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Astria Therapeutics, Inc. a US-based biopharmaceutical company, has exclusively licensed development and commercialisation rights in Japan to Kaken Pharmaceutical, a Japanese specialty pharmaceutical company, for navenibart, a long-acting investigational monoclonal antibody inhibitor of plasma kallikrein, in Phase 3 development for the preventative treatment of the rare disease hereditary angioedema (HAE).
Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of severe swelling, often affecting the face, extremities, gastrointestinal tract, and airways.
Under the agreement, Astria will receive an upfront payment of $16 million, with the potential for an additional $16 million in total commercialization and sales milestones. In addition to these payments, Astria is also eligible for tiered royalties with the royalty rate as a percentage of net sales up to 30%, and partial Phase 3 cost reimbursement.
Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics said, “In addition to our shared values that put patients first, Kaken brings strong relationships with the Japanese medical community that we believe will support both our Phase 3 ALPHA-ORBIT trial as well as the potential commercialization of navenibart in the future.”
Hiroyuki Horiuchi, President and Representative Director of Kaken said, “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.”
Kaken will also provide support for the ALPHA-ORBIT Phase 3 trial in Japan, be responsible for regulatory submissions in Japan, and will reimburse Astria for a portion of the costs of the navenibart Phase 3 programme.
