Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY® in Combination with Pembrolizumab and Platinum Chemotherapy
December 19 2022 - 6:50AM
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) announced today that the U.S. Food and Drug
Administration (“FDA”) has approved an additional indication for
PEMFEXY® (pemetrexed injection) in combination with pembrolizumab
and platinum chemotherapy for the initial treatment of patients
with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”)
with no EGFR or ALK genomic tumor aberrations. Eagle’s approved
PEMFEXY (pemetrexed injection) is a ready-to-dilute (“RTD”) novel
liquid intravenous formulation developed to eliminate the
reconstitution step of the Listed Drug (“LD”), ALIMTA®.
“With this fifth indication, PEMFEXY is now approved for all of
the same indications as ALIMTA, and we believe it allows for key
advantages such as eliminating the need for reconstitution. Since
its initial launch in February 2022, PEMFEXY has been an important
addition to Eagle’s hospital and acute care product portfolio, and
we are pleased to bring this treatment option to patients
undergoing chemotherapy. At the same time, we also believe that
Eagle is well positioned to capture the commercial opportunity that
PEMFEXY represents,” stated Scott Tarriff, President and Chief
Executive Officer of Eagle Pharmaceuticals.
Effective October 1, 2022, the Company amended its agreement to
reduce future royalties related to PEMFEXY profits from 25% to a
range of 0% to 12.5% based on aggregate profits achieved in
exchange for a one-time payment of $15 million.
In February 2020, Eagle received approval from the FDA of its
New Drug Application for PEMFEXY, following the settlement
agreement of patent litigation with Eli Lilly and Company (NYSE:
LLY) in December 2019. The agreement provided for a release of all
claims by the parties and allowed for an initial entry of PEMFEXY
into the market (equivalent to approximately a three-week supply of
current ALIMTA utilization) on February 1, 2022, and a subsequent
uncapped entry on April 1, 2022.
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,”
“future,” “belief,” “guidance,” “opportunity,” “advantages,” and
similar expressions are intended to identify forward-looking
statements. These statements include, but are not limited to, the
commercial potential of PEMFEXY and Eagle’s ability to capture its
commercial opportunity; future profits and royalties related to
PEMFEXY sales; and the potential of Eagle’s products candidates to
address underserved therapeutic areas across multiple disease
states. 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;
whether the Company will incur unforeseen expenses or liabilities
or other market factors; 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; whether
the Company will successfully implement its development plan for
its product candidates, including its fulvestrant product; 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; successful
compliance with the FDA and other governmental regulations
applicable to product approvals, manufacturing facilities, products
and/or businesses; general economic conditions, including the
potential adverse effects of public health issues, including the
COVID-19 pandemic, on economic activity and the performance of the
financial markets generally; 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; the risks inherent in drug development and in
conducting clinical trials; and those risks and uncertainties
identified in the “Risk Factors” section 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 quarters
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,
filed with the SEC on August 9, 2022, 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
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