NEW YORK, Nov. 14, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that two posters highlighting potential cost savings based on observations from previous clinical trials of Zerenex (ferric citrate) were presented by DaVita Clinical Research this past weekend during the American Society of Nephrology (ASN) Kidney Week 2011 Annual Meeting and Exposition in Philadelphia. Zerenex, an oral, ferric iron-based drug candidate, is currently in Phase 3 clinical development for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.
Key highlights from the two poster presentations are as follows:
Poster #1566: TSAT and Serum Ferritin Increases Observed in Ferric Citrate Clinical Trials May Lead to Dialysis Cost Savings
DaVita Clinical Research developed a cost model quantifying potential savings associated with reduced erythropoietin stimulating agent (ESA) and intravenous (IV) iron dosing observed in a large database of hemodialysis patients experiencing similar increases in iron storage markers as observed in previous clinical trials of Zerenex.
The results of the cost model, using publicly available industry cost data, indicate that Zerenex, a ferric iron containing phosphate binder, could produce monthly cost savings of $125/patient for moderate ESA users (4,500 to <9,000 units per session) and $320/patient for high ESA users (greater than or equal to 9,000 units per session).
Poster #2647: Physician Reaction to Spontaneous Rises in Transferrin Saturation and Serum Ferritin Levels in End Stage Renal Disease Patients
DaVita Clinical Research examined, via a large database of hemodialysis patients receiving phosphate binder therapy over a two-year period, ESA and iron prescribing behavior in response to spontaneous, non-treatment related increases in transferrin saturation (TSAT) and serum ferritin similar to those measured in previous clinical trials of Zerenex. Data were analyzed from patients experiencing rises in TSAT (greater than or equal to 10%) and serum ferritin (greater than or equal to 15% and less than or equal to 25%).
The researchers concluded that physicians may respond to rises in TSAT and serum ferritin by reducing ESA and iron doses, particularly in patients with high baseline use, and, if approved, Zerenex may reduce ESA and iron usage by hemodialysis patients and have incremental economic value within the Medicare bundle reimbursement plan.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, “It’s encouraging to see from a large database of dialysis patients that increases in TSAT and ferritin parameters, similar to those observed in clinical trials of Zerenex, could result in lower ESA and IV iron use, potentially generating significant cost savings for dialysis clinics.” Mr. Bentsur, continued, “We’d like to thank DaVita Clinical Research for conducting these important analyses.”
The Zerenex Phase 3 registration program, which is being conducted pursuant to a SPA agreement with the FDA, is comprised of an already successfully completed Phase 3 short-term study, and an ongoing Phase 3 long-term study.
Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating the outcome of clinical trials and the future business prospects for Zerenex (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: our ability to successfully complete clinical trials for Zerenex; our ability to meet anticipated development timelines for Zerenex due to clinical trial results, manufacturing capabilities or other factors; our ability to replicate in our ongoing long-term Phase 3 clinical study the efficacy and safety of Zerenex observed in the previous Phase 2 studies and the short-term Phase 3 study, and the effects on intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) use observed in the Phase 2 Open Label Extension study; the ability for Zerenex to generate cost savings for dialysis centers; whether those cost savings would encourage the inclusion of Zerenex in the Medicare bundling; 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 intend 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 www.keryx.com. The information on our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
