New PROVENGE® (sipuleucel-T) Data to Be Presented at 2013 American Society of Clinical Oncology (ASCO) Genitourinary Cancers

  New PROVENGE® (sipuleucel-T) Data to Be Presented at 2013 American Society
  of Clinical Oncology (ASCO) Genitourinary Cancers Symposium

-- Two studies examine potential for PROVENGE in combination or sequenced with
two approved advanced prostate cancer therapies

-- Additional retrospective study data suggest that relative to placebo,
PROVENGE may delay time to first opioid use for pain in patients with advanced
prostate cancer

-- Preliminary data on NeuACT study for high-risk urothelial carcinoma show
high frequency of HER2 expression at primary tumor and lymph node samples

Business Wire

BRIDGEWATER, N.J. -- February 13, 2013

February 13, 2013--Dendreon Corporation (NASDAQ: DNDN) today announced that
results from several ongoing or completed studies investigating the utility of
PROVENGE^®  (sipuleucel-T)  in the treatment of advanced prostate cancer,
including studies that may lead to new treatment approaches, as well as the
investigational immunotherapy DN24-02 in patients with surgically-resected
urothelial cancer, will be presented at the 2013 American Society of Clinical
Oncology (ASCO) Genitourinary Cancers Symposium in Orlando, Florida, from
February 14-16, 2013.

“This year’s ASCO GU meeting is important for Dendreon because of the wide
range of studies being presented that help us better understand PROVENGE,”
said Mark Frohlich, M.D., executive vice president of research and development
and chief medical officer at Dendreon. “The studies that inform us about the
potential use of PROVENGE in combination or sequenced with other advanced
prostate cancer treatments are encouraging, and we look forward to additional
data from these studies.”

Data presented include and can be accessed via the following links:

  *Abstract #34:  Randomized Phase II Trial Evaluating the Optimal Sequencing
    of Sipuleucel-T and Androgen Deprivation Therapy (ADT) in Patients with
    Biochemically-Recurrent Prostate Cancer (BRPC): A Phase II sequencing
    study evaluating PROVENGE followed by ADT or ADT followed by PROVENGE in
    men with biochemically-recurrent prostate cancer showed a prime-boost
    immune response effect based on antigen presenting cell activation
    patterns, and an analysis of serum samples indicated that there were no
    differences between the arms in cellular or humoral immune responses.
    Adverse events for each treatment were consistent with what was seen in
    pivotal trials.
  *Abstract #114: A Randomized Phase II, Open-Label Study of Sipuleucel-T
    with Concurrent or Sequential Abiraterone Acetate (AA) in Metastatic
    Castrate-Resistant Prostate Cancer (mCRPC): A Phase II study evaluating
    concurrent or sequential therapy with AA plus prednisone (P) in men with
    metastatic castrate resistant prostate cancer demonstrated no significant
    differences in median cumulative CD54 upregulation (31.6 vs. 36.6), or the
    measure of antigen presenting cell activation, and CD54+ count (1.9 vs.
    2.1x10^9) between the two arms, suggesting that PROVENGE can be
    manufactured during treatment with AA + P therapy. Adverse events for each
    treatment were consistent with what was seen in pivotal trials.
  *Abstract #74: Sipuleucel-T Appears to Delay Time to First Use of Opioid
    Analgesics (TFOA) in Patients with Asymptomatic or Minimally Symptomatic
    Metastatic Castration Resistant Prostate Cancer (mCRPC) on the IMPACT
    Trial: A retrospective analysis of a subset of the IMPACT trial
    demonstrated that relative to placebo, treatment with PROVENGE appeared to
    delay the first use of opioid analgesics for pain associated with advanced
    prostate cancer. Opioid therapy is currently recommended by the World
    Health Organization (WHO) for moderate to severe pain associated with
    cancer. In patients with advanced cancer, pain is described as moderate to
    severe in approximately 40-50 percent and very severe or excruciating in
    25-30 percent of cases.^1
  *Abstract #292: HER2 Expression in Patients with Surgically Resected
    Urothelial Cancer at High Risk of Recurrence Screened for the Phase II
    Randomized, Open-Label Trial of DN24-02, an Autologous Cellular
    Immunotherapy Targeting HER2: In the NeuACT study, Dendreon’s
    investigational DN24-02 is being studied in urothelial carcinoma.
    Preliminary data presented show a high frequency (>80 percent) of HER2
    expression score of >1+ found in primary tumor and lymph node samples of
    patients with high-risk urothelial carcinoma, as is consistent with
    previously published data.

“These preliminary PROVENGE data are promising for the treatment of metastatic
castrate resistant prostate cancer," said Eric Small, M.D., Chief of the
Division of Hematology and Oncology, and Deputy Director, UCSF Helen Diller
Family Comprehensive Cancer Center. “The medical community is particularly
excited about the studies investigating the potential for treatment with
PROVENGE and other currently approved treatments for advanced prostate cancer,
which may provide us with new therapeutic approaches to help men fight this
disease in the future.”

