Mitchell Gold M.D.
President and CEO
Dendreon Corporation
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Current View to Evolution of Cancer Immunotherapy and
Complex Therapeutics
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Sound Familiar?
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PROVENGE (sipuleucel-T): D9901
Phase 3 Study in Advanced Prostate Cancer to Serve as
Primary Basis of BLA
Double Blind, Placebo Controlled
Treatment
at Weeks
0 2 4
• First randomized, double blind, • Primary endpoint: Median
placebo-controlled Phase 3 study time to objective disease
of a cancer immunotherapy progression
• 127 patients with advanced • Secondary endpoint: Delay in
androgen-independent PCa onset of disease related pain
• 3 intravenous infusions lasting • Study protocol required
30-60 minutes given at 2-week survival follow up for 3 years
intervals
• Fast Track Status
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D9901 Final Overall 3-year Survival (ITT)
PROVENGE Extends Survival – Gold Standard of Oncology Endpoints
100
p = 0.01 (log rank)
HR = 1.7
Median Survival Benefit = 4.5 months
75
Percent Survival
PROVENGE (n=82)
Median Survival: 25.9 mos.
50
APC-Placebo (n=45)
Median Survival: 21.4 mos. 34%
25
11%
0
0 10 20 30 40
Survival (months)
Phase 3 Trial D9901 5
Competitive Profile
PROVENGE Taxotere®
Administration Q 2 Weeks x 3 via infusion Q 3 Weeks x 10 via infusion
Patient Population Asymptomatic, Metastatic HRPC Metastatic HRPC
Efficacy 4.5 month MST Advantage 2.4 Month MST Advantage
HR= 1.71 HR= 1.32
P= .01 P=.009
Safety: Rigors 5% Alopecia 65%
Grade 3/4 Pyrexia 2% Fatigue 53%
Nausea/Vomiting 42%
Event Rate
Diarrhea 32%
Neutropenia 32%
Nail Changes 30%
Neuropathy 30%
Stomatitis 20%
Peripheral Edema 19%
Change in Taste 18%
Anorexia 17%
Dsypnea 15%
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Source: Taxotere label
CBER/Dendreon
Pre-BLA Meeting
PROVENGE® (sipuleucel-T)
Key Pre-BLA Meeting Outcomes
• FDA agreed that:
– Survival benefit observed in Study D9901, in conjunction with the
data obtained in Study D9902A and the absence of significant
toxicity, is sufficient to serve as the clinical basis of a BLA filing
for PROVENGE
– Efficacy data from other clinical studies, i.e., P-11 and D9902B,
will not be required for BLA package
– No additional clinical studies are necessary from a CMC
perspective for the BLA submission
• Company plans to submit BLA in 2006
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Estimated Commercialization Timeline
D9902B
Complete BLA Potential
Data
Submission Launch
2006 2007 2008
Complete NJ
Construction Potential
Advisory
Committee
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The Potential
The Prostate Cancer Continuum
PROVENGE is Being Studied in Early and Late Stages of Disease
Early Stage Advanced Stage
Androgen Dependent PCa Androgen Independent PCa
Primary Androgen Asymptomatic Symptomatic
Therapy Deprivation
PROVENGE®
• Radical • Lupron • Palliative
Prostatectomy • Zoladex Interventions
• Brachytherapy • Casodex
• Radiation Therapy • Bisphosphonates
• Eulexin
• Cryotherapy • Taxotere • Taxotere
• Watchful Waiting • Ketoconazole • Novantrone
• Emcyt
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Androgen Independent PCa Patient Population
368 376 382
357 363
Patients (000's)
184 188 192
177 181
0
2006 2007 2008 2009 2010
US EU JAP
Source: “Understanding the Market Potential for Provenge in Prostate Cancer,” Quantitative Primary Research, 3/05, Provenge Forecast
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Comparable Oncologics--Pricing
Price per 2004
Product Indication Efficacy
DOT† Sales
Provenge® PCa Survival Adv: 4.5 months TBD N/A
Avastin® 4.7 months survival benefit $60,500
(2/04)
CRC $555M*
Delayed TTP
Erbitux®
(2/04)
CRC Median duration of response $50,000 $389M**
w/irinotecan: 5.7 months
Low Grade Delayed TTP
Rituxan®
(11/97) Overall median duration of $30,000 $1.7B
NHL response: 11.6 months
Taxotere® Survival Adv: 2.4 months
(5/04 PCa)
PCa $26,000 $600M
• Annual cost of comparable products does not include price of concomitant
therapies or supportive care.
† Duration of Therapy, drug pricing based on AWP
* 10 months post-US launch
** 10 mos. post-US launch; 3rd & 4th Quarter incl. global$
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Tax sales are global
Excerpt from ASCO Press Release Issued Prior to 2005
Multidisciplinary Prostate Cancer Conference
Prostate Cancer Vaccine Is First to Increase Survival
February, 2005 -- For the first time, researchers have found that a novel
immunologic therapy increases survival by nearly 18% in men with advanced
prostate cancer that no longer responds to hormone therapy. The therapeutic
cancer vaccine, called APC8015 (Provenge), is likely to become a new
standard of care for patients with metastatic prostate cancer. This is the first
study to demonstrate a survival benefit from immunologic therapies or vaccines
in patients with advanced prostate cancer.
"We're very pleased with the results. A therapy that prolongs life yet avoids the
side effects of other therapeutic approaches is clearly attractive to patients and
physicians alike," said Eric Small, MD, Professor of Medicine and Urology at
the University of California, San Francisco School of Medicine, and lead …
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A Different Perspective On Where We Are Today
…………..(Has Arrived)
Today
Works
AND
We’ve Dealt
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Let me tell you the secret that has led me to my goal.
My strength lies solely in my tenacity.
-Louis Pasteur
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