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 December 2004
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-________
DOCUMENTS INDEX
Documents Description
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1. AEterna Zentaris Receives Regulatory Approval for
Impavido(R)in Germany
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AEterna Zentaris Inc. 1405 du Parc-Technologique Blvd. AEterna Zentaris
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS RECEIVES REGULATORY APPROVAL FOR IMPAVIDO(R) IN GERMANY
QUEBEC CITY, CANADA, DECEMBER 6, 2004 - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS) today announced that it has received German Food and Drug
Agency (BfarM) approval for miltefosine (Impavido(R)), the first-ever
orally-administered, breakthrough therapy for visceral and cutaneous
leishmaniasis, a parasitic disease estimated to affect millions of people
worldwide. The approval enables AEterna Zentaris to market Impavido(R) in
Germany, as well as to distribute it to military personnel who have become
infected with leishmaniasis while serving in Afghanistan and Iraq. In
addition, the German regulatory approval enables AEterna Zentaris to receive
a Free Sales Certificate (FSC), which can provide the basis for registration
in countries where leishmaniasis is endemic, such as Colombia and Pakistan.
Impavido(R), or miltefosine, is an alkylphospholipid that has been marketed
in India since 2003 through cooperation with German Remedies (a member of
Zydus Cadila). It is the first orally-administered therapy for visceral and
cutaneous leishmaniasis, a parasitic infection, also known as black fever,
which affects millions of people and is, according to WHO, endemic in 88
countries in 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. Leishmaniasis is a very virulent
tropical disease, second only to malaria.
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. The cutaneous form of leishmaniasis, although not deadly,
is a chronic, severely disfiguring condition.
In Europe, leishmaniasis is a growing problem, especially in the southern
regions where, until recently, it was not considered endemic.
Immunocompromised HIV patients, in particular those with AIDS, 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. HIV patients are also particularly susceptible to repeated
recurrences of leishmaniasis due to their immune system's inability to fight
off the infection. Recently, in November 2004, AEterna Zentaris
announced a publication in the peer-reviewed CLINICAL INFECTIOUS DISEASES
JOURNAL, demonstrating the therapeutic utility and favourable tolerability of
oral miltefosine (Impavido(R)) as an initial and maintenance treatment of
recurrent visceral leishmaniasis in immunocompromised HIV-infected patients.
"In addition to providing an orally-effective new medication with the
potential to alleviate some human suffering from this horrible disease which
unfortunately affects mostly the poorest people on earth, this approval
represents the culmination of twenty years of Research and Development work
conducted by Dr. Jurgen Engel and his colleagues from the World Health
Organization, the Max Planck Institute and the University of Goettingen in
Germany", said Gilles Gagnon, President and Chief Executive Officer at
AEterna Zentaris. "Dr. Engel, our Executive Vice President, Global R&D and
Chief Operating Officer, won the Galien Prize in 1995 in Germany for the
discovery and development of this alkylphospholipid-based product, today
recognized as an innovative medicine that can cure this potentially lethal
disease which has now spread even to some parts of Southern Europe."
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.
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
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
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: December 6, 2004 By: /s/ Mario Paradis
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Mario Paradis
Senior Finance Director and
Corporate Secretary