AB2 Bio signs USD 600 million agreement with Nippon Shinyaku

AB2 Bio has entered into an option and licensing agreement with Nippon Shinyaku Co. Ltd., a leading Japanese pharmaceutical company with extensive experience in marketing rare disease therapeutics in the U.S. Under the terms of the agreement, Nippon Shinyaku received an option to acquire exclusive U.S. rights to commercialize Tadekinig alfa to treat Primary Monogenic IL-18 driven Hyperinflammatory Syndrome, a rare and potentially life-threatening pediatric disease that, if left untreated, may rapidly lead to multiple-organ failure and death. AB2 Bio will continue to prepare for filing for U.S. Biologics License Application (BLA) approval for Tadekinig alfa in the indication.

AB2 Bio receives early payments of up to USD 36 million (including an initial payment of USD 6 million upon closing) and would be eligible for development milestone payments of up to USD 150 million and and commercial milestone and royalty payments of up to USD 500 million. Nippon Shinyaku would have the exclusive right to commercialize Tadekinig alfa for its lead indication, Primary Monogenic IL-18 driven Hyperinflammatory Syndrome in patients with NLRC4 mutation and XIAP deficiency, in the U.S. AB2 Bio retains rights to Tadekinig alfa for all other indications in the U.S. and all indications in the rest of the world.

Tadekinig alfa is a novel, recombinant human interleukin-18 Binding Protein (IL-18 BP) that binds and inhibits IL-18, a major proinflammatory cytokine. AB2 Bio is currently conducting a pivotal Phase III clinical trial in patients (children and adults) with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency.

“This partnership will accelerate bringing Tadekinig alfa to young patients suffering from this rare and devastating disease and potentially provide a significant improvement in treatment,” said Dr. Djordje Filipovic, CEO of AB2 Bio. “Nippon Shinyaku has an impressive and established track record of commercializing rare disease therapies in the U.S., and their expertise will be invaluable for maximizing the potential of Tadekinig alfa.”

“AB2 Bio is a global pioneer in developing therapies for IL-18 driven diseases and conditions,” said Dr. Toru Nakai, President & Representative Director of Nippon Shinyaku. “Monogenic IL-18 driven hyperinflammation is a rare, serious, and potentially life-threatening condition without any FDA- approved treatment options. I am delighted to enter into an agreement with AB2 Bio to bring this extremely promising therapy to the U.S. patients that need it.”