FDA grants Fast Track designation for AEterna Zentaris' perifosine

Dec 2 2009

AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma. Keryx Biopharmaceuticals, Inc. ("Keryx") ( KERX), is AEterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while AEterna Zentaris retains rights for the rest of the world.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

"We are very pleased with the FDA's Fast Track designation and we look forward to the emergence of the data from the forthcoming Phase 3 clinical trial in multiple myeloma to be conducted by our partner Keryx, which we hope will establish perifosine as a novel treatment of this serious condition", stated Juergen Engel, Ph.D., President and CEO at AEterna Zentaris. "We further believe that this North American clinical development program will also be very useful to support the development and registration of perifosine for the benefit of patients in the rest of the world."

A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE(R)) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.