Spectrum Pharmaceuticals Settles FOLOTYN® (pralatrexate injection) ANDA Patent Litigation
July 13 2016 - 7:00AM
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 that it has settled its ANDA patent
litigation relating to FOLOTYN. As a result of the settlement with
the last remaining ANDA filer, Fresenius Kabi USA, LLC, and the
previously reported settlements with Teva Pharmaceuticals USA,
Inc., Dr. Reddy’s Laboratories, Ltd. & Dr. Reddy’s
Laboratories, Inc. and Sandoz Inc., absent certain circumstances,
generic versions of FOLOTYN will not be permitted to be marketed in
the United States until November 15, 2022. The Company will submit
the settlement agreement to the Federal Trade Commission and the
Department of Justice. Details of the settlement are
confidential.
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 expects
an FDA decision on another drug in the second half of
2016. Additionally, Spectrum’s pipeline includes three drugs in
advanced stages of clinical development that management believes
have 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 contains
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 regarding the anticipated results of the settlements and
litigation, 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 whether the court
approves the dismissal of the litigation, governmental review of
the settlement agreements, potential future challenges from generic
companies, 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.® and FOLOTYN® are registered
trademarks of Spectrum Pharmaceuticals, Inc and its affiliate.
REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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version on businesswire.com: http://www.businesswire.com/news/home/20160713005453/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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