PROVENGE® (sipuleucel-T) Data Presented at An Annual Scientific Urology Meeting

  PROVENGE® (sipuleucel-T) Data Presented at An Annual Scientific Urology

       Three Presentations Inform the Use of PROVENGE in the Metastatic
            Castrate-Resistant Prostate Cancer Treatment Continuum

AUA Annual Meeting

Business Wire

SEATTLE -- May 06, 2013

May 6, 2013--Dendreon Corporation (NASDAQ: DNDN) today announced the
presentation of three PROVENGE^® (sipuleucel-T) abstracts from new and ongoing
clinical trials at the 2013 American Urological Association (AUA) Annual
Meeting from May 4-8, 2013 in San Diego, California.

“The PROVENGE research presented at this year's AUA Annual Meeting reflects
Dendreon's ongoing commitment to men in need of new treatment options for
advanced prostate cancer,” said Mark Frohlich, M.D., executive vice president
of research and development and chief medical officer at Dendreon. "Data from
the pivotal Phase III IMPACT trial, the Phase II ProACT study and the Phase IV
PROCEED registry provide the healthcare community with a better understanding
of the role of PROVENGE in the metastatic castrate-resistant prostate cancer
treatment continuum."

Clinical presentations featuring PROVENGE data will be highlighted during a
moderated poster session on Monday, May 6 from 10:30 a.m. to 12:30 p.m. PT in
Room 11 at the San Diego Convention Center. The abstracts include:

  *Abstract #960: E. David Crawford, M.D., professor of surgery, urology, and
    radiation oncology, and head of the section of urologic oncology at the
    University of Colorado Denver School of Medicine, will present a poster
    titled “Optimal Timing for Treatment of Metastatic Castration-Resistant
    Prostate Cancer (mCRPC): Sequencing and Identifying Parameters of Early
    Progression with Sipuleucel-T:” In the Phase 3 IMPACT trial, a
    retrospective subgroup analysis suggested a greater PROVENGE treatment
    effect in those patients with a lower baseline PSA. These data were
    recently published in the international journal, Urology.
  *Abstract #971: Thomas Gardner, M.D., associate professor in the Department
    of Microbiology and Immunology at Indiana University School of Medicine,
    will present a poster titled “Safety and Changes in Laboratory Parameters
    Associated with Sipuleucel-T in Patients with Metastatic
    Castration-Resistant Prostate Cancer: Phase II ProACT study:” A Phase II
    study evaluated immune responses and overall survival of patients
    receiving PROVENGE manufactured with different concentrations of antigen.
    Increased globulin protein and transient increased eosinophil counts were
    consistent with previous studies and positively correlated with immune
    response and overall survival. The safety profile of PROVENGE was
    consistent with that observed in previous clinical trials.
  *Abstract #972: Matthew Cooperberg, M.D., assistant professor of urology,
    epidemiology and biostatistics, University of California, San Francisco,
    will present a poster titled “Treatment Practice Patterns in Metastatic
    Castration-Resistant Prostate Cancer (mCRPC) Patients Prior to Receiving
    Sipuleucel-T: Data from PROCEED:” In a Phase IV registry study, data on
    patients enrolled before they received PROVENGE provides a window into
    current treatment patterns for patients with advanced prostate cancer and
    will continue to yield important information that can be used to track
    trends in patient demographics and treatment prior to and after receiving

“These presentations at AUA provide the medical community with possible new
insight on the role of PROVENGE in men with advanced prostate cancer,” said E.
David Crawford, M.D., professor of surgery, urology, and radiation oncology,
and head of the section of urologic oncology at the University of Colorado,
Denver School of Medicine. “PROVENGE is an innovative treatment option that
uses a patient’s own cells to activate the immune system to fight the disease,
and these data reinforce what we have seen in the clinical setting.”


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

For the FDA approved full prescribing information, please visit


Dendreon Corporation is 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 U.S. Food and Drug
Administration (FDA) in April 2010. Dendreon is exploring the application of
additional ACI product candidates and small molecules for the potential
treatment of a variety of cancers. The Company is headquartered in Seattle,
Washington and is traded on the NASDAQ Global Market under the symbol DNDN.
For more information about the Company and its programs, visit

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 financial position, profitability and Dendreon's
ability to break even and achieve improved performance as a result of the
restructuring, expectations regarding reductions of cost of goods sold,
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, beliefs regarding the impact of our direct to consumer
advertising, expectations with respect to our sales force execution, 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,
instability in our sales force, including the risk that we cannot replace
vacant sales positions on a prompt basis, 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; the
impact of competing therapies on sales of PROVENGE, and other factors
discussed in the "Risk Factors" section of Dendreon's Annual Report on Form
10-K for the year ended December 31, 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.


Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
Investor Relations
Nicole Soley, 206-455-2220
Press spacebar to pause and continue. Press esc to stop.