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Mark Frohlich, MD, SVP and Chief Medical Officer September 25, 2008 Washington, DC 4 th Annual African American Prostate Cancer Disparity Summit.

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Presentation on theme: "Mark Frohlich, MD, SVP and Chief Medical Officer September 25, 2008 Washington, DC 4 th Annual African American Prostate Cancer Disparity Summit."— Presentation transcript:

1 Mark Frohlich, MD, SVP and Chief Medical Officer September 25, 2008 Washington, DC 4 th Annual African American Prostate Cancer Disparity Summit

2 P. 2 Time Death The Prostate Cancer Epidemic Treatment Continuum Metastatic Tumor volume & activity Castration Chemotherapy Local Therapy Non-Metastatic Symptomatic Asymptomatic Androgen Dependent Androgen Independent

3 4th Annual African American Prostate Cancer Disparity Summit P. 3 The Prostate Cancer Epidemic: Current Standard of Care Administration Q 3 Weeks x 10 via infusion Efficacy 2.4 Month median survival Advantage HR= 1.32 P=.009 Safety: Grade 3/4 Event Rate 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 Docetaxel

4 4th Annual African American Prostate Cancer Disparity Summit P. 4 The Prostate Cancer Epidemic: Patient Dissatisfaction Source: USTOO Survey Press Release, September 8, 2005; 2006 Prostate Cancer Symposia Poster #222 65% 52% 0% 20% 40% 60% 80% 100% Would Consider Chemotherapy Impact on QOL Outweighs Benefit Advanced Prostate Cancer Patients “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

5 4th Annual African American Prostate Cancer Disparity Summit P. 5 Dendreon » Product Focus: Oncology » Lead Product: PROVENGE ® (sipuleucel-T) » Headquarters: Seattle » Commercial Manufacturing: Morris Plains, NJ » Founded: 1992 » Employees: ~200 Ray -- Prostate Cancer Survivor and PROVENGE Study Patient Survival is what matters

6 4th Annual African American Prostate Cancer Disparity Summit P. 6 What is Provenge? » Provenge is an investigational Active Cellular Immunotherapy (ACI) » ACIs are a new class of drug, often referred to as “therapeutic cancer vaccines” » ACIs are very different from traditional vaccines Traditional Vaccines: PREVENT disease by, e.g., exposing the immune system to weakened virus or portion of a virus Therapeutic 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.

7 4th Annual African American Prostate Cancer Disparity Summit P. 7 Targeting Tumor Cells and Mounting a Strong Anti-Cancer Response APC takes up the antigen Recombinant Prostatic Acid Phosphatase (PAP) antigen combines with resting antigen presenting cell (APC) Fully activated, the APC is now sipuleucel-T The precise mechanism of sipuleucel-T in prostate cancer has not been established. Antigen is processed and presented on surface of the APC INFUSE PATIENT T-cells proliferate and attack cancer cells Sipuleucel-T activates T-cells in the body Active T-cell Inactive T-cell

8 4th Annual African American Prostate Cancer Disparity Summit P. 8 Active Cellular Immunotherapy: Production and Delivery Convenient for both physician and patient Complete course of therapy is one month

9 4th Annual African American Prostate Cancer Disparity Summit P. 9 PROVENGE Study D9901: Increased Survival Phase 3 Study in Androgen-Independent PCa 34% 11% Median benefit 4.5 months Months Probability of Surviving

10 4th Annual African American Prostate Cancer Disparity Summit P. 10 Provenge Safety Profile » Most frequent events associated with product infusion » Chills » Fever » Adverse drug reactions » Generally mild to moderate in severity » Majority resolved within 24 hours » < 3% of patients unable to receive all 3 infusions due to treatment- related adverse events

11 4th Annual African American Prostate Cancer Disparity Summit P. 11 Regulatory Timeline » Dendreon completes license application November 2006 » Positive FDA Advisory Panel Meeting March 2007 » FDA requests additional clinical data May 2007

12 4th Annual African American Prostate Cancer Disparity Summit P. 12 IMPACT Phase 3 Study (D9902B) IM munotherapy for P rostate A deno C arcinoma T reatment Asymptomatic or minimally symptomatic Metastatic Androgen Independent Prostate Cancer (n=~500) Placebo Q 2 weeks x 3 Provenge Q 2 weeks x 3 PROGRESSIONPROGRESSION PB01 (Salvage) Q 2 weeks x 3 Treated at MD discretion 2:1 Followed for survival Primary endpoint: Overall Survival Secondary endpoint: Time to Disease Progression

13 4th Annual African American Prostate Cancer Disparity Summit P. 13 Regulatory Timeline » Dendreon completes license application November 2006 » Positive FDA Advisory Panel Meeting March 2007 » FDA requests additional clinical data May 2007 » Confirmatory IMPACT study fully enrolled November 2007 » FDA agrees that either a positive interim or final analysis for survival from the IMPACT study would be sufficient to meet request for additional clinical information to support efficacy claim » Interim results from IMPACT study in October 2008; final results in 2009

14 4th Annual African American Prostate Cancer Disparity Summit P. 14 Time Death Provenge: Addressing an Unmet Need Metastatic Tumor volume & activity Castration Chemotherapy Local Therapy Non-Metastatic Symptomatic Asymptomatic Androgen Dependent Androgen Independent Provenge

15 4th Annual African American Prostate Cancer Disparity Summit P. 15 Ongoing PROVENGE Clinical Studies » Neoadjuvant Trial (n=40, single site study, open for enrollment) » Assess safety and immune response of PROVENGE prior to radical prostatectomy » Immune response to PROVENGE will be assessed in the prostatectomy specimen and in the peripheral blood » All patients will be scheduled to receive active treatment » PRO-ACT Trial (n=120, multicenter study, open for enrollment) » P07-2 PRO-ACT (PROstate Active Cellular Therapy) study has essentially the same enrollment criteria as the IMPACT study » Patients receive PROVENGE made with differing concentrations of immunizing antigen » All patients in the trial will receive active treatment

16 4th Annual African American Prostate Cancer Disparity Summit P. 16 Case Study » 83 years old » Diagnosis of metastatic HRPC in 2001 » 5 years from receiving treatment Eduardo -- Prostate Cancer Survivor and Sipuleucel-T Study D9901 Patient

17 4th Annual African American Prostate Cancer Disparity Summit P. 17 Survival is the ultimate goal in cancer treatment… Improving survival for people with cancer is a goal worth fighting for.

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