2022-07-04| Licensing

Akebia Therapeutics Gains $55M Following Deal Termination by Otsuka Pharmaceutical

by Fujie Tham
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Otsuka Pharmaceutical agreed to pay Cambridge, Massachusetts-based Akebia Therapeutics $55 million for terminating the vadadustat oral anemia drug’s licensing deal following rejection by the FDA.

As a result of the termination, the biotech is regaining rights from Otsuka for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor inside and outside the US. Earlier this May, the FDA issued a complete response letter in response to vadadustat’s safety concerns, deeming the drug is not ready for approval.

Related article: FDA Halts Sanofi’s $3.7B Multiple Sclerosis Investment


Otsuka Terminates Deal Following Safety Issues 


FDA concluded that the data in vadadustat’s New Drug Application (NDA) showed increased risk of cardiovascular issues (thromboembolic events) and drug-induced liver injury. FDA said that Akebia could explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials.

A few weeks later, Otsuka decided to drop the medicine, causing disputes between both companies. Otsuka alleged breaches that could lead to a premature termination of the partnership, while Akebia denies said claims.

“Otsuka has been a strong partner for many years, and we appreciate their desire to have an efficient transfer of the responsibilities back to Akebia. We plan to continue to pursue approval for vadadustat to make it available to patients in these territories, and we are excited about the potential additional value this brings to Akebia, as we continue to work to build the company into the future,” said John Butler, Akebia CEO.

Vadadustat is currently under review by the European Medicines Agency (EMA) for treating anemia due to chronic kidney disease in adults. In Japan, the drug is approved for chronic kidney disease anemia in both dialysis and non-dialysis dependent adults.

For Akebia, this cash injection is a significant sum, making the smaller biotech better funded than competitors on a similar scale. Following the news, Akebia’s share price jumped 50%, crossing the $0.50 mark.


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