CRANFORD, N.J., Jan. 7, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and its oncology-focused subsidiary, Citius Oncology (Nasdaq: CTOR), today announced significant progress in preparations for the commercial launch of LYMPHIR™, an innovative immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Management is focused on making LYMPHIR available to patients as quickly as possible, with preparations underway for launch in the first half of 2025.
"Since LYMPHIR's approval in August 2024, we have worked diligently toward supporting its successful launch. We are making significant progress to finalize our manufacturing, marketing, reimbursement and sales efforts. This is a pivotal inflection point as we transition from clinical development to revenue generation. Our strategy not only focuses on a successful U.S. market penetration, but also includes exploring additional growth opportunities, including licensing partnerships in key international markets, for which discussions are underway, expanded indications for LYMPHIR, in addition to LYMPHIR's potential as a combination immunotherapy. Our unwavering goal remains to deliver substantial value to patients, healthcare providers, and shareholders by bringing this innovative cancer treatment to market," stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius Oncology.
Key Launch Preparations and Activities:
- Manufacturing Scale-Up and Supply Chain Optimization:
- Secured commercial supply agreements with leading contract manufacturing organizations (CMOs).
- First Year Launch Supply has been produced.
- Healthcare Provider Engagement:
- Rolled out targeted education programs aimed at oncologists, hematologists, and other key medical professionals.
- Launched an information platform that offers clinical data, dosing guidelines, and safety information for healthcare providers.
- Market Access and Reimbursement Efforts:
- Working closely with payers and healthcare providers to secure reimbursement pathways that facilitate patient access.
- Submitted an application for a unique J-code under the Healthcare Common Procedure Coding System (HCPCS) to streamline reimbursement processes.
- Secured LYMPHIR's inclusion in the National Comprehensive Cancer Network (NCCN) guidelines, a key factor in influencing clinical decision-making and payer coverage in the U.S.
- Patient Support Initiatives:
- Designed a patient assistance program to help with financial support and access to LYMPHIR.
- Developing a best-in-class patient services center to assist LYMPHIR patients with administrative and prescribing needs.
- Marketing and Sales Initiatives:
- Launched a core marketing campaign to raise awareness among healthcare providers, ensuring that top CTCL prescribers are informed of LYMPHIR's availability.
- Building an experienced specialized field sales team to partner with CTCL providers and office staff.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the 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. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and 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. LYMPHIR was approved by the FDA in August 2024.
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.
INDICATION
LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CAPILLARY LEAK SYNDROME
Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS
Capillary Leak Syndrome
LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin