KalVista Licenses Right to HAE Therapy in Japan to Kaken

Rare Daily Staff

KalVista Pharmaceuticals said that it has licensed commercialization rights to its experimental hereditary angioedema therapy sebetralstat in Japan to Kaken Pharmaceutical for $11 million upfront.

KalVista is eligible to receive an additional $11 million upon achievement of a regulatory milestone anticipated in early 2026. It is also eligible for commercial milestone payments, plus royalties based on the Japan National Health Insurance price, with the royalty rate as a percentage of sales approximately in the mid-twenties.

Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of edema, or swelling, in various parts of the body, including the abdomen, face, feet, genitals, hands, and throat. The swelling can be debilitating and painful. Attacks that obstruct the airways can cause asphyxiation and are potentially life-threatening.

Sebetralstat is an experimental, novel oral plasma kallikrein inhibitor for the treatment of HAE. The company has filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older. It is also investigating its use in children aged 2 to 11.

KalVista received Orphan Drug designation for sebetralstat from Japan’s Ministry of Health, Labour and Welfare and the company has submitted a New Drug Application for sebetralstat in Japan. If approved, sebetralstat would be the first oral on-demand treatment for HAE in the country.

“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,” said Ben Palleiko, CEO of KalVista. “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.”

Photo: Benjamin Palleiko, CEO of KalVista