Spectrum Pharmaceuticals Settles FOLOTYN® (pralatrexate injection) ANDA Patent Litigation

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 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