Eagle Pharmaceuticals Granted Patent for PEMFEXY®
October 24 2023 - 7:40AM
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that the U.S. Patent and Trademark
Office has granted the Company U.S. Patent No. 11,793,813 (“the
‘813 patent”) entitled “Pemetrexed Formulations.” Eagle has
submitted the patent for listing in the U.S. Food and Drug
Administration’s Orange Book.1 The ‘813 patent is directed to
pemetrexed formulations, including the FDA-approved commercial
formulation of PEMFEXY®.
The ‘813 patent will expire in 2036. This is the second patent
to be listed in the Orange Book for PEMFEXY, and to date Eagle has
not received any notice of a Paragraph IV certification for an
application referencing PEMFEXY.
“The issuance of this patent is meaningful, as we continue to
vigorously protect the commercial success of PEMFEXY and to add to
the overall strength of our patent portfolio. PEMFEXY maintains a
unique J-Code from CMS and sales remain strong, with a 24% share in
the commercial (non-340B) pemetrexed market leaving the third
quarter of 2023,” stated Scott Tarriff, President and Chief
Executive Office of Eagle.
About PEMFEXYPEMFEXY is a pemetrexed injection
ready-to-dilute formulation for locally advanced or metastatic
nonsquamous non-small cell lung cancer in combination with
cisplatin; locally advanced or metastatic nonsquamous non-small
cell lung cancer whose disease has not progressed after four cycles
of platinum-based first-line chemotherapy, as maintenance
treatment; locally advanced or metastatic nonsquamous non-small
cell lung cancer after prior chemotherapy as a single agent; and
malignant pleural mesothelioma whose disease is unresectable or who
are otherwise not candidates for curative surgery in combination
with cisplatin.About Eagle Pharmaceuticals, Inc.
Eagle is a fully integrated pharmaceutical company with research
and development, clinical, manufacturing and commercial expertise.
Eagle is committed to developing innovative medicines that result
in meaningful improvements in patients’ lives. Eagle’s
commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®,
BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS® through
its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and
CNS/metabolic critical care pipeline includes product candidates
with the potential to address underserved therapeutic areas across
multiple disease states, and the company is focused on developing
medicines with the potential to become part of the personalized
medicine paradigm in cancer care. Additional information is
available on Eagle’s website at www.eagleus.com.
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “could,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to:
statements regarding the Company’s expectations regarding the
patent portfolio for PEMFEXY; the listing of patents for PEMFEXY in
the FDA’s Orange Book; the maintenance of a unique J-Code with CMS;
and the sales of PEMFEXY and related market share. All
of such statements are subject to certain risks and uncertainties,
many of which are difficult to predict and generally beyond the
Company’s control, that could cause actual results to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. Such risks and
uncertainties include, but are not limited to: the impacts of the
post- COVID-19 environment and geopolitical factors such as the
conflict in Ukraine; delay in or failure to obtain regulatory
approval of the Company's or its partners’ product candidates and
successful compliance with FDA, European Medicines Agency and other
governmental regulations applicable to product approvals; changes
in the regulatory environment; the uncertainties and timing of the
regulatory approval process; whether the Company can successfully
market and commercialize its product candidates; the success of the
Company's relationships with its partners; the outcome of
litigation involving any of its products or that may have an impact
on any of its products; the strength and enforceability of the
Company’s intellectual property rights or the rights of third
parties; competition from other pharmaceutical and biotechnology
companies and the potential for competition from generic entrants
into the market; unexpected safety or efficacy data observed during
clinical trials; clinical trial site activation or enrollment rates
that are lower than expected; the risks inherent in drug
development and in conducting clinical trials; unanticipated
factors in addition to the foregoing that may impact the Company’s
financial and business projections and guidance and may cause the
Company’s actual results and outcomes to materially differ from its
projections and guidance; and those risks and uncertainties
identified in the “Risk Factors” sections of the Company's Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the Securities and Exchange Commission (the “SEC”) on March
23, 2023, the Company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, filed with the SEC on May 9, 2023,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2023, filed with the SEC on August 8, 2023 and its other
subsequent filings with the SEC. Readers are cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, the Company undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
1 Orange Book: Approved Drug Products with Therapeutic
Equivalence Evaluations (fda.gov)
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