Dendreon Sells New Jersey Immunotherapy Manufacturing Facility
BRIDGEWATER, N.J.--(BUSINESS WIRE)--
Dendreon Corporation (NASDAQ: DNDN) today announced the sale of its
immunotherapy manufacturing facility (IMF) based in Morris Plains, New
Jersey, to Novartis Pharmaceuticals Corporation for $43 million in cash.
"This agreement represents a positive outcome for Dendreon, our
shareholders and New Jersey," said John H. Johnson, chairman, president
and chief executive officer of Dendreon. "Dendreon continues to make
progress in improving our financial strength, and this transaction is
aligned with that goal as we work to build value for our shareholders.
We are also pleased that approximately 100 of the existing employees at
the facility will have the opportunity to retain their jobs and work for
Novartis as the company builds out its immunotherapy operations and
develops new treatments for patients."
Dendreon's Morris Plains, New Jersey, facility is a 173,100 square foot
state-of-the-art IMF, featuring revolutionary capabilities to
manufacture PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy to receive U.S. Food and Drug Administration approval for
the treatment of asymptomatic or minimally symptomatic metastatic
castrate resistant prostate cancer. Earlier this year, Dendreon
announced its intent to wind down the manufacturing of PROVENGE® at the
Morris Plains facility in conjunction with a strategic restructuring
plan designed to accelerate the Company's path to profitability and
future growth.
"Activated Cellular Immunotherapy offers the potential to treat a
variety of diseases in a revolutionary way. We are pleased that Novartis
has selected our facility to advance and accelerate their work in this
exciting and emerging field," said Christine Mikail, executive vice
president, corporate development at Dendreon.
About PROVENGE®
PROVENGE® Indication and Important Safety
Information
PROVENGE® is an autologous cellular immunotherapy indicated
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. 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.
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 1500 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 http://www.provenge.com
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.
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
profitability and Dendreon's ability to achieve improved performance as
a result of the restructuring, expectations regarding regulatory
approval of PROVENGE in Europe, expectations regarding the presentation
of clinical data, developments affecting Dendreon's business and
prospects and potential revenue and earnings from product sales, 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 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, 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; and other
factors discussed in the "Risk Factors" section of Dendreon's Quarterly
Report on Form 10-Q for the quarter ended September 30, 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 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
media@dendreon.com
or
Joele
Frank, Wilkinson Brimmer Katcher
Investor Relations
Andrea
Rose, 212-355-4449
InvestorRelations@dendreon.com
Source: Dendreon Corporation
News Provided by Acquire Media
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