Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that the U.S. Food and Drug
Administration (FDA) has granted Qualified Infectious Disease
Product (QIDP) Designation under the Generating Antibiotic
Incentives Now (GAIN) Act and Fast Track Designation for CAL02, a
first-in-class non-biological bacterial virulence neutralizer,
anti-infective agent being developed to treat severe
community-acquired bacterial pneumonia (SCABP) as an add-on therapy
to standard of care.
“Receiving QIDP designation underscores the importance of CAL02
for potentially treating SCABP, and the Fast Track Designation
allows us to work even closer with the FDA to bring patients a new
treatment option sooner as we would also be eligible to request
Priority Review for our application. Antibiotics alone,
unfortunately, cannot win the war against pneumonia. CAL02 would
serve as an add-on to standard of care antibiotic therapy for the
prompt treatment of severe bacterial pneumonia and its devastating
consequences. In an era of increasing resistance to standard
therapies, CAL02 represents a potential resistance-free empiric
therapy to protect organs and prevent pro-inflammatory cascades
leading to severe and fatal outcomes. This treatment could
represent a true paradigm shift and offer healthcare providers
another option in combating this complex disease,” stated Scott
Tarriff, President and Chief Executive Officer of Eagle
Pharmaceuticals. “Eagle believes that CAL02 is the first potential
therapy engineered to neutralize a broad range of bacterial toxins
for SCABP to receive QIDP designation, and we look forward to
providing updates as CAL02 advances through the clinical
program.”
The QIDP designation was created by the GAIN Act implemented in
2012 to encourage the development of treatments for
antibiotic-resistant organisms known to cause serious or
life-threatening infections.
Eagle believes that CAL02 could also be eligible for
breakthrough therapy designation.
Eagle is also further developing the patent estate to protect
the intellectual property resulting from the development of this
novel, first-in-class therapy. CAL02 is currently protected by
issued U.S. Patent No.10,744,089, which extends until September
2035, and may be eligible for Patent Term Extension for up to five
years until 2040. CAL02 is also protected by granted counterparts
in important markets globally, e.g., Europe and Japan. In addition,
CAL02 and its uses are the subject of pending patent families as
reflected in published applications WO2017216282, WO2018158375,
WO2019201937, WO2019202101, US2023/0028179, US2021/0275452,
US2021/0030677, US2021/0259967, and other families under
development. These families would provide patent term until
approximately 2037 or later.
SCABP is a worldwide prevalent infectious disease associated
with high morbidity and mortality, despite the availability of
vaccines, effective antibiotic regimens, and state-of-the-art
critical care therapy. CAL02 is a novel first-in-class
broad-spectrum anti-virulence agent being developed as an add-on to
standard of care treatment of SCABP. CAL02 consists of proprietary,
engineered liposomes that capture and neutralize bacterial
toxins known to dysregulate inflammation, cause organ damage, and
impede immune defense. A Phase 1 safety and tolerability trial in
SCABP patients was successfully completed, in which encouraging
trends for efficacy were observed. The results were published in
The Lancet Infectious Diseases, where accompanying comments
characterized CAL02 as “One step closer to precision medicine for
infectious diseases,” describing the study as a “medical
breakthrough.”
About the Phase 2 CAL02 StudyA Phase 2
adaptive, randomized, double-blind, placebo-controlled study is
underway, designed to assess the efficacy and safety of CAL02
administered intravenously in addition to standard of care in
patients with severe community-acquired bacterial pneumonia
(SCABP). The study plans to enroll approximately 276 patients with
SCABP worldwide. Additional details are available on
ClinicalTrials.gov (Identifier: NCT05776004).
About CAL02 CAL02 is an investigational,
innovative, first-in-class anti-infective agent that acts as a
competitive decoy, or lure, for bacterial virulence factors, which
contribute to infection-related complications, sepsis, septic
shock, and death. CAL02 consists of proprietary liposomes
engineered to capture the virulence factors produced by a broad
range of Gram-positive and Gram-negative bacteria causing severe
infectious diseases, including severe pneumonia. CAL02 is poised to
play a key role in the fight against anti-microbial resistance. Its
action is complementary to that of antibiotics, and it does not
appear to exert any selective pressure, which can contribute to
antibiotic resistance. Because of these characteristics, CAL02
could be administered empirically in combination with standard of
care as soon as patients show signs of severe pneumonia. Clinical
results to date underscore the potential of CAL02 to transform the
standard of care and to dramatically reduce the time and the cost
of care for millions of critically ill SCABP patients. Eagle has a
worldwide exclusive license on CAL02 acquired from Combioxin
SA.
About Virulence FactorsVirulence is a
bacteria’s ability to infect a host and produce disease. Virulence
factors are produced by a variety of pathogens and assist in
potentiating infection, evading and suppressing the immune system,
and damaging host cells, including immune cells, and organs.
Blocking the activities of virulence factors is a new approach that
has emerged over the last decade.1 Anti-virulence drugs, a new
class of drugs, target virulence factors of pathogens, effectively
disarming infectious pathogens.
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. 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
regarding the Company’s expectations for the design and timing of
the planned Phase 2 study, including with respect to enrollment and
site selection and the timing thereof; statements regarding the
potential of CAL02 to be a medical breakthrough and offer unique or
meaningful therapeutic benefits to seriously ill patients,
potentially improving the treatment regimen for patients with
severe community-acquired pneumonia, shortening the duration of
illness and improving patient outcomes; statements regarding
potential regulatory exclusivity, CAL02’s potential eligibility for
fast track and breakthrough therapy designations and the potential
for a CAL02 new drug application for the treatment of SCABP to
qualify for priority review; statements regarding the Company’s
expectation to strengthen the patent portfolio for CAL02; and the
potential of the Company’s pipeline and product 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;
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, 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 quarters ended March 31, 2023, filed with the SEC on
May 9, 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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9719373/#:~:text=Blocking%20the%20activities%20of%20virulence,and%20consequently%20disarm%20infectious%20pathogens
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