Eagle Pharmaceuticals Reaches Settlement Agreement with Accord Healthcare, Inc. Related to BENDEKA® (bendamustine hydrochloride)
December 12 2022 - 6:50AM
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that it has reached a settlement
agreement with Accord Healthcare, Inc. (“Accord”). Eagle had
asserted its Orange Book-listed patents against Accord related to
Accord’s new drug application (“NDA”) referencing BENDEKA®. The
settlement agreement provides that Accord has the right to market
its product beginning January 17, 2028, or earlier based on certain
circumstances. The settlement agreement is confidential and subject
to review by the U.S. Federal Trade Commission and the U.S.
Department of Justice.
The settlement with Accord follows Eagle’s previously announced
settlement with Hospira, Inc. (“Hospira”) regarding two Orange
Book-listed patents, which granted Hospira the right to market its
product beginning January 17, 2028, or earlier based on certain
circumstances.
“We are pleased with the settlement. Eagle intends to continue
to expand and vigorously enforce its intellectual property rights
around BENDEKA and our bendamustine franchise,” stated Scott
Tarriff, President and Chief Executive Officer of Eagle.
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 vasopressin, 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. 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,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” “opportunity,” “estimate,” and
similar expressions are intended to identify forward-looking
statements. These statements include, but are not limited to,
statements regarding future events such as: the resolution of
patent litigation and all related settlement terms, including dates
of market entry and the potential for earlier market entry under
certain circumstances and submission of the settlement agreement to
the U.S. Federal Trade Commission and the U.S. Department of
Justice for review; the strength of the Company’s intellectual
property rights for BENDEKA and BELRAPZO; and the expected
expansion, defense and enforcement of intellectual property rights.
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
ongoing COVID-19 pandemic, including interruptions or other adverse
effects on clinical trials and delays in regulatory review or
further disruption or delay of any pending or future litigation;
delay in or failure to obtain regulatory approval of the Company's
product candidates and successful compliance with FDA, European
Medicines Agency and other governmental regulations applicable to
product approvals; 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; the risks inherent in drug
development and in conducting clinical trials; 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, 2021, filed with the Securities and Exchange Commission (the
“SEC”) on March 8, 2022, the Company’s Quarterly Reports on Form
10-Q for the quarter ended March 31, 2022, June 30, 2022 and
September 30, 2022, filed with the SEC on May 9, 2022, August 9,
2022, and November 9, 2022, respectively, 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: 212-452-2793E:
lwilson@insitecony.com
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