Kyowa Kirin and Knight Therapeutics Enter Into Exclusive Distribution Agreement for POTELIGEO ® (mogamulizumab) for Cutaneous T-Cell Lymphoma (CTCL) Patients Across Latin America

Kyowa Kirin International, a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), today announced the signing of an exclusive distribution agreement with Knight Therapeutics (“Knight”) (TSX: GUD) for the distribution of mogamulizumab in select countries in Latin America.

Under the terms of the agreement, Knight will be responsible for seeking the necessary regulatory approvals and commercialising mogamulizumab for mycosis fungoides (MF) and Sézary syndrome (SS), two subtypes of CTCL, a rare non-Hodgkin’s lymphoma, in Argentina, Brazil, Colombia and Mexico. Knight will hold exclusive distribution rights for the medicine in these markets.

Kyowa Kirin and Knight’s collaboration aims to support CTCL patients and improve their access to innovative therapies in Latin America.

Céline Rhême, Cluster General Manager, Emerging Growth Markets, Kyowa Kirin, commented: “CTCL is more common in this region than many realise, and further work is needed to identify unmet needs and therefore drive improvements in patient outcomes.¹ We have an opportunity, and a responsibility to change that. Through our proud partnership with Knight Therapeutics, we can help to increase patient access in Latin America, as part of our ongoing and relentless commitment to bring life-changing value and make people smile.”

The exclusive agreement marks Kyowa Kirin's first collaboration into Latin America with mogamulizumab and represents an important milestone in the company's growth strategy. By combining Kyowa Kirin's expertise in rare diseases with Knight's established regional presence, the partnership will help extend the company's reach to more patients living with CTCL and other rare diseases across the region.

About Kyowa Kirin

Kyowa Kirin aims to discover novel medicines with life-changing value. As a global specialty pharmaceutical company, we have invested in drug discovery and biotechnology innovation for more than 75 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our three regions-JAPAC, North America, and EMEA.

You can learn more about the business of Kyowa Kirin at: https://kyowakirininternational.com/

About mycosis fungoides (MF) and Sézary syndrome (SS)

MF and SS are two subtypes of CTCL, which is itself a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin.² CTCL is treatable, but is not generally considered to be curable, and there has been a clear unmet need for novel treatment options. As well as the obvious impact of symptoms upon patients, there can be significant erosions to quality of life for those caring for an individual living with CTCL.³

MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.⁴ These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin.^5-7 When these cancerous T cells move to the skin, this results in the visible early skin symptoms of red patches or plaques which can resemble psoriasis or eczema in the early stages of the disease.⁸ Later, for some patients, skin involvement may evolve to include tumours or reddening of the majority of the skin’s surface (erythroderma).

MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs⁹ and is typically indolent, characterised by skin symptoms including patches or plaques, skin redness and tumours. SS is much rarer, accounting for around 5% of CTCLs,¹⁰ and is more aggressive,⁸ with high levels of blood involvement.¹⁰ It can cause severe itching, erythroderma, intense scaling of the skin and hair loss.⁸ CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.⁸

About POTELIGEO^® (mogamulizumab)

Mogamulizumab is a first-in-class humanised monoclonal antibody (mAb) directed against CC-chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both mycosis fungoides and Sézary syndrome.^5-7 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.¹¹

References

1 Dobos G, Pohrt A, Ram-Wolff C, Lebbé C, Bouaziz JD, Battistella M, Bagot M, de Masson A. Epidemiology of Cutaneous T-Cell Lymphomas: A Systematic Review and Meta-Analysis of 16,953 Patients. Cancers (Basel). 2020 Oct 11;12(10):2921. doi: 10.3390/cancers12102921. PMID: 33050643; PMCID: PMC7600606.

2 Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204.

3 Williams et al (2020) – Health state utilities associated with caring for an individual with CTCL. Journal of Medical Economics. 2020; 23(10):1142-1150

4 Scarisbrick JJ, Prince M, Vermeer MH, et al. Cutaneous Lymphoma International Consortium Study of Outcome in Advanced Stages of Mycosis Fungoides and Sézary Syndrome: Effect of Specific Prognostic Markers on Survival and Development of a Prognostic Model. J Clin Oncol. 2015;33(32):3766-3773.

5 Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol.

2002;119:1405-10.

6 Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia

Virus Type 1-transformed T cells. Blood. 2002;99(5):1505-11.

7 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res. 2003;9:3625-34.

8 Lymphoma Coalition. Cutaneous lymphoma – a patient’s guide. Available at: https://lymphomacoalition.org/wp-content/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf Last accessed: November 2025.

9 Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714.

10 Trautinger F, et al. European Organisation for Research and Treatment of Cancer consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome - Update 2017. European Journal of Cancer. 2017;77:57–74.

11 Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171-174.

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