AEterna Zentaris Announces Decision to Continue Cetrorelix Development in Benign Prostate Hyperplasia in Japan
March 16 2005 - 7:31AM
PR Newswire (US)
AEterna Zentaris Announces Decision to Continue Cetrorelix
Development in Benign Prostate Hyperplasia in Japan QUEBEC CITY,
March 16 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today announced the decision of its Japanese partners
Shionogi & Co., Ltd., and Nippon Kayaku Co., Ltd., to push
ahead with the development of cetrorelix, a luteinizing
hormone-releasing hormone (LHRH) antagonist, in the benign prostate
hyperplasia (BPH) indication. The decision comes on the heels of
the earlier announcement by Solvay Pharmaceuticals, the Company's
worldwide (ex-Japan) exclusive development and marketing partner
for cetrorelix, to conduct its upcoming Phase III development in
endometriosis as a primary indication. Cetrorelix, AEterna
Zentaris' lead drug in the class of LHRH antagonists, has
successfully completed a broad seven Phase II trial program in
endometriosis, BPH and uterine myoma in 2004. "These results have
paved the way for the advanced programs to be performed along with
and financially supported by our partners. We are excited by the
decision of Shionogi and Nippon Kayaku to progress with the
development of cetrorelix in BPH in Japan", said Prof. Jurgen
Engel, Executive Vice President Gobal R&D and Chief Operation
Officer at AEterna Zentaris. The first Phase IIa-trial in the
Japanese market with cetrorelix in BPH, to be initiated in Q2 2005,
will be designed to evaluate safety (systemic and local
tolerability) and to explore efficacy (effects on BPH-related
parameters such as the International Prostate Symptom Score
(IPSS)). The multicenter, placebo-controlled and randomized trial
using cetrorelix pamoate will comprise both single and multiple
dose groups. Data generated in this trial will serve as
verification for the applicability of the results from European
studies on cetrorelix in BPH to Japanese patients. According to
Gilles Gagnon, President and Chief Executive Officer at AEterna
Zentaris: "We are delighted with this decision from our Japanese
partners to pursue the development of cetrorelix in BPH in Japan, a
country where the most well-known competing products to treat this
condition have not yet been launched. This decision represents a
major step in completing the implementation of our strategic plan
that should allow for the full development of cetrorelix in the two
indications, endometriosis and BPH, where the most statistically
significant Phase II results were demonstrated with this novel
therapeutic agent. We feel privileged to work with such serious
partners like Solvay, Shionogi and Nippon Kayaku to develop our
lead compound in endocrinology." About Benign Prostate Hyperplasia
Benign Prostate Hyperplasia (BPH) is characterized by an abnormal
benign growth of the prostatic tissues caused by testosterone.
Symptoms linked to BPH include pain while urinating and frequent
urges to urinate during the night and sometimes, kidney problems.
In some cases, if left untreated, BPH may develop into prostate
cancer. Contrary to most of the present treatments for BPH,
cetrorelix is not associated with side effects such as erectile
dysfunction, loss of libido and chemical castration. Worldwide, BPH
affects 33 million men 60 and over and represents a market of
US$1.7 billion. About AEterna Zentaris Inc. AEterna Zentaris Inc.
is an oncology and endocrine therapy focused biopharmaceutical
company with proven expertise in drug discovery, development and
commercialization. The Company's broad 20 product pipeline
leverages five different therapeutic approaches, including LHRH
antagonists and signal transduction inhibitors. The lead LHRH
antagonist compound, cetrorelix, is currently marketed for in vitro
fertilization under the brand name Cetrotide(R), and has
successfully completed a broad Phase II program in endometriosis
and benign prostate hyperplasia (BPH). The lead signal transduction
inhibitor compound, perifosine, is an orally-active AKT inhibitor
that is in several Phase II trials for multiple cancers. AEterna
Zentaris owns 61.1% of Atrium Biotechnologies Inc., a leading
developer, manufacturer and marketer of value-added products for
the cosmetics, pharmaceutical, chemical and nutritional industries.
News releases and additional information about AEterna Zentaris are
available on its Web site 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,
; Investor Relations: Ginette Vallieres, (418) 652-8525 ext. 265, ;
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