Aeterna Zentaris Provides Update on NDA Filing for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency

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[{"type":"text","content":"\n\n\n\n\n\nQUÉBEC CITY, QC, Sept. 26, 2012 /CNW Telbec/ - Aeterna Zentaris Inc.\n (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\") today announced that it\n continues to expect to file a New Drug Application (NDA) early next\n year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for\n adult growth hormone deficiency (AGHD), after receiving notification\n from the United States Food and Drug Administration (FDA) that Fast\n Track designation had not been granted.\n\n\nJuergen Engel, PhD, President and CEO of Aeterna Zentaris stated,\n \"Although the FDA's decision will not allow us to submit our New Drug\n Application on a rolling basis, it should not affect the timing of our\n filing of the NDA for AEZS-130, which is expected early next year, nor\n should it affect the potential of obtaining priority review. We are\n actively pursuing our strategy to advance AEZS-130 towards regulatory\n approval for AGHD, as it could become the first orally administered\n test in this indication.\"\n\n\nAbout AGHD \nAGHD affects 35,000 adult Americans, with 6,000 new adult patients\n diagnosed each year. Growth hormone not only plays an important role in\n growth from childhood to adulthood, but helps promote good health\n throughout life. AGHD is usually characterized by low energy levels,\n decreased strength and exercise tolerance, increased weight or\n difficulty losing weight, emotional changes, anxiety and impaired\n sleep.\n\n\nAbout AEZS-130\n\n\nAEZS-130, a ghrelin agonist, is a novel orally-active small molecule\n that stimulates the secretion of growth hormone. The Company has\n completed a Phase 3 trial for use as an oral diagnostic test for AGHD.\n AEZS-130 has been granted orphan drug designation by the FDA for use in\n this indication. AEZS-130 is also in a Phase 2A trial as a treatment\n for cancer induced cachexia. Aeterna Zentaris owns the worldwide rights\n to AEZS-130.\n\n\nAbout Aeterna Zentaris \n\n\nAeterna Zentaris is an oncology and endocrinology drug development\n company currently investigating treatments for various unmet medical\n needs. The Company's pipeline encompasses compounds at all stages of\n development, from drug discovery through to marketed products. For more\n information please visit www.aezsinc.com.\n\n\nForward-Looking Statements\n\n\nThis press release contains forward-looki...

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