Additional Dendreon abstracts accepted for presentation at the meeting can be
accessed via the following links:

  *Abstract #148: Immune Response with Sipuleucel-T in Patients with
    Metastatic Castrate-Resistant Prostate Cancer (mCRPC): Phase II PROACT
    Study
  *Abstract #147: P10-1 Open Label, Multicenter Study of Sipuleucel-T in
    Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Patients Previously
    Treated with Sipuleucel-T: Evaluation of Antigen Presenting Cell (APC)
    Activation
  *Abstract #131: Real-World Experience with Sipuleucel-T in Metastatic
    Castration-Resistant Prostate Cancer (mCRPC) Patients >80 Years Old: Data
    from PROCEED
  *Abstract #30: Real-World Experience with Sipuleucel-T in Patients with
    Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Received Prior
    Docetaxel (D): Data from PROCEED

About PROVENGE

Indication and Important Safety Information
PROVENGE^® (sipuleucel-T) is an autologous cellular immunotherapy indicated
for the treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for
transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in
four randomized clinical trials who underwent at least one leukapheresis. The
most common adverse events (incidence greater-than or equal to 15%) are
chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious
adverse events reported in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In controlled
clinical trials, severe (Grade 3) acute infusion reactions were reported in
3.5% of patients in the PROVENGE group. Reactions included chills, fever,
fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache,
hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute
infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing
commitment to patients, Dendreon will conduct a registry of approximately 1500
patients to further evaluate a small potential safety signal of
cerebrovascular events. In four randomized clinical trials of PROVENGE in
prostate cancer patients, cerebrovascular events were observed in 3.5% of
patients in the PROVENGE group compared with 2.6% of patients in the control
group.

For the FDA approved full prescribing information, please visit
http://www.provenge.com.

AboutDendreon

Dendreon Corporationis a biotechnology company whose mission is to target
cancer and transform lives through the discovery, development,
commercialization and manufacturing of novel therapeutics. The Company applies
its expertise in antigen identification, engineering and cell processing to
produce active cellular immunotherapy (ACI) product candidates designed to
stimulate an immune response in a variety of tumor types. Dendreon's first
product, PROVENGE^® (sipuleucel-T), was approved by the FDA inApril 2010.
Dendreonis exploring the application of additional ACI product candidates and
small molecules for the potential treatment of a variety of cancers. The
Company is headquartered inSeattle, Washingtonand is traded on theNASDAQ
Global Marketunder the symbol DNDN. For more information about the Company
and its programs, visit http://www.dendreon.com.

Statements in this press release that are not strictly historical in nature
constitute “forward-looking statements.” Such statements include, but are not
limited to, statements regarding the expected benefits of the restructuring,
the timing and elements of the restructuring, the timing and form of related
charges, the expected annual operating expense reduction, expectations and
beliefs regarding Dendreon’s profitability and Dendreon’s ability to achieve
improved performance as a result of the restructuring, expectations regarding
regulatory approval of PROVENGE^® in Europe, expectations regarding the
presentation of clinical data, developments affecting Dendreon's U.S. and
global business and prospects and potential revenue and earnings from product
sales, expectations regarding market size and market opportunity, and progress
generally on commercialization efforts for PROVENGE. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause Dendreon’s actual results to be materially different from
historical results or from any results expressed or implied by such
forward-looking statements. These factors include, but are not limited to, our
inability to achieve and sustain commercial success for PROVENGE; the
identification of efficacy, safety or other issues with PROVENGE; a slower
than anticipated adoption by treating physicians of PROVENGE for the treatment
of patients with advanced prostate cancer due to competing therapies,
perceived difficulties in the treatment process, delays in obtaining
reimbursement or for other reasons; any promotional limitations imposed by the
FDA on our ability to commercialize and market PROVENGE; unexpected
difficulties and costs associated with the rapid expansion of our operations
to support the commercial launch of PROVENGE; and other factors discussed in
the “Risk Factors” section of Dendreon’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2012. All forward-looking statements are qualified
in their entirety by this cautionary statement. Dendreon is providing this
information as of the date of this press release and does not undertake any
obligation to update any forward-looking statements contained in this release
as a result of new information, future events or otherwise.

1.Coyle N, Adelhardt J, Foley KM, Portenoy RK. Character of terminal illness
    in the advanced cancer patient: pain and other symptoms during the last
    four weeks of life. J Pain Symptom Manage 1990;5:83–93.

Contact:

Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
media@dendreon.com
or
Joele Frank, Wilkinson Brimmer Katcher
Investor Relations
Andrea Rose, 212-355-4449
InvestorRelations@dendreon.com
 
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