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45th ASCO Annual Meeting Roche and Genentech Investor Event – Part 1 Sunday, May 31, 2009 - Orlando, Florida #1 Roche and Genentech This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1. pricing and product initiatives of competitors; 2. legislative and regulatory developments and economic conditions; 3. delay or inability in obtaining regulatory approvals or bringing products to market; 4. fluctuations in currency exchange rates and general financial market conditions; 5. uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6. increased government pricing pressures; 7. interruptions in production; 8. loss of or inability to obtain adequate protection for intellectual property rights; 9. litigation; 10. loss of key executives or other employees; and 11. adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information at www.roche.com or www.gene.com. All mentioned trademarks are legally protected. #2 ASCO 2009 Analyst Meeting Agenda Sunday, May 31, 2009 Roche and Genentech 6:30 PM (5 min) Welcome/ Introductions/ Agenda Dr. Karl Mahler Head of Investor Relations, Roche Kathee Littrell, Ph.D., R.N. Vice President, Investor Relations, Clinical Support, Genentech 6:35 PM (10 min) Opening Remarks William M. Burns Chief Executive Officer Division Roche Pharmaceuticals 6:45 PM (35 min) Avastin: NSABP C-08 Data Overview; Followed by Q&A Carmen J. Allegra, M.D. (clinical data) University of Florida, Shands Cancer Center, Professor and Chief, Division of Hematology/ Oncology, Department of Medicine Philippe Bishop, M.D. Vice President, Clinical Development, Avastin, Genentech Varun Nanda Global Product Strategy, Head of Oncology 7:20 PM (20 min) Tarceva: SATURN and ATLAS Data Overview Ivan Melezinek, M.D., Ph.D. (SATURN) Clinical Science Leader, Tarceva, Roche Pharmaceuticals Mark “Kip” Benyunes, M.D. (ATLAS) Senior Group Director, Clinical Hematology/Oncology, Genentech 7:40 PM (10 min) Closing Remarks Hal Barron, M.D. Executive Vice President, Global Development and Chief Medical Officer 7:50 PM (10 min) Q&A Additional Panel Speakers: John Orwin, Senior Vice President, Sales and Marketing, BioOncology, Genentech Stefan Frings, M.D., Ph.D., Lifecycle Leader, Avastin BC/Gyn, Roche Pharmaceuticals Anne Corder, M.Sc. (Hons), MBA, Lifecycle Leader, Tarceva, Roche Pharmaceuticals #3 Roche and Genentech Opening Remarks William M. Burns Chief Executive Officer Division Roche Pharmaceuticals #4 ASCO 2009 Key Takeaways Roche and Genentech • More than 500 scientific abstracts across 20 types of cancer to be presented • Combined Genentech and Roche oncology pipeline includes 27 new investigational agents in clinical studies • Personalized cancer treatments – Data supports our approach to develop potential new therapies that uniquely target the disease #5 Market Leadership Through Innovation Roche and Genentech Breakthrough Clinical Data Drives e Business ASCO 2007-2009: Broader Avastin, Herceptin & Tarceva use (more combinations, indications, and earlier use) ASCO 2005: 19.7 Herceptin adjuvant Avastin mNSCLC; mBC ASCO 2004: Tarceva mNSCLC 2L and 3L ASCO 2003: Avastin mCRC 1L CHF bn 1.6 #6 Roche and Genentech Understanding Biology to Improve Patient Outcomes Cancer Type Marketed Products Key Products in Development Gastrointestinal Avastin, Tarceva, Xeloda Avastin, Herceptin, Xeloda, Hedgehog Pathway Inhibitor Breast Avastin, Herceptin, Xeloda Avastin, pertuzumab, T-DM1, Xeloda, IGF-1R mAb Lung Avastin, Tarceva