Mitchell H. Gold, M.D. President and CEO 2 nd Annual African American Prostate Cancer Disparity Summit September 22, 2006 1
Dendreon Corporation: A Biotechnology Company on the Verge of Changing the Way Advanced Prostate Cancer is Treated Headquarters: Seattle, Washington Commercial Manufacturing: Hanover, New Jersey Founded: 1992 in Mountain View, CA No. Employees: ~220 Public Company: Nasdaq: DNDN Product Focus: Oncology 2
The Prostate Cancer Epidemic: Treatment Continuum A Need for Better Treatments Early Stage 511,600 1 Patients with Active Disease in 2006 Advanced Stage Primary Therapy Androgen Dependent Androgen Deprivation Androgen Independent Asymptomatic Symptomatic Radical Prostatectomy Brachytherapy Radiation Therapy Cryotherapy Watchful Waiting Lupron Zoladex Casodex Eulexin Ketoconazole Taxotere Palliative Interventions Bisphosphonates Taxotere Novantrone Emcyt 1 The Mattson Jack Group, CancerMETRIC SM database 2005 2 Dendreon Quantitative Primary Research, March/December 2005 132,500 1,2 Hormone Refractory Patients 96,600 1,2 Metastatic HRPC Patients 3
The Statistics in African American Men 30,770 new cases diagnosed each year Second leading cause of cancer related deaths African American men are diagnosed at later stages and have a 2.5 times higher mortality rate Points to need for better education and early detection Desperately need better therapies for Advanced Prostate Cancer than are currently available 4
Metastatic Prostate Cancer Competitive Profile Docetaxel Administration Patient Population Efficacy Safety: Grade 3/4 Event Rate Q 3 Weeks x 10 via infusion Metastatic HRPC 2.4 Month MST Advantage HR= 1.32 P=.009 Hair Loss 65% Fatigue 53% Nausea/Vomiting 42% Diarrhea 32% Neutropenia 32% Nail Changes 30% Neuropathy 30% Stomatitis 20% Peripheral Edema 19% Change in Taste 18% Anorexia 17% Dyspnea 15% Source: Taxotere label 5
Patients Dissatisfied With Current Treatment 100% 80% 60% 40% 52% Advanced Prostate Cancer Patients 65% 20% 0% Would Consider Chemotherapy Impact on QOL Outweighs Benefit Men with late-stage disease need more options. These men and their families shouldn t have to compromise their quality of lives. We need better treatments that fight this disease, address the most painful symptoms, and lessen the side effects of treatment. -Thomas Kirk, president and CEO of Us Too International Source: USTOO Survey Press Release, September 8, 2005; 2006 Prostate Cancer Symposia Poster #222 6
Androgen-Independent (Hormone-Refractory) Prostate Cancer Metastatic, androgen-independent (HRPC) prostate cancer is a deadly disease Modest survival advantage seen with docetaxel-based regimens in HRPC patients Majority of patients elect not to go on chemotherapy mostly due to impact on QOL Novel treatments and approaches with acceptable toxicity and safety profiles are needed 7
Sipuleucel-T: Active Cellular Immunotherapy for Advanced Prostate Cancer
The Prostate Cancer Treatment Continuum Sipuleucel-T Potentially Addresses Large Unmet Need Early Stage Primary Therapy Androgen Dependent Androgen Deprivation Androgen Independent Asymptomatic Advanced Stage Symptomatic Sipuleucel-T Radical Prostatectomy Brachytherapy Radiation Therapy Cryotherapy Watchful Waiting Lupron Zoladex Casodex Eulexin Ketoconazole Proposed Label: PROVENGE (sipuleucel-t) is indicated for the treatment of asymptomatic men with metastatic, androgen independent prostatic adenocarcinomas Taxotere Palliative Interventions Bisphosphonates Taxotere Novantrone Emcyt 9
What is Sipuleucel-T? Sipuleucel-T is an investigational Active Cellular Immunotherapy (ACI) ACIs are a new class of drug, often referred to as cancer vaccines ACIs are very different from traditional vaccines Traditional Vaccines: PREVENT disease by exposing the immune system to weakened virus or portion of a virus Cancer Vaccine/ ACIs: TREAT disease by using the body s immune system to fight the cancer Immunotherapies are designed to be specific, affecting only cancer cells. 10
