Kaken Pharmaceutical Expands HAE Portfolio with $32M Deal for Astria's Navenibart in Japan

Kaken Pharmaceutical has significantly bolstered its presence in the hereditary angioedema (HAE) market through a new licensing agreement with Astria Therapeutics. The deal, valued at up to $32 million, grants Kaken the rights to develop and commercialize navenibart, Astria's phase 3-stage HAE drug, in Japan.

Deal Structure and Financial Terms

Under the terms of the agreement, Kaken will pay an upfront fee of $16 million to Astria Therapeutics. The deal includes potential additional payments of up to $16 million in commercialization and sales milestones. Astria is also eligible for tiered royalties on net sales and partial reimbursement of its ongoing phase 3 trial costs.

Jill Milne, Ph.D., CEO of Astria Therapeutics, expressed enthusiasm about the partnership, stating, "We are thrilled to partner with Kaken for the development and commercialization of navenibart in Japan, which advances our strategy to enable broad access to navenibart globally."

Navenibart: A Promising HAE Treatment

Navenibart is a monoclonal antibody inhibitor of plasma kallikrein, currently in phase 3 clinical trials for HAE treatment. The drug demonstrated promising results in a phase 1b/2 trial last year, showing up to a 92% reduction in HAE attacks at six months.

HAE is a genetic disorder characterized by low levels or dysfunction of the C1 inhibitor, leading to severe swelling attacks across the body. These attacks can be potentially fatal if they affect the lungs.

Kaken's Strategic Expansion in HAE

This deal marks Kaken's second major acquisition in the HAE space this year. In April, the company secured the Japanese rights to KalVista Pharmaceuticals' sebetralstat, another late-stage HAE asset. Sebetralstat, now branded as Ekterly, received FDA approval last month.

Hiroyuki Horiuchi, President of Kaken, commented on the strategic fit of navenibart, saying, "We believe that navenibart is a complementary fit with our HAE portfolio, providing patients in Japan with the potential for low-burden treatments to better manage their disease."

Competitive Landscape in HAE Treatment

The HAE treatment market has seen significant activity recently. Earlier this year, CSL's HAE preventative treatment Andembry was approved in Japan, followed by FDA approval in June. These developments set the stage for increased competition with established treatments like Takeda's Takhzyro and BioCryst Pharmaceuticals' Orladeyo.

As Kaken strengthens its position in the HAE market, the company continues to expand its portfolio across various therapeutic areas, including dermatology and osteoarthritis. This latest deal with Astria Therapeutics further solidifies Kaken's commitment to addressing unmet medical needs in the Japanese healthcare landscape.