Spectrum Pharmaceuticals In-Licenses a Novel, Long-Acting GCSF Drug in U.S. Clinical Trials from Hanmi Pharmaceuticals
SPI-2012, Spectrum's Third Biological Drug, Is a Long-Acting GCSF
That Utilizes Hanmi's Proprietary Platform Technology, LAPSCOVERY™;
SPI-2012 Could Have Potential Advantages for More Rapid and
Profound Granulocyte Recovery in Patients with Chemotherapy Induced
Neutropenia, A Multibillion Dollar Worldwide Market;
In a U.S. Based Phase 1 Study in Healthy Volunteers, SPI-2012
Demonstrated Activity Similar to Neulasta®
(pegfilgrastim) at One-Third the Dose;
Spectrum Expects to Initiate Phase 2 Trials In Collaboration
With Hanmi in 2012;
If SPI-2012 is Ultimately Commercialized, Spectrum Shall Own
Worldwide Rights Except For Korea, China, and Japan.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced that it has entered
into a co-development and commercialization agreement with Hanmi
Pharmaceutical Company for SPI-2012 (formerly known as "LAPS-GCSF"), a
drug for the treatment of chemotherapy induced neutropenia based on
Hanmi's proprietary LAPSCOVERY™ Technology.
Granulocyte colony-stimulating factor (GCSF) stimulates the production
of white blood cells by the bone marrow. A recombinant form of GCSF is
used in appropriate cancer patients to accelerate recovery from
neutropenia after chemotherapy, allowing higher-intensity treatment
regimens to be given at full-dose and on schedule. Chemotherapy can
cause myelosuppression and unacceptably low levels of white blood cells,
making patients prone to infections, hospitalizations, and interruption
of additional chemotherapy treatments. The worldwide market for
GCSF-related drugs was over $5 billion in 2011.
LAPSCOVERY™ (Long Acting
is a platform technology that can be applied to various molecules
including glycosylated proteins, modified or artificial peptides with
unnatural amino acid sequences. LAPSCOVERY™ can select the optimal
conjugation sites from the proteins or peptides to minimize the
structural hindrance and maximize the pharmacological activity.
"We were very impressed by Hanmi's platform technology and are delighted
to add SPI-2012, our third biologic drug, to our mid-stage pipeline,"
said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and
President of Spectrum Pharmaceuticals. "Early evidence suggests that
there could be advantages of SPI-2012 over currently approved therapies
in increasing the rate and intensity of neutrophil recovery. We believe
this agreement is consistent with our strategy of acquiring promising
drug candidates at reasonable upfront and developmental costs, while
maintaining significant economics for our shareholders in the long-term."
"Spectrum Pharmaceuticals has a proven history in in-licensing,
developing and commercializing drugs. As a result, we expect this
collaboration to help significantly advance SPI-2012 through the
clinical and regulatory pathways, and commercial success," said Dr.
Gwan-Sun Lee, Chief Executive Officer and President of Hanmi
About Hanmi Pharmaceuticals
Established in 1973, Hanmi Pharmaceutical has now become the 2nd largest
Korean pharmaceutical company with sales up to $558 million in 2008.
Hanmi Pharmaceutical was successful in developing competitive products
through ‘First Generic → IMD (Incrementally Modified Drug) → New drug'
Korean type R&D strategy. By investing the cash from this success into
new product development, Hanmi was able to become a competitive
pharmaceutical company in the global market. While other Korean
pharmaceutical companies focused only on in-licensing products from
foreign companies, Hanmi concentrated on developing domestic products
through in-house API synthesis. This allowed Hanmi to be successful in
developing the competitive modifying technology.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus
in oncology and hematology, currently markets two oncology drugs, FUSILEV®
(levoleucovorin) for Injection and ZEVALIN®(ibritumomab
tiuxetan) Injection for intravenous use. In addition, Spectrum has two
drugs, apaziquone and belinostat, in late stage development with a goal
of filing New Drug Applications (NDAs) with the U.S. Food & Drug
Administration in 2012. The Company also has a diversified pipeline of
novel drug candidates. The Company's strategy is comprised of acquiring,
developing and commercializing a broad and diverse pipeline of
late-stage clinical and commercial drug products. The Company has
aggressive business development and commercial operation teams that
support a robust drug development program encompassing clinical
development, medical research, regulatory affairs, biostatistics and
data management. The Company also leverages the expertise of its
worldwide partners to assist in the execution of its strategy. For more
information, please visit the Company's website at www.sppirx.com.
Neulasta® is a registered trademark of Amgen Inc.
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 may not receive approval, and other regulatory
agencies 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.®, ZEVALIN®,
and FUSILEV® are registered trademarks of
Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the
Spectrum Pharmaceutical logos are trademarks owned by Spectrum
© 2012 Spectrum Pharmaceuticals, Inc. All Rights
Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Senior Manager, Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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