AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multip...( QUEBEC CITY Sept. 16 / AEterna Zentar...)

QUEBEC CITY, Sept. 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), 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 AEterna 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."

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. It also provides tax credits for clinical research costs, the ability to apply
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