Eagle Pharmaceuticals Announces FDA Acceptance of Investigational New Drug Application for CAL02, a Novel First-in-Class Broad-Spectrum Anti-Virulence Agent for the Adjunct Treatment of Severe Community-Acquired Bacterial Pneumonia
November 14 2022 - 6:50AM
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) announced today that the U.S. Food and Drug
Administration (“FDA”) has accepted its investigational new drug
(“IND”) application for CAL02, a novel first-in-class
broad-spectrum anti-virulence agent for the adjunct treatment of
severe community-acquired bacterial pneumonia (“SCABP”).
The Phase 2 study is expected to begin enrollment
of approximately 276 patients with severe community-acquired
pneumonia at approximately 120 sites worldwide as early as the
beginning of 2023.
“We are pleased that the CAL02 IND has been
accepted by FDA and look forward to commencement of the Phase 2
study anticipated early in 2023. We already have identified a pool
of eligible sites across 22 countries, which we believe could yield
approximately 120 sites worldwide,” stated Scott Tarriff, President
and Chief Executive Officer of Eagle Pharmaceuticals. “This is an
exciting program, and we believe that CAL02 has the potential to
improve the treatment regimen for patients with severe
community-acquired pneumonia, as well as to shorten the duration of
illness and improve patient outcomes,” concluded Tarriff.
CAL02 is potentially eligible for ten years of
regulatory exclusivity, including five years as a new chemical
entity and five years as a qualified infectious disease product
(“QIDP”) under the Generating Antibiotic Incentives Now (“GAIN”)
Act. Eagle believes that CAL02 could be eligible for fast track and
breakthrough therapy designations. In addition, Eagle believes a
CAL02 new drug application for the treatment of SCABP may qualify
for priority review. The Company expects to strengthen the patent
portfolio for this asset.
In August 2021, Eagle entered into a worldwide
licensing agreement with Combioxin SA, a clinical-stage
biotechnology company based in Epalinges, Switzerland, for the
commercial rights to CAL02.
Investor Day Registration
Information
Eagle will host an Investor Day on Tuesday,
December 6, 2022, at the Lotte New York Palace Hotel, at 8:00am
ET.
The program will provide an opportunity for an
in-depth look at the Company’s hospital-based products and
product candidates, including CAL02, BARHEMSYS® and BYFAVO®,
landiolol, and Enalare’s ENA-001. Featured speakers include
Scott Tarriff, President and Chief Executive Officer, senior
members of Eagle’s clinical and commercial teams, and noteworthy
Key Opinion Leaders, who will discuss the scientific rationale and
potential unmet medical needs for each pipeline asset and
commercial product.
Advance registration is required for this event.
Institutional investors and analysts are kindly requested
to RSVP through this link to attend.
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,” 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
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, 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, 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:
212-452-2793 E: lwilson@insitecony.com
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