FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
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Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of April 2005
AETERNA ZENTARIS INC.
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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
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Documents Description
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1. Press release dated April 14, 2005 -AEterna Zentaris to Present Exciting
New Data on Impavido(R) at the Third World Conference on Leishmaniasis
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[AETERNA ZENTARIS]
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 TO PRESENT EXCITING NEW DATA ON IMPAVIDO(R)
AT THE THIRD WORLD CONFERENCE ON LEISHMANIASIS
QUEBEC CITY, CANADA, APRIL 14, 2005 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) announced that it will host a satellite symposium at the Third World
Conference on leishmaniasis held in Palermo, Sicily, Italy later today. As part
of the symposium, new data on safety and efficacy of Impavido(R) (miltefosine),
the first orally-administered, breakthrough therapy for both visceral and
cutaneous forms of leishmaniasis, a severe parasitic disease second only to
malaria, will be presented.
The satellite symposium will be chaired by Professor Henry W. Murray, from
Cornell University, New York, NY, USA, who will give a brief overview of the
development program. Professor Shyam Sundar, from Varanasi University, India, a
world leading expert in leishmaniasis and clinical investigator of all studies
that eventually led to the approval of Impavido(R) in India, will summarize the
clinical studies and share his experiences gained in the first post-marketing
(Phase IV) study with Impavido(R).
Dr. Sujit Bhattachariya, Head of the Indian Council of Medical Research (ICMR)
Kala Azar-Center in Patna, India, will present details on the Phase IV study
which involved more than 1,100 patients in 13 clinics and was co-sponsored by
the ICMR and the WHO (World Health Organization). This study, the first in which
the medication was taken by the patients in a domestic setting and not under the
direct observation in hospitals, serves as feasibility test for the planned
field use of the drug in future leishmaniasis control programs. Safety and
efficacy of earlier studies were impressively confirmed. With even fewer cases
of vomiting and diarrhoea being reported compared with earlier studies,
tolerability did not present any problem for treatment compliance.
Dr. Jaime Soto from Bogota, Colombia, will present a summary of the trial data
for cutaneous leishmaniasis which led to the approval of Impavido(R) in
Colombia. He will also report on very encouraging results from a Bolivian study
run in cooperation with the University of La Paz in patients suffering from
mucocutaneous leishmaniasis, a form of the disease potentially leading to major
disfigurements. In this ongoing study, about 90% of the patients showed at least
a major improvement of their mucocutaneous lesions and - importantly and
unexpectedly - so far, no patient showed a progression of the disease. The study
was initiated as a randomized controlled study with amphotericin B as reference
treatment. However, with study participants reporting treatment failures when
receiving amphotericin B compared with responses for the
[AETERNA ZENTARIS]
much more convenient and less painful treatment with Impavido(R), study
candidates increasingly refused being allocated to the reference treatment.
Eventually, the control arm had to be closed for entry of new patients.
Dr. Olga Zerpa, from the Instituto de Biomedicina in Caracas, Venezuela, will
report about therapeutic results of Impavido(R) in another difficult to treat
form of leishmaniasis, so-called diffuse cutaneous leishmaniasis. This spreading
form of the disease is associated with an inability of the body to maintain a
durable immune control over parasites that usually persist any anti-infective
treatment. Affected patients require lengthy treatment and often also repetitive
treatment courses, similar to HIV-co-infected patients.
In absence of effective treatment, patients suffering from diffuse cutaneous
leishmaniasis and the related disfiguring skin abnormalities are often banned
from public life. In a first set of 12 patients, treatment with Impavido(R)
showed rapid improvement taking into account that treatment beyond four weeks
was required to clear the skin from parasites. Following 60 and 75 days of
treatment the skin of 83% and 100% of patients, respectively, was free of
detectable parasites.
"The combined set of data presented at this leading conference on leishmaniasis
strongly validates the unique advantages of Impavido(R) in fighting all
different forms of this dreadful disease", says Prof. Jurgen Engel, Executive
Vice President Global R&D and Chief Operating Officer at AEterna Zentaris. "We
have selected - committed to cure - as our Company mission statement. Today, we
are proud to deliver on this promise with Impavido(R)."
ABOUT LEISHMANIASIS
Leishmaniasis is a severe tropical disease, second only to malaria. Transmitted
by sand flies, leishmaniasis affects millions of people and is, according to the
World Health Organisation, endemic in 88 countries throughout the world with
nearly 350 million people at risk. It is estimated that 12 million people
currently suffer from this disease with 1-1.5 million new cases reported
annually.
Symptoms of the visceral form of the disease 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. The cutaneous form of leishmaniasis, although not deadly, is a chronic,
severely disfiguring condition.
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).
Cetrorelix is also in late-stage clinical development for 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.
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[AETERNA ZENTARIS]
AEterna Zentaris owns 50.7% of Atrium Biotechnologies Inc. (ATB.sv), 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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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
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: April 14, 2005 By: /s/Mario Paradis
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Mario Paradis
Senior Finance Director and Corporate Secretary