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Last updated on April 19, 2014 at 13:20 EDT

Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD

November 5, 2013

QUEBEC, Nov. 5, 2013 /PRNewswire/ – Aeterna Zentaris Inc. (NASDAQ: AEZS)
(TSX: AEZS) (the “Company”) today announced that it has submitted a New
Drug Application (“NDA”) to the U.S. Food and Drug Administration
(“FDA”) for its ghrelin agonist, macimorelin acetate (AEZS-130). Phase
3 data have demonstrated that the compound has the potential to become
the first orally-approved product that induces growth hormone release
to evaluate adult growth hormone deficiency (“AGHD”), with accuracy
comparable to available intravenous and intramuscular testing
procedures.

David Dodd, President and CEO of Aeterna Zentaris, commented, “The
submission of the NDA to the FDA is another major milestone in our
strategy to bring macimorelin acetate to market as the first approved
oral product for AGHD evaluation. We are also looking at potential
expansion into traumatic brain injury victims and pediatrics which
would represent significant growth opportunities for the Company.
Finally, I would like to congratulate and thank all those involved in
our drug development and regulatory affairs departments for this
exciting accomplishment.”

About Macimorelin Acetate (AEZS-130)

Macimorelin acetate, 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 in evaluating AGHD, and has
submitted a NDA to the FDA in this indication. Macimorelin acetate has
been granted orphan drug designation by the FDA for use in AGHD.
Furthermore, macimorelin acetate is in a Phase 2 trial as a treatment
for cancer-induced cachexia. Aeterna Zentaris owns the worldwide rights
to this novel patented compound.

About AGHD

AGHD affects about 75,000 adults across the U.S., Canada and Europe.
Growth hormone not only plays an important role in growth from
childhood to adulthood, but also helps promote a hormonally-balanced
health status. AGHD mostly results from damage to the pituitary gland.
It is usually characterized by a reduction in bone mineral density,
lean mass, exercise capacity, and overall quality of life.

About Aeterna Zentaris

Aeterna Zentaris is a specialty biopharmaceutical company engaged in
developing novel treatments in oncology and endocrinology. The
Company’s pipeline encompasses compounds from drug discovery to
regulatory approval. For more information, 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.


Source: PR Newswire