Æterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine
Æterna Zentaris Inc. announced that Keryx Biopharmaceuticals, Inc., its partner and licensee for perifosine in the North American market, has received orphan-drug designation for this compound from the U.S. food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, Keryx announced that it had reached agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial with perifosine in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.
Juergen Engel, Ph. D., President and CEO of Æterna Zentaris stated, "We are very pleased with perifosine gaining Orphan Drug Designation from the FDA as it would provide extra market exclusivity protection for this compound. We now look forward to the start of Keryx's Phase 3 trial in multiple myeloma by year-end."
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