QUÉBEC CITY, July 24, 2012 /PRNewswire/ – Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the “Company”) today announced that it has filed a
request with the United States Food and Drug Administration (FDA) for
Fast Track designation for its oral ghrelin agonist, AEZS-130, as a
diagnostic test for adult growth hormone deficiency (AGHD). The request
is part of the Company’s New Drug Application (“NDA”) strategy for
AEZS-130 to advance the product towards regulatory approval as
efficiently as possible.

The FDA’s Fast Track program is designed, among other things, to
facilitate the development and expedite the review of new drugs that
demonstrate the potential to address unmet medical needs. According to
its guidance on Fast Track applications, the FDA responds within 60
days of receipt of such requests.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, “After
a lengthy series of informative discussions with the FDA, we now have
the valuable guidance needed to move ahead as quickly as possible with
our NDA filing plans. In conjunction with that, obtaining Fast Track
designation would give us the opportunity to submit our NDA on a
rolling basis. This means we could submit certain modules of our NDA
progressively, with the expectation that review of those portions of
the NDA would be complete or well underway before we complete the NDA
submission. Should we obtain agreement on our Fast Track designation
and rolling submission strategy, we would expect to begin filing
modules before year-end and complete the NDA submission in the first
quarter of 2013. Furthermore, we believe our request for Fast Track
designation is warranted since there is currently no approved
diagnostic test for AGHD in North America, and AEZS-130 could provide a
safe and effective test which would be more convenient because it is
administered orally.”

About Fast Track Designation

The Fast Track program of the FDA is designed to facilitate the
development and expedite the review of new drugs that are intended to
treat serious or life-threatening conditions and that demonstrate the
potential to address unmet medical needs. Fast Track designated drugs
ordinarily qualify for priority review, thereby expediting the FDA
review process.

The rolling submission is an FDA provision available to drug candidates
that have received Fast Track designation, and allows for completed
sections of an NDA to be submitted on an ongoing basis.

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.