QUÉBEC CITY, QC, Sept. 26, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it continues to expect to file a New Drug Application (NDA) early next year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD), after receiving notification from the United States Food and Drug Administration (FDA) that Fast Track designation had not been granted.
Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "Although the FDA's decision will not allow us to submit our New Drug Application on a rolling basis, it should not affect the timing of our filing of the NDA for AEZS-130, which is expected early next year, nor should it affect the potential of obtaining priority review. We are actively pursuing our strategy to advance AEZS-130 towards regulatory approval for AGHD, as it could become the first orally administered test in this indication."
About AGHD AGHD affects 35,000 adult Americans, with 6,000 new adult patients diagnosed each year. Growth hormone not only plays an important role in growth from childhood to adulthood, but helps promote good health throughout life. AGHD is usually characterized by low energy levels, decreased strength and exercise tolerance, increased weight or difficulty losing weight, emotional changes, anxiety and impaired sleep.
About AEZS-130AEZS-130, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. The Company has completed a Phase 3 trial for use as an oral diagnostic test for AGHD. AEZS-130 has been granted orphan drug designation by the FDA for use in this indication. AEZS-130 is also in a Phase 2A trial as a treatment for cancer induced cachexia. Aeterna Zentaris owns the worldwide rights to AEZS-130. About Aeterna Zentaris Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com. Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.