Why Doesn t the Immune System Currently Fight Cancer? Cancer Can Avoid Detection by the Immune System Cancer cells are made up of the body s own tissues Immune system is not trained to attack them Tumors also produce substances that tell the immune system to stand down ACIs help address this problem by allowing the body to see cancer and attack it 11
Antigen Delivery Cassette : The Key to Generating a Robust Immune Response Targets well known antigen Prostatic Acid Phosphatase Manufacture as recombinant proteins Shown to produce a robust, reproducible and well characterized immune response in clinical studies GM-CSF Prostatic Acid Phosphatase (PAP) 12
Marshalling the Body s Own Resources to Fight Cancer Recombinant PAP antigen combines with resting antigen presenting cell (APC) APC takes up the antigen Antigen is processed and presented on surface of the APC Fully activated, the APC is now sipuleucel-t INFUSE PATIENT Active T-cell Inactive T-cell T-cells proliferate and attack cancer cells Sipuleucel-T activates T-cells in the body The precise mechanism of sipuleucel-t in prostate cancer has not been established. 13
Dendreon s Active Immunotherapy: Potential Advantages Well tolerated compared to chemotherapeutic agents Immunotherapies are designed to be specific, affecting only cancer cells Potential to be used both prior to and in combination with other agents Immune response has potential to be durable Complete course of therapy completed in one month Allows patient to resume normal quality of life 14
Sipuleucel-T Phase 3 Study (D9901) Basis of Biologics License Application to FDA First randomized, double blind, placebo-controlled trial of a cancer immunotherapy to show survival benefit 127 asymptomatic metastatic, AIPC patients at 19 U.S. centers Primary endpoint: Median time to objective disease progression (p-value = 0.052; HR = 1.45) Study protocol required survival follow up to 3 years after randomization 100% of patients assessed for survival Full results published in Journal of Clinical Oncology (JCO) 15
PROVENGE: Metastatic, Hormone Refractory Prostate Cancer D9901 Phase 3 Study Key Findings Results showed that men who received PROVENGE: Median survival time 4.5 months longer than men assigned to receive placebo 41% overall reduction in the risk of death 34% of patients were alive 36 months after treatment compared to 11% of patients randomized to receive placebo PROVENGE appears to be safe and well tolerated in 600+ patients treated in 10 clinical trials 16
Sipuleucel-T is Well Tolerated Event [n(%)] PROVENGE (n=82) Placebo (n=45) Grade 1-2 Grade 3-4 Grade 1-2 Grade 3-4 p-value Rigors (chills) 45 (54.9) 4 (4.9) 4 (8.9) 0 (0.0) <0.001 Pyrexia (fever) 22 (26.8) 2 (2.4) 1 (2.2) 0 (0.0) 0.0001 Tremor 8 (9.8) 0 (0.0) 0 (0.0) 0 (0.0) 0.0497 Feeling Cold 7 (8.5) 0 (0.0) 0 (0.0) 0 (0.0) 0.0505 Phase 3 Trial D9901 17
Summary of Sipuleucel-T Studies in Prostate Cancer Early Stage Androgen Dependent Study D9905 P-16 P-11 Advanced Stage Androgen Independent D9901 D9902A D9902B Phase Phase 2 Phase 2 Phase 3 Phase 3 Phase 3 Phase 3 No. of Subjects 19 22 ~175 127 98 ~ 500 Results Sipuleucel-T may lead to improved PSADT Sipuleucel-T plus Avastin increased PSADT 2H 2006 At 36 months, showed 4.5 month median survival benefit for men who received Sipuleucel-T At 36 months, showed 3.3 month median survival benefit for men who received Sipuleucel-T Enrolling Complete 18
Anticipated Regulatory Timeline Potential Advisory Committee Potential Launch 2006 2007 Plan to Complete Submission to FDA Prior to Year End 19
Commercial Manufacturing Capacity in New Jersey New Jersey manufacturing facility to support clinical and future anticipated commercial capacity for Sipuleucel-T 20
Case Study 83 years old Diagnosis of metastatic HRPC in 2001 Significant loss of energy Gained energy after participation in clinical trial 5 years from receiving treatment Eduardo -- Prostate Cancer Survivor and Sipuleucel-T Study D9901 Patient 21
Survival is the ultimate goal in cancer treatment Improving survival for people with cancer is a goal worth fighting for. 22
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