Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced a positive Type C meeting with the U.S.
Food and Drug Administration (“FDA”). Eagle and the FDA agreed on a
path forward to advance the clinical development of EA-114, an
estrogen receptor antagonist used in the treatment of breast cancer
in post-menopausal women. EA-114 has the potential to provide
healthcare providers with a formulation that meaningfully optimizes
the dosing regimen for all fulvestrant patients. Eagle currently
anticipates filing a new drug application (“NDA”) for EA-114 in
2024. If approved for all uses, EA-114 would allow physicians to
provide a personalized treatment regimen to all patients, including
specific sub-populations.
Over the course of five years and multiple
studies, Eagle has dosed more than 800 people with the brand
formulation of fulvestrant and multiple Eagle internally developed
formulations. The Company’s rigorous analysis of the data from
these studies yielded significant insights which led Eagle to
develop a novel formulation, EA-114, which if approved would
optimize the dosing regimen of fulvestrant to allow for a more
personalized treatment approach. EA-114 has the potential to
improve treatment for all fulvestrant patients, including multiple
subpopulations. These subpopulations collectively represent
approximately half of the total patient population. EA-114 may
additionally result in improved patient outcomes.
Eagle is committed to conducting the necessary
clinical program to support approval of this novel formulation of
fulvestrant. It is anticipated that EA-114 would be approved as a
monotherapy and for use in combination with CDK4/6 inhibitors as
described in the approved labeling for Faslodex®. According to
IQVIA, products anticipated to be co-administered with EA-114 have
had sales of $7 billion in the 12 months ending June 30th, 2023,
and grew by 27% over the prior 12-month period.1
Eagle anticipates filing the NDA in 2024 while
pursuing a label expansion for the subpopulations in parallel.
“We are very pleased that the Eagle team’s
perseverance, motivated by our desire to help breast cancer
patients, has resulted in this novel formulation. We anticipate
EA-114 being a very important part of a more personalized treatment
regimen for post-menopausal metastatic breast cancer patients,”
stated Scott Tarriff, President and Chief Executive Officer of
Eagle Pharmaceuticals. “Eagle is very proud that this development
program has been created in-house by the company’s formulation,
clinical, and regulatory teams. We believe EA-114 has the potential
to become an ever-increasing part of the personalized medicine
paradigm in cancer care,” concluded Tarriff.
Eagle continues to advance personalized medicine
in the oncology sector by working to bring critically needed novel
and complementary therapies to market. If approved, this will be
Eagle’s seventh internally developed NDA, highlighting the depth of
Eagle’s pipeline and its research and development capabilities in
the area of medical oncology.
Eagle has filed a patent application pertaining
to EA-114 and anticipates pursuing a robust patent portfolio over
time. The Company believes EA-114 is eligible for a
unique J-code from CMS under the current regulatory framework.
In addition, Eagle believes EA-114, if the label
expansion for subpopulations is approved, may be eligible
for a period of regulatory exclusivity of three years and
a separate period of potential patent protection, including
potential patents eligible for listing in the Orange Book.
Currently, fulvestrant is indicated as
monotherapy first-line endocrine treatment in post-menopausal women
with hormone receptor-positive metastatic breast cancer (MBC) and
in combination therapy to treat hormone receptor positive,
advanced breast cancer in women whose breast cancer has spread or
worsened after being treated with anti-estrogen medications.
Eagle intends to provide additional updates on
the progress of the EA-114 development program for the
sub-populations as discussions with the FDA progress.
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: the
Company’s ability to develop innovative medicines that address
unmet medical needs; the potential development of EA-114; the
Company’s expectations for the design and timing of clinical trials
and studies including with respect to enrollment, site selection,
data meetings with regulatory agencies, and the timing thereof; the
timing for filing a NDA for EA-114; the potential of EA-114 to
offer unique or meaningful therapeutic benefits to patients and
potentially improving the treatment regimen for patients, and
improving patient outcomes; the potential for regulatory
exclusivity; the potential for an approved label expansion for
subpopulations; the potential market size for EA-114 and potential
sales associated therewith; the potential for a unique J-Code from
CMS; and the Company’s expectation to pursue a robust patent
portfolio for EA-114, potential listing in the Orange Book and
protections associated therewith. 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 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.
PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan),
and BYFAVO® and BARHEMSYS® are trademarks of Eagle Pharmaceuticals,
Inc. All other trademarks are the property of their respective
owners.
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-Ward T:
817-807-8044 E: faith@eagleus.com
1 IQVIA SMART – US Edition Monthly.
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