Targeted immune therapy
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Citius Oncology Expands LYMPHIR™ Distribution to Turkey and Middle East Countries Through Exclusive Agreement with Er-Kim
Prnewswire· 2025-12-04 13:37
Core Insights - Citius Oncology has entered an exclusive distribution agreement with Er-Kim for LYMPHIR, expanding its access to patients with cutaneous T-cell lymphoma in Turkey and key Gulf Cooperation Council (GCC) countries [1][3] - The partnership increases Citius Oncology's international strategy to a total of 19 markets outside the U.S., leveraging Named Patient Programs for access [2] - LYMPHIR is a targeted immune therapy approved by the FDA for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy [5][9] Company Overview - Citius Oncology, a subsidiary of Citius Pharmaceuticals, focuses on developing and commercializing novel targeted oncology therapies, with LYMPHIR being a significant addition to its portfolio [9][10] - The initial market for LYMPHIR is estimated to exceed $400 million, indicating a growing and underserved market for this therapy [9] - Citius Pharmaceuticals holds a 79% stake in Citius Oncology and is dedicated to critical care product development [10] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a recombinant fusion protein that targets IL-2 receptors, leading to cell death in tumors expressing these receptors [5] - The therapy has shown the ability to deplete immunosuppressive regulatory T lymphocytes and has direct antitumor activity [5] - LYMPHIR was launched in the U.S. in December 2025 after receiving FDA approval [6] Partnership Significance - The agreement with Er-Kim is viewed as a significant milestone in Citius Oncology's global expansion strategy, leveraging Er-Kim's industry experience and regulatory capabilities [3][4] - Er-Kim will handle sales, marketing, and reimbursement activities in the designated territories, while Citius Oncology will supply the finished product [3] Market Context - Cutaneous T-cell lymphoma is the most common type of cutaneous lymphoma, affecting men more frequently and typically diagnosed in individuals aged 50 to 60 [7][8] - There is currently no curative therapy for advanced CTCL, making innovative treatments like LYMPHIR critical for patient care [8]