Eagle Pharmaceuticals Provides Update on Bendamustine Intellectual Property Portfolio
January 18 2024 - 6:50AM
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today provided an update on its bendamustine
intellectual property portfolio.
On January 16, 2024, the United States Court of Appeals for the
Federal Circuit affirmed the previously announced decision by the
United States District Court for the District of Delaware finding
that the 505(b)(2) drug applications referencing BELRAPZO® filed by
Slayback Pharma Limited Liability Company (“Slayback”)1 and Apotex
Inc. and Apotex Corp. (“Apotex”) did not infringe Eagle’s
previously issued ‘483 patent. Slayback, Apotex, and Baxter
Healthcare Corporation (“Baxter”) launched their respective
products in December of 2022.
Eagle is also announcing that the U.S. Patent and Trademark
Office has granted U.S. Patent Nos. 11844783 (the “‘783 patent”)
and 11872214 (the “‘214 patent”) covering Eagle’s innovative
bendamustine liquid formulations. The patents are listed in the
Orange Book for both BENDEKA® and BELRAPZO.
On January 17, 2024, Eagle filed lawsuits asserting that
505(b)(2) products referencing BELRAPZO marketed by Slayback,
Apotex, and Baxter each infringe one or more claims of the newly
issued ‘783 and ‘214 patents and requesting damages for any
infringing sales of the parties’ respective accused products. Eagle
intends to seek lost profits and other damages from any and all
infringing sales of the defendants’ bendamustine products, as well
as injunctive relief requiring the defendants to cease all sales of
their infringing products until the expiration of the patents in
2031.
“We are pleased to maximize our intellectual property for the
bendamustine franchise and will continue to take appropriate steps
to enforce our rights related to the newly issued patents,” stated
Michael Graves, Interim Principal Executive Officer and Interim
Executive Chairman of the Board of Eagle.
Eagle cannot predict the timing or ultimate outcome of the
litigation described above or the impact of this litigation on its
business. In addition, Eagle made the allegations described above
based only on information currently known to it. These allegations
have not been fully litigated and the information and assumptions
underlying these allegations may change after the date of hereof.
Moreover, notwithstanding Eagle's allegations and its views on the
merits of this litigation, litigation is inherently uncertain and
there can be no guarantee that the court will agree with Eagle's
allegations or interpretation of applicable regulations or laws, or
that Eagle will otherwise prevail in this litigation. Accordingly,
the allegations described above are not intended to be statements
of fact to be relied upon by Eagle's shareholders or potential
investors.
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 StatementsThis 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,”
“intend,” “remain,” “potential,” “prepare,” “expected,” “believe,”
“plan,” “seek,” “continue,” “estimate,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to: the
Company’s expectations relating to BENDEKA and BELRAPZO, including
related litigation, including the Company's allegations with
respect to infringement of its '783 and '214 patents and potential
damages related thereto and the Company’s expectations with respect
to enforcement of its intellectual property rights; the issuance
and listing of patents for BENDEKA and BELRAPZO in the FDA’s Orange
Book and related consequences therefrom; the Company’s ability to
develop innovative medicines that result in meaningful improvements
in patients’ lives; the ability of the Company’s products and
product candidates to address underserved therapeutic areas across
multiple disease states; and the Company’s ability to develop
medicines with the potential to become part of the personalized
medicine paradigm in cancer care. All 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 completion of the review and preparation of the
Company’s financial statements and internal control over financial
reporting and disclosure controls and procedures and the timing
thereof; the discovery of additional information; further delays in
the Company’s financial reporting, including as a result of
unanticipated factors; the Company’s ability to comply with its
obligations under its credit agreement; the possibility that the
Company will be unable to regain compliance with, or thereafter
continue to comply with, the Nasdaq Listing Rules, or experience
violations of additional Nasdaq Listing Rules; the possibility that
the Nasdaq may delist the Company’s securities; the Company’s
ability to remediate material weaknesses in its internal control
over financial reporting; the Company’s ability to recruit and hire
a new Chief Executive Officer; the impacts of the post- COVID-19
environment and geopolitical factors such as the conflicts between
Russia and Ukraine and Gaza and Israel; delay in or failure to
obtain regulatory approval of the Company’s or its partners’
product candidates and successful compliance with Federal Drug
Administration, 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 products; the success of the Company's
relationships with its partners; the outcome of litigation; 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 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; risks inherent in estimates or judgments relating to the
Company’s critical accounting policies, or any of the Company’s
estimates or projections, which may prove to be inaccurate;
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 estimates, 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
Reports on Form 10-Q for the quarter ended March 31, 2023, filed
with the SEC on May 9, 2023, and 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 On September 27, 2023,
Azurity Pharmaceuticals acquired Slayback Pharma.
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