Based on communication with the FDA, Spectrum anticipates an
Advisory Committee meeting to review a potential NDA for apaziquone.
The Company expects to file an NDA, which Spectrum will seek to
expedite as part of a plan to achieve potential commercialization of
apaziquone in key markets.
Apaziquone is in development to treat non-muscle invasive bladder
cancer (NIMBC) as a single instillation following transurethral
resection of bladder tumor (TURBT).
Approximately 70% of all patients with newly diagnosed bladder
cancer have NMIBC, and yet there are no FDA-approved agents for post
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced the Company
has reacquired development and commercialization rights for apaziquone
in the United States, Europe and other territories pursuant to an
agreed-upon restructuring of Spectrum's collaboration with Allergan,
Inc. In exchange, Allergan will receive a royalty on future revenue.
Apaziquone is an anticancer agent being developed for the treatment of
non-muscle invasive bladder cancer (NIMBC) as a single instillation
following transurethral resection of bladder tumor (TURBT).
Spectrum also announced that a scheduled meeting with the U.S. Food &
Drug Administration (FDA) was held last month to discuss the results
from the Company's Phase 3 clinical trials. Based on the discussions
with the FDA, Spectrum understands that the FDA can accept the NDA
filing with the current Phase III data and will likely convene an
Advisory Committee meeting. Further, based on discussions with the FDA,
Spectrum has agreed to conduct one additional Phase III study following
consultation with the FDA on its design.
"Regaining apaziquone rights will enable Spectrum to take the steps we
believe are essential to advancing apaziquone toward commercialization
in the U.S., Europe and other key territories," stated Rajesh C.
Shrotriya, M.D., Chairman, President and Chief Executive Officer of
Spectrum Pharmaceuticals, Inc. "Spectrum is committed to expediting our
program for apaziquone, with the goal of accelerating potential
registration and integrating apaziquone into our plan to expand our
footprint in the U.S. and build our presence in the EU. Spectrum is
grateful to the FDA for its thoughtful feedback on the apaziquone
clinical program. We believe there continues to be a significant unmet
need as no drugs have been approved and marketed in the U.S. for more
than 20 years for low-grade NMIBC."
Apaziquone is an anticancer drug that requires activation by
bio-reductive enzymes that are over-expressed in bladder cancer cells,
to render it a cytotoxic alkylating agent. Spectrum conducted two
multi-center, international Phase 3 trials of a single dose of
intravesical instillation of apaziquone into the bladder in the
immediate post-operative period after surgical resection of low-grade,
non-muscle invasive bladder tumors. In April 2012, Spectrum announced
that the Phase 3 trials did not meet their primary endpoint of a
statistically significant difference in the rate of tumor recurrence at
2 years between treatment and placebo arms. However, analysis of the
pooled data from both studies showed a statistically significant
treatment effect in favor of apaziquone in the primary endpoint of the
rate of tumor recurrence at 2 years (p-value = 0.0174) and in a key
secondary endpoint, time to recurrence (p-value = 0.0076).
NMIBC is a form of bladder cancer localized in the surface layers of the
bladder that has not spread to the deeper muscle layer. Approximately
70% of all patients newly diagnosed with bladder cancer have NMIBC. More
than one million patients in the U.S. and Europe are estimated to be
affected by the disease, which is treated predominantly by urologists.
Professional urology associations and NCCN Guidelines recommend
instillation of a cytotoxic agent following transurethral resection of
bladder tumor (TURBT) for NMIBC. However, in the US, there are no
FDA-approved agents for this indication.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in oncology and hematology. Spectrum and its affiliates market
three oncology drugs ─ FUSILEV® (levoleucovorin) for
Injection in the U.S.; FOLOTYN® (pralatrexate injection),
also marketed in the U.S.; and ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights. Spectrum's strong track record in
in-licensing and acquiring differentiated drugs, and expertise in
clinical development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase 3
studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including certain
company milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, leveraging the expertise of partners and employees
around the world to assist us in the execution of our strategy, and any
statements that relate to the intent, belief, plans or expectations of
Spectrum or its management, or that are not a statement of historical
fact. Risks that could cause actual results to differ include the
possibility that our existing and new drug candidates may not prove safe
or effective, the possibility that our existing and new applications to
the FDA and other regulatory agencies may not receive approval in a
timely manner or at all, the possibility that our existing and new drug
candidates, if approved, may not be more effective, safer or more cost
efficient than competing drugs, the possibility that our efforts to
acquire or in-license and develop additional drug candidates may fail,
our lack of sustained revenue history, our limited marketing experience,
our dependence on third parties for clinical trials, manufacturing,
distribution and quality control and other risks that are described in
further detail in the Company's reports filed with the Securities and
Exchange Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the information
contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®,
FOLOTYN®, and ZEVALIN®
are registered trademarks of Spectrum Pharmaceuticals, Inc and its
affiliates. REDEFINING CANCER CARE™ and
the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum
© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
President, Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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