Published: November 23, 2009
Spectrum Pharmaceuticals and Handok Pharmaceuticals Announce Collaboration Agreement for Apaziquone in South Korea
IRVINE, Calif. - (BUSINESS WIRE) - Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage
biotechnology company with a primary focus in oncology, and Handok
Pharmaceuticals Co., Ltd., a fully integrated Korean pharmaceutical
company, today announced a collaboration for the development and
commercialization of apaziquone in South Korea. Apaziquone is an
antineoplastic agent currently being investigated for the treatment of
non-muscle invasive bladder cancer by intravesical instillation.
Spectrum Pharmaceuticals has previously entered into a strategic
collaboration with Allergan, Inc. (NYSE: AGN) for North America, Europe,
and other key markets and Nippon Kayaku Co., Ltd. for Asian countries
excluding South Korea.
"This collaboration with Handok completes the Company's stated objective
of achieving solid strategic partnerships that are aimed at fully
exploiting developmental goals for apaziquone on a worldwide basis,"
said Rajesh C. Shrotriya, MD, Chairman of the Board, Chief Executive
Officer, and President of Spectrum Pharmaceuticals. "Handok
Pharmaceuticals is one of South Korea's most progressive pharmaceutical
companies and we are delighted to partner apaziquone with an established
Korean company."
"Apaziquone is a strategic fit for Handok," said Young-Jin Kim, Chief
Executive Officer and Chairman of Handok. "Urology is one
of the areas where we are trying to expand and we believe Spectrum's
apaziquone will strengthen our presence in the field. We look forward to
working with Spectrum in developing apaziquone for non-muscle invasive
bladder cancer in South Korea."
Under the terms of the agreement, Handok will pay Spectrum an upfront
payment and potential milestone payments totaling over $19MM. The
potential milestones will be based on the achievement of certain
regulatory and commercialization milestones. Handok received rights to
apaziquone for the treatment of non-muscle invasive bladder cancer in
South Korea. Handok will conduct the apaziquone clinical trials pursuant
to a development plan and will be responsible for all expenses relating
to the development and commercialization of apaziquone in South Korea.
Spectrum is currently conducting two Phase 3 clinical trials to
investigate apaziquone's safety and efficacy in non-muscle invasive
bladder cancer. Spectrum's goal is to complete enrollment in both Phase
3 studies by year-end 2009.
About Non-Muscle Invasive Bladder Cancer
Non-muscle invasive bladder cancer is a form of bladder cancer localized
in the surface layers of the bladder and is commonly treated with
intravesical therapies. Approximately 70% of all patients newly
diagnosed with bladder cancer have non-muscle invasive bladder cancer.1
More than one million patients in the United States, Europe and Japan
are estimated to be affected by the disease, which is treated
predominantly by urologists.2
About Apaziquone
Apaziquone, an anti-cancer agent that becomes activated by reductase
enzymes found in cancer cells, is formulated for administration directly
into the urinary bladder. Phase 2 data has confirmed anti-tumor activity
in patients with multiple, recurrent non-muscle invasive bladder cancer,
as evidenced by 31 of 46 patients (67%) showing a complete response
after receiving six weekly treatments with 4 mg of apaziquone instilled
into the urinary bladder in a marker lesion study. In another Phase 2
study, apaziquone instilled into the bladder following surgery was well
tolerated and was not absorbed in any detectable amount from the bladder
wall into the bloodstream and therefore, is expected to carry a low risk
of systemic toxicity, if any.
The apaziquone registration plan, which the U.S. Food and Drug
Administration (FDA) concurred with under a Special Protocol Assessment,
calls for two double blind, placebo-controlled, randomized Phase 3
clinical studies, each with 562 patients with Ta G1 or G2 low risk
non-invasive bladder cancer. Patients are randomized in a one-to-one
ratio to apaziquone or placebo. Under the protocol, the patients are
given a single 4 mg dose following surgical removal of the tumors. The
primary endpoint is a statistically significant difference (p<0.05) in
the rate of tumor recurrence between the two treatment groups by year
two. The FDA has granted Fast Track Designation for the investigation of
apaziquone for the treatment of non-muscle invasive bladder cancer.
Spectrum also received scientific advice from the European Medicines
Agency (EMEA) whereby the EMEA agreed that the two Phase 3 studies as
designed should be sufficient for a regulatory decision regarding
European registration.
About Handok Pharmaceuticals Co., LTD.
HANDOK Pharmaceuticals Co., Ltd., (002390 KS), based in Seoul, Korea, is
a company posting 275B KRW in pharmaceutical, diagnostic, and OTC sales
in 2008. HANDOK, founded in 1954, is the pharmaceutical company in Korea
with a distinguished and successful track record in various types of
strategic partnerships. HANDOK is known to have leading expertise in
various therapeutic categories including diabetes, CV, Urology and
respiratory system and is planning to expand into additional categories
such as oncology and CNS. HANDOK maintains a world class GMP
manufacturing facility and was the first local Korean company to
incorporate clinical research capabilities with medical directors on
staff. For more information, visit the HANDOK website at www.handok.co.kr/english.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company
with a primary focus in oncology. The Company's strategy is comprised of
acquiring and developing a broad and diverse pipeline of late-stage
clinical and commercial products; establishing a commercial organization
for its approved drugs; continuing to build a team with people who have
demonstrated skills, passion, commitment and have a track record of
success in its areas of focus; and, leveraging the expertise of partners
around the world to assist it in the execution of its strategy. For more
information, please visit the Company's website at www.sppirx.com.
Forward Looking Statements - This press release may also 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 include but are not limited to statements that relate
to Spectrum's business and its future, Spectrum's ability to identify,
acquire, develop and commercialize a broad and diverse pipeline of
late-stage clinical and commercial products, establishing a commercial
organization for Spectrum's approved drugs, continuing to build
Spectrum's team, leveraging the expertise of partners around the world
to assist Spectrum in the execution of its strategy, the safety and
efficacy of apaziquone, that enrollment will be completed by year-end
2009, that apaziquone is expected to carry a low risk of systemic
toxicity, if any 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 Spectrum's existing and new drug
candidates may not prove safe or effective, the possibility that
Spectrum's existing and new drug candidates may not receive approval
from the FDA, and other regulatory agencies in a timely manner or at
all, the possibility that Spectrum's existing and new drug candidates,
if approved, may not be more effective, safer or more cost efficient
than competing drugs, the possibility that Spectrum's efforts to acquire
or in-license and develop additional drug candidates may fail,
Spectrum's lack of revenues, limited marketing experience, dependence on
third parties for clinical trials, manufacturing, distribution and
quality control and other risks that are described in further detail in
Spectrum's reports filed with the Securities and Exchange Commission.
Spectrum does 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.
Information regarding Handok Pharmaceuticals has been obtained from
Handok Pharmaceuticals and not independently verified by Spectrum.
SPECTRUM PHARMACEUTICALS, INC. is a registered trademark of
Spectrum, TURNING INSIGHTS INTO HOPE and the Spectrum Pharmaceutical
logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
(c) 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
1 Kirkali Z, et al. Bladder Cancer: Epidemiology,
Staging and Grading, and Diagnosis. Urology 66 (Suppl 6A): 4-34,
2005.
2 For U.S. see National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/statfacts/html/urinb.html
accessed 10-23-2008; For Europe see Globocan 2002 database, http://www-dep.iarc.fr/
accessed 10-23-2008.
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager,
Investor Relations
949-788-6700x216
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