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Atrium Innovations Inc. (ATB)
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Jun 20, 2013, 12:03 AM EDT
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AEterna Zentaris Launches Cetrotide(R) (cetrorelix) in Japan for In Vitro Fertilization

QUEBEC CITY, Sept. 21 /CNW Telbec/ - AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today announced that Cetrotide(R) (cetrorelix) has been launched
in Japan for in vitro fertilization. Cetrotide(R) (cetrorelix) is being
manufactured and marketed in Japan by partners Nippon Kayaku Co., Ltd. and
Shionogi & Co., Ltd. AEterna Zentaris will receive revenue from the supply of
Cetrotide(R) (cetrorelix) to its Japanese partners. Cetrotide(R) (cetrorelix)
had gained market approval for in vitro fertilization in Japan in April 2006.
Cetrotide(R) (cetrorelix) has been marketed worldwide (except Japan) by
Serono S.A. (NYSE: SRA) since 1999, providing AEterna Zentaris with annual
revenue of over US$20 million per year.
"We are excited to launch Cetrotide(R) (cetrorelix) in Japan. This
represents a significant achievement for our Company as Cetrotide(R)
(cetrorelix) is now approved worldwide", said Gilles Gagnon, President and
Chief Executive Officer at AEterna Zentaris. "We look forward to generating
additional revenue with Cetrotide(R) (cetrorelix), the first luteinizing
hormone-releasing hormone (LHRH) antagonist to be marketed in Japan, and we
are confident that working with partners such as Nippon Kayaku and Shionogi
will ensure its successful commercialization in this market, as we continue to
aggressively advance our lead compounds and execute our focused business
plan."

About Cetrotide(R) (cetrorelix)

Cetrotide(R) (cetrorelix) was the first luteinizing hormone-releasing
hormone (LHRH) antagonist treatment approved for in vitro fertilization. It is
administered to women to prevent premature ovulation in order to increase
fertility success rate. Developed in cooperation with Medicine Nobel-Prize
winner, Professor Andrew Schally, of Veterans Affairs, Miami, Florida, it was
launched in Europe in 1999 and in the United States in 2001. Cetrotide(R)
(cetrorelix) is currently marketed worldwide by Serono, except for Japan where
it gained approval to be manufactured and marketed by Nippon Kayaku and
Shionogi.
Cetrotide(R) (cetrorelix) is the only treatment in its class that offers
a choice of two highly effective dosage strengths which enable precise
control. Due to its immediate onset of action, Cetrotide(R) (cetrorelix)
permits a simplified, more convenient and shorter treatment involving fewer
injections and causing fewer side effects than other forms of in vitro
fertilization treatment.

About Cetrorelix

Cetrorelix is part of our luteinizing hormone-releasing hormone (LHRH)
antagonist therapeutic approach. This peptide-based active substance was
developed by the Company in cooperation with Nobel-Prize winner, Professor
Andrew Schally of Veterans Affairs, Miami, Florida.
Cetrorelix is currently in a pivotal clinical program for endometriosis
with our partner, Solvay, as well as in a Phase 2 trial program for BPH in
Japan, conducted by our partners, Nippon Kayaku and Shionogi. Furthermore,
last June, we received a green light from the FDA to file an IND to move into
a Phase 3 program in benign prostatic hyperplasia (BPH) with cetrorelix in the
United States. The program launch is expected by year-end.
For the treatment of BPH, cetrorelix has shown to adequately suppress the
formation of the male sex hormone testosterone, which plays a principal role
in cell growth of the prostate. Since cell growth is stopped, surgical removal
of the prostate might be avoided. All studies performed so far with cetrorelix
in patients with symptomatic BPH, revealed an improvement in symptoms as
assessed primarily by the I-PSS (International Prostate Symptom Score), an
increase in urinary peak flow rate as well as a reduction in prostate volume.
Studies have also shown the excellent safety and tolerability profile of
cetrorelix.

Cetrorelix Successful Phase 2 Program

Cetrorelix has successfully completed a broad seven-Phase 2 program in
BPH, endometriosis, and uterine myoma. This extensive clinical program
involved 735 patients and yielded significant and medically important results.
Rapid and durable responses were observed without chemical castration and
cetrorelix proved to have an excellent safety and tolerability profile.
Overall, cetrorelix has shown to have a fast onset of action allowing for
a shorter treatment period, which could translate into an intermittent/chronic
therapy. Such long treatment-free intervals are actually supported by the
results derived from multiple Phase 2 placebo-controlled studies.

Partners for Cetrorelix

Cetrorelix has been licensed exclusively to Solvay Pharmaceuticals
worldwide (except Japan) for all indications with the exception of
IVF/COS/ART, which rights belong to Serono, and BPH for which AEterna Zentaris
Inc. holds exclusive worldwide (except Japan) rights. Japanese manufacturing
and marketing rights are held by Nippon Kayaku and Shionogi for all potential
indications.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a growing global biopharmaceutical company
focused on endocrine therapy and oncology, with proven expertise in drug
discovery, development and commercialization.
AEterna Zentaris also owns 48.3% of the equity of Atrium Biotechnologies
Inc. (TSX: ATB) and 64.7% of its voting rights. Atrium is a developer,
manufacturer and marketer of science-based products for the cosmetics,
pharmaceutical, chemical and nutritional industries.

News releases and additional information are available at
www.aeternazentaris.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to
the safe harbor provisions of the U.S. Securities Litigation Reform Act of
1995. Forward-looking statements involve known and unknown risks and
uncertainties, which 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 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 the 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.

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