On June 30, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that it has executed an agreement to terminate the U.S. and ex-U.S. vadadustat Collaboration and License Agreements with Otsuka Pharmaceutical Co., Ltd. (Otsuka) (Press release, Akebia, JUN 30, 2022, View Source [SID1234616419]). As part of the termination, Otsuka has agreed to pay Akebia a settlement fee of $55 million.

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As a result of the termination of the agreements, Akebia is regaining the rights from Otsuka for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in the United States, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories.

"We continue to believe in the potential of vadadustat as an oral treatment for patients with anemia due to chronic kidney disease, and we are pleased to be regaining the full rights to the product in these important markets," said John Butler, Chief Executive Officer of Akebia. "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."

In October 2021, Otsuka submitted an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for vadadustat for the treatment of anemia associated with chronic kidney disease (CKD) in adults. The review is in progress. Otsuka and Akebia will coordinate to transfer the MAA to Akebia through processes outlined by the EMA. Vadadustat is also under review in the United Kingdom, Switzerland, and Australia through the Access Consortium. Responsibilities for that review will transfer to Akebia as well at a date to be agreed upon.

In the U.S., Akebia received a Complete Response Letter from the U.S. Food & Drug Administration (FDA) for vadadustat. Akebia plans to evaluate and determine potential next steps for vadadustat in the U.S. following the end of review conference with the FDA.

In the U.S., Akebia separately has a distribution agreement in place with Vifor Pharma, providing potential access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships. Mitsubishi Tanabe Pharma Corporation owns development and commercialization rights to vadadustat in Japan and certain other Asian counties.