Femara: The Best-in-Class AI
Femara® : The Best-in-Class AI Unmatched Clinical Results • Femara® is the only AI with a survival advantage over tamoxifen in advanced breast cancer • Femara® is the first and only treatment proven effective in the extended adjuvant setting – after standard tamoxifen − Submitted to health authoriti
Slide 8: Estimated Progression Free Survival in CML at 30 Months is 95%
Estimated Progression Free Survival (without AP / BC) in CML at 30 Months is 95% IRIS trial – First line imatinib 100 95% 90 % Without Progression 80 88% 70 60 50 40 30 20 Progression Free Survival 10 Survival without Acute Phase / Blast Crisis 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Months Since Rando
Slide 9: Survival Impacted by Reduction in bcr-abl Transcripts
Survival Significantly Impacted by Degree of Reduction Achieved in bcr-abl Transcripts 100 90 80 % without progression 70 60 50 40 Estimated PFS at 30 months 30 No CCyR within 12 months 81% <3 log reduction 93% 20 >=3 log reduction 100% 10 = Censored observations 0 0 3 6 9 12 15 18 21 24 27 30 33 36
Slide 10: Update on CML Dosing
Update on CML Dosing Average Glivec® / Gleevec® dose by CML phase, US mg per patient per day, US Q3 02 Q1 04 705 608 613 544 430 394 Chronic Accelerated Blast Source: Cancer eSearch 19 ASCO 2004 / D. Epstein / June 7, 2004 Glivec® / Gleevec® has Dramatically Changed the Survival Profile of GIST Pati
Slide 11: Key Findings at ASCO 2004 Highlight Glivec as Cornerstone of GIST Therapy
Key Findings at ASCO 2004 Highlight Glivec® / Gleevec® as Cornerstone of GIST Therapy • Glivec® / Gleevec® is a life long therapy1 • Rapid worsening of GIST may occur if Glivec® / Gleevec® is stopped2,5 • Continue Glivec® / Gleevec® despite limited progression1,2,5 • If limited progression, consider
Slide 12: Preliminary Data for Glivec in Ph+ ALL
Preliminary Data for Glivec® / Gleevec® in Ph + ALL Source: Dr. Deborah Thomas, MD Anderson Cancer Center 23 ASCO 2004 / D. Epstein / June 7, 2004 Glivec® / Gleevec® Plus Taxotere Phase II in HR Prostate Cancer Under Way Docetaxel • Current experience 30mg/m2 + shows Gleevec is well R Imatinib toler
Slide 13: Promising Preliminary Data in Refractory GBM
Promising Preliminary Data in Combination with Hydroxyurea in Refractory GBM Recurrent GBMs Dresemann et. al. Patients 26 CR 1 PR 4 SD 9 CR+PR+SD1 14 PD 12 Median PFS 6 months Median OS 9 months 1 Based on RECIST criteria Source: Proc Am Soc Clin Oncol 23: pg 119, 2004 (poster 1550) 25 ASCO 2004 / D
Slide 14: Glivec – Broadening Indications and Building a Blockbuster
Glivec® / Gleevec® – Broadening Indications and Building a Blockbuster Cumulative value USD bn Non Heme / Onc1 Indications Other Heme / Onc Indications GIST CML Time & investment 1 Hematology / Oncology 27 ASCO 2004 / D. Epstein / June 7, 2004 Building 3 Oncology Blockbusters Blockbuster by 2008 dri
Slide 15: A Full Oncology Pipeline with Exciting Late-Stage Products
Agenda • Broadening the Potential of Marketed Brands • Building a Best in Class Pipeline 29 ASCO 2004 / D. Epstein / June 7, 2004 A Full Oncology Pipeline with Exciting Late-Stage Products Phase I Phase II Phase III Registration LAQ824 EPO906 ICL670 Zometa® Bisphosphonate – Histone deacetylation Ant
Slide 16: PTK787: First Oral Angiogenesis Inhibitor in Colorectal Cancer
PTK7871 : First Oral Angiogenesis Inhibitor in Colorectal Cancer and Other Key Solid Tumors • Novel, oral multi-VEGF2 receptor inhibitor blocking all known VEGF receptors • Potential to provide most complete inhibition of VEGF signaling • Blockbuster potential • Co-development with Schering AG, Germ
Slide 17: PTK787: First Indication Colorectal Cancer
Multiple VEGF Ligands & Receptors are Involved Avastin VEGF-A VEGF-A VEGF-C VEGF-B VEGF-C VEGF-D PlGF-1,2 VEGF-D VEGF-E Extracellular Intracellular PTK787 PTK 787 VEGFR-1 VEGFR-2 VEGFR-3 Cl (Flt-1) (KDR/Flk-1) (Flt-4) H N COOH N N COOH N ANGIOGENESIS LYMPHANGIOGENESIS 33 ASCO 2004 / D. Epstein / Jun
