FDA acceptance of the completed resubmission
package and issuance of a Prescription Drug User Fee Act (PDUFA)
date is expected within 30 days of resubmission
CRANFORD, N.J., Feb. 13,
2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc.
("Citius" or the "Company") (Nasdaq: CTXR), a late-stage
biopharmaceutical company dedicated to the development and
commercialization of first-in-class critical care products today
announced the resubmission of the Company's Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for
the treatment of patients with relapsed or refractory cutaneous
T-cell lymphoma (CTCL) after at least one prior systemic
therapy.
The resubmission follows ongoing engagement with the FDA
resulting from a Complete Response Letter (CRL) received on
July 28, 2023. Citius believes it has
addressed enhanced product testing and additional manufacturing
controls noted in the letter. There were no safety or efficacy
issues cited and no additional trials required. Based on Center for
Drug Evaluation and Research timelines, FDA acceptance of the
completed resubmission package and issuance of a Prescription Drug
User Fee Act (PDUFA) date is expected within 30 days of
resubmission.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a recombinant fusion protein that combines the
interleukin-2 (IL-2) receptor binding domain with diphtheria toxin
fragments. The agent specifically binds to IL-2 receptors on the
cell surface, causing diphtheria toxin fragments that have entered
cells to inhibit protein synthesis. In 2011 and 2013, the FDA
granted orphan drug designation to LYMPHIR for the treatment of
PTCL and CTCL, respectively. In 2021, denileukin diftitox received
regulatory approval in Japan for
the treatment of CTCL and peripheral T-cell lymphoma (PTCL).
Subsequently in 2021, Citius acquired an exclusive license with
rights to develop and commercialize LYMPHIR in all markets except
for Japan and certain parts of
Asia.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin
lymphoma (NHL) that comes in a variety of forms and is the most
common type of cutaneous lymphoma. In CTCL, T-cells, a type of
lymphocyte that plays a role in the immune system, become cancerous
and develop into skin lesions, leading to a decrease in the quality
of life of patients with this disease due to severe pain and
pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise
the majority of CTCL cases. Depending on the type of CTCL, the
disease may progress slowly and can take anywhere from several
years to upwards of ten to potentially reach tumor stage. However,
once the disease reaches this stage, the cancer is highly malignant
and can spread to the lymph nodes and internal organs, resulting in
a poor prognosis. Given the duration of the disease, patients
typically cycle through multiple agents to control disease
progression. CTCL affects men twice as often as women and is
typically first diagnosed in patients between the ages of 50 and 60
years of age. Other than allogeneic stem cell transplantation, for
which only a small fraction of patients qualify, there is currently
no curative therapy for advanced CTCL.
About Citius Pharmaceuticals, Inc.
Citius Pharma is a late-stage biopharmaceutical company
dedicated to the development and commercialization of
first-in-class critical care products. The Company's diversified
pipeline includes two late-stage product candidates. At the end of
2023, Citius completed enrollment in a Phase 3 Pivotal superiority
trial of Mino-Lok®, an antibiotic lock solution to salvage
catheters in patients with catheter-related bloodstream infections.
Citius has recently resubmitted the Biologics License Application
for LYMPHIR™, a novel IL-2R immunotherapy for an initial indication
in the treatment of cutaneous T-cell lymphoma. Citius previously
announced plans to form Citius Oncology, a standalone publicly
traded company with LYMPHIR as its primary asset. LYMPHIR received
orphan drug designation by the FDA for the treatment of CTCL and
PTCL. In addition, Citius completed enrollment in its Phase
2b trial of CITI-002 (Halo-Lido), a
topical formulation for the relief of hemorrhoids. For more
information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
are made based on our expectations and beliefs concerning future
events impacting Citius. You can identify these statements by the
fact that they use words such as "will," "anticipate," "estimate,"
"expect," "plan," "should," and "may" and other words and terms of
similar meaning or use of future dates. Forward-looking statements
are based on management's current expectations and are subject to
risks and uncertainties that could negatively affect our business,
operating results, financial condition and stock price. Factors
that could cause actual results to differ materially from those
currently anticipated are: the FDA may not accept the BLA or,
if accepted, approve LYMPHIR; risks relating to the results of
research and development activities, including those from our
existing and any new pipeline assets; our need for substantial
additional funds; our ability to commercialize our products if
approved by the FDA; our dependence on third-party suppliers; our
ability to procure cGMP commercial-scale supply; the estimated
markets for our product candidates and the acceptance thereof by
any market; the ability of our product candidates to impact the
quality of life of our target patient populations; our ability to
obtain, perform under and maintain financing and strategic
agreements and relationships; uncertainties relating to preclinical
and clinical testing; the early stage of products under
development; market and other conditions; risks related to our
growth strategy; patent and intellectual property matters; our
ability to identify, acquire, close and integrate product
candidates and companies successfully and on a timely basis;
government regulation; competition; as well as other risks
described in our SEC filings. These risks have been and may be
further impacted by Covid-19 and could be impacted by any future
public health risks. Accordingly, these forward-looking statements
do not constitute guarantees of future performance, and you are
cautioned not to place undue reliance on these forward-looking
statements. Risks regarding our business are described in detail in
our Securities and Exchange Commission ("SEC") filings which are
available on the SEC's website at www.sec.gov, including in our
Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on
December 29, 2023, and updated by our
subsequent filings with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date hereof,
and we expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
Investor Relations for Citius Pharmaceuticals:
Investor Contact:
Ilanit
Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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