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April 14, 2009: Promising Test for Dendreon's Prostate Cancer Drug

http://investor.dendreon.com/releasedetail.cfm?ReleaseID=376922

SEATTLE, April 14, 2009 - Dendreon Corporation (Nasdaq: DNDN)
announced today that the pivotal Phase 3 IMPACT study of PROVENGE®
(sipuleucel-T) in men with advanced prostate cancer met its primary
endpoint of improving overall survival compared to a placebo control. The
magnitude of the survival difference observed in the intent to treat
population resulted in the study successfully achieving the pre-specified
level of statistical significance defined by the study's design. The
safety profile of PROVENGE appeared to be consistent with prior trials.

The 512-patient, multi-center, randomized, double-blind,
placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma
Treatment) study enrolled men with metastatic androgen-independent
prostate cancer was conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration (FDA).

PROVENGE is Dendreon's investigational product candidate for men with
advanced prostate cancer and may represent the first in a new class of
active cellular immunotherapies specifically designed to engage the
patient's own immune system against cancer.

"Survival is the gold standard outcome for oncology clinical trials, and
overall survival was the primary endpoint of the IMPACT trial. The
positive results from this landmark study provide confirmatory evidence
demonstrating that treatment with PROVENGE may prolong survival," said
Mitchell H. Gold, M.D., president and chief executive officer of Dendreon.
"We are immensely grateful to our clinical investigators and the more than
1,000 men with advanced prostate cancer who have participated in our
studies over the last decade and whose courage and contribution have
significantly advanced the understanding and treatment of prostate cancer
and the potential role of cancer immunotherapies."

"The successful outcome from the Phase 3 IMPACT study provides validation
of the long-pursued goal of harnessing the human immune system against a
patient's own cancer," continued Dr. Gold.

Because the data meet the criteria and specifications outlined in its
Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends
to file an amendment to its existing Biologic License Application (BLA) in
the fourth quarter of this year to gain licensure of PROVENGE.

Prostate cancer is the most common non-skin cancer in the United States
and the third most common cancer worldwide. More than one million men in
the United States have prostate cancer, with an estimated 186,320 new
cases and approximately 28,660 men who were expected to die from the
disease in 2008. Currently there are limited treatment options for men
with advanced, metastatic prostate cancer.

About PROVENGE

PROVENGE® (sipuleucel-T), an investigational product in development for
men with androgen-independent prostate cancer, may represent the first
product in a new class of active cellular immunotherapies (ACIs). PROVENGE
and other ACIs are uniquely designed to use live human cells to engage the
patient's own immune system with the goal of eliciting a specific
long-lasting response against cancer. In controlled clinical trials, the
most common adverse events were chills, fever, headache, fatigue,
shortness of breath, vomiting and tremor. These events were primarily low
grade with a short duration of 1-2 days following infusion.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target
cancer and transform lives through the discovery, development and
commercialization of novel therapeutics. The Company applies its expertise
in antigen identification, engineering and cell processing to produce
active cellular immunotherapy product candidates designed to stimulate an
immune response. Dendreon is also developing an orally-available small
molecule that targets TRPM8 that could be applicable to multiple types of
cancer as well as benign prostatic hyperplasia. The Company has its
headquarters 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 www.dendreon.com.

Except for historical information contained herein, this news release
contains forward-looking statements that are subject to risks and
uncertainties surrounding the efficacy of PROVENGE to treat men suffering
from prostate cancer, risks and uncertainties surrounding the presentation
of data to the FDA and approval of product applications by the FDA and
risks and uncertainties inherent in the process of discovering, developing
and commercializing drugs that are safe and effective for use as human
therapeutics. Factors that may cause such differences include risks
related to our limited operating history, risks associated with completing
our clinical trials, the risk that the safety and/or efficacy results of
existing clinical trials or from additional clinical trials for PROVENGE
will not support approval for a biologics license, the risk that the FDA
may interpret data differently than we do or require more data or a more
rigorous analysis of data than expected, the risk that the FDA will not
approve a product for which a biologics license has been applied, the risk
that the results of a clinical trial for PROVENGE or other product may not
be indicative of results obtained in a later clinical trial, risks that we
may lack the financial resources and access to capital to fund required
clinical trials or commercialization of PROVENGE, our dependence on the
efforts of third parties, and our dependence on intellectual property.
Further information on the factors and risks that could affect Dendreon's
business, financial condition and results of operations are contained in
Dendreon's public disclosure filings with the U.S. Securities and Exchange
Commission, which are available at www.sec.gov.

Contact Information:

Investors:
Jennifer Cook Williams
Dendreon Corporation
(206) 829-1500

Media:
Katherine Stueland
WeissComm Partners
kstueland@wcpglobal.com
(312) 608-0320

 


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