SPI-2012 met the primary endpoint in a multicenter Phase 2 study
that evaluated the effectiveness and safety of SPI-2012 compared to a
standard dose of pegfilgrastim.
The Company plans to meet with the FDA to discuss its Phase 3
design before year-end and submit Phase 2 results for presentation at
a premier scientific conference in the first half of 2015.
The Company has identified more than 50 clinical sites for the
Phase 3 Trial.
SPI-2012 is a Long-Acting GCSF that utilizes a proprietary platform
technology of Hanmi Pharm. Co., LAPSCOVERY™, designed to maximize
pharmacological activity of GCSF.
The worldwide commercial opportunity for neutropenia treatments
totals over $6 billion.
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 Phase 3
Go/No-Go decision for SPI-2012, its long acting Granulocyte Stimulating
Factor (GCSF), and is planning for the start of Phase 3 clinical trials
"We are pleased with the Phase 2 results (N= 156) that we have seen and
have strong conviction that we can have a very exciting novel biologic
drug in this very large market," said Rajesh C. Shrotriya, MD, Chairman
and Chief Executive Officer of Spectrum Pharmaceuticals. "SPI-2012 is
built upon the 3rd generation LAPSCOVERY technology of Hanmi Pharm. Co.
that differentiates our drug from the existing drugs used to treat
neutropenia, and it could potentially have advantages relating to more
rapid and potent granulocyte (white blood cell) recovery compared to
pegylated filgrastim. SPI-2012 is one of the highest priorities at
Spectrum because of the value of this opportunity with its successful
commercialization. We will use the learnings from our Phase 2 enrollment
to accelerate Phase 3 enrollment and, if SPI-2012 is approved, use our
specialized commercial expertise to get this drug to market as soon as
possible. The decision to go into Phase 3 with SPI-2012 is a landmark
decision in Spectrum's history, and significantly enhances the future
growth prospects of the company."
Spectrum's Phase 2 trial was a multicenter, dose-ranging study that
evaluated the effectiveness and safety of SPI-2012 relative to a fixed,
standard dose of pegfilgrastim as a concurrent active control. The
primary objective and endpoint of this study was to assess the effect of
SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in
patients with breast cancer who received adjuvant or neoadjuvant
chemotherapy. Three doses of SPI-2012 were evaluated compared to
pegfilgrastim. The company plans to present results for presentation at
a premier scientific conference in the first half of 2015.
In January 2012, Spectrum entered into a co-development and
commercialization agreement with Hanmi Pharm. Co., Korea, gaining rights
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
five oncology drugs─ FUSILEV® (levoleucovorin) for Injection in the
U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.;
ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which
the Company has worldwide marketing rights; MARQIBO® (vinCRIStine
sulfate LIPOSOME injection) for intravenous infusion, for which the
Company has worldwide marketing rights and BELEODAQ™ (belinostat)
for Injection in the U.S. 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.
About Hanmi Pharm. Co., Ltd.
Hanmi Pharm. Co., Ltd. is a Korea-based pharmaceutical company focusing
on new drug development. It is a top R&D investor in the local
pharmaceutical industry by investing over 15% of its annual revenue in
the research and development. To date, the company has 23 global R&D
programs, consisting of (1) the novel long acting biologics based on
LAPSCOVERY™ platform including weekly Insulin, weekly to monthly GLP-1,
and their combination for diabetes and obesity (collectively referred as
Quantum Project); (2) the novel targeted anti-cancer drugs with improved
tolerance and safety profile; and (3) the incrementally modified drugs
and fixed-dosed combination drugs. Hanmi has been collaborating with
global companies on various co-development and business opportunities.
More information on Hanmi is available at www.hanmipharm.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®, ZEVALIN®, and
MARQIBO® are registered trademarks of Spectrum Pharmaceuticals, Inc and
its affiliates. BELEODAQ™, REDEFINING CANCER CARE™ and the
Spectrum Pharmaceuticals logos are trademarks owned by Spectrum
Pharmaceuticals, Inc. Any other trademarks are the property of
their respective owners.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Vice President, Strategic
Planning & Investor Relations
Source: Spectrum Pharmaceuticals
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