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 June 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
Documents Description
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1. Press Release dated June 2, 2003: AEterna Presents Status on Neovastat
Phase III Trials in Kidney Cancer and Lung Cancer
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[LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA PRESENTS STATUS ON NEOVASTAT PHASE III TRIALS
IN KIDNEY CANCER AND LUNG CANCER
Presentations by Dr. Bernard Escudier and Dr. Charles Lu
at the American Society of Clinical Oncology Meeting in Chicago
CHICAGO, ILLINOIS, JUNE 2, 2003 - Dr. Bernard Escudier, Head of the
Immunotherapy Unit at Institut Gustave-Roussy in Paris, France and lead
investigator in Europe for AEterna Laboratories (Nasdaq: AELA, TSX: AEL)
Neovastat Phase III trial in renal cell carcinoma gave a status report on the
trial during a presentation today at the American Society of Clinical Oncology
(ASCO) Meeting in Chicago. More than 20,000 oncologists and scientists attend
this meeting each year. Dr. Charles Lu of the M.D. Anderson Cancer Center in
Houston, Texas and lead investigator for AEterna's Phase III trial in lung
cancer also gave a status on this trial.
CURRENT PHASE III TRIAL IN KIDNEY CANCER
AEterna is currently conducting a double-blind randomized placebo controlled
Phase III trial for renal cell carcinoma with its lead antiangiogenic compound,
Neovastat, involving 302 patients. Patient recruitment was completed in December
2001 and the trial is still at the patient survival monitoring stage, increased
patient survival time being the primary endpoint of the study. Following
discussions with the FDA (USA), Health Products and Food Branch (Canada) and
Medicines Control Agency (UK), analysis of the trial's database will start when
the number of deceased patients has reached 230. Furthermore, it has been agreed
with these health authorities that should that number not be reached by
September 30, 2003, analysis of the trial's database would begin at that time
and all patients still taking part in the trial would receive Neovastat. Dr.
Escudier announced that as of today, the number of deceased patients stands at
218. Trial results will be available during the current year.
"The trial is still ongoing and on three occasions, the Data Safety Monitoring
Board (DSMB) stated that the study could continue without adjustments since no
safety concerns have been reported," explained Dr. Escudier. The DSMB is an
independent body of oncologists and statisticians responsible for evaluating
patient safety and ensuring the integrity of the trial. "Confirming Neovastat's
favourable safety profile in patients suffering from serious and potentially
life-threatening conditions is a valuable asset in developing a new anticancer
drug, especially when it has to be taken on a chronic basis," concluded Dr.
Escudier.
Gilles Gagnon, President and Chief Executive Officer at AEterna added, "We are
at an exciting and also important stage of Neovastat's development. Positive
results from this study could allow us to reach our goal which is to bring to
market a self-administered oral drug that is not only efficient in fighting
cancer but also almost devoid of debilitating side effects so as to enhance
patient quality of life."
NEOVASTAT POSITIVE RESULTS IN PRIOR PHASE I/II TRIAL IN KIDNEY CANCER
In March, 2001, AEterna presented results of a Phase I/II kidney cancer trial
with Neovastat on patients suffering from metastatic renal cell carcinoma and
refractory to standard therapies at the Annual Meeting of the American
Association for Cancer Research (AACR) in New Orleans. Results showed a
statistically significant two-fold increase (p(less than)0.01) in median
survival time for patients who had received a higher dose of Neovastat. Median
survival time for patients treated with a twice-daily dose of 30mL of Neovastat
was 7.1 months compared to 16.3 months for patients receiving a twice-daily dose
of 120mL. These results were published last year in the European scientific
review ANNALS OF ONCOLOGY. "AEterna is generating highly credible data with
Neovastat which seem encouraging in the development of this new approach in
fighting cancer," said Dr. Gerald Batist, Director of the McGill Centre for
Translational Research in Cancer and Professor at the Department of Oncology and
Medicine at McGill University in Montreal, as well as lead investigator in
Canada for the current Phase III trial in kidney cancer.
Renal cell carcinoma is the most common type of kidney cancer in adults. There
are about 34,000 new cases of renal cell carcinoma in North America each year
and about 38,000 new cases in Europe. The five-year mortality rate for this
disease is approximately 90%. The therapies currently available are effective in
less than 20% of cases and are associated with a large number of serious side
effects.
CURRENT PHASE III TRIAL IN LUNG CANCER
AEterna is also conducting a Phase III trial with Neovastat in non-small cell
lung cancer. Sponsored by the U.S. National Cancer Institute (NCI), the study is
being held in approximately 40 hospital centers in the United States and Canada.
Patients are receiving chemotherapy and radiotherapy treatments in combination
with a placebo or Neovastat and the main endpoint is an increase in median
survival time. At the current ASCO meeting, Dr. Charles Lu of the M.D. Anderson
Cancer Center in Houston, Texas and lead investigator of this study for the
United States, announced that as of today, 240 patients have been enrolled out
of a total of 760. He also outlined Neovastat's excellent safety profile
following recently obtained data.
NEOVASTAT POSITIVE RESULTS IN PRIOR PHASE I/II TRIAL IN LUNG CANCER
Back in September 1999, at the 10th European Cancer Conference in Vienna (ECCO
10), AEterna had divulged results of an open-label, non-small cell lung cancer
Phase I/II study. Results showed that higher doses (240 mL per day) of Neovastat
significantly increased (p (less than)0.02) the median survival time by 33% as
compared to patients receiving lower doses. Results were published in early 2003
in CLINICAL LUNG CANCER.
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 marketing.
AEterna has strategic worldwide partners such as Access Oncology, Ardana
Bioscience, Baxter Healthcare S.A., German Remedies Ltd., Grupo Ferrer
Internacional, Hainan Chang An Pharmaceutical ltd, LG Life Sciences Ltd., Mayne
Group, Medac GmbH, Nippon Kayaku, Serono International S.A., Shionogi & Co. Ltd,
Solvay Pharmaceuticals B.V. and Teikoku Hormone Mfg. Co. Ltd.
AEterna owns 100% of the biopharmaceutical company, Zentaris GmbH, 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, nutrition, fine chemicals and
pharmaceuticals industries. Atrium markets over 500 products in 20 countries to
industry leaders such as Estee Lauder, L'Oreal, Clarins, Chanel, Avnetis,
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.
PS. FOR MORE INFORMATION ON THE PHASE III TRIAL IN NON-SMALL CELL LUNG CANCER,
CALL 1-888-349-3232.
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:
Paul Burroughs Jacques Raymond
Tel.: (418) 652-8525 ext. 406 Tel.: (418) 652-8525 ext 360
Cell.: (418) 573-8982 Cell.: (514) 703-5654
Fax: (418) 577-7700 Fax: (418) 577-7700
E-mail: paul.burroughs@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: June 2, 2003 By: /s/ Claude Vadboncoeur
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary