Otsuka and Akebia Therapeutics expanded their existing collaboration for U.S. development of the latter’s hypoxia-inducible factor (HIF) stabilizer vadadustat (AKB-6548) to encompass additional territories, including Europe, Canada, China, Russia, Australia, and the Middle East. Vadadustat acts by inhibiting HIF prolyl hydroxylase (HIF-PH), and is undergoing Phase III evaluation as an oral therapy for anemia associated with chronic kidney disease (CKD).

Otsuka and Akebia inked their potentially $1 billion deal for vadadustat in the U.S. in December 2016. Under terms of the expanded collaboration, announced late yesterday, Akebia will receive a $73 million up-front fee, plus at least $135 million in development funding and up to $657 million in milestones. The firm will also potentially earn royalties of up to 30% on net sales of the drug in Otsuka’s designated territories.

Commenting on the deal, John P. Butler, president and CEO at Cambridge, MA-based Akebia, stated, “We now have a single, strong collaborator for the two largest markets, the U.S. and Europe. This simplifies governance and decision making, maximizing the efficiency of our global Phase III development program and ultimately the commercialization of vadadustat. We are able to accomplish this while obtaining substantial funding for our vadadustat development program and retaining significant long-term value for Akebia.”

In December 2015, Akebia and Mitsubishi Tanabe agreed a potentially $390 million deal to develop and commercialize vadadustat in Japan, Taiwan, South Korea, Indonesia, India, and other Asian countries. The financial arrangements included a $100 million investment by Mitsubishi into the global Phase III program for the drug.

Vadadustat is being evaluated in two Phase III programs in patients with anemia secondary to chronic kidney disease. The PRO2TECT™ trials involve nondialysis patients, and the INNO2VATE™ program includes dialysis-dependent patients.

In February, Akebia negotiated a research and license deal with Janssen Pharmaceutica for the latter’s portfolio of novel HIF-PF–targeting compounds.

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