Dendreon Receives Positive Opinion for PROVENGE® in the European Union

  Dendreon Receives Positive Opinion for PROVENGE® in the European Union

Business Wire

SEATTLE -- June 28, 2013

June 28, 2013--Dendreon Corporation (Nasdaq: DNDN) today announced that the
European Medicines Agency (EMA) Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion recommending that PROVENGE^® (autologous
peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T)
be granted marketing authorization 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. The CHMP’s recommendation follows a positive
recommendation by the Committee for Advanced Therapy (CAT).

“We are pleased with this outcome and look forward to a final regulatory
decision by the European Commission later this year,” said Mark Frohlich,
Executive Vice President of Research and Development and Chief Medical Officer
of Dendreon. “By using the body’s own immune system to fight cancer, PROVENGE
is a novel therapy that addresses a genuine unmet patient need. If approved,
PROVENGE would help extend the lives of appropriate prostate cancer patients
in Europe.”

The CHMP will make a final recommendation to the European Commission (EC)
within the coming months on the marketing authorization application for
PROVENGE in the EU. A regulatory decision is anticipated from the EC in the
second half of this year.

“PROVENGE is the first immunotherapy to have demonstrated an overall survival
improvement in prostate cancer. The positive CHMP opinion for PROVENGE is
great news for advanced prostate cancer patients and physicians in Europe, and
we look forward to the European Commission’s final decision on this novel
treatment option,” 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.

John H. Johnson, Dendreon’s chairman, president and chief executive officer,
said, “This recommendation represents a significant milestone for Dendreon as
we advance the global market opportunity for PROVENGE. We are finalizing our
plans for a capital-efficient launch in Europe, including evaluating our
partnering options. We look forward to bringing the innovative treatment of
PROVENGE to patients around the world."

Important U.S. Label Safety Information for PROVENGE

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.

For more information on PROVENGE, please see the full prescribing information
at or call 1-877-336-3736.

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 for the treatment of asymptomatic or
minimally symptomatic metastatic castrate resistant (hormone refractory)
prostate cancer. 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 Company's expectations concerning the
settlement of the pending securities litigation against the Company and three
of its current or former officers, 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 ability to complete documentation of the settlement among the parties
to the litigation and with Dendreon's insurers and to obtain court approval of
the settlement, neither of which can be assured; 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
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