Akebia Therapeutics Inc (NASDAQ: AKBA) has announced the execution of an agreement to end the ex-US and US vadadustat Collaboration and License Agreements with Otsuka Pharmaceutical Co. Ltd. Otsuka will pay Akebia around $55 million in settlement fee as part of the collaboration termination.
Akebia regains access to major markets after the termination of the agreement
Following the termination of the agreement, Akebia will regain ownership of Vadadustat rights from Otsuka in the US, China, Europe, Russia, Australia, Canada, Middle East, Russia, and other territories where Otsuka previously held the rights. Vadadustat is an experimental oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia caused because of chronic disease.
CEO of Akebia John Butler said, “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.”
Otsuka had submitted an MAA to the EMA for vadadustat
In October last year, Otsuka submitted a preliminary Marketing Authorization Application to the European Medicines Agency for vadadustat in treating anemia related to CKD in adults. The evaluation is ongoing. Through procedures defined by the EMA, Otsuka and Akebia will work together to pass the MAA to Akebia. Also, through the Access Consortium, Vadadustat is being evaluated in Australia, Switzerland, and the UK. The accountability for that evaluation will also be transferred to Akebia at a later period that will be determined.
The US FDA sent Akebia a Complete Response Letter for vadadustat in the US. After the FDA end-of-review meeting, Akebia intends to assess and decide on possible next moves for vadadustat in the US. In the US, Akebia has a separate distribution deal in place with Vifor Pharma, which gives access to almost 60% of dialysis patients via Vifor Pharma’s existing relationships.