Full Press Release Details
Citius Pharmaceuticals Resubmits the Biologics
License Application of LYMPHIR (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
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., February 14, 2024 --
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 S zary 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
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