Mitsubishi Tanabe backs Akebia PhIII with a $350M Asian deal for vadadustat

Akebia CEO John Butler

Three months after reassuring investors with upbeat Phase II data for its lead drug, Akebia Therapeutics ($AKBA) has inked a $350 million Asian deal on the therapy, gaining a $40 million upfront and $60 million more in cash support for the pivotal study.

Mitsubishi Tanabe Pharma is stepping up to take the commercial lead on a roster of Asian markets, backing a Phase III program for vadadustat, an oral treatment for anemia related to chronic kidney disease. In addition to the cash, Akebia will also garner royalties ranging up to 20% for future sales in Asia.

Akebia's shares were up 13% in early trading Monday.

Akebia had startled investors earlier in the year with some mixed data for the drug, but then calmed things down considerably in early September with positive Phase II results. In the latest data, the biotech showed that patients transferring from a standard treatment maintained healthy hemoglobin levels.

There were also no serious adverse events to report, helping to maintain confidence in safety.

Akebia has some well-financed rivals in this field. FibroGen ($FGEN) and its global partners AstraZeneca ($AZN) and Astellas launched a Phase III for roxadustat (FG-4592) last year while GlaxoSmithKline ($GSK) has been navigating a mid-stage program for a similar anemia drug dubbed daprodustat (GSK1278863).

In October, Akebia outlined its Phase III strategy. The Cambridge, MA-based biotech is planning to mount two late-stage studies enrolling 3,100 patients with non-dialysis dependent chronic kidney disease. One study will enroll patients who are not on recombinant erythropoiesis stimulating agents (rESAs) while the other study enrolls patients who are on rESAs and convert them to the experimental level, looking to maintain hemoglobin levels. 

"MTPC is one of the largest, most successful pharmaceutical companies in Japan with a substantial presence in these Asian markets," Akebia CEO John Butler noted in a statement. "They are committed to the development and commercialization of innovative products, with a strategic focus on products for renal disease and diabetes, making them an ideal partner for Akebia."

- here's the release