Akebia Therapeutics Inc. and Otsuka Pharmaceutical Co. Ltd have entered into a collaboration and license agreement in the U.S. for vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in development to treat anemia associated with chronic kidney disease.
The collaboration provides capital for the global development program for vadadustat, and commercial resources for a U.S. launch of the drug upon approval by the U.S. Food and Drug Administration.
Under the terms of the agreement, Akebia will receive $265 million in committed funds plus development and commercial milestones, representing a total transaction value that could exceed $1 billion.
The companies said they intend to contribute equally to commercialization efforts and share equally all costs and revenue in the U.S., where sales of erythropoiesis stimulating agents are estimated to be $3.5 billion.
Akebia said it will continue to lead the ongoing global Phase 3 development program for vadadustat.
“Vadadustat has the potential to significantly change the current standard of care for patients with anemia associated with CKD and addresses a high unmet need for those suffering with this disease,” said Tatsuo Higuchi, president and representative director of Otsuka.
In addition to the collaboration with Otsuka, Akebia has established a collaboration with Mitsubishi Tanabe Pharma Corporation for the development and commercialization of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and other countries in Asia.