Akebia Therapeutics and Keryx Biopharmaceuticals Complete Merger, Creating Fully Integrated Renal Company
"We are very pleased to announce the completion of our merger with Keryx
to create a fully integrated renal company that has the potential to set
new standards of care for patients with kidney disease," said John P.
Butler, President and Chief Executive Officer of Akebia. "With
established renal development, manufacturing and commercial
capabilities, strong cash position, a flexible balance sheet and
experienced management team, our company is uniquely positioned to
capitalize on the significant market opportunity by maximizing the
growth of Auryxia® (ferric citrate) and build launch momentum for our
Phase 3 product candidate, vadadustat, subject to approval by the
As previously announced, Keryx shareholders are entitled to receive 0.37433 common shares of Akebia for each common share of Keryx they own.
The combined company will be
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) currently in global Phase 3 development for the treatment of anemia due to chronic kidney disease. Vadadustat’s proposed mechanism of action is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery. Vadadustat is an investigational therapy and is not approved by the FDA or any regulatory authority.
About Auryxia (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the FDA on
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)
Contraindication: Patients with iron overload syndrome, e.g., hemochromatosis, should not take AURYXIA® (ferric citrate).
Iron Overload: Iron absorption from AURYXIA may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on AURYXIA. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep AURYXIA away from children. Call a poison control center or your physician in case of an accidental overdose in a child.
Adverse Events: The most common adverse events occurring in at least 5% of patients treated with AURYXIA were, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and high levels of potassium in the blood.
AURYXIA contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Please click here to see full prescribing information for Auryxia.
About Akebia Therapeutics
Forward Looking Statements
This document contains forward-looking statements within the meaning of
the federal securities law. Such statements are based upon current
plans, estimates and expectations that are subject to various risks and
uncertainties. The inclusion of forward-looking statements should not be
regarded as a representation that such plans, estimates and expectations
will be achieved. Words such as “anticipate,” “create,” “expect,”
“project,” “intend,” “believe,” “may,” “will,” “should,” “plan,”
“could,” “target,” “contemplate,” “estimate,” “position,” “predict,”
“potential,” “opportunity,” “working to,” “look forward” and words and
terms of similar substance used in connection with any discussion of
future plans, actions or events identify forward-looking statements. All
statements, other than historical facts, including the potential to set
a new standard of care, market and growth opportunity and potential, and
the potential to realize benefits following the merger, are forward
looking statements. Important factors that could cause actual results to
differ materially from Akebia’s plans, estimates or expectations could
include, but are not limited to: the outcome of any legal proceedings
related to the merger; Akebia may be adversely affected by various
economic, business, and/or competitive factors, including the receipt by
Keryx of a notice letters on
Melissa Forst / Maghan Meyers