Akebia Regains Rights to Anemia Drug After Otsuka Partnership Dissolves

Otsuka Pharmaceutical terminated a deal with Akebia Therapeutics, ending the U.S. and ex-U.S. vadadustat Collaboration and License Agreements. As part of the termination of the deal, Otsuka will pay Akebia a $55 million settlement fee.

Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor. Essentially, it mimics the physiologic effect of altitude on oxygen available. It is under development for anemia due to chronic kidney disease (CKD).

Back in May, Otsuka announced plans to terminate the deal. They originally entered the pacts in December 2016 for the U.S. and April 2017 for Europe and other regions. The two companies were co-developing the drug for renal anemia.

On March 30, the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for vadadustat to treat anemia due to chronic kidney disease, citing safety concerns. A month later, Akebia laid off 42% of its workforce, or about 180 people, to “refocus its strategic priorities.” It also planned to shift resources to its commercial drug, Auryxia, and its development pipeline.

At Akebia’s first-quarter financial report on May 9, John Butler, CEO, said, “While we were surprised and disappointed by the vadadustat Complete Response Letter we received from the FDA in March, our team has responded aggressively by working to strengthen and secure the company financially, with an aim of allowing us to continue to deliver on our purpose to better the lives of people impacted by kidney disease.”

The drug is being reviewed by the European Medicines Agency (EMA), and the two companies plan to coordinate on transferring the Marketing Authorization Application (MAA) to Akebia as described by EMA guidelines. It is also under review in the UK, Switzerland, and Australia via the Access Consortium. Those will also transfer to Akebia at a date the two companies will agree upon.

Akebia has a distribution deal in the U.S. with Vifor Pharma, which could potentially provide access to up to 60% of U.S. dialysis patients. In Japan and certain other Asian countries, Mitsubishi Tanabe Pharma Corporation owns development and commercialization rights to vadadustat.

“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,” 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.”

For its part, Otsuka and its partner Lundbeck reported positive results from a Phase III trial this week for brexpiprazole for the treatment of agitation in patients with Alzheimer’s dementia. The drug demonstrated a statistically significantly greater reduction in agitation compared to the placebo. The drug was discovered by Otsuka and is being co-developed by both companies.

The drug was first approved in July 2015 in the U.S. as an adjunctive therapy to antidepressants in adults with major depressive disorder and adults with schizophrenia.

Based on that clinical result, they expect to file a supplemental New Drug Application (sNDA) to the FDA later this year. The FDA granted fast-track designation for the drug for this indication in February 2016.