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."
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
AEZS-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
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.
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.
SOURCE AETERNA ZENTARIS INC.