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Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

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Citius Pharmaceuticals, Inc. announces the resubmission of the BLA for LYMPHIR™ to the FDA for the treatment of CTCL, expecting FDA acceptance within 30 days.
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The resubmission of a Biologics License Application (BLA) by Citius Pharmaceuticals for LYMPHIR™ is a pivotal moment for the company, given that the drug targets a specific patient population with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The fact that the FDA did not cite safety or efficacy issues and did not require additional trials is a positive sign, suggesting that the concerns were primarily related to product testing and manufacturing controls.

From a pharmaceutical development standpoint, this resubmission could signify a near-term catalyst for Citius, potentially leading to an accelerated path to market, assuming FDA approval. The issuance of a PDUFA date provides a tangible timeline for investors and the company to anticipate a regulatory decision. For stakeholders, the approval of LYMPHIR™ could translate into a new treatment option for CTCL patients and potentially drive revenue growth for Citius. However, it's important to consider the competitive landscape and reimbursement challenges that Citius may face upon market entry.

Analyzing the market impact of Citius Pharmaceuticals' BLA resubmission, it is essential to consider the market size for CTCL treatments and the potential market share LYMPHIR™ could capture. The acceptance of the resubmission by the FDA and the setting of a PDUFA date are critical steps in the drug's lifecycle and can influence investor sentiment. If approved, LYMPHIR™ could provide a competitive edge for Citius, especially if it demonstrates advantages over existing therapies in terms of efficacy, safety, or cost.

Investors should monitor the company's ability to scale manufacturing and navigate the commercialization process. The company's stock price may fluctuate in response to FDA communications and eventual approval status, reflecting market sentiment and perceived value. It is also important to evaluate the company's overall pipeline and diversification, as reliance on a single product can be risky.

In the context of regulatory compliance, the resubmission of the BLA by Citius Pharmaceuticals indicates a proactive approach to addressing the FDA's concerns outlined in the Complete Response Letter (CRL). The CRL is a formal notification from the FDA indicating that the review process of a new drug application cannot proceed until specific issues are resolved. Addressing these issues without safety or efficacy concerns is a favorable outcome, as it suggests that the barriers to approval are administrative rather than scientific.

It is crucial for Citius to ensure that their enhanced product testing and additional manufacturing controls meet FDA standards to avoid further delays or denials. The legal implications of non-compliance can lead to significant financial losses and damage to the company's reputation. The stakeholders should be aware of the regulatory risks and the company's strategies to mitigate them.

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 

Citius Pharmaceuticals, a late-stage biopharmaceutical company (PRNewsfoto/Citius Pharmaceuticals, Inc.)

 

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SOURCE Citius Pharmaceuticals, Inc.

FAQ

What is the name of the late-stage biopharmaceutical company that announced the resubmission of the BLA for LYMPHIR™ to the FDA?

Citius Pharmaceuticals, Inc.

What is the ticker symbol of Citius Pharmaceuticals, Inc.?

CTXR

What is the drug being submitted for approval by Citius Pharmaceuticals, Inc.?

LYMPHIR™

What is the expected timeframe for FDA acceptance after the resubmission of the BLA for LYMPHIR™?

Within 30 days

What is the indication for which LYMPHIR™ is being developed?

Treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy

Citius Pharmaceuticals, Inc.

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