AEterna Zentaris Launches Cetrotide(R) (cetrorelix) in Japan for In Vitro Fertilization
September 21 2006 - 8:30AM
PR Newswire (US)
QUEBEC CITY, Sept. 21 /PRNewswire-FirstCall/ -- 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 http://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. DATASOURCE: AETERNA
ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
LABORATORIES INC.) CONTACT: Media Relations: Paul Burroughs, (418)
652-8525 ext. 406, ; Investor Relations: Jenene Thomas, (418)
655-6420, (908) 996-3154,
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