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.