Akebia partners with Otsuka on anemia drug
- Cambridge, MA-based Akebia Therapeutics has signed a deal potentially worth over $1 billion with Japanese pharma Otsuka Pharmaceutical for the U.S. commercialization of its anemia drug vadadustat.
- The companies will split costs and revenues of vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer, should it get approved by the Food and Drug Administration. Akebia will continue Phase 3 development, and will get $265 million in committed funds from Otsuka, including $125 million upon signing and another $35 million in the first quarter of 2017.
- The agreement provides Akebia with $105 million in funding, along with development and commercial milestones of up to $765 million.
Anemia associated with chronic kidney disease affects around 1.8 million people in the U.S., and if it is untreated it increases illness and risk of death. Sales of the current standard of care, erythropoiesis-stimulating agents (ESAs), are around $3.5 billion.
The deal between Akebia and Otsuka Pharmaceutical, the U.S. subsidiary of Japanese company Otsuka Holdings, covers capital for the PRO2TECT and INNO2VATE Phase 3 studies for non-dialysis-dependent and dialysis-dependent chronic kidney disease, and commercial resources for a U.S. launch should vadadustat gain FDA approval.
Vadadustat fits into Otsuka's cardio-renal franchise, where it will sit alongside programs for treating autosomal dominant polycystic kidney disease (ADPKD).
"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. "With Akebia's renal expertise, this collaboration will enable Otsuka to expand our cardio-renal portfolio."
This isn't the first pharma deal for Akebia's vadadustat. Back in May 2015, Akebia signed a $350 million deal with Mitsubishi Tanabe Pharma for the Asian market, including Japan, Taiwan, South Korea, Indonesia, and India. This deal also incorporated funding towards global Phase 3 trials.
Follow Suzanne Elvidge on Twitter