Akebia Therapeutics and Keryx Biopharmaceuticals have inked a merger agreement that will create a fully integrated biopharmaceutical company focused on chronic kidney disease (CKD). The combined company, with a value of about $1.3 billion, will be named Akebia Therapeutics, Inc.

John P. Butler, president and chief executive officer, Akebia, is expected to lead the combined company, and Keryx will appoint the chairperson of the board of directors of the combined company. Additionally, Jason A. Amello, Akebia’s chief financial officer, is expected to serve in the same capacity on the management team of the combined company.

The merger of the two companies creates a renal-focused company. Keryx’s Auryxia (ferric citrate) is a U.S. FDA-approved medicine to treat dialysis dependent CKD patients for hyperphosphatemia and non-dialysis dependent CKD patients for iron deficiency anemia (IDA). Akebia’s vadadustat is an investigational Phase 3 oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) with the potential to advance the treatment of patients with anemia due to CKD, many of whom are currently receiving injectable erythropoietin-stimulating agents (ESAs). The companies believe that Auryxia and vadadustat, if FDA-approved, have the potential to deliver an all-oral treatment approach for patients with anemia due to CKD. More broadly, the combined company has the potential to offer therapeutic options to patients across all stages of CKD, including non-dialysis dependent and dialysis dependent patients, and to become a partner of choice for the renal community and for companies developing renal products.

“The strategic and financial drivers of this merger are compelling,” said Mr. Butler. “The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia, a product with significant growth opportunity, and vadadustat, an investigational late-stage HIF-PHI that has the potential to provide a new oral standard of care to patients with anemia due to CKD. Combining Akebia and Keryx creates a leading renal company and provides it with the infrastructure to maximize the market potential of Auryxia and build launch momentum for vadadustat in the U.S., subject to FDA approval.”

Jodie Morrison, interim chief executive officer, Keryx, said, “Bringing Keryx together with Akebia represents a unique, value-enhancing opportunity for stakeholders of both companies. Akebia shareholders gain access to the only oral iron tablet approved in the U.S. to treat dialysis dependent CKD patients for hyperphosphatemia and non-dialysis dependent CKD patients for iron deficiency anemia. Keryx shareholders gain access to an innovative Phase 3 product candidate with the potential to compete in a complementary multi-billion-dollar market upon successful completion of its development program.”