FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of March 2005
AETERNA ZENTARIS INC.
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(Formerly named AEterna Laboratories Inc.)
1405, boul. du Parc-Technologique
Quebec, Quebec
Canada, G1P 4P5
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F.
Form 20-F Form 40-F X
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Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934
Yes No X
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If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
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DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
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1. Press release dated March 16, 2005 - AEterna Zentaris Announces Decision
to Continue Cetrorelix Development in Benign Prostate Hyperplasia in
Japan
[AETERNA ZENTARIS LOGO]
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS ANNOUNCES DECISION TO CONTINUE CETRORELIX DEVELOPMENT IN BENIGN
PROSTATE HYPERPLASIA IN JAPAN
QUEBEC CITY, CANADA, MARCH 16, 2005 - 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."
[AETERNA ZENTARIS LOGO]
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 www.aeternazentaris.com.
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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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[AETERNA ZENTARIS LOGO]
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CONTACTS:
MEDIA RELATIONS
Paul Burroughs
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
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INVESTOR RELATIONS
Ginette Vallieres
(418) 652-8525 ext. 265
ginette.vallieres@aeternazentaris.com
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EUROPE
EUROPE
Matthias Seeber
+49-6942602-3425
matthias.seeber@zentaris.com
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
AETERNA ZENTARIS INC.
Date: March 17, 2005 By: /s/ Mario Paradis
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Mario Paradis
Senior Finance Director and
Corporate Secretary