Akebia Therapeutics, Inc. (AKBA - Free Report) and Switzerland-based Vifor Pharma Group amended the license agreement to sell vadadustat in the United States to include certain third-party dialysis organizations.
The original agreement, signed in 2017, allowed Vifor Pharma to sell vadadustat, following an FDA approval, solely to dialysis clinics of Fresenius Medical Care North America. Per the amended terms of the agreement, Vifor Pharma will be eligible to sell vadadustat to certain third-party dialysis organizations in the United States, which will help the drug to cover 60% of the U.S. dialysis patient population.
Akebia is evaluating vadadustat, an oral hypoxia-inducible factor ("HIF") prolyl hydroxylase inhibitor, in late-stage global development programs for treatment of anemia due to chronic kidney disease (“CKD”).
Shares of the company have increased 34.9% so far this year compared with the industry’s rise of 16.7%.
The amended terms of the agreement make Akebia eligible to receive $25 million, an additional $5 million, from Vifor Pharma upon potential approval of vadadustat and determination of the reimbursement system for the drug by the Centers for Medicare & Medicaid. The license agreement, upon amendment, will remain valid for two CMS reimbursement programs – End Stage Renal Disease Prospective Payment System and Transitional Drug Add-on Payment Adjustment.
In March, Akebia announced positive top-line data from four phase III studies evaluating the candidate in patients in Japan with anemia due to CKD. Data from the studies showed that vadadustat met the primary endpoint of non-inferiority to Amgen’s (AMGN - Free Report) Aranesp (darbepoetin alfa) in improving mean hemoglobin level from baseline after treatment for 20 and 24 weeks. The company plans to submit a regulatory application in Japan seeking approval for vadadustat later this year. Pivotal studies to support approval of the candidate in the United States and Europe are currently underway.
Vadadustat may face competition upon approval from already approved drugs for anemia in CKD patients. The already approved drugs include Amgen’s Epogen and Aranesp and J&J’s (JNJ - Free Report) Procrit and Eprex. Several other pharma companies are developing candidates with similar mechanism including FibroGen (FGEN - Free Report) and Glaxo.
Akebia has one product in its marketed portfolio, Auryxia, approved for two indications — to control serum phosphorus levels in CKD patients and to treat iron deficiency anemia in patients with CKD. Sales of the drug were encouraging in 2018, increasing 72% year over year to $96 million.
We remind investors that in December Akebia completed its merger with Keryx Biopharmaceuticals to boost its pipeline of renal candidates.
Akebia currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
See Latest Stocks Today >>