Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401(Perifosine) for the Treatment of Multiple Myeloma
Wed, 09/16/2009 - 4:39am
Keryx Biopharmaceuticals, Inc.hasannounced that KRX-0401 (perifosine) has received Orphan-Drug designation fromthe FDA for the treatment of multiplemyeloma. In August, the company announced that it had reached an agreementwith the FDA regarding a Special Protocol Assessment (SPA) on the design of aPhase 3 trial in relapsed/refractory multiple myeloma and that the study isexpected to start by year-end. Ron Bentsur, Chief Executive Officer of Keryx, commented, "The Orphan-Drugdesignation for perifosine in multiple myeloma is a very important milestonefor Keryx, as the market exclusivity protection provided by this designationsignificantly enhances the commercial opportunity of perifosine in thisindication." Mr. Bentsur continued, "Following our exciting announcement lastmonth that we had reached an agreement with the FDA on an SPA for a Phase 3trial for perifosine in relapsed/refractory multiple myeloma, it isencouraging to further add to the value of the perifosine program with thisOrphan-Drug designation. We look forward to commencing the Phase 3 study byyear-end." KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc.in the United States, Canada and Mexico.