Citius Oncology Prepares for Upcoming Launch of LYMPHIR™ in 2025

Citius Oncology Prepares for Launch of LYMPHIR™ in 2025

Citius Oncology, a focused subsidiary of Citius Pharmaceuticals, is gearing up for the commercial launch of LYMPHIR™, an innovative immunotherapy recently approved by the FDA for the treatment of adults suffering from relapsed or refractory cutaneous T-cell lymphoma (CTCL). This product launch marks a significant transition for the company, as they shift from a developmental phase to a fully operational commercial entity.

Anticipated Launch Timeline

Scheduled for launch in the latter half of 2025, Citius Oncology is optimistic about their operational capabilities. Leonard Mazur, Chairman and CEO of both Citius Oncology and Citius Pharma, commented on the positive momentum built over the past months. With a fully secured supply chain and marketing strategies in place, the company is positioned for success: "We've made steady and meaningful progress toward commercialization, and we believe LYMPHIR's launch will be a pivotal moment for both our company and the CTCL community."

Manufacturing and Distribution Plans

Citius Oncology has achieved several crucial milestones in manufacturing. They successfully completed large-scale production of LYMPHIR, storing sufficient inventory at a leading global Contract Development and Manufacturing Organization (CDMO). The stock, designed to last for 12 to 18 months post-launch, boasts a shelf life of five years, ensuring reliable availability for patients in need. The company has also forged partnerships with top-tier global pharmaceutical logistics partners for swift access, aiming to enhance treatment availability across the United States, especially in cancer centers and community settings.

Engaging with Healthcare Professionals

In preparation for the product rollout, Citius Oncology has engaged extensively with U.S. Key Opinion Leaders (KOLs) in the CTCL domain. By participating in medical congresses and community forums, the company aims to increase awareness about LYMPHIR. Their collaboration with organizations such as the Cutaneous Lymphoma Foundation helps shape the commercial approach to prioritize patient needs.

Following an advisory board meeting at the American Society of Hematology Annual Meeting in 2024, the company refined its launch strategy and target patient profiles based on insights from leading CTCL experts. A strong interest from the oncology community is apparent, with over 70 institutional centers already signed up to access LYMPHIR.

Commercial Marketing Strategies

Citius Oncology has devised a detailed launch strategy that employs a proprietary generative AI model to promote key accounts efficiently. This tailored marketing effort aims to provide healthcare providers with essential tools to interact meaningfully with patients, ensuring they receive the therapies they need promptly. A wide array of educational materials has been produced, ranging from clinical guides to awareness content designed for patients and caregivers alike.

Regulatory and Reimbursement Positioning

Notably, LYMPHIR's addition to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and its assigned J-code under HCPCS pave the way for efficient reimbursement and coverage upon launch. Citius Oncology's continuous engagement with insurance payors further enhances the product's market accessibility.

Financial Support and Strategic Partnerships

Citius Pharma's recent capital raise bolsters final preparations for LYMPHIR’s commercialization and supports the anticipated launch. Ongoing discussions regarding strategic partnerships allow the company to expand its market reach and explore future development opportunities.

About LYMPHIR™

LYMPHIR is a targeted immunotherapy effective in treating adult patients with relapsed or refractory CTCL, indicated after at least one prior systemic therapy. This unique recombinant fusion protein links the IL-2 receptor binding domain with fragments of the diphtheria toxin, selectively targeting tumor cells and immunosuppressive regulatory T-cells for improved antitumor activity. Following its initial approval in Japan for CTCL and peripheral T-cell lymphoma, Citius Oncology acquired the rights to develop and market LYMPHIR outside Japan, with FDA approval granted in August 2024.

Understanding Cutaneous T-cell Lymphoma

CTCL is the predominant form of cutaneous lymphoma characterized by T-cells turning cancerous, leading to painful and severe skin lesions affecting quality of life. The main types of CTCL, Mycosis Fungoides (MF) and Sézary Syndrome (SS), usually progress slowly over years, but once they reach an advanced stage, the prognosis diminishes significantly. Unfortunately, the current treatment landscape lacks curative options for advanced cases, leaving many patients cycling through therapies to manage the disease.

As Citius Oncology anticipates the launch of LYMPHIR, the company emphasizes its commitment to improving the lives of CTCL patients and the significance of their upcoming commercial transition.