Kiniksa Pharmaceuticals International, plc

Kiniksa Pharmaceuticals International, plc is a biopharmaceutical company that develops and commercializes new therapies for diseases with unmet medical needs, primarily focusing on cardiovascular conditions. The company's main product is ARCALYST, an interleukin-1α ("IL-1α") and interleukin-1β ("IL-1β") cytokine trap. Kiniksa licensed ARCALYST from Regeneron in 2017, acquiring exclusive worldwide rights, excluding the Middle East and North Africa, for all applications except oncology and local administration to the eye or ear. In March 2021, the FDA approved ARCALYST for treating recurrent pericarditis and reducing the risk of recurrence in adults and children aged 12 years and older. Recurrent pericarditis is an inflammatory cardiovascular disease affecting an estimated 40,000 patients in the United States who seek and receive medical treatment. ARCALYST is also approved in the United States for treating Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Autoinflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome in adults and children aged 12 years and older. Additionally, it is approved for maintaining remission in Deficiency of Interleukin-1 Receptor Antagonist ("DIRA") in adults and children weighing 10 kg or more. ARCALYST is sold across the United States through a network of specialty pharmacies. Kiniksa handles sales and distribution for all approved indications in the United States and shares profits from sales and third-party proceeds equally with Regeneron. In 2022, Kiniksa granted Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. ("Huadong") exclusive rights to develop and commercialize ARCALYST in the Huadong Territory. Regeneron began transferring the ARCALYST drug substance manufacturing process in 2023, and Kiniksa is working to qualify Samsung as its new contract development and manufacturing organization (CDMO). In December 2024, Kiniksa started a collaborative study with The Mayo Clinic (and Johns Hopkins University) to research ARCALYST's effects in treating cardiac sarcoidosis.