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 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
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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 November 15, 2004 -- Clinical Experience
on AEterna Zentaris' Impavido(R) Published in CLINICAL
INFECTIOUS DISEASES
[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
CLINICAL EXPERIENCE ON AETERNA ZENTARIS' IMPAVIDO(R) PUBLISHED IN CLINICAL
INFECTIOUS DISEASES
Results support the therapeutic utility of Impavido(R) in immunocompromised
HIV-infected patients with recurrent leishmaniasis
QUEBEC CITY, CANADA, NOVEMBER 15, 2004 - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS) today announced a publication in the peer-reviewed CLINICAL
INFECTIOUS DISEASES Journal demonstrating the therapeutic utility and favourable
tolerability of oral miltefosine (Impavido(R)) as initial and maintenance
treatment of recurrent visceral leishmaniasis, an opportunistic life-threatening
infection also known as black fever, in immunocompromised HIV-infected patients.
The results come from a compassionate use program of oral miltefosine in 39
HIV-infected patients, all with parasitologically verified leishmaniasis, who
had failed at least one and as many as nine prior courses of standard therapy
for leishmaniasis and were receiving antiviral combination therapy for HIV. The
initial response and initial cure rates for miltefosine were shown to be 64% and
41%, respectively, a significant positive finding in this tough-to-treat patient
population that currently lacks treatment alternatives. All currently existing
drug treatments for leishmaniasis have a high rate of relapse and, unlike
miltefosine, are for parenteral (injection) use. Miltefosine was generally
well-tolerated, with no dose-limiting side effects or adverse interactions with
antiviral therapy, even when used for extended periods of maintenance treatment
for up to two years. The most frequently observed side effects in this study
were gastrointestinal and included vomiting, nausea and diarrhea. Miltefosine's
safety and tolerability profile compares favourably to that of other treatment
modalities, which can be associated with treatment-limiting side effects such as
kidney toxicity.
"The results of this study continue to support the use of Impavido(R) as a
much-needed treatment alternative that combines the convenience of oral use with
favourable efficacy and tolerability for patients with leishmaniasis," said
Prof. Jurgen Engel, Executive Vice President, Global R&D and Chief Operating
Officer at AEterna Zentaris. "Leishmaniasis is becoming a growing problem in
countries in Southern Europe where, until recently, it was not considered
endemic. Immunocompromised patients, in particular, are at an increased risk for
this life-threatening disease, with approximately 25%-70% of leishmaniasis cases
in Southern Europe being associated with HIV infection."
[AETERNA ZENTARIS LOGO]
Impavido(R) is currently marketed in India through cooperation with German
Remedies (a member of Zydus Cadila) and has been submitted for registration in
Germany, Pakistan and Colombia. It is the first orally-administered therapy for
visceral and cutaneous leishmaniasis, a parasitic infection which affects
millions of people and is, according to WHO, endemic in 88 countries in the
world. It is estimated that annually 1-1.5 million people are newly infected and
a total of 12 million people are infected. The cure rate of Impavido(R) is 95%,
even in patients resistant to antimony-based standard therapy. Leishmaniasis is
transmitted by sand flies. The symptoms of visceral leishmaniasis include fever,
spleen and liver enlargement, blood deficiencies, bleeding of mucous membranes,
and severe weight loss. If left untreated, visceral leishmaniasis can lead to
death within 0.5-2 years.
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 cetrorelix and perifosine. Cetrorelix, an LHRH antagonist
already marketed for IN VITRO fertilization under the brand name Cetrotide(R),
is also in advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH). Perifosine, an
orally-active AKT inhibitor, is in several Phase II trials for multiple cancers.
AEterna Zentaris also owns 60% of Atrium Biotechnologies Inc., which develops,
manufactures 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.
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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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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
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[AETERNA ZENTARIS LOGO]
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Dr. Mathias Pietras
Kim Golodetz +49 69 42602 3423
(212) 838-3777 mathias.pietras@zentaris.de
kgolodetz@lhai.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: November 16, 2004 By: /s/ Mario Paradis
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Mario Paradis
Senior Finance Director and
Corporate Secretary