QUÉBEC CITY, Oct. 27, 2014 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced the formal implementation of
its own full-time U.S. sales force with field selling of ASCEND
Therapeutics US LLC's ("ASCEND"),
EstroGel®, scheduled to start the week of
November 17, 2014.
EstroGel® is the leading non-patch transdermal brand of
estrogen replacement therapy commercialized in the U.S. The selling
of EstroGel® by Aeterna Zentaris is part of the
strategic co-promotion services agreement signed last August with
ASCEND which stipulates that Aeterna Zentaris will market this
product, in specific U.S. territories. For its part, ASCEND would
market, in specific U.S. territories, Aeterna Zentaris' product,
Macrilen™, for use in the evaluation of adult
growth-hormone deficiency ("AGHD"). A New Drug Application ("NDA")
for Macrilen is currently under review by the FDA, with a
Prescription Drug User Fee Act ("PDUFA") date of November 5, 2014. In consideration for
these co-promotion services, each party will be entitled to
receive, from the other party, commissions on net sales of each
other's product.
As part of its commercial strategy, Aeterna Zentaris anticipates
using approximately 20 full-time sales representatives to cover its
assigned U.S. specific territories, while ASCEND will use its
existing sales force of over 35 sales representatives to cover its
territories. Overall, more than 50 sales representatives are
expected to promote both EstroGel® and Macrilen™.
Aeterna Zentaris is expected to book all future sales of Macrilen™,
while ASCEND will continue to book all sales of
EstroGel®.
David Dodd, Chairman, CEO at
Aeterna Zentaris stated, "The implementation of our own sales force
and the field selling of ASCEND's EstroGel®, mark an
important step in our strategy of transitioning into a commercially
operating specialty biopharmaceutical company, while the FDA
continues its active NDA review for the approval of Macrilen™ in
the evaluation of AGHD. We very much look forward to working with
ASCEND, as it will enable us to use our new commercial structure
not only for the co‑promotion of EstroGel®, but also for
the potential launch of Macrilen™, as well as for other commercial
products that we plan to acquire, in-license or co-promote in the
future."
Jay Bua, President & CEO at
ASCEND Therapeutics stated, "We are very pleased to be joining
forces with Aeterna Zentaris as it will immediately extend our
share of voice of the EstroGel® franchise, and also open
opportunities to future co-promotional activities."
About EstroGel®
EstroGel® 0.06% (estradiol gel) is an FDA-approved,
estrogen therapy ("ET") gel and the only non-patch transdermal ET
that provides relief for two major problems due to menopause:
moderate to severe vasomotor symptoms and moderate to severe
symptoms of vulvar/vaginal atrophy. EstroGel® is
marketed in over 70 countries and is the most prescribed estrogen
product in Europe, as well as the
most prescribed transdermal estrogen product in Canada. Using
estrogen-alone may increase your chance of getting cancer of the
uterus (womb). For full prescribing information and boxed
warning, please see www.estrogel.com.
About Macrilen™ (macimorelin)
Macimorelin, 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 a NDA in this indication for macimorelin, under the trade name
Macrilen™, is currently under review by the FDA with a PDUFA date
of November 5, 2014. Macrilen™ has
been granted orphan drug designation by the FDA for use in AGHD.
Furthermore, macimorelin 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 ASCEND Therapeutics
ASCEND Therapeutics US, LLC, is a specialty pharmaceutical
company solely focused on women's healthcare. Built on more than
100 years of success by its parent company Besins Healthcare S.A.,
ASCEND continues to embody excellence by concentrating on high
standards in commercial and product development. ASCEND sustains
its commitment to making a difference in women's healthcare through
knowledge, innovation and quality products in all aspects of
outreach. For more information, visit
www.ascendtherapeutics.com.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology and endocrinology. 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 US 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, the
specific outcome of our recently announced global resources
optimization program and the financial impact on the Company
resulting therefrom, and general changes in economic conditions.
Investors should consult the Company's quarterly and annual filings
with the Canadian and US 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.