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-130
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 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.
SOURCE AETERNA ZENTARIS INC.