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 February 2003
AETERNA LABORATORIES INC.
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(Translation of registrant's name into English)
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 of February 27, 2003: AEterna's Subsidiary, Zentaris,
to start distribution of Impavido(R) in India
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[LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA'S SUBSIDIARY, ZENTARIS, TO START
DISTRIBUTION OF IMPAVIDO(R) IN INDIA
The first oral drug against visceral leishmaniasis is now available in the
Indian market. More countries will follow soon.
NEW YORK CITY, U.S., FEBRUARY 27, 2003 - AEterna Laboratories Inc. (TSX: AEL,
NASDAQ: AELA) announced today at the BIO CEO & Investor Conference that its
wholly-owned company, Zentaris AG, has signed an exclusive distribution and
marketing agreement with German Remedies Limited for the marketing of
Impavido(R) (Miltefosine) in India and Bangladesh. It is the beginning of global
marketing of Miltefosine which will be available, as early as possible, in all
countries burdened with leishmaniasis disease. The contract foresees that German
Remedies will market the product in the private sectors of India. In addition,
German Remedies will distribute the product in Bangladesh upon registration.
Both of these countries are suffering the most from the deadly visceral
leishmaniasis.
Visceral leishmaniasis (Kalar-Azar, black fever) is one of the most problematic
tropical infection diseases of our time in developing countries. The World
Health Organization (WHO) estimates that more than 315,000 people are infected
annually in India only. The mortality rate is still high.
Impavido(R) is the first oral drug against visceral leishmaniasis and has been
proven to be highly effective and less toxic than current therapies (New England
Journal of Medicine 2002 Vol.347, No.22, p.1739). Nowadays, antimonial therapies
tend to fail because of resistance and severe side effects. Because the
injectable therapies available require the hospitalization of patients, an oral
drug is certainly an important avenue that can bring important savings in
healthcare costs.
A Phase IV clinical trial has already been started and is sponsored by the
Indian Council of Medical Research (ICMR). A Phase III clinical trial for the
cutaneous leishmaniasis is ongoing and results are expected in the first half of
this year. Because of its outstanding position, Impavido(R) has received
worldwide attention, which is reflected in many recent international
publications.
"We developed this product to help and cure the poorest of the world. Our aim is
to make it available as quickly as possible to those who suffer from the
disease. We are delighted to have German Remedies/Zydus Cadila, one of the major
players in the Indian pharmaceutical market, as our partner for the marketing of
Impavido(R)," said Prof.
Jurgen Engel, Chief Executive Officer at Zentaris, as well as AEterna's
Executive Vice President, Global Research and Development and Chief Operating
Officer.
"While representing an important milestone for our shareholders, the launch of
this compound is an example of the magnitude and potential of our product
pipeline and reflects the competency of our world class drug discovery and
pharmaceutical development teams," concluded Gilles Gagnon, President and Chief
Executive Officer at AEterna.
AEterna has an impressive portfolio of products in the market and in
development. Impavido(R) is the third marketed product besides Cetrotide
(Serono) and Lobaplatin (Hainan Tianwang, China). Six additional products are in
clinical stages and four are in preclinical development.
ABOUT GERMAN REMEDIES LIMITED
German Remedies Limited, a member of the Zydus Cadila Group, is a public company
since 1973 and is one of the leading Indian pharmaceutical companies with 1,700
employees. It manufactures pharmaceutical specialties in various therapeutic
groups with major emphasis in the fields of female healthcare, gastroenterology,
respiratory care, oncology and diagnostics. The company has state-of-the-art
manufacturing plants and adheres to International Standards of Good
Manufacturing Practices and Quality Management. Zydus Cadila is the 4th largest
pharmaceutical group in India.
ABOUT AETERNA LABORATORIES INC.
AEterna is a biopharmaceutical company focused on the development of novel
therapeutic treatments, mainly in oncology and endocrinology. The product
pipeline includes 12 products ranging from preclinical stage up to
commercialization. AEterna has strategic worldwide partners such as Access
Oncology, Ardana Bioscience, Baxter Healthcare S.A., Grupo Ferrer, Hainan
Tianwang International Pharmaceutical, Mayne Group, Medac GmbH, Nippon Kayaku,
Serono International S.A., Shionogi & Co., Ltd. and Solvay Pharmaceuticals B.V.
AEterna owns 100% of the biopharmaceutical company, Zentaris AG, based in
Frankfurt, Germany.
AEterna also owns 61.8% of Atrium Biotechnologies Inc., which develops and
markets nutritional supplements, as well as active ingredients and fine
chemicals intended for the cosmetics, nutritional, fine chemical and
pharmaceutical industries. Atrium markets over 500 products in 20 countries to
industry leaders such as Estee Lauder, L'Oreal, Clarins, Chanel, Aventis,
SanofiSynthelabo and Nestle.
AEterna and its entities have 270 employees in Canada and Europe.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the NASDAQ
National Market (AELA).
News releases and additional information about AEterna are available on its Web
site at www.aeterna.com.
SAFE HARBOR STATEMENT
This press release contains forward-looking statements, which are 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 the business opportunities in
the pharmaceutical industry, uncertainties related to the regulatory process and
general changes in economic conditions. Investors should consult the Company's
ongoing 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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CANADA
Media Relations: Investor Relations:
Normand Tremblay Jacques Raymond
Tel.: (418) 652-8525 ext. 241 Tel.: (418) 652-8525 ext. 360
Cell.: (514) 703-5654
Fax: (418) 577-7671 Fax: (418) 577-7700
E-mail: normand.tremblay@aeterna.com E-mail: jacques.raymond@aeterna.com
USA EUROPE
The Investor Relations Group Investor relations
Lisa Lindberg Matthias Seeber
Tel.: (212) 825-3210 Tel.: 011 49 69 4 26 02 34 25
Fax: (212) 825-3229 Fax: 011 49 69 4 26 02 34 44
E-mail: TheProTeam@aol.com E-mail: matthias.seeber@zentaris.de
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 LABORATORIES INC.
Date: February 27, 2003 By: /s/Claude Vadboncoeur
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary