Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multip...( NEW YORK Sept. 16 /- Kery...),Health

NEW YORK, Sept. 16 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.

Ron Bentsur, Chief Executive Officer of Keryx, commented, "The Orphan-Drug designation for perifosine in multiple myeloma is a very important milestone for Keryx, as the market exclusivity protection provided by this designation significantly enhances the commercial opportunity of perifosine in this indication." Mr. Bentsur continued, "Following our exciting announcement last month that we had reached an agreement with the FDA on an SPA for a Phase 3 trial for perifosine in relapsed/refractory multiple myeloma, it is encouraging to further add to the value of the perifosine program with this Orphan-Drug designation. We look forward to commencing the Phase 3 study by year-end."

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credi
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