CS-1 Results of the Phase 3 Clinical Trials of Abraxane vs. Taxol in Metastatic Breast Cancer William J. Gradishar, MD, FACP Professor of Medicine Northwestern University In Metastatic Breast Cancer Abraxane Has Greater Anti-tumor Activity Than Taxol

CS-2 Removal of Cremophor Resulted in Superior Anti-tumor and Intratumor Paclitaxel Concentrations in Preclinical Models

CS-3 Desai N, et al. Clin Cancer Res 2006;12(4), Athymic mice with human xenografts (n = 10 per group; daily administration for 5 days) Breast MX-1 tumor model equidose paclitaxel comparison Preclinical Finding: Replacing Cremophor with Albumin Enhanced the Efficacy of Paclitaxel in Breast Cancer

CS-4 Abraxane Results in Higher Intra-tumoral Concentration of Paclitaxel Compared to Taxol ABI-007 = 1.33 X Taxol Desai et al. Clin Can Res, Intratumor paclitaxel levels following equal doses ABI-007 and Taxol in nude mice bearing MX-1 human breast cancer xenografts

CS-5 Lung H522 (equitoxic dose comparison) Prostate PC3 (equitoxic dose comparison) Ovarian SKOV3 (equitoxic dose comparison) Desai N, et al. Clin Cancer Res 2006;12(4), Athymic mice with human xenografts (n = 10 per group; daily administration for 5 days) Preclinical Superiority of Abraxane over Taxol: Anti-tumor Activity Predicted Results in the Clinic Colon HT29 (equitoxic dose comparison)

CS-6 Abraxane vs. Taxol Phase 3 Clinical Trial Journal Clin Oncology, 2005;23.

CS-7 Phase 3 Trial Design Randomization (1:1) N = 460 Taxol 175 mg/m 2 IV over 3 hrs q 3 wk Standard Premedication with Dexamethasone and Anti-histamines Abraxane 260 mg/m2 IV over 30 min q 3 wk No Standard Premedication

CS-8 Investigator Response Demonstrating Superior Efficacy Across All Lines of Therapy in Metastatic Breast Cancer Replacement of Cremophor with albumin enhanced the efficacy of paclitaxel in metastatic breast cancer Source: Abraxane NDA

CS-9 Response Assessment Demonstrated Superiority of Cremophor-free Paclitaxel Independent of Dataset and Reviewer Source: Abraxane NDA Reconciled Target Lesion Response Rate Investigator Target Lesion Response Rate Blinded Radiologist Target Lesion Response Rate

CS-10 Abraxane Response Rate (Package Insert) Statistically Significantly Higher than Taxol Source: Abraxane Package Insert

CS-11 Prolonged Time to Disease Progression Independent Radiology Laboratory Response Dataset, Investigator Response Dataset, and Follow-up Disease Progression Data Note: P-value from log-rank test. Source: NDA Labeling Supplement Abraxane (N = 233) Taxol (N = 227) P-value = Hazard Ratio = Proportion of no Progression

CS-12 No Difference in Overall Survival All Patients Proportion of no Progression Abraxane (N = 129) Taxol (N = 143) P-value = Hazard Ratio = Note: P-value from log-rank test. Source: NDA Labeling Supplement

CS-13 Second Phase 3 Randomized Controlled Clinical Trial Confirms the Results from CA012 Abraxane 260 mg/m 2 Taxol 175 mg/m 2 P-value Patients Evaluable (All)N = 81N = Response Rate38%21% Patients Evaluable (First Line)N = 47N = Response Rate47%19%  GCP study required by the Chinese Regulatory Authorities for Approval of Abraxane in China (PI:Guan Zhong-Zen)  100 Patients per arm (Abraxane vs. Taxol)  Dose: Abraxane 260 mg/m 2, Taxol 175 mg/m 2 q3w

CS-14 Preliminary Progression-Free Survival Per-Protocol Population (Study CA201) Abraxane 260 mg/m 2 (N = 94) Taxol 175 mg/m 2 (N = 93) P-value = HR = Proportion Not Progressed 33% of events

CS-15 Hypotheses for Increased Anti-tumor Activity 50% higher paclitaxel dose 33% higher intra-tumor paclitaxel A Combination of Two Factors

CS-16 Summary: Abraxane is Efficacious and Well Tolerated at a Higher Paclitaxel Dose  Abraxane consistently demonstrated superior anti-tumor activity compared to Taxol in metastatic breast cancer  There is no scientific reason to believe that Abraxane would be less effective in the adjuvant setting