Vifor Pharma will make a $50 million equity investment in Akebia Therapeutics, the companies said, as part of a deal through which Vifor agreed to sell Akebia’s anemia drug vadadustat to Fresenius Medical Care dialysis clinics in the U.S. if the Phase III candidate is approved by the FDA.
Vifor Pharma will snap up shares of Akebia at $14 per share, 7% below yesterday’s closing price of $15.01 per share minutes before the deal was announced.
Under a licensing agreement inked by the companies, Vifor Pharma will exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its U.S. dialysis facilities. Fresenius is the largest kidney dialysis provider in the U.S., treating more than 185,000 dialysis patients last year—nearly 40% of the U.S. dialysis patient population.
“This transaction strengthens the nephrology product portfolio of Vifor Pharma and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease,” Stefan Schulze, Vifor Pharma COO and president of the company’s Executive Committee, said yesterday in a statement.
The agreement is structured as a profit-sharing arrangement between Akebia and Vifor Pharma. In addition to FDA approval, the deal is also subject to inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma.
Akebia has agreed to share revenue from the profit share and the milestone payment with Otsuka Pharmaceutical, its U.S. collaborator. Akebia and Otsuka plan to commercialize vadadustat in other dialysis organizations and centers as well as in the nondialysis market in the U.S.
Just last month, Otsuka and Akebia expanded their collaboration for U.S. development of vadadustat to encompass additional territories, including Europe, Canada, China, Russia, Australia, and the Middle East.
Vadadustat (also called AKB-6548) is an hypoxia-inducible factor (HIF) stabilizer candidate that acts by inhibiting HIF prolyl hydroxylase (HIF-PH), and is undergoing Phase III evaluation as an oral therapy for anemia associated with chronic kidney disease (CKD). Vadadustat is designed to apply the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude.
“This agreement provides the opportunity to build greater commercial momentum for vadadustat in the U.S. rapidly upon launch,” added Akebia president and CEO John P. Butler. “We believe that this commitment provides significant further validation of vadadustat’s potential.”
The agreement enhances Vifor Pharma’s topline months after its former sister unit Galenica Santé was spun off through an initial public offering on the SIX Swiss Exchange that raised $1.9 billion—Europe’s largest IPO so far this year.
The deal also adds further to vadadustat’s potential revenue, which has been enhanced through partnerships by Akebia with Otsuka as well as Mitsubishi Tanabe Pharma.
In December 2015, Akebia and Mitsubishi Tanabe agreed a potentially $390 million deal to develop and commercialize vadadustat in Japan, Taiwan, South Korea, Indonesia, India, and other Asian countries. The financial arrangements included a $100 million investment by Mitsubishi into the global Phase III program for the drug.