QUEBEC CITY, Jan. 6, 2014 /CNW Telbec/ - 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.
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 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.