AEterna Zentaris Gains Market Approval for Cetrotide(R) (cetrorelix) in Japan for In Vitro Fertilization
April 20 2006 - 11:58AM
PR Newswire (US)
QUEBEC CITY, April 20 /PRNewswire-FirstCall/ -- AEterna Zentaris
Inc. (TSX: AEZ; NASDAQ: AEZS) today announced it gained market
approval for Cetrotide(R) (cetrorelix) in Japan for in vitro
fertilization. Cetrotide(R) (cetrorelix) will be manufactured and
marketed in Japan by partners Nippon Kayaku Co., Ltd. and Shionogi
& Co., Ltd. AEterna Zentaris obtained an undisclosed milestone
payment from its partners and will receive revenues from the supply
of Cetrotide(R) (cetrorelix) to its Japanese partners. Cetrotide(R)
(cetrorelix) is expected to be launched in Japan by year-end.
Cetrotide(R) (cetrorelix) has been marketed worldwide (ex-Japan) by
Serono S.A. (NYSE:SRA) since 1999, providing AEterna Zentaris with
annual revenues of over US$20 million per year. "We are very
pleased that Cetrotide(R) (cetrorelix) has been approved for in
vitro fertilization in Japan and also very proud to work with such
highly respected partners as Nippon Kayaku and Shionogi to ensure
the successful commercialisation of our product on the Japanese
market. This approval marks a significant achievement for AEterna
Zentaris as Cetrotide(R) (cetrorelix) is now approved worldwide and
further demonstrates our ability to develop and market novel
efficient therapies for conditions affecting millions of people
around the world," said Gilles Gagnon, President and Chief
Executive Officer at AEterna Zentaris. Dr. Jurgen Engel, Executive
Vice President Global R&D and Chief Operating Officer at
AEterna Zentaris stated, "Cetrotide(R) (cetrorelix) has a well-
established safety profile with over 250,000 women treated
worldwide. The approval of Cetrotide(R) (cetrorelix) in Japan,
coupled with our focused development strategy for this product,
further validates our world class development capabilities. We
believe this product has great potential in additional benign
indications as cetrorelix is currently in mid-to late-stage
clinical development for the treatment of benign prostate
hyperplasia (BPH) and endometriosis. We are encouraged by the
prospects of cetrorelix and look forward to further advancing this
product throughout the year. 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. 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 oncology and endocrine therapy
with proven expertise in drug discovery, development and
commercialization. AEterna Zentaris also owns 48.36% of the equity
of Atrium Biotechnologies Inc. (TSX: ATB.sv) and 64.77% 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
CONTACT: Media Relations: Paul Burroughs, (418) 652-8525 ext. 406,
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