Dendreon Announces Marketing Authorization for PROVENGE® in the European Union

  Dendreon Announces Marketing Authorization for PROVENGE® in the European
  Union

Business Wire

SEATTLE -- September 17, 2013

September 17, 2013– Dendreon Corporation (Nasdaq: DNDN) today announced that
the European Commission (EC) has granted marketing authorization for
PROVENGE^® (autologous peripheral blood mononuclear cells activated with
PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union (EU)
for the treatment of asymptomatic or minimally symptomatic metastatic
(non-visceral) castrate resistant prostate cancer in male adults in whom
chemotherapy is not yet clinically indicated. This final decision by the EC
follows recent positive opinions from both the European Medicines Agency (EMA)
Committee for Advanced Therapy (CAT) and the Committee for Medicinal Products
for Human Use (CHMP) recommending that PROVENGE be granted marketing
authorization in the EU.

The marketing authorization provides approval for the commercialization of
PROVENGE in all 28 countries of the EU as well as Norway, Iceland and
Liechtenstein.

John H. Johnson, chairman, president and chief executive officer of Dendreon
said, “The marketing authorization of PROVENGE in the EU represents an
important achievement for Dendreon. As the first personalized immunotherapy
approved for the treatment of mCRPC in Europe, PROVENGE may help extend the
lives of appropriate prostate cancer patients.”

“With sipuleucel-T, we have the potential to create a new treatment paradigm
in advanced prostate cancer, with the integration of this novel therapy to
harness a patient’s own immune system to fight their cancer,” said Prof. Karim
Fizazi, M.D., Ph.D., Head of the Department of Cancer Medicine, The Institut
Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of
Paris, France.

The European marketing authorization for PROVENGE was granted based upon data
from three randomized, placebo-controlled, multi-center Phase III studies,
which enrolled 737 patients. In the pivotal Phase III IMPACT study, an
improvement in overall survival (OS) was observed, with a median survival of
4.1 months longer in patients who received PROVENGE versus those who received
placebo (HR=0.775, 95%-CI 0.614, 0.979, P =0.032). Similar effects were
observed in the two supportive studies.

“This milestone demonstrates the importance of providing a new therapeutic
option with a differing mechanism of action than other approved treatments for
appropriate prostate cancer patients in the EU,” said Mark Frohlich, executive
vice president of research and development and chief medical officer of
Dendreon. “We continue to enroll patients in the EU open-label study, and plan
to have a presence at the upcoming European Cancer Organization (ECCO) and
European Society for Medical Oncology (ESMO) conferences.”

Important Safety Information for PROVENGE^1

PROVENGE is intended solely for autologous use and should under no
circumstances be administered to other patients.

The safety evaluation of PROVENGE was based on data from 601 prostate cancer
patients in four randomized clinical trials and post-marketing surveillance.

PROVENGE should be delayed in patients with active systemic infection until
resolution and used with caution in patients with a history of embolic and
thrombotic events, including cerebrovascular disease and cardiovascular
disorders.

Serious adverse reactions reported include acute infusion reactions (occurring
within 1 day of infusion), catheter sepsis, staphylococcal bacteremia,
myocardial infarction and cerebrovascular events.

The most commonly reported adverse reactions were chills, fatigue, pyrexia
(fever), nausea, arthralgia (joint ache), headache, and vomiting.

About Dendreon

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
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 financial position, profitability and Dendreon's
ability to break even and achieve improved performance as a result of the
restructuring, statements regarding sequencing studies, statements regarding
studies to advance understanding of immunotherapy and the treatment of
advanced prostate cancer, statements regarding biomarkers, expectations about
the early detection study, expectations about advancing our pipeline,
expectations regarding reductions of cost of goods sold, expectations
regarding the presentation of clinical data, developments affecting Dendreon's
U.S. and global business and prospects, beliefs and expectations regarding
potential revenue and earnings from product sales, including beliefs regarding
Dendreon's ability to grow sales, expectations regarding market size, target
market, and market opportunity, beliefs regarding the impact of our direct to
consumer advertising, expectations with respect to our sales force execution
and effectiveness, progress generally on commercialization efforts for
PROVENGE, and expectations about clinical trial enrollments. 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 for a variety of reasons, including
competing therapies, instability in our sales force, 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 commercial operations to support the commercial launch
of PROVENGE; the impact of competing therapies on sales of PROVENGE,
manufacturing difficulties, disruptions or delays and other factors discussed
in the "Risk Factors" section of Dendreon's Annual Report on Form 10-Q for the
quarter ended June 30, 2013. 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 PROVENGE Summary of Product Characteristics (SmPC) for the European Union

Contact:

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