Takeda, Arrowhead Ink Collaboration And Licensing Deal To Develop ARO-AAT

(RTTNews) - Japan's Takeda Pharmaceutical Co. Ltd. (TAK) and Arrowhead Pharmaceuticals Inc. (ARWR) said Thursday they have entered into a collaboration and licensing agreement to develop ARO-AAT, a Phase 2 investigational RNA interference (RNAi) therapy in development to treat alpha-1 antitrypsin-associated liver disease (AATLD).

ARO-AAT is a potential first-in-class therapy designed to reduce the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression.

Alpha-1 Antitrypsin-Associated Deficiency or AATD is a rare genetic disorder associated with liver disease in children and adults and pulmonary disease in adults. AATD is estimated to affect 1 per 3,000 to 5,000 people in the United States and 1 per 2,500 in Europe.

Under the terms of the deal, Takeda and Arrowhead will co-develop ARO-AAT which, if approved, will be co-commercialized in the U.S. under a 50/50 profit-sharing structure.

Outside the U.S., Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT, with Arrowhead eligible to receive tiered royalties of 20 percent to 25 percent on net sales.

Arrowhead will receive an upfront payment of $300 million and is eligible to receive potential development, regulatory and commercial milestones up to $740 million.

Closing of the transaction is contingent on completion of review under antitrust laws.

"AAT-associated liver disease is a devastating condition for which there are no approved therapies. With its RNAi-based mechanism of action, ARO-AAT has the potential to treat the underlying cause of AATLD, thereby helping patients avoid the need for liver transplantation and associated co-morbidities," said Asit Parikh, Head, Gastroenterology Therapeutic Area Unit at Takeda.