SEATTLE, Jan. 7, 2011 /PRNewswire/ -- Dendreon Corporation
(Nasdaq: DNDN) today announced several updates regarding the U.S.
commercialization of PROVENGE® (sipuleucel-T), the European
strategy for PROVENGE, and progress on its pipeline. The Company
will host a conference call at 9:00 a.m.
ET to review additional details.
"Last year was foundational for Dendreon with the successful
introduction of PROVENGE as the world's first autologous cellular
immunotherapy," said Mitchell H.
Gold, MD, president and chief executive officer. "As
we look to 2011 and beyond, we are positioned for significant
growth with our increased capacity in the U.S., our European
strategy for filing now set, and our progress in advancing our ACI
pipeline in bladder cancer. Most importantly, we are proud to
deliver on our commitment to transform the lives of patients with
cancer by making PROVENGE more broadly available in the U.S. and
abroad."
U.S. Commercialization
- In 2010, Dendreon achieved revenues from PROVENGE of
approximately $48 million.
- In anticipation of a ten-fold increase in capacity from its
facilities in New Jersey,
Los Angeles, and Atlanta coming on line this year, Dendreon has
increased its sales force to approximately 100 reps to service
approximately 450 centers by the end of 2011.
- In 2011, Dendreon plans to increase marketing and awareness
efforts to educate physicians and patients and to maximize the
additional capacity.
European Plans
- Following a number of pre-submission meetings with European
Union (E.U.) National Agencies, the company expects that data from
the IMPACT study, supported by data from D9901 and D9902A, will be
sufficient to seek regulatory approval in the E.U.
- Dendreon plans to use the clinical data described in its U.S.
Biologics License to file its marketing authorization application
(MAA) to the European Medicines Agency (EMA) in late 2011/early
2012.
- To accelerate the regulatory timeline, initially PROVENGE will
be manufactured through a Contract Manufacturing Organization (CMO)
while Dendreon concurrently builds an immunotherapy manufacturing
facility in Europe.
- The company anticipates a regulatory decision in the first half
of 2013.
DN24-02 IND Filing
- Dendreon filed an Investigational New Drug (IND) application in
December 2010 with the U.S. Food and
Drug Administration (FDA) for DN24-02 for the treatment of invasive
bladder cancer.
- The randomized Phase 2 study will evaluate the safety and
efficacy of DN24-02 in patients with HER2+ invasive transitional
cell carcinoma (TCC) of the bladder following cystectomy.
- The primary endpoint is to evaluate overall survival.
Approximately 180 patients will be enrolled at clinical sites
throughout the U.S.
Conference Call Information
Dendreon will host a conference call today at 6:00 a.m. PT, 9:00 a.m.
ET. To access the live call, dial 1-877-548-9590 (domestic)
or +1-720-545-0037 (international). The call will also be audio
webcast and will be available from the Company's website at
www.dendreon.com under the "Investor/Webcasts and Presentations"
section. A phone replay of the call will be available for 3 days by
calling 1-800-642-1687 (domestic) or +1-706-645-9291
(international); Passcode: 35063654.
PROVENGE Indication and Safety
PROVENGE® (sipuleucel-T) is an 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 Dendreon ON
Call at 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 http://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
progress on the commercialization efforts for 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