Nippon Shinyaku to pay $36M to reserve US rights to AB2 Bio's near-approval autoimmune drug

puzzle, pact
For now, AB2 Bio will continue preparing to make an approval application to the FDA for hyperinflammatory syndrome. (iStock / Getty Images Plus)

Japan’s Nippon Shinyaku is continuing to scoop up the international rights to some intriguing drugs, this time penning a $686 million biobucks deal for AB2 Bio’s late-stage autoimmune disease therapy.

AB2 has been developing the IL-18 inhibitor, called tadekinig alfa, as a potential treatment for monogenic IL-18-driven hyperinflammatory syndrome in patients with NLRC4 mutation and XIAP deficiency. The Swiss biotech has completed a phase 3 trial of the drug in this indication, a rare disease seen in children that can lead to organ failure and death if left untreated. There are currently no approved therapies for the disease.

In return for the option to secure the U.S. rights to commercialize the drug for IL-18-driven hyperinflammation, Nippon Shinyaku is making an upfront payment of $6 million and early payments of an additional $30 million. AB2 will also be in line for up to $150 million in development milestones and another $500 million in commercial milestones and royalty payments should the drug make it to market.

For now, AB2 Bio will continue preparing to make an approval application to the FDA for hyperinflammatory syndrome. The agreement also leaves the Swiss biotech with the rights to commercialize tadekinig alfa in the U.S. for any other indications, as well as all rights outside of the U.S.

“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,” AB2 CEO Djordje Filipovic, Ph.D., said in the Jan. 27 release. “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.”

Nippon has been on the hunt for assets to commercialize in various markets. Having secured the U.S. license for Capricor Therapeutics’ late-stage Duchenne muscular dystrophy therapy in 2022, it tacked on the European rights last September. Earlier this month, the Kyoto-based company paid out $110 million for the U.S. and Asia rights to RegenXBio’s Hunter syndrome gene therapy.