KalVista Pharmaceuticals has licensed commercialisation rights for sebetralstat, an oral on-demand treatment for hereditary angioedema (HAE), to Kaken Pharmaceutical in Japan.
KalVista will be paid $11m upfront, with the possibility of a further $11m upon reaching a regulatory milestone expected by early 2026.
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Based on the Japan National Health Insurance price, the company is also qualified for commercial milestone payments, with the rate as a sales percentage in the mid-20s.
The oral plasma kallikrein blocker sebetralstat has been granted orphan drug status by Japan’s Ministry of Health, Labour and Welfare, and KalVista has filed a new drug application for the treatment in the country.
Sebetralstat becomes the country’s first oral on-demand HAE treatment.
KalVista CEO Ben Palleiko stated: “We are pleased to partner with Kaken, whose expertise and demonstrated success in the region make them well-suited to work alongside our exceptional team to bring sebetralstat to the HAE community in Japan.
“This collaboration is an important part of our strategy to expand the global reach of sebetralstat as we prepare for several commercial launches starting this year. Our focus remains on delivering a safe and effective oral on-demand therapy that we believe will make a meaningful difference for people living with HAE worldwide.”
The therapy is currently undergoing US Food and Drug Administration regulatory review, with a Prescription Drug User Fee Act goal date set for 17 June 2025.
The company has also submitted applications for marketing authorisation to the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency and other worldwide regulatory bodies.
Research is underway to assess the therapy’s use in paediatric patients aged two to 11.
This licensing agreement follows a partnership formed in March 2025 between Alumis and Kaken Pharmaceutical, focusing on the development and commercialisation of ESK-001 for dermatological conditions in Japan.
