Cambridge, MA & Salisbury, England— KalVista Pharmaceuticals has entered into a licensing agreement with Tokyo-based Kaken Pharmaceutical to commercialize sebetralstat, an investigational treatment for hereditary angioedema (HAE), in Japan. The deal could be worth up to $24 million, in addition to royalties based on product sales.
Under the terms of the agreement, KalVista will receive $11 million upfront, with an additional $11 million contingent on regulatory approval expected in early 2026. The company is also eligible for commercial milestone payments and royalties estimated to be in the mid-twenties percentage range, based on Japan’s National Health Insurance (NHI) price.
Sebetralstat, an oral, on-demand therapy for HAE attacks, has the potential to become the first treatment of its kind available in Japan. The drug has already received Orphan Drug Designation from Japan’s Ministry of Health, Labour and Welfare (MHLW), and a New Drug Application (NDA) has been submitted for regulatory review.
KalVista CEO Ben Palleiko said the collaboration supports the company’s broader strategy of global expansion for sebetralstat. “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,” Palleiko said.
Kaken, known for its successful commercialization of innovative therapies in Japan, is expected to leverage its regional expertise to support the drug’s rollout, should it receive approval.
If approved, sebetralstat would provide a new, convenient oral option for patients managing the rare and potentially life-threatening genetic condition, marking a significant advancement in the treatment landscape for HAE in Japan.