Avastin, Apomab, dulanermin, Tarceva, IGF-1R mAb Hematological MabThera/Rituxan Avastin, MabThera/Rituxan, GA101, dacetuzumab, Apomab, dulanermin, ABT-263 Genito-urinary Avastin Avastin, pertuzumab, Hedgehog Pathway Inhibitor Skin & Soft Tissue IGF-1R mAb, Apomab, Hedgehog Pathway Inhibitor, PLX4032 (B-raf inhibitor) Brain Avastin Childhood Cancers IGF-1R mAb, Xeloda, Avastin #7 Roche and Genentech Personalizing Cancer Treatment Biomarker Development rough All Stages of the Portfolio Phase I / II Prospectively assessing opportunities for patient selection IGF-1R mAb (R1507) – Range of candidate markers MDM2 antag (R7112) - P53 sequence wild-type - MDM2 expression PLX4032 (R7204) T-DM1 (R3502) - BRAFV600E gene mutation - HER2 expression - HER2 gene amplification Phase III / Market Identifying patients who have an improved clinical benefit Herceptin - HER2 expression - HER2 gene amplification Avastin - Range of candidate markers for hypothesis investigation Pertuzumab - HER Receptor/ligand mRNA Tarceva - EGFR expression (IHC) - EGFR gene copy number (FISH) - EGFR mutations - KRAS mutations #8 Organizational Setup: Pharma US CEO Group S. Schwan Roche and Genentech Board Genentech A. Levinson (Chair) Genentech gRED R. Scheller CEO Genentech P. Soriot Comm Ops NA P. Soriot Finance NA S. Krognes Operations A. Lee-Karlon Research M. Tessier-Lavigne GPS I. Clark Legal NA R. Kentz Early Development S. Bohen Global Dev. /CMO H. Barron HR NA S. Grossman Bus. Development J. McCracken Techn Ops (GTO) P. Yang HR Genentech D. Smith-Hams GPS = Global Product Strategy Corp Relation NA C. Castro Global functions Local/regional support function #9 Avastin for Adjuvant Colon Cancer Carmen J. Allegra, M.D. University of Florida, Shands Cancer Center, Professor and Chief, Division of Hematology/Oncology, Department of Medicine #10 Avastin® (R435) A Phase III Trial Comparing mFOLFOX6 to mFOLFOX6 Plus Bevacizumab in Stage II or III Carcinoma of the Colon: Results of NSABP Protocol C-08 N. Wolmark et al, ASCO 2009 #11 Avastin Phase III NSABP C-08 Trial: Study Design Stage ll + lll Colon Cancer (N=2,710) Stratified by # positive nodes Randomized mFOLFOX6 q2w X 6 months (n=1,356) *5mg/kg Primary endpoint – Disease-free survival Statistical planning assumptions – 25% reduction in event rate (HR = 0.75) mFOLFOX6 + Avastin* q2w X 6 months followed by Avastin* for 6 months (n=1,354) #12 Avastin Phase III NSABP C-08 Results: Patient Characteristics mFOLFOX6 mFOLFOX6 + Avastin < 60 yr 58.3% 58.2% Male 49.8% 49.9% Stage II (0) 24.9% 24.9% Stage III (1-3) 45.4% 45.5% Stage III (4+) 29.7% 29.6% #13 Avastin Phase III NSABP C-08 Results: Grade 3+ Toxicities Increased with Avastin (%) mFOLFOX6 mFOLFOX6 + Avastin p value Hypertension 1.8% 12% <0.0001 Pain 6.3% 11.1% <0.0001 Proteinuria 0.8% 2.7% <0.001 Wound Complications 0.3% 1.7% <0.001 Median duration of Avastin = 11.5 months Allegra et al JCO May 4, 2009 #14 Avastin Phase III NSABP C-08 Results: Disease-free Survival • Median follow-up: 35.6 months mFOLFOX6 + Avastin mFOLFOX6 HR P value Overall DFS based on all events. Events (n=603) n=291 n=312 3-year DFS 77.4% 75.5% 0.89 0.15 #15 Avastin Phase III NSABP C-08 Results: Disease-free Survival By Stage Percentage (%) DFS Stage II mFOLFOX6 + Avastin mFOLFOX6 Difference in rate HR P value DFS Stage III Events 3-year DFS N=40 87.4% N=47 84.7% ∆2.7 0.82 0.35 mFOLFOX6 + Avastin mFOLFOX6 Difference in rate HR P value Events 3-year DFS N=251 74.2% N=265 72.4% ∆1.8 0.90 0.25 #16 Avastin Phase III NSABP C-08 Results: