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 October 2002
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-____
EXHIBIT INDEX
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Exhibit Description
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1. Press Release of October 29, 2002 - FDA Grants Orphan-Drug Status to
AEterna's Neovastat(R) for Kidney Cancer.
[AETERNA LOGO HERE]
PRESS RELEASE
FOR IMMEDIATE RELEASE
FDA GRANTS ORPHAN-DRUG STATUS TO
AETERNA'S NEOVASTAT(R) FOR KIDNEY CANCER
QUEBEC CITY, QUEBEC, OCTOBER 29, 2002 - AEterna Laboratories Inc. (Nasdaq: AELA;
TSX: AEL) announced that the U.S. Food and Drug Administration (FDA) has granted
its lead product, Neovastat(R), antiangiogenic components extracted from marine
cartilage, orphan-drug status for the treatment of renal cell carcinoma, a form
of kidney cancer.
"We are pleased with this designation from the FDA which acknowledges the
potential clinical benefit of Neovastat in renal cell carcinoma. This
orphan-drug status together with the invaluable commitment from investigators in
the current international Phase III clinical trials in renal cell carcinoma and
non-small cell lung cancer are very encouraging, as we are completing late-stage
development of this unique oral multifunctional antiangiogenic drug", said
Dr. Claude Hariton, AEterna's Vice President and Chief Medical Officer.
Gilles Gagnon, President and COO at AEterna Laboratories, added, "It
illustrates to our stakeholders that we continue to put in place all processes
to insure the success of Neovastat's registration according to our
time-to-market strategy which could enable AEterna to open a new anti-cancer
therapy class."
ORPHAN DRUG STATUS
The Orphan Drug status entitles a product to seven-year exclusive marketing
rights upon receiving approval