Takeda to make an upfront payment of $300m and up to $740m to Arrowhead as potential milestone payments


Takeda Pharmaceutical Company headquarters in Chuo-ku, Osaka, Japan. (Credit: J o/Wikipedia.)

Japan-based pharmaceutical firm Takeda has signed a collaboration and licensing agreement with US-based Arrowhead Pharmaceuticals, for ARO-AAT to treat a type of liver disease.

Under the terms of the agreement, Takeda and Arrowhead will jointly develop ARO-AAT, and commercialise in the US under a 50/50 profit-sharing basis, if approved.

Takeda gets an exclusive license to commercialise ARO-AAT outside the US, and will lead the global commercialisation strategy. Arrowhead will receive royalties of 20-25% on net sales of the product.

Arrowhead will receive a payment of $300m upfront and is entitled to receive up to $740m in potential development, regulatory and commercial milestone payments.

Closure of the deal is subject to completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the US, said the company.

Takeda gastroenterology therapeutic area unit head Asit Parikh said: “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.

“We are excited to collaborate with Arrowhead to bring forward this exciting late-stage liver asset for the Alpha-1 community as part of our growing GI portfolio.”

ARO-AAT to treat AATLD by limiting the production of Z-AAT protein by liver

ARO-AAT is an investigational RNA interference (RNAi) therapy under Phase 2 development, to treat alpha-1 antitrypsin-associated liver disease (AATLD).

AATD is a rare genetic disorder related to liver disease in paediatric and adult patients and pulmonary disease in adults. The protein AAT is primarily synthesized and secreted by liver hepatocytes.

Arrowhead has designed the potential therapy to reduce the hepatic production of mutant alpha-1 antitrypsin (Z-AAT) protein, the cause of progressive liver disease in AATD patients.

Lowering the production of the inflammatory Z-AAT protein is believed to prevent the progression of liver disease and is anticipated to regenerate and repair the tissue, said the company.

Arrowhead president and CEO Christopher Anzalone said: “Takeda’s global presence and experience with payers and regulators in the rare disease and GI therapy space, combined with its long history 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 severe unmet need of patients with Alpha-1 liver disease.

“This agreement also supports our strategy of using partnering selectively to continue to invest in our Targeted RNAi Molecule (TRiMTM) platform and the growing pipeline of RNAi therapeutics targeting diverse tissue types, while focusing our commercial organization on opportunities in two key areas of cardiometabolic and pulmonary.”