Spectrum Pharmaceuticals Makes Decision to Advance SPI-2012, a Novel Long-Acting GCSF, to Phase 3 Due to Positive Phase 2 Res...
September 09 2014 - 7:00AM
Business Wire
- 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.
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 next year.
“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 for SPI-2012.
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.
Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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