, Jan. 6, 2014
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZS) (the "Company") today announced that the U.S. Food
and Drug Administration ("FDA") has accepted for filing the Company's
New Drug Application ("NDA") for its ghrelin agonist, macimorelin
acetate, in Adult Growth Hormone Deficiency ("AGHD"). The acceptance
for filing of the NDA indicates the FDA has determined that the
application is sufficiently complete to permit a substantive review.
The Company's NDA, submitted on November 5, 2013, seeks approval for the
commercialization of macimorelin acetate as the first
orally-administered product that induces growth hormone release to
evaluate AGHD. Phase 3 data have demonstrated the compound to be well
tolerated, with accuracy comparable to available intravenous and
intramuscular testing procedures. The application will be subject to a
standard review and will have a Prescription Drug User Fee Act
("PDUFA") date of November 5, 2014. The PDUFA date is the goal date for
the FDA to complete its review of the NDA.
David Dodd, President and CEO of Aeterna Zentaris, commented, "The FDA's
acceptance of this NDA submission is another significant milestone in
our strategy to commercialize macimorelin acetate as the first approved
oral product for AGHD evaluation. We are finalizing our commercial plan
for this exciting new product.We are also looking to broaden the commercial application of macimorelin
acetate in AGHD for use related to traumatic brain injury victims and
other developmental areas, which would represent significant benefit to
the evaluation of growth hormone deficiency, while presenting further
potential revenue growth opportunities for the Company."
About Macimorelin Acetate
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 filed
an 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.
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
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 efficiently commercialize one or more of its
products or product candidates, 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.