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Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA
QUEBEC CITY , Jan. 6, 2014 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:
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About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\nQUEBEC CITY, Jan. 6, 2014 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZS) (the \"Company\") today announced that the U.S. Food\n and Drug Administration (\"FDA\") has accepted for filing the Company's\n New Drug Application (\"NDA\") for its ghrelin agonist, macimorelin\n acetate, in Adult Growth Hormone Deficiency (\"AGHD\"). The acceptance\n for filing of the NDA indicates the FDA has determined that the\n application is sufficiently complete to permit a substantive review.\n\n\nThe Company's NDA, submitted on November 5, 2013, seeks approval for the\n commercialization of macimorelin acetate as the first\n orally-administered product that induces growth hormone release to\n evaluate AGHD.  Phase 3 data have demonstrated the compound to be well\n tolerated, with accuracy comparable to available intravenous and\n intramuscular testing procedures. The application will be subject to a\n standard review and will have a Prescription Drug User Fee Act\n (\"PDUFA\") date of November 5, 2014. The PDUFA date is the goal date for\n the FDA to complete its review of the NDA.\n\n\nDavid Dodd, President and CEO of Aeterna Zentaris, commented, \"The FDA's\n acceptance of this NDA submission is another significant milestone in\n our strategy to commercialize macimorelin acetate as the first approved\n oral product for AGHD evaluation. We are finalizing our commercial plan\n for this exciting new product. We are also looking to broaden the commercial application of macimorelin\n acetate in AGHD for use related to traumatic brain injury victims and\n other developmental areas, which would represent significant benefit to\n the evaluation of growth hormone deficiency, while presenting further\n potential revenue growth opportunities for the Company.\"\n\n\nAbout Macimorelin Acetate \n\n\nMacimorelin acetate, a ghrelin agonist, is a novel orally-active small\n molecule that stimulates the secretion of growth hormone. The Company\n has completed a Phase 3 trial for use in evaluating AGHD, and has filed\n an NDA to the FDA in this indication. Macimorelin acetate has been\n granted orphan drug designation by the FDA for use in AGHD.\n Furthermore, macimorelin acetate is in a Phase 2 trial as a treatment\n for cancer-induced cachexia. Aeterna Zentaris owns the worldwide rights\n to this novel patented compound....