Citius Oncology Expands Access to LYMPHIR™ in Southern Europe for Patients

Citius Oncology Enhances Patient Access to LYMPHIR™ in Southern Europe

Citius Oncology, Inc. is taking significant steps to enhance patient access to its novel therapeutic, LYMPHIR™ (denileukin diftitox-cxdl), through the introduction of Named Patient Programs (NPPs) across Southern Europe. This initiative aims to facilitate access to LYMPHIR for patients suffering from severe conditions, specifically relapsed or refractory cutaneous T-cell lymphoma (CTCL), in regions such as Greece, Cyprus, and various Balkan countries.

The company has strategically partnered with Integris Pharma S.A., a reputable pharmaceutical distributor based in Athens, Greece. This exclusive distribution agreement spans several countries, including Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro, and North Macedonia. By collaborating with Integris, Citius Oncology is poised to leverage their deep expertise in oncology and established networks to ensure that eligible patients receive timely access to LYMPHIR.

Named Patient Programs represent a formal pathway that allows patients to obtain access to investigational therapies when conventional treatment options are insufficient. These programs are crucial as they provide physicians with the ability to request LYMPHIR on behalf of patients who have exhausted all approved alternatives, thereby bridging the gap between clinical trials and commercial availability. Notably, this ensures that patients encountering critical health challenges are not left without options while awaiting regulatory approvals.

Leonard Mazur, Chairman and CEO of Citius Oncology, articulated the importance of this strategic move, stating, "While we prepare for the U.S. launch of LYMPHIR, expanding international access through Named Patient Programs fulfills a vital patient-driven mission. We aim to provide urgent new treatment options while enabling physicians to gather significant real-world data on LYMPHIR's efficacy."

For patients with imminent health risks, accessing innovative therapies like LYMPHIR can greatly enhance their treatment options. Physicians involved in NPPs will have the opportunity to gain invaluable real-world experience with the therapy, informing their clinical practice based on firsthand data. This aligns with Citius Oncology's long-term objectives of establishing LYMPHIR as a cornerstone treatment globally.

LYMPHIR is a targeted immune therapy uniquely designed to combat relapsed or refractory CTCL in adult patients who have undergone prior systemic treatments. As a recombinant fusion protein, LYMPHIR works by binding to IL-2 receptors on tumor cells, subsequently inducing cell death and fostering a robust immune response. The therapy has received FDA approval in August 2024 for use in the United States.

Citius Oncology acknowledges the vital role of Integris Pharma in navigating the complexities of the Southern European pharmaceutical landscape. As a partner, Integris offers comprehensive support that encompasses regulatory affairs, market access strategies, and logistical operations, fundamentally ensuring the swift delivery of LYMPHIR to impacted patients. This partnership signifies a commitment to patient welfare while enhancing the therapeutic landscape across these key regions.

Furthermore, Citius Oncology is actively pursuing discussions with various potential distribution partners in additional regions, including other EU countries, parts of South America, and select Middle Eastern territories. These ongoing efforts underscore the company's dedication to improving global access to LYMPHIR, further highlighting its commitment to addressing the unmet medical needs of patients worldwide.

In conclusion, Citius Oncology's strategic initiatives to expand access to LYMPHIR through Named Patient Programs represent a significant advance in providing essential therapies to patients in Southern Europe. The company’s collaboration with Integris Pharma exemplifies a patient-first approach that seeks to bring innovative treatments to those who need them the most—right at the brink of critical health challenges. This collaborative effort not only promises to strengthen clinical adoption of LYMPHIR but also fosters robust relationships with top oncology centers in these regions, marking a pivotal moment in the fight against CTCL.