FDA assigns Prescription Drug User Fee Act
(PDUFA) target action date of August 13,
2024
CRANFORD, N.J., March 18, 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 that the U.S. Food and Drug Administration (FDA)
has accepted the resubmission of the Company's Biologics License
Application (BLA) 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 FDA has assigned a PDUFA goal date of
August 13, 2024.
"The acceptance of the BLA resubmission reflects the
completeness of our response to the enhanced product testing and
additional controls highlighted by the FDA in their July 2023 CRL. No concerns relating to
safety or efficacy were noted in the letter, and we remain
confident in the robustness of the clinical data package included
with the initial BLA submission," stated Leonard Mazur, Chairman and CEO of
Citius.
"We believe there remains a critical unmet need for an
additional viable treatment option for patients with relapsed or
refractory CTCL as current therapies are non-curative. We are
grateful for the FDA's vital support for rare disease drug
development as we work to expand treatment options for patients
with cutaneous T-cell lymphoma. We look forward to the FDA's
decision and the potential benefit LYMPHIR may provide patients
with relapsed or refractory CTCL," added Mazur.
The BLA is supported by a pivotal Phase 3 study (NCT01871727).
The resubmission follows dialog 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.
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.
A Biologics License Application for LYMPHIR™, a novel IL-2R
immunotherapy for an initial indication in the treatment of
cutaneous T-cell lymphoma, is currently under review by the FDA
with August 13, 2024 assigned as the
PDUFA target action date. 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 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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SOURCE Citius Pharmaceuticals, Inc.