Citius Oncology Taps Uniphar to Bring Cancer Drug LYMPHIR to Europe

CRANFORD, NJ – February 11, 2026 – Citius Oncology announced today it has finalized an exclusive distribution agreement with the international healthcare services company Uniphar, a strategic move designed to bring its targeted lymphoma therapy, LYMPHIR™, to patients across Western and Eastern Europe. The deal marks a significant step in the company's global expansion, leveraging specialized regulatory pathways to address an urgent unmet medical need for a rare and debilitating cancer.

The partnership is Citius Oncology's third international agreement for LYMPHIR (denileukin diftitox-cxdl), a treatment for relapsed or refractory cutaneous T-cell lymphoma (CTCL) that gained FDA approval in the United States in late 2025. Under the terms, Dublin-based Uniphar will manage all market access and distribution activities in designated European territories, navigating a complex web of national regulations to make the drug available to patients before it receives formal marketing authorization in the region.

"This agreement with Uniphar builds on the momentum of our international expansion efforts and reflects our commitment to partnering with experienced organizations that have deep regional expertise and proven execution capabilities," said Leonard Mazur, Chairman and CEO of Citius Oncology and its parent company, Citius Pharmaceuticals. "This partnership further strengthens our ability to responsibly expand access to LYMPHIR for patients with limited treatment options, while continuing to lay the groundwork for long-term global growth."

A Lifeline Through Managed Access

Crucially, the distribution of LYMPHIR in Europe will occur through "country-specific managed access programs." These programs are vital regulatory mechanisms that provide a lifeline for patients with life-threatening or seriously debilitating diseases who have exhausted all authorized treatment options and cannot enroll in clinical trials. While LYMPHIR is not yet commercially approved in Europe, this agreement allows physicians to request the drug for individual patients or specific patient groups on a compassionate use basis.

The European landscape for such programs is a complex patchwork, governed by overarching EU guidelines but ultimately implemented and controlled at the national level. Terminology varies, including Compassionate Use Programs (CUPs), which typically serve patient cohorts, and Named Patient Programs (NPPs), initiated by physicians for specific individuals. These pathways are designed to bridge the often-protracted gap between a drug's successful clinical trials and its full commercial availability, a period that can leave vulnerable patients in limbo.

By partnering with Uniphar, a company with extensive experience in navigating these diverse national systems, Citius Oncology can facilitate early access while gathering valuable real-world data on LYMPHIR's use in a European context. This data can, in turn, support future applications for full marketing authorization with the European Medicines Agency (EMA) and national health authorities.

The Unseen Battle Against a Rare Cancer

The urgency behind this agreement is rooted in the severe nature of cutaneous T-cell lymphoma. CTCL is a rare form of non-Hodgkin lymphoma where the body's T-cells, a key component of the immune system, become cancerous and primarily affect the skin. Patients often suffer from painful, intensely itchy skin lesions that severely diminish their quality of life.

While the disease can progress slowly over many years, advanced stages become highly malignant, with the potential to spread to lymph nodes and internal organs, leading to a poor prognosis. Affecting men twice as often as women and typically diagnosed in patients between 50 and 60 years old, CTCL has limited curative options. Outside of an allogeneic stem cell transplant, for which very few patients are eligible, no definitive cure exists for advanced disease, forcing patients to cycle through multiple therapies to manage its progression.

LYMPHIR offers a novel approach. It is a recombinant fusion protein that cleverly combines a portion of an Interleukin-2 (IL-2) receptor with fragments of the diphtheria toxin. The therapy works by binding to IL-2 receptors, which are highly expressed on the surface of the cancerous T-cells. Once bound, the drug is internalized by the cell, where the diphtheria toxin fragment is released. This potent toxin then shuts down the cell's ability to produce proteins, leading directly to cell death. This targeted mechanism allows it to destroy malignant cells while also depleting certain regulatory T-cells that can suppress the body's natural anti-tumor response.

A Strategic Blueprint for Global Reach

This European expansion is not a standalone effort but the latest execution of a deliberate global strategy. The Uniphar deal follows previously announced exclusive distribution partnerships covering Southern Europe, the Balkans, Turkey, and the Middle East. This methodical, partner-led approach allows a specialized company like Citius Oncology to establish a global footprint without the immense cost and logistical burden of building commercial infrastructure from scratch in every region.

By leveraging the established networks and local regulatory expertise of partners like Uniphar, Citius mitigates risk while accelerating access to key markets. This model is particularly effective for specialized therapies targeting rare diseases, where deep relationships with key opinion leaders and treatment centers are paramount. The strategy lays a commercial foundation and builds market awareness well ahead of any potential full-scale launch.

The partnership with Uniphar, a global giant in healthcare services operating in 180 countries, underscores the significance of this phase of Citius's expansion. Uniphar's role will extend beyond simple logistics to include navigating market access and reimbursement hurdles on a country-by-country basis.

"We are thrilled to partner with Citius Oncology to expand access to LYMPHIR across Europe," stated Brian O'Shaughnessy, Chief Commercial Officer of Uniphar. "Uniphar is committed to connecting patients with innovative therapies, and this agreement strengthens our ability to support clinicians and improve outcomes for those living with or relapsed or refractory cutaneous T-cell lymphoma."

With an estimated initial market in the U.S. exceeding $400 million, the expansion into Europe represents a substantial long-term growth opportunity. As LYMPHIR becomes available through these managed access programs, it will provide a new therapeutic option for a patient population in desperate need, while simultaneously advancing Citius Oncology's ambition to become a global force in targeted oncology.