Date: 12-Oct-2020

Takeda And Arrowhead Cooperate To Jointly Develop And Commercialize ARO-AATs For Alpha-1 Antitrypsin Associated Liver Disease

Takeda Pharmaceutical Company Limited and Arrowhead Pharmaceuticals Inc. announced a collaboration agreement and license 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 possible first-class therapy designed to reduce the production of the mutant alpha-1 antitrypsin protein, which is the cause of AATLD progression.

Under the terms of the agreement, Takeda and Arrowhead will jointly develop ARO-AAT which, if approved, will be jointly marketed in the United States under a 50/50 profit sharing structure. Outside of the United States, Takeda will drive the global marketing strategy and receive an exclusive license to trade ARO-AAT with Arrowhead eligible to receive tiered royalties of 20-25% on net sales. Arrowhead will receive an initial payment of $ 300 million and is eligible to receive up to $ 740 million for potential development, regulatory and business milestones. The closing of the transaction is conditional on the completion of the review of antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the US.

"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 patients avoid the need for a liver transplant and associated comorbidities, "said Dr. Asit Parikh, chief of the Gastroenterology Therapeutic Area Unit at Takeda. "We are excited to collaborate with Arrowhead to introduce this promising late-stage liver asset to the alpha-1 community as part of our growing GI portfolio."

"Takeda's global presence and expertise with payers and regulators in the rare disease and gastrointestinal therapy space, combined with its long history of serving the alpha-1 community, make it the ideal partner for ARO-AAT. It is well positioned to work with the patient and medical community to help meet the serious unmet needs of patients with alpha-1 liver disease, "said Dr. Christopher Anzalone, Arrowhead President and CEO. "This agreement also supports our strategy of using the association selectively to continue investing in our platform directed RNAi molecule (TRIM TM) and the growing structure of RNAi therapeutics targeting diverse tissue types, while our business organization focuses on opportunities in two key areas, cardiometabolism and lung disease