QUÉBEC CITY, Aug. 5, 2014
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced a strategic co-promotion
services agreement with ASCEND Therapeutics® US, LLC,
("ASCEND"). Under the terms of the agreement, expected to start in
the fourth quarter of 2014, Aeterna Zentaris will use its newly
established commercial structure to market, in specific U.S.
territories, ASCEND's EstroGel® a non-patch transdermal
U.S. Food & Drug Administration ("FDA") approved and
commercialized estrogen replacement therapy. For its part, ASCEND
would market, in specific U.S. territories, MacrilenTM,
Aeterna Zentaris' product for use in the evaluation of adult
growth-hormone deficiency ("AGHD"), for which a New Drug
Application ("NDA") 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 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 MacrilenTM. Aeterna
Zentaris is expected to book all future sales of
MacrilenTM, while ASCEND will book all sales of
EstroGel®.
David Dodd, Chairman, CEO at
Aeterna Zentaris stated, "This co-promotion agreement is an
important step in our strategy of transitioning into a commercially
operating specialty biopharmaceutical company; the co‑promotion of
ASCEND's EstroGel® will jump start our commercial
activities, while the FDA continues its active NDA review for the
approval of MacrilenTM 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
MacrilenTM, 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 look forward to collaborating with
Aeterna Zentaris on this co-promotion agreement. It will
immediately extend our share of voice of the EstroGel®
franchise as well as open opportunities to future co-promotional
activities."
About MacrilenTM (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
MacrilenTM, is currently under review by the FDA with a
PDUFA date of November 5, 2014.
MacrilenTM 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 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 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. The Company's pipeline encompasses
compounds at various stages of development. 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.