Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ENTERS INTO EXCLUSIVE DISTRIBUTION AGREEMENT WITH KYOWA KIRIN INTERNATIONAL FOR POTELIGEO (MOGAMULIZUMAB)

Knight Therapeutics Inc. has signed an exclusive distribution agreement with Kyowa Kirin International, a wholly owned subsidiary of Kyowa Kirin Co. Ltd., a Japan-based global specialty pharmaceutical company, for mogamulizumab (sold as Poteligeo in the United States and Europe) across certain Latin American countries. Under the terms of this agreement, Knight will be responsible for obtaining regulatory approval and commercializing mogamulizumab in Brazil, Mexico, Colombia and Argentina.

Mogamulizumab is a humanized monoclonal antibody (mAb) targeting chemokine receptor 4 (CCR4), a receptor expressed on malignant T-cells. Poteligeo is approved in the United States and Europe for treatment of adult patients with relapsed or refractory mycosis fungoides or Sezary syndrome after at least one prior systemic therapy, the two most common subtypes of cutaneous T-cell lymphoma. CTCL is a rare form of non-Hodgkin lymphoma that can affect the skin, blood, lymph nodes and internal organs. CTCL often presents with persistent, inflamed skin lesions that can resemble benign dermatologic conditions, leading to delayed diagnosis and treatment. Patients frequently endure painful, itchy and disfiguring skin symptoms that fluctuate unpredictably, contributing to physical discomfort and emotional distress, and can lead to a reduced life expectancy. Epidemiological data for CTCL in Latin America is limited, but is believed to be in line with the United States where the reported annual incidences of MF and SS are 5.42 per million and 0.21 per million, respectively. Together, MF and SS represent approximately 65 per cent of all cases of CTCL.

"We are thrilled to add Kyowa Kirin, a Japan-based global specialty pharmaceutical company, as a new Knight partner. Poteligeo represents an innovative advancement in the treatment of rare cancers, specifically mycosis fungoides and Sezary syndrome. Its addition to our hemato-oncology portfolio addresses a significant unmet medical need and will provide patients across our key Latin American markets with access to a much needed new therapeutic option," said Samira Sakhia, president and chief executive officer of Knight Therapeutics.

Celine Rheme, cluster general manager, emerging growth markets, Kyowa Kirin International, commented: "CTCL is more common in this region than many realize, and further work is needed to identify unmet needs and therefore drive improvements in patient outcomes. 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."

About mogamulizumab

Mogamulizumab is a first-in-class humanized mAb directed against CCR4, a protein expressed on cancerous cells seen in both MF and SS. Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.

The approval of Poteligeo (mogamulizumab) is supported by the Mavoric (mogamulizumab anti-CCR4 antibody versus ComparatOR in CTCL) study, which is the largest randomized trial in MF and SS and the first to compare systemic therapies using progression-free survival as a primary end point. Mavoric was a phase 3 open-label, multicentre, randomized study of mogamulizumab versus vorinostat in patients with MF and SS who have failed at least one prior systemic treatment. The study randomized a total of 372 patients to mogamulizumab or vorinostat. The results showed that mogamulizumab demonstrated significantly superior PFS at a median of 7.7 months (95 per cent CI: 5.7, 10.3) compared with 3.1 months with vorinostat (95-per-cent CI: 2.9, 4.1) (hazard ratio 0.53: 95-per-cent CI: 0.41, 0.69; p is less than 0.001). The confirmed overall response rate for mogamulizumab and vorinostat was 28 per cent and 5 per cent, respectively (risk ratio 23.1, 95-per-cent CI 12.8 to 33.1; p is less than 0.001). The most common side effects associated with mogamulizumab versus vorinostat included rash (36 per cent versus 22 per cent), infusion-related reactions (33 per cent versus less than 1 per cent), upper respiratory tract infections (22 per cent versus 16 per cent), musculoskeletal pain (22 per cent versus 17 per cent), fever (18 per cent versus 6 per cent) and mucositis (14 per cent versus 6 per cent), respectively.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics' shares trade on the Toronto Stock Exchange under the symbol GUD.

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