HENDERSON, Nev.--(BUSINESS WIRE)--May 1, 2018--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced it has entered
into an agreement with Thermo Fisher Scientific to leverage the
Oncomine™ Dx Target Test as a companion diagnostic for Spectrum’s novel
pan-HER inhibitor, poziotinib, which is in development for the treatment
of non-small lung cancer (NSCLC) patients with EGFR and HER2 exon 20
insertion mutations.
“Spectrum is committed to precision medicine for unmet medical needs in
oncology,” said Tom Riga, Executive Vice President, Chief Operating and
Commercial Officer of Spectrum Pharmaceuticals. “Thermo Fisher pioneered
next-generation sequencing as the first multi-drug companion diagnostic
for patients with non-small cell lung cancer when Oncomine™ Dx Target
Test received premarket approval by the FDA in June 2017. Therefore, we
believe Thermo Fisher will be an outstanding partner to help us advance
the development of poziotinib. As promising clinical data continue to
emerge with poziotinib for the treatment of patients with EGFR and HER2
exon 20 insertion mutations, the expansion of Oncomine™ Dx Target Test
will aid in faster detection and future treatment of patients who are
not well-served by currently available therapies.”
Oncomine Dx Target Test is FDA approved to simultaneously report 23
genes clinically associated with NSCLC. Of those 23, three contain
markers that are approved for use as companion diagnostics, enabling
physicians to match patients to three FDA-approved therapies in days
instead of weeks. The test uses Thermo Fisher’s proprietary Ion PGM Dx
sequencing platform to interrogate patient samples with high
reproducibility and rapid turnaround times, even when limited tumor
tissue is available.
Under the terms of the collaboration agreement, the goal of the expanded
use of the Oncomine™ Dx Target Test is to identify NSCLC patients with
EGFR or HER2 exon 20 insertion mutations who may be candidates for
treatment with poziotinib in Spectrum’s global territories.
“We are pleased to partner with Spectrum Pharmaceuticals to help advance
its drug development program and expand the clinical utility of Oncomine
Dx Target Test,” said Joydeep Goswami, president of Clinical
Next-Generation Sequencing and Oncology at Thermo Fisher Scientific. “We
remain committed to help drive better health outcomes for patients who
can benefit from targeted therapies more quickly.”
About Poziotinib
Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase
Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR
as well as HER2 and HER4. Importantly this, in turn, leads to the
inhibition of the proliferation of tumor cells that overexpress these
receptors. Mutations or overexpression/amplification of EGFR family
receptors have been associated with a number of different cancers,
including non-small cell lung cancer (NSCLC), breast cancer, and gastric
cancer. Spectrum received exclusive license to develop, manufacture, and
commercialize worldwide excluding Korea and China from Hanmi
Pharmaceuticals. Poziotinib is currently being investigated by Spectrum
and Hanmi in several mid-stage trials in multiple solid tumor
indications.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in Hematology and Oncology. Spectrum currently markets six
hematology/oncology drugs, and has an advanced stage pipeline that has
the potential to transform the company. Spectrum's strong track record
for 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 Spectrum’s 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, the timing and results of FDA decisions, 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 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 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.The company does not plan to
update any such forward-looking statements and expressly disclaims any
duty to update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a
registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate.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.
© 2018 Spectrum Pharmaceuticals, Inc.All Rights Reserved

View source version on businesswire.com: https://www.businesswire.com/news/home/20180501005455/en/
Source: Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice
President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com