QUEBEC,
Nov. 5, 2013 /CNW Telbec/ - 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.