Pharmacoeconomic Abstract Selected for Oral Presentation
Results from a Long-Term Safety Extension Study in Chronic Kidney Disease
Selected as a Late-Breaking Poster Presentation
NEW YORK, Oct. 23, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that two Ferric Citrate-related abstracts have been accepted for presentation at the upcoming American Society of Nephrology (ASN) Kidney Week 2014 annual meeting in Philadelphia, PA from November 11-16, 2014. An abstract regarding the pharmacoeconomic impact of Ferric Citrate has been selected for oral presentation and an abstract with results from the long-term open label extension ("OLE") study of Ferric Citrate in dialysis dependent chronic kidney disease ("CKD") patients with elevated serum phosphorus has been selected as a late-breaking poster presentation. Abstracts are now available on the ASN website.
Details of the presentations are as follows:
Friday, November 14th
-
Abstract # FR-OR045
- Description: The potential pharmacoeconomic impact of Ferric Citrate.
- Session Name: Dialysis Identifying Risk Factors and Improving Noncardiovascular Outcomes
- Presentation Time: 4:30PM
Saturday, November 15th:
-
Abstract # SA-PO1102
- Description: Results from the long-term open label extension ("OLE") study of Ferric Citrate in dialysis dependent chronic kidney disease ("CKD") patients with elevated serum phosphorus.
- Session Name: Late-Breaking Posters
- Presentation Time: 10:00 a.m. – 12:00 noon
"We are thrilled about the presentations of key clinical and pharmacoeconomic data that we believe can further reinforce Ferric Citrate's value, at the upcoming ASN conference, occurring just a few weeks before our expected launch," stated Ron Bentsur, Chief Executive Officer of Keryx. "This conference is an outstanding renal venue known for its high academic standards and typically draws over 10,000 treating nephrologists and dialysis professionals from the U.S. and abroad."
About Ferric Citrate
Ferric Citrate was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Keryx plans to make Ferric Citrate available to U.S. dialysis patients in early December.
In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
Keryx has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), seeking the approval of Ferric Citrate as a treatment of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent patients, and that application is currently under review.
Ferric Citrate is also being developed in the U.S. as a treatment for iron deficiency anemia in patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease (CKD). The pivotal Phase 3 study in this indication commenced in September 2014.
For Full Prescribing Information for Ferric Citrate, please visit http://www.keryx.com/wp-content/uploads/Keryx_FerricCitrate_PI.pdf.
Important Safety Information about Ferric Citrate
Contraindication: Patients with an accumulation of iron in their body, e.g. hemochromatosis, should not take Ferric Citrate.
Iron Overload: Iron absorption from Ferric Citrate may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Ferric Citrate. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.
Accidental Overdose of Iron: Keep Ferric Citrate away from children as it contains iron. Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Call a poison control center or your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.
Adverse Events: The most common adverse events with Ferric Citrate were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Ferric Citrate (14%).
Ferric Citrate contains iron and may cause dark stools, which is considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be taken at least 1 hour before Ferric Citrate.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients with renal disease. The Company's lead product, Ferric Citrate, is approved in the United States for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Keryx plans to commercially launch Ferric Citrate in the U.S. in the fourth quarter of 2014. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. For more information about Keryx, please visit www.keryx.com.
Cautionary Statement
Some of the statements included in this press release, particularly those regarding the commercialization of Ferric Citrate, 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: whether Ferric Citrate will be successfully launched and marketed in the U.S.; whether the FDA will approve a brand name for Ferric Citrate prior to the projected launch date; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the ASN website is not incorporated by reference into this press release and is included for reference purposes only.