Otsuka calls it quits on multibillion-dollar Akebia deal

May 16, 2022

Japanese drugmaker Otsuka Pharmaceutical has decided to terminate its global license agreements with Akebia Therapeutics for vadadustat, under development as an oral treatment for anemia associated with chronic kidney disease (renal anemia), following the drug's FDA rejection.

The U.S. FDA rejected Akebia's anemia pill, vadadustat, in late March over safety concerns. When compared with currently approved injectable medicines for patients with chronic kidney disease, the risk-benefit did not fall in vadadustat's favor, according to the agency. 

The drug was the cornerstone of two deals with Otsuka. The agreements — one for the U.S. and one international — were signed in December 2016 and April 2017, respectively. Now, Otsuka is bailing on both.

As reported by Akebia in an SEC filing, Massachusetts-based biotech received written notice on May 12 that Otsuka elected to terminate the collaboration and license agreements. The international agreement will end in May 2023, however, the U.S deal may end much sooner if Otsuka gets its way. According to Akebia, Otsuka has provided notice of termination for alleged "material breaches." If these alleged breaches are not fixed, it could result in the U.S. agreement ending as soon as June 12, 2022.

But according to Akebia, the company disagrees with and intends to dispute Otsuka’s allegations of material breach and "does not believe that Otsuka has a right to terminate the Otsuka U.S. Agreement for material breach."

As for vadadustat, Akebia plans to request an end of review meeting with the FDA and will then evaluate and determine potential next steps for vadadustat in the U.S.