Slide 18: 1st Line Therapies in Colorectal Cancer
1st Line Therapies in Colorectal Cancer Comparison across major trials: Note – cross-study comparisons IFL2alone Avastin + IFL FOLFOX2 (Goldberg/ (Hurwitz) (Goldberg) Hurwitz) Progression-free 6.9/ 6.4 10.6 8.7 Survival (mo) Overall Survival (mo) 14.6/ 15.6 20.3 19.4 Target results for PTK + FOLFOX
Slide 19: PTK787 On Track – First Data Available 1H 2005
PTK787 On Track – First Data Available 1H 2005 1st line, 1090 patients 2nd line, 830 patients • Progression-free • Overall survival (OS) Study Design Survival (PFS) • Overall survival (OS) Enrollment: Enrollment: • Completed in Apr 04 • Expect complete end Status Final Analyses: 3Q 04 • 2Q 05 for PF
Slide 20: Exploring Other Solid Tumors for PTK; ICL670 Iron Chelation
Exploring Activity in Several Key Solid Tumors to Maximize PTK’s Potential • Activity in phase I/II trials established in renal cell cancer and glioblastoma • Broad phase I/II program to identify further indications and combinations includes: – Prostate – Ovarian – Breast – Pancreas – Non-Small Cell
Slide 21: Compliance Significantly Impacts Survival in Iron Overload
Compliance Significantly Impacts Survival in Iron Overload Kaplan-Meier Analysis of Survival in 257 Consecutive Thalassemic Patients According to the Mean Compliance with s.c. DFO Therapy 100 90 •• Currently Currently low low 80 compliance, compliance, 70 high high mortality, mortality, 60 and and n
Slide 22: Gimatecan: A Promising Oral Topoisomerase I Inhibitor
Gimatecan: A Promising Oral Topoisomerase I Inhibitor Topoisomerase I market segment is large and growing steadily USD m 1 000 900 800 Gimatecan: 700 • Novel topoisomerase I inhibitor 600 • Third generation camptothecin 500 derivative 400 300 • Orally active 200 100 0 2000 2001 2002 2003E Irinotecan
Slide 23: Encouraging Clinical Data for Gimatecan; Patupilone
Encouraging Clinical Data for Gimatecan Phase I (solid tumors) showed responses in several Phase Phase II Data Data indications: • >120 patients treated in various doses/schedules • 7 confirmed partial responses across several tumor types − Endometrial, NSCLC, Cervix, Breast, Rhabdomyosarcoma − Seve
Slide 24: Phase I/II Continues for Patupilone; AEE788
Phase I/II Continues for Patupilone (EPO906) • Control of diarrhea has enabled a 50% increase (to date) in dose in ongoing dose escalation • Activity seen in Phase I dose escalation: − Ovarian cancer − NSCLC • New MTD has yet to be reached; Ph II set to open when new MTD is achieved • Plan to expand
Slide 25: AEE788 Inhibits Tumor Growth & Angiogenesis; RAD001C
AEE788 Inhibits Both Tumor Cell Growth & Angiogenesis EGF, TGF- TGF-α AEE788 VEGF EGFR HER2 VEGFR VEGF Currently Currently in in Phase Phase II Cancer Cell Endothelial Cell AEE788 inhibits both tumor cell growth & angiogenesis through inhibition of EGFR, HER2 & VEGFR 49 ASCO 2004 / D. Epstein / June
Slide 26: RAD001C: Anti-Tumor Mechanisms and Settings
RAD001C: 2 Anti-Tumor Mechanisms Tumor Tumor growth growth inhibition inhibition Angiogenesis Angiogenesis inhibition inhibition Growth Factors VEGF Nutrients Amino Acids VEGFR PTEN PI3K Integrins PI3K AKT/PKB ILK AKT/PKB TSC1/2 RAD001 RAD001 Energy mTOR RAD001 mTOR FKBP12 FKBP12 4E-BP1 eIF-4E P 70
Slide 27: We are Organizing to Maximize Success
We are Organizing to Maximize Success Experimental Oncology Therapeutics Research Development Exp. Onc. Therapeutics • Overlapping responsibility ensures earlier interaction between Research and Development for preparing for and conducting Proof of Concept trials • Early involvement of Phase I inves
Slide 28: Novartis Oncology: Intelligent Innovation
Novartis Oncology: Intelligent Innovation Track record of Best-in-class Organized for success Pipeline Success • 3 major launches • Broad and deep • Business Unit in 5 years structure reflects • Both near-term • Above market and longer-term commitment to growth opportunities Oncology • Significant i