More Information on Provenge's FDA Approval

From: Dendreon Corporation Investor Relations
[mailto:newsdesk@broadcast.shareholder.com]
Sent: Thursday, June 30, 2011 4:52 PM
To: Riccio, Scott
Subject: Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE

Dendreon Corporation


Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE

- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS
Announces National Coverage Decision, and Product Specific Q-Code Effective
-

SEATTLE, June 30, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced significant milestones that support broad availability for
on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
* The U.S. Food and Drug Administration (FDA) approved the Los Angeles
immunotherapy manufacturing facility on June 29, 2011. The facility includes
36 workstations, and Dendreon will bring these on in a staged approach.
* In addition, the Centers for Medicare and Medicaid Services (CMS)
issued a final National Coverage Decision (NCD) for PROVENGE on June 30,
2011, requiring Medicare contractors to cover the use of PROVENGE for
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. The NCD will standardize
coverage processes across the country for all Medicare patients with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer and provides the local Medicare Administrative
Contractors (MACs) specific criteria, consistent with the label, on how
PROVENGE should be covered.
* PROVENGE was issued a product specific Q-code effective July 1,
2011, which allows for electronic submission of claims and is expected to
accelerate time to payment for physicians.
* As part of this expanded access, Dendreon supports programs to
provide comprehensive assistance for eligible patients seeking access to
treatment with PROVENGE, including through grants to independent foundations
and establishment of a patient assistance program for uninsured patients.
Dendreon provides grants to independently run foundations providing
qualifying patients with financial assistance for co-pays, co-insurance, and
treatment-related travel costs.

"These significant achievements support broad access to PROVENGE, the
foundation of care for men with asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "The increased capacity
and positive National Coverage Decision by CMS in conjunction with the
patient assistance programs will ensure patients who may benefit from
treatment with PROVENGE have increased access to it."

For information about these programs, please visit www.provenge.com
or call 1-877-336-3736.

PROVENGE Indication and Safety

PROVENGE was approved by the U.S. Food and Drug Administration in April 2010
as the first autologous cellular immunotherapy 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
procedure. The most common adverse events (incidence greater than or equal
to 15%) reported in patients in the PROVENGE group are chills, fatigue,
fever, back pain, nausea, joint ache, and headache. Serious adverse events
reported in patients 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 1,500 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 group.

For more information on PROVENGE, please see the full Prescribing
Information at www.provenge.com or call
1-877-336-3736.