Jul 27 2011
Company expects to file New Drug Application
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced completion of its Phase 3 study with AEZS-130 as the first oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The Company is currently proceeding with detailed analyses of the data and preparing for a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) in the upcoming months, which would be followed by the filing of a NDA for the registration of AEZS-130 in the United States.
"We wish to thank all those involved in this project for their utmost dedication. Preliminary results are encouraging and we therefore expect to submit a NDA to the FDA. We believe that AEZS-130 could become the first approved oral test for the diagnosis of AGHD, providing patients with a potentially safer, accurate and more convenient alternative to the current injectable tests", stated Juergen Engel, Ph.D., President and CEO at Aeterna Zentaris.
SOURCE AETERNA ZENTARIS INC.