Citius’s Er-Kim Deal Unlocks Rare Cancer Therapy in New Markets

CRANFORD, NJ – December 04, 2025 – In a move that underscores a shrewd and calculated approach to global expansion, Citius Oncology has inked an exclusive distribution agreement with the Turkish pharmaceutical powerhouse Er-Kim. The deal is set to bring LYMPHIR, the company's recently FDA-approved therapy for a rare and aggressive form of skin cancer, to patients across Turkey and six key Gulf Cooperation Council (GCC) nations. While on the surface this appears to be a standard distribution deal, a deeper analysis reveals a sophisticated strategy for penetrating complex emerging markets, leveraging local expertise to navigate regulatory mazes and deliver hope to an underserved patient population.

The transaction gives Er-Kim exclusive rights to distribute LYMPHIR for cutaneous T-cell lymphoma (CTCL) in Turkey, Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates. This is not just about placing a product on new shelves; it’s a tactical maneuver that highlights a growing trend among agile biotechs: partnering with established regional leaders to bypass the immense capital and time required to build an international commercial footprint from scratch.

The Anatomy of a Strategic Partnership

For a company like Citius Oncology, which just launched its flagship product in the U.S. this month, the choice of a partner for its first major international push outside of Europe is paramount. The selection of Er-Kim is a testament to this strategic calculus. Established in 1981, Er-Kim is far more than a simple logistics provider. With revenues exceeding €305 million and a network spanning over 50 countries, it is a dominant force in the biopharmaceutical landscape of the EMEA region.

Er-Kim’s track record is particularly strong in the highly specialized fields of oncology and rare diseases. The company has secured similar exclusive deals with other innovative biotechs, such as Immunocore for its uveal melanoma treatment and Ascendis Pharma for its rare endocrinology portfolio. This history demonstrates a proven ability to handle complex biologics and to successfully commercialize them in regions with diverse and often challenging regulatory and reimbursement systems. Citius Oncology's Chairman and CEO, Leonard Mazur, noted this directly, calling Er-Kim an "ideal partner" due to its "deep industry experience and a strong track record of providing access to oncology therapies in complex international markets."

This partnership allows Citius to effectively outsource the intricate and resource-intensive functions of market entry. Er-Kim will take charge of sales, marketing, and crucially, reimbursement activities. For a high-value, specialized therapy like LYMPHIR, navigating reimbursement is a critical barrier to patient access and commercial success. Er-Kim's local expertise in dealing with entities like Turkey’s TİTCK or Saudi Arabia’s SFDA provides Citius with a pre-built bridge across a potential bureaucratic chasm.

Unlocking Access Through Named Patient Programs

The masterstroke of this agreement lies in its framework: leveraging Named Patient Programs (NPPs). These programs are regulatory pathways that allow physicians to legally access and prescribe unapproved or unavailable medicines for individual patients who have exhausted all other treatment options. For Citius, this is a game-changer. Instead of waiting years for full commercial approval in each of the seven countries, LYMPHIR can become available almost immediately to the patients who need it most.

This strategy is particularly well-suited for rare diseases like CTCL, where the patient population is small and the unmet medical need is high. CTCL is a devastating disease that, in its advanced stages, has no curative therapy outside of a stem cell transplant, for which few qualify. NPPs provide an ethical and regulated channel to bring life-altering therapies to these patients without delay. This approach not only serves a critical humanitarian need but also allows Citius to establish an early market presence, building invaluable experience and relationships with key opinion leaders and treatment centers in the region long before a full commercial launch.

However, NPPs are not a simple logistical exercise. They involve complex importation rules, cold-chain management for sensitive biologics, and intricate reimbursement negotiations, which can fall to the patient, private insurers, or special government funds. Er-Kim's commitment to managing these activities is a core pillar of the deal's value, de-risking the process for Citius and ensuring that access is more than just a theoretical possibility.

Targeting an Unmet Need in a Growing Market

While CTCL is a rare disease, the agreement plants Citius Oncology's flag in one of the world's fastest-growing pharmaceutical regions. The broader Middle East oncology drug market is already valued at approximately $5 billion, and the overall MENA pharma sector is projected to hit $60 billion by 2025. Countries like Saudi Arabia and the UAE are investing heavily in their healthcare infrastructure, with a growing demand for innovative, branded therapies, especially in oncology.

LYMPHIR, a novel IL-2 receptor-directed cytotoxin, fits perfectly into this trend. It offers a targeted mechanism of action, directly attacking cancer cells that express the IL-2 receptor, which is a hallmark of CTCL. Given that patients with this disease often cycle through multiple therapies with diminishing returns, a new, targeted agent represents a significant advancement. Citius estimates the initial U.S. market for LYMPHIR exceeds $400 million, signaling the substantial value of an effective therapy for this underserved condition. While the market in Turkey and the GCC will be a fraction of this, the cumulative potential across 19 international markets is significant and provides a vital secondary revenue stream to support the company's growth.

This expansion is not happening in a vacuum. It is part of a deliberate international playbook that Citius Oncology is executing with precision. This latest deal follows a similar agreement in October 2025 that opened access to LYMPHIR in 12 markets across Central and Eastern Europe. The pattern is clear: identify regions with unmet needs, partner with a best-in-class local expert, and use NPPs to establish an early-access beachhead. This strategy is evidently resonating with investors, as Citius Oncology's stock (CTOR) has seen a 30% gain over the past six months, with analysts setting price targets that suggest significant further upside. For Citius Oncology, this isn't just about expanding its map; it's about writing a new playbook for globalizing specialized medicine, one strategic partnership at a time.