Was ere A Significant Transient Effect Of Avastin? • Cumulative Hazard Ratio Over Time P=0.004 P=0.02 P=0.05 P=0.08 P=0.0004 Interval DFS analyses based on DFS events occurring by 1 year, 2 year ,etc. #17 Avastin Phase III NSABP C-08 Results: Was ere a Significant Interaction Between the Effect of Avastin and Time? Percentage (%) DFS at 1 Year Event-free at 1 Year Time-Treatment Interaction P = 0.001 mFOLFOX6 + Avastin mFOLFOX6 Difference in rate HR P value Events 1-year DFS N=75 94.3% mFOLFOX6 + Avastin N=216 N=122 90.7% mFOLFOX6 HR P value N=190 1.07 0.48 ∆3.6 0.60 0.0004 Events #18 “Evasive Resistance” - Escape ? Response (dormancy) Source: Paez-Ribes, Cancer Cell March ‘09 ↑Metastasis #19 Avastin Phase III NSABP C-08 Results: Status at 36 Months Median Follow-up mFOLFOX6 mFOLFOX6 + Avastin P value Recurrence (N) 248 227 NS Death (N) 146 132 NS Second Cancer (N) 46 47 NS 2-year Survival Post Recurrence (%) 41 37 NS Recurrence Multiple Sites (%) 18 18 NS – – NS Sites of Recurrence Primum non nocere NS = not statistically significant #20 Avastin Phase III NSABP C-08: Conclusion • The addition of Avastin to mFOLFOX6 did not result in an overall statistically significant prolongation in disease-free survival (DFS) • There was a transient benefit in DFS during the one year that Avastin was utilized • Consideration should be given to clinical trials assessing longer duration of Avastin administration #21 Avastin for Adjuvant Colon Cancer Philippe Bishop, M.D. Vice President, Clinical Development, Avastin, Genentech #22 Roche and Genentech NSABP C-08 Provides Insights into Avastin’s Potential in Early-stage Colon Cancer Key Takeaways – Highly informative trial despite primary endpoint of DFS not met – Avastin demonstrated significant on-treatment effect (40% reduction of chance of cancer returning) – Data suggests relationship between duration of Avastin therapy and clinical outcomes – Data support our hypothesis that Avastin’s MOA is important in early-stage cancer – Avastin’s safety is consistent with previously established profile What We Know from the Metastatic Setting – Clinical benefit of treatment through multiple lines of therapy is well documented in the metastatic setting (BRiTE, AVF2107) – Importance of treatment to progression is also described in studies such as NO16966 Considerations – Plan to evaluate whether longer durations of Avastin treatment in the early-stage setting translate into improved patient outcomes – These data may or may not be representative of potential outcomes in other tumor types (i.e., breast cancer) #23 Avastin Adjuvant Phase III Program Roche and Genentech • In discussions with NSABP regarding an adjuvant colon cancer trial with longer duration of Avastin • Evaluating next steps Tumor Type Trial Adjuvant Colon Cancer NSABP-C08 N Dosing Status N=2,710 • 5 mg/kg q2 weeks • Study did not meet its primary endpoint AVANT N=3,451 • 5 mg/kg q2 weeks in FOLFOX arms • 7.5 mg/kg q3 weeks in XELOX arm • Study completed enrollment Q2 2008; expect efficacy analyses 2010; event-driven Adjuvant Nonsmall Cell Lung Cancer ECOG 1505 N=1,500 • 15 mg/kg q3 weeks • Trial ongoing Adjuvant Breast Cancer ECOG 5103 (HER2-) N=4,950 • 15 mg/kg q3 weeks • Trial ongoing BEATRICE (Triplenegative) N=2,530 • Dosing equivalent to 5 mg/kg /per week • Trial ongoing BETH (HER2+ combo with Herceptin) N=3,600 • 15 mg/kg q3 weeks • Trial ongoing NSABP = National Surgical Adjuvant Breast and Bowel Project; ECOG = Eastern Cooperative Oncology Group. #24 Roche and Genentech Impact Of Avastin On Overall Survival In Patients With Metastatic Colorectal Cancer: A Population-based Study from the British Columbia Cancer Agency • Median overall survival (OS) significantly increased between 2003/04 and 2006 • Improvement in survival appears to be limited to patients treated with systemic therapy (ST) for metastatic disease • There were no differences in the proportion of patients receiving oxaliplatin, nor were there changes in OS in patients not receiving ST, suggesting that OS improvement was attributable to the introduction of Avastin Pre-Avastin Era 2003/2004 (n=969) Avastin Era 2006 (n=448) P value Median OS for entire cohort 13.8 mos 17.3 mos p<0.001 Median OS for patients who received ST 18.6 mos 23.6 mos p=.001 Median OS for patients who did not receive ST 6.1 mos 5.9 mos p=0.65 D. J. Renouf et al, ASCO 2009 (Abstract #4114) #25 Roche and Genentech Avastin for Adjuvant Colon Cancer Varun Nanda Global Product Strategy, Head of Oncology #26 Roche and Genentech Avastin Target Populations Each Cancer Type is Different…and Needs a Specific Treatment Approach Incidence Survival Adjuvant DFS at 3 years* Metastatic median OS* 72% (Stage III) 81% ~45% (OS at 5-years) 18-22 months ~24 months 10-12 months • Assuming best current care, Incidence: GLOBOCAN 2002 and Roche market research DFS = Disease-free Survival; OS = Overall Survival. #27 Avastin Phase III NSABP C-08 Results Question & Answer Session #28 Roche and Genentech Tarceva SATURN Clinical Data Overview Ivan Melezinek, M.D., Ph.D. Clinical Science Leader, Tarceva, Roche Pharmaceuticals #29 Tarceva® (R1415) SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following non-progression with 1st-line platinumbased chemotherapy in patients with advanced NSCLC. F. Cappuzzo et al, ASCO 2009 #30 Tarceva Phase III SATURN Trial: Study Design Tarceva 150mg/day Chemonaïve advanced NSCLC n=1,949 4 cycles of 1st-line platinumbased doublet* Non-PD n=889 PD 1:1 Placebo PD Mandatory tumor sampling Stratification factors: • • • • • • Co-primary endpoints: EGFR IHC (positive vs negative vs indeterminate) • Progression-free survival (PFS) in all patients Stage (IIIB vs IV) • PFS in patients with EGFR IHC+ tumors ECOG PS (0 vs 1) CT regimen (cis/gem vs carbo/doc vs others) Secondary endpoints: Smoking history (current vs former vs never) • Overall survival (OS) in all patients and those with Region EGFR IHC+ tumors, OS and PFS in EGFR IHC– tumors; biomarker analyses; safety; time to symptom progression; QoL *Cisplatin/paclitaxel; cisplatin/gemcitabine; cisplatin/docetaxel cisplatin/vinorelbine; carboplatin/gemcitabine; carboplatin/docetaxel carboplatin/ paclitaxel #31 Tarceva Phase III SATURN Results: Progression-free Survival All patients (ITT population) Tarceva Placebo PFS at 12 wks (%) 53 40 PFS at 24 wks (%) 31 17 HR=0.71 (0.62 – 0.82) Log-rank p <0.0001 Tarceva (n=437) Placebo (n=447) #32 Tarceva Phase III SATURN Results: Progression-free Survival in EGFR IHC+ Patients Co-primary endpoint Tarceva Placebo PFS at 12 wks (%) 54 40 PFS at 24 wks (%) 32 18 HR=0.69 (0.58 – 0.82) Log-rank p <0.0001 Tarceva (n=307) Placebo (n=311) #33 Tarceva Phase III SATURN Results: Subgroup Analysis of Progression-free Survival HR (95% CI) n All 0.71 (0.62–0.82) 884 Male 0.78 (0.66–0.92) 654 Female 0.56 (0.42–0.76) 230 Caucasian 0.75 (0.64–0.88) 744 Asian 0.58 (0.38–0.87) 128 Adenocarcinoma 0.60 (0.48–0.75) 401 Squamous-cell 0.76 (0.60–0.95) 359 Never smoker 0.56 (0.38–0.81) 152 Former smoker 0.66 (0.50–0.88) 242 Current smoker 0.80 (0.67–0.97) 490 0.4 0.6 0.8 Favors Tarceva 1.0 HR 1.2 Favors Placebo #34 Tarceva Phase III SATURN Results: Progression-free Survival According to Biomarker Status HR (95% CI) n All 0.71 (0.62–0.82) 884 EGFR IHC+ 0.69 (0.58–0.82) 618 EGFR IHC– 0.77 (0.51–1.14) 121 EGFR FISH+ 0.68 (0.51–0.90) 231 EGFR FISH– 0.81 (0.62–1.07) 255 KRAS mutation+ 0.77 (0.50–1.19) 90 KRAS wild-type 0.70 (0.57–0.87) 403 0.4 0.6 0.8 1.0 1.2 Favors Tarceva HR Favors Placebo #35 Tarceva Phase III SATURN Results: Progression-free Survival in EGFR Mutation+ Tumors Tarceva (n=22) Placebo (n=27) HR=0.10 (0.04 – 0.25) Log-rank p <0.0001 #36 Tarceva Phase III SATURN Results: Progression-free Survival in EGFR Wild Type Tumors Tarceva (n=199) Placebo (n=189) HR=0.78 (0.63–0.96) Log-rank p=0.0185 #37 Tarceva Phase III SATURN Results: Safety • No new safety signals detected • No deterioration of quality of life AEs occurring in ≥ 10% of patients Rash Diarrhea Tarceva (N=433) All Grades Grade 3/4 60% 9% 20% 2% *Number of patients with at least 1 dose reduction/interruption Patients can contribute to more than one category Placebo (N=445) All Grades Grade 3/4 9% 0% 4% 0% #38 Tarceva Phase III SATURN Results: Conclusions • Tarceva maintenance therapy significantly improved progression-free survival (PFS) versus placebo - Met both co-primary endpoints with statistical significance - HR = 0.71 or 29% reduction in hazard (41% improvement in PFS compared with placebo) • Overall survival data immature; expect data 2H 2009 • Clinical benefit across majority of patient subgroups, irrespective of histology, race, smoking status or biomarkers - EGFR IHC, EGFR FISH and KRAS mutations are not strong predictive factors and selection of patients based on these is not warranted - EGFR mutations are a strong predictive biomarker, but patients with EGFR wild-type tumours also derive benefit from Tarceva treatment • Tolerability profile consistent with previous trials #39 Roche and Genentech Tarceva ATLAS Clinical Data Overview Mark “Kip” Benyunes, M.D. Senior Group Director, Clinical Hematology/Oncology, Genentech #40 Tarceva® (R1415) A Randomized, Double-blind, Placebo-controlled, Phase IIIb Trial (ATLAS) Comparing Bevacizumab (B) erapy With Or Without Erlotinib Aer Completion Of Chemotherapy With B For First-line Treatment of Locally Advanced, Recurrent, or Metastatic NSCLC. V. A. Miller et al, ASCO 2009 #41 Tarceva Phase IIIb ATLAS Trial: Study Design Chemo-naïve Advanced NSCLC N=1,160 4 cycles of 1st-line chemotherapy* + Avastin Avastin (15mg/kg)+ Tarceva (150mg) to PD Non-PD n=768 (66%) Eligibility • Stage IIIB**/IV NSCLC • ECOG performance status 0-1 Stratification factors • Gender • Smoking history (never vs former/ current) • ECOG performance status (0 vs >1) • Chemotherapy regimen 1:1 Unblind at PD Post progression therapy Avastin + Placebo to PD Primary endpoint • Progression-free survival in all randomized patients Secondary endpoints • Overall survival • Safety Exploratory endpoints • Biomarker analyses (IHC, FISH, EGFR & KRAS mutation) *Carbo/paclitaxel; cis/vinorelbine; carbo or cis/gemcitabine; carbo or cis/docetaxel. **IIIB wih pleural effusion. #42 Tarceva Phase IIIb ATLAS Trial: Randomized Patients by Region Europe 27 North America 659 Asia 76 Africa Latin America 3 Australia 3 #43 Tarceva Phase IIIb ATLAS Results: Progression-Free Survival ITT population, investigator assessment Proportion Without Event 1.0 Avastin + Placebo (n=373) Avastin + Tarceva (n=370) 0.8 HR=0.722 (0.592-0.881) Log-rank P=0.0012 0.6 0.4 0.2 0.0 0 3 6 9 12 15 18 21 Progression-Free Survival (months) No. of patients at risk: Avastin + Placebo 373 142 58 27 15 6 3 0 Avastin + Tarceva 370 178 81 43 20 6 3 1 #44 Tarceva Phase IIIb ATLAS Results: Progression-Free Survival in Subgroups ITT population Avastin + Placebo Avastin + Tarceva Total (n) Pts with an Event (n) Total (n) Pts with an Event (n) HRa 95% CI Age <65 years ≥65 years 189 184 119 119 201 169 106 96 0.66 0.69 0.51–0.86 0.53–0.90 Race/ethnicity White Black Asian or Pacific Islander Other 290 29 45 9 193 21 19 5 293 22 43 12 179 14 5 4 0.75 0.81 0.18 0.43 0.61–0.92 0.41–1.60 0.06–0.55 0.11–1.64 Gender Male Female 195 178 122 116 193 177 105 97 0.75 0.63 0.58–0.98 0.48–0.83 Smoking history Never Current/former 66 307 36 202 61 309 20 182 0.34 0.76 0.19–0.61 0.62–0.93 ECOG PS at randomization 0 ≥1* 125 245 77 160 126 241 66 136 0.65 0.72 0.47–0.91 0.57–0.91 0.2 * Includes <1% patients with ECOG PS 2. 0.5 Favors Tarceva 1 2 Favors Placebo #45 Tarceva Phase IIIb ATLAS Results: Progression-Free Survival in Subgroups ITT population Avastin + Placebo Chemotherapy Carboplatin + Paclitaxel Carboplatin + Gemcitabine Carboplatin + Docetaxel Cisplatin + Gemcitabine Other Avastin + Tarceva Total (n) Events (n) Total (n) Events (n) HR 95% CI 174 104 54 32 9 118 68 36 11 5 178 105 46 33 8 97 63 30 7 5 0.68 0.71 0.81 0.43 0.40 0.52–0.89 0.50–1.00 0.49–1.33 0.16–1.16 0.09–1.74 0.2 0.5 Favors Tarceva 1 2 Favors Placebo #46 Tarceva Phase IIIb ATLAS Results: Summary for Post Chemotherapy Treatment Phase Safety population Avastin + Placebo, n (%) (n=368) Avastin + Tarceva, n (%) (n=367) Any Grade Adverse Event 313 (85.1%) 349 (95.1%) Grade 3–4 Adverse Event 112 (30.4%) 162 (44.1%) Grade 5 Adverse Event 4 (1.1%) 8 (2.2%) Serious Adverse Event 60 (16.3%) 84 (22.9%) The most common adverse event were rash and diarrhea. Formal statistical comparison testing between treatment arms was not done. #47 Tarceva Phase IIIb ATLAS Results: Conclusions and Future Directions • The addition of Tarceva to Avastin after 4 cycles of Avastin and chemotherapy significantly improved progression-free survival (HR 0.722, p= 0.0012) • Independent review of progression-free survival data is being conducted − Overall survival data are expected in 2H of 2009 • No new safety signals were observed • Biomarker analyses are being conducted - results will be presented at an upcoming meeting #48 Tarceva SATURN and ATLAS Roche and Genentech Conclusions • Both studies met their primary endpoint of improvement in progression-free survival • In SATURN, there was consistency of effect among subgroups including: – Squamous cell carcinoma – EGFR wild type – KRAS mutations • In SATURN, patients with EGFR mutations had marked benefit • In ATLAS, biomarker analyses are being conducted and will be presented at a future meeting #49 Roche and Genentech Closing Remarks Hal Barron, M.D. Executive Vice President, Global Development and Chief Medical Officer #50 ASCO 2009 Roche and Genentech • Avastin (NSABP C-08, RIBBON-1, AVADO, and ATLAS) – Data supports hypothesis that VEGF plays an important role in all stages of cancer – C-08 provides valuable insights for future trials of Avastin in early stage disease – Versatility of Avastin: ability to combine with multiple chemotherapies and targeted agents – Changing the natural history of the disease in colorectal cancer • Tarceva (SATURN and ATLAS) – Evolving treatment regimens are improving patients outcomes in lung cancer • Innovation in personalized medicine – HER2-positive: Herceptin for gastric cancer – BRAF mutation: PLX4032 for advanced melanoma • HER2+ Metastatic Breast Cancer – T-DM1: Addressing an important unmet medical need for patients who have progressed on multiple HER2-directed therapies #51 Roche and Genentech Roche Group – Oncology Development Pipeline – 27 New Molecules in Development Early-stage Phase I (17 NMEs) ABT-263 Anti-EGFL7 Anti-PlGF (R7334) BRAF Inhibitor (R7204) CIF/MEK Inhibitor (R7167) CKI27/Casein Kinase I (R7304) GC33/Anti-Glypican-3 MAb1 IAP Antagonist MDM2 Antagonist (R7112) MEK Inhibitor MetMAb/Anti-cMet NME Antibody Drug Conjugate NME MAb (R7160) NME Small Molecule (R4733) NME Small Molecule PI3 Kinase Inhibitor TP300/Topoisomerase I Inhibitor1 Late-stage Phase II (8 NMEs) ABT-869 Advanced RCC Anti-IGF-1R (R1507) Recurrent or refractory sarcoma Breast cancer Advanced NSCLC Apomab Indolent relapsed NHL 1L mNSCLC Avastin (R435) Extensive small cell lung cancer 1L metastatic melanoma 1L metastatic squamous NSCLC Non-squamous NSCLC with previously treated CNS metastases Relapsed multiple myeloma Dacetuzumab (AntiCD40) 2L diffuse large B-cell lymphoma Dulanermin (rhApo2L/ TRAIL) Indolent relapsed NHL 1L mNSCLC GA101/3rd Gen. AntiCD20 (R7159) Relapsed or refractory hematologic malignancies Indolent NHL Hedgehog Pathway Inhibitor (R3616) Advanced basal cell carcinoma 1L mCRC Ovarian cancer maintenance therapy MetMAb/Anti-cMet 2L and 3L mNSCLC Pertuzumab (R1273) Neoadjuvant HER2+ BC 2L mNSCLC Trastuzumab-DM1 (R3502) 1L HER2+ mBC 2L+ HER2+ mBC 3L HER2+ mBC Phase III (2 NMEs) Avastin Adjuvant colon cancer Adjuvant HER2- BC Adjuvant HER2+ BC Adjuvant NSCLC Diffuse large B-cell lymphoma 1L advanced gastric cancer 1L HER2- mBC 1L HER2+ mBC 1L metastatic ovarian cancer Gastrointestinal stromal tumors High risk carcinoid Hormone refractory prostate cancer Newly diagnosed GBM Relapsed platinumsensitive ovarian cancer 2L HER2- mBC 2L mCRC Avastin +/- Tarceva 1L metastatic nonsquamous, NSCLC Herceptin Adjuvant HER2+ BC (HERA 2-year treatment) MabThera/Rituxan (R105) Follicular NHL Pertuzumab (R1273) 1L HER2+ mBC Platinum-resistant ovarian cancer1 Tarceva Adjuvant NSCLC 1L metastatic EGFR mutant+ NSCLC Trastuzumab-DM1 (R3502) 2L HER2+ mBC Xeloda Adjuvant BC Adjuvant CC As of May 31, 2009 1 Being develop by Chugai Pharamceuticals NME = New Molecular Entity #52 Roche and Genentech Oncology Late-stage Pipeline 2009 -2011 Key Anticipated Milestones Phase III Clinical Data Results: – Avastin • Hormone-refractory prostate cancer • Ovarian cancer studies • Adjuvant colon cancer (AVANT) • Adjuvant triple-negative BC • Second-line mBC • Gastric cancer – Herceptin HERA 2-year adjuvant treatment data (HERA) – Rituxan follicular NHL maintenance data (PRIMA) Pending Submissions: – Avastin for 1L mBC – Herceptin for 1L metastatic gastric cancer (ToGA ) Pending Approvals: – Avastin for 1L mBC (AVADO) – Avastin for 1L metastatic RCC – Rituxan for previously untreated and relapsed CLL – Tarceva for 1L maintenance therapy for advanced NSCLC – Xeloda for 1L and 2L mCRC (US) #53 Roche and Genentech Preview Topics to be Addressed Tomorrow • ToGA: Herceptin for gastric cancer • RIBBON-1 and AVADO: Avastin for 1L mBC • Early Stage Pipeline – PLX4032 for advanced melanoma – T-DM1 for 2L+ mBC – ABT-263 for CLL Roche and Genentech Investor Event – Part 2 June 1, 2009 Rosen Shingle Creek Hotel, Orlando 6:30pm-8:00pm #54 Question & Answer Session #55 Roche and Genentech We Innovate Healthcare #56