Dendreon Completes Submission of Biologics License Application for PROVENGE

Mon Nov 2, 2009 8:31am EST
 
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SEATTLE, Nov. 2 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced that it has completed the submission of the amended Biologics
License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead
investigational product, to the U.S. Food and Drug Administration (FDA). 
Dendreon is seeking licensure for PROVENGE for men with metastatic
castrate-resistant prostate cancer (CRPC).  If approved by the FDA, PROVENGE
would represent the first product in the new therapeutic class known as active
cellular immunotherapies.

The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol
Assessment agreement with the FDA.  The IMPACT study met its pre-specified
primary endpoint demonstrating a statistically significant improvement in
overall survival in men with metastatic CRPC.

"With the BLA submission complete, we have taken an important step towards
reaching our goal of bringing a new therapy to men with advanced prostate
cancer," said Mitchell H. Gold, MD, president and chief executive officer of
Dendreon. "We look forward to working with the FDA to potentially make
PROVENGE the first active cellular immunotherapy to be licensed in the United
States." 

PROVENGE is available through several ongoing clinical trials, including
OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT
(PROstate cancer Active Cellular immunoTherapy), and NeoACT (NEOadjuvant
Active Cellular immunotherapy).  For more information regarding these studies,
visit www.clinicaltrials.gov.

About PROVENGE
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 (ACIs) specifically designed to engage the patient's own
immune system against cancer.  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. 

About Prostate Cancer
According to the American Cancer Society, 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.  An estimated 192,280 new cases are expected to be diagnosed in 2009. 
Approximately 27,360 men are expected to die this year from the disease.  

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.

This news release contains forward-looking statements that are subject to
risks and uncertainties. Factors that could affect these forward-looking
statements include, but are not limited to, developments affecting Dendreon's
business and prospects, including the FDA's actions with respect to the BLA
and whether the FDA determines to convene an advisory committee to review the
BLA; progress on the commercialization efforts for PROVENGE, including the
expansion of Dendreon's manufacturing capacity and other necessary
infrastructure; success in the hiring of additional personnel to support
business growth and expansion; the outcome of pre-approval inspection of
Dendreon's expanded manufacturing facility; and requisite receipt of FDA
licensure for marketing of PROVENGE and the risk that additional capital could
be needed in the future for the potential commercialization of PROVENGE.
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. Dendreon cautions investors not to place
undue reliance on the forward-looking statements contained in this press
release. All forward-looking statements are based on information currently
available to Dendreon on the date hereof, and Dendreon undertakes no
obligation to revise or update these forward-looking statements to reflect
events or circumstances after the date of this press release, except as
required by law. 

SOURCE  Dendreon Corporation

Katherine Stueland, Vice President, Corporate Communications and Investor
Relations of Dendreon Corporation, +1-206-829-1522, or kstueland@dendreon.com

 

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