Keryx Biopharmaceuticals Announces Changes to Management and Preliminary First Quarter 2018 Revenue
Gregory Madisonresigned as president and chief executive officer of the company and from its board of directors Jodie Morrison, current Keryx board member, named interim chief executive officer
- Company expects to report first quarter 2018 total revenue of
$21.0 million - $22.5 million, including Auryxia® net U.S. product sales of $20.0 million - $21.0 million
“On behalf of the entire board I would like to thank Greg for his contributions to Keryx over the past four years, in particular for his role in transitioning Keryx from a development-stage organization to a commercial entity, and wish him well in his future endeavors,” said
“We have a very talented leadership team at Keryx and I look forward to working with them to review our business in the coming weeks,” said
Preliminary Financial Data
The company expects to report total revenue for the first quarter of 2018 of between
The preliminary financial data for the first quarter of 2018 set forth above are derived from preliminary internal financial reports. The company has not yet finalized its complete results of operations for the quarter ended
About Auryxia® (ferric citrate) Tablets
Auryxia (ferric citrate) was approved by the
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)
AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. 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 ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
Most common adverse reactions with AURYXIA were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
- Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
- Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact
Please click here to view the Full Prescribing Information for Auryxia.
Some of the statements included in this press release, particularly those regarding the preliminary financial data and the management transition may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the risk that we may identify items that would require us to make adjustments, some of which could be material, to the preliminary financial data; our ability to successfully transition the chief executive role to Ms. Morrison and to a full-time chief executive; our ability to successfully market Auryxia and whether we can increase adoption of Auryxia in patients with chronic kidney disease on dialysis and successfully launch Auryxia for the treatment of iron deficiency anemia in patients with chronic kidney disease, not on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; our ability to continue to supply Auryxia to the market; the risk that increased utilization by
KERYX BIOPHARMACEUTICALS CONTACT
Amy SullivanSenior Vice President, Corporate Affairs T: 617.466.3519 firstname.lastname@example.org
Source: Keryx Biopharmaceuticals, Inc.