Keryx Biopharmaceuticals Announces That Congress Delays Implementation Of Oral-Only ESRD-Related Drugs, Including Phosphate Binders, In The Bundled ESRD Prospective Payment System By Two-Years, Until January 2016
NEW YORK, Jan. 3, 2013 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that earlier this week Congress passed legislation known as the American Taxpayer Relief Act of 2012, which, among other things, delays by two years the implementation of oral-only end-stage renal disease (ESRD) related drugs, including phosphate binders, in the bundled ESRD prospective payment system, until January 1, 2016. The legislation has been signed into law by the President.
Currently, Medicare pays dialysis facilities a single bundled payment for providing a dialysis treatment and certain related items and services, including injectable ESRD drugs and their oral equivalents. Prior to this week's act of Congress, the bundled payment was to be expanded in January 2014 to include payment for certain oral, dialysis-related drugs that do not have injectable equivalents, including oral phosphate binders, which are currently covered under Medicare Part D. This law will delay the implementation of the oral drugs into the bundle by two years.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "While we have always believed that with its potentially highly differentiated product profile, Zerenex would succeed in a bundled environment, we are very encouraged by the two-year delay in the inclusion of the oral phosphate binders in the dialysis reimbursement bundle. Should Zerenex gain FDA approval, we believe that this delay could provide Zerenex with the opportunity to better establish its position in the phosphate binder landscape and significantly enhance its market potential in the U.S." Mr. Bentsur continued, "We eagerly await the pending top-line data analysis from our long-term Phase 3 study of Zerenex."
About Keryx Biopharmaceuticals, Inc.Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The U.S.-based 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 a Special Protocol Assessment (SPA) agreement with the FDA. Zerenex is also in Phase 2 development for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease. Keryx is headquartered in New York City.
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