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 October 2004
AETERNA ZENTARIS INC.
------------------------------------------
(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
------ ------
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
----- -----
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
-----
DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
--------- ------------------------------------------------------------------
1. Press release dated October 7, 2004 - AEterna Zentaris Reports
Statistically Significant Positive Phase II Data on Cetrorelix in
Benign Prostatic Hyperplasia
[AETERNA ZENTARIS LOGO]
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 577-7597
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS REPORTS STATISTICALLY SIGNIFICANT POSITIVE
PHASE II DATA ON CETRORELIX IN BENIGN PROSTATIC HYPERPLASIA
Broad, seven-study Phase II program on cetrorelix in BPH, endometriosis and
uterine myoma now successfully completed.
Data demonstrated a dose-dependent, durable, and statistically significant
improvement of clinical symptoms characteristic of BPH, as well as excellent
safety and tolerability profile.
QUEBEC CITY, CANADA, OCTOBER 7, 2004 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today announced statistically significant positive results from a
randomized, double-blind, placebo-controlled Phase II trial designed to evaluate
different dosage regimens of a depot formulation of cetrorelix, a luteinizing
hormone-releasing hormone (LHRH) antagonist, in 250 patients with symptomatic
benign prostatic hyperplasia (BPH). These new data demonstrate a dose-dependent,
durable and statistically significant (p less than 0.001) improvement of
clinical symptoms characteristic of BPH, including IPSS (International Prostate
Symptom Score), at all dosages except the lowest, as well as an excellent safety
and tolerability profile. These positive results are consistent with data from
earlier studies and provide the basis for further development of cetrorelix in
BPH through collaboration with Solvay Pharmaceuticals and Shionogi/Nippon
Kayaku.
Benign prostate hyperplasia is characterized by an abnormal, but not malignant,
testosterone-mediated growth of prostate tissue. BPH is estimated to affect
approximately 33 million men over 60 years of age. In 2004, the amount spent on
drug treatment for this condition is expected to be around US$1.8 billion.
"We are very excited about the positive results from this new Phase II trial,
the last one from a broad seven-study Phase II program evaluating cetrorelix in
a combination of indications, and believe it provides strong evidence for the
efficacy and safety of cetrorelix in BPH, endometriosis and myoma," said Prof.
Jurgen Engel, Executive Vice President, Global R&D and Chief Operating Officer
at AEterna Zentaris. "These results, in our opinion, compare very favorably to
currently marketed therapies for BPH, which require daily administration. We
look forward to continued advancement of this program by our development and
marketing partners worldwide, and the initiation of pivotal programs on
cetrorelix, including in BPH."
"The successful completion of this latest trial is a remarkable achievement and
confirms the excellent partnership we have built with AEterna Zentaris. We
believe that the results of the
[AETERNA ZENTARIS LOGO]
extensive Phase II program will now allow us to finalize the development plans
for the compound," stated Dr. Werner Cautreels, Solvay Pharmaceuticals' Global
Head of R&D.
The randomized, double-blind, placebo-controlled trial enrolled patients with
symptomatic and objectively defined BPH (decreased urine flow) and was conducted
in Europe, under the coordination of Professor Frans MJ Debruyne from the
Department of Urology, University Medical Center in Nijmegen. All eligible
patients received two intramuscular injections of placebo, two weeks apart,
during a run-in period. After the initial four-week run-in period, 250 patients
with symptomatic BPH were randomized into five equal groups receiving either
placebo injections or four different dosage regimens from 60 to 120 mg in two or
three injections of a depot formulation of cetrorelix over the course of four
weeks.
Patients were followed for up to 26 weeks after the last injection for efficacy
and safety assessments, as well as for levels of testosterone and quality of
life and sexual function. As early as one month following the initiation of
therapy, the use of cetrorelix was associated with a dose-dependent,
statistically significant improvement of clinical signs and symptoms, including
IPSS and maximum uroflow, compared to placebo. Importantly, for all dosage
regimens the therapeutic response lasted until the last observation point, i.e.
24 to 26 weeks following cessation of cetrorelix administration.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a biopharmaceutical company focused in oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to marketed
products, includes perifosine, an orally-active AKT inhibitor in several Phase
II trials for multiple cancers, and cetrorelix, an LHRH antagonist already
marketed for IN VITRO fertilization under the brand name Cetrotide(R), and also
in advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH).
AEterna Zentaris also owns 62% of Atrium Biotechnologies Inc., which develops,
distributes and markets active ingredients, specialty fine chemicals, cosmetic
and nutritional products for the cosmetics, chemical, pharmaceutical and
nutritional industries.
News releases and additional information about AEterna Zentaris are available on
its new Web site 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.
[AETERNA ZENTARIS LOGO]
Investors are cautioned not to rely on these forward-looking statements. The
Company does not undertake to update these forward-looking statements.
-30-
CONTACTS:
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
paul.burroughs@aeternazentaris.com jacques.raymond@aeternazentaris.com
---------------------------------- -----------------------------------
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Matthias Seeber
Kim Golodetz +49 69 42602 3425
(212) 838-3777 matthias.seeber@zentaris.de
kgolodetz@lhai.com ---------------------------
------------------
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: October 7, 2004 By: /s/ Mario Paradis
---------------------- ---------------------------
Mario Paradis
Senior Finance Director and
Corporate Secretary