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 November 2005
AETERNA ZENTARIS 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-_________
DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
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1. Press release dated November 21, 2005: AEterna Zentaris
Announces Completion of Patient Enrollment for Ozarelix
(D-63153) Phase II Trial in Benign Prostatic Hyperplasia
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[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 COMPLETION OF PATIENT
ENROLLMENT FOR OZARELIX (D-63153) PHASE II TRIAL IN BENIGN
PROSTATIC HYPERPLASIA
>> ENROLLMENT COMPLETED FOUR MONTHS AHEAD OF SCHEDULE
>> RESULTS EXPECTED IN 2H 2006
QUEBEC CITY, CANADA, NOVEMBER 21, 2005 - AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today announced it has completed enrollment of 144 patients for a
Phase II trial with ozarelix (D-63153) in benign prostatic hyperplasia (BPH),
more than four months ahead of schedule. The randomized, placebo-controlled
multi-center clinical trial is designed to evaluate both objective parameters,
such as improvement in urine flow and shrinkage of the prostate volume, as well
as various symptoms of BPH over a period of several months. The trial is being
conducted in Europe with the collaboration of Spectrum Pharmaceuticals Inc.
(NASDAQ: SPPI) and results are expected to be disclosed during the second half
of 2006.
"We are pleased to have already achieved full patient enrollment for this Phase
II trial in BPH which only started last April", stated Dr. Jurgen Engel,
Executive Vice President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "In August of this year, we had previously announced the completion of
patient enrollment for a current Phase II trial with ozarelix in prostate
cancer, again, a full four months in advance. These milestones reflect the
quality of our partnership with Spectrum Pharmaceuticals for the development of
ozarelix in both indications."
Gilles Gagnon, AEterna Zentaris President and Chief Executive Officer added,
"The swift patient enrollment in both prostate cancer and BPH trials reinforce
the confidence of our investigators in the potential benefit of ozarelix, the
second lead product in our Luteinizing Hormone Releasing Hormone antagonist
therapeutic approach. It also emphasizes our commitment to advance products
through the pipeline as quickly as possible for the benefit of patients in need
of innovative and efficient therapies that can improve their quality of life."
Benign prostatic hyperplasia has marked adverse symptoms such as increased
frequency of urination and difficulty in passing urine. Because ozarelix is
expected to have dual effects, by first directly shrinking the prostate and
second, through controlled reduction in the amount of testosterone (testosterone
fuels the prostate gland), it is hoped that a single injection of ozarelix,
repeated every few months, may be able to reduce the size of the prostate as
well as accompanying symptoms.
ABOUT OZARELIX (D-63153) AND DEVELOPMENT ALLIANCE WITH SPECTRUM PHARMACEUTICALS
Ozarelix is a fourth generation LHRH (Luteinizing Hormone Releasing Hormone)
antagonist administered as a depot formulation for the treatment of
hormone-dependent prostate cancer and benign prostatic hyperplasia.
In August 2004, AEterna Zentaris granted Spectrum Pharmaceuticals an exclusive
license to develop and market ozarelix for all potential indications in North
America (including Canada and Mexico) and India. AEterna Zentaris retains
exclusive rights to the rest of the world and will share with Spectrum upfront
and milestone payments, royalties or profits from potential sales in Japan.
ABOUT BENIGN PROSTATIC HYPERPLASIA (BPH)
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the
prostate frequently occurring in men over the age of 50. The enlargement can
result in the gradual squeezing of the urethra, resulting in increased frequency
or difficulty in urinating. Enlargement of the prostate is controlled by
testosterone. According to the National Institutes of Health, BPH affects more
than 50% of men over the age of 60 and as many as 90% of men over the age of 70.
Treatment options for BPH include surgery and medications to reduce the amount
of tissue and increase the flow of urine. Current treatment options are
inconvenient, leading to ineffective compliance and are only effective in
roughly half of the patients treated.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a growing global biopharmaceutical company engaged in
the discovery, development and marketing of therapies for cancer and endocrine
disorders.
AEterna Zentaris also owns 50.03% of Atrium Biotechnologies Inc. (TSX: ATB.sv),
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
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.
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CONTACTS
MEDIA RELATIONS
Paul Burroughs
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
INVESTOR RELATIONS
Ginette Vallieres
(418) 652-8525 ext. 265
ginette.vallieres@aeternazentaris.com
EUROPE
Matthias Seeber
+49 69 42602 3425
matthias.seeber@zentaris.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: NOVEMBER 21, 2005 By: /s/ MARIO PARADIS
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Mario Paradis
Senior Finance Director and
Corporate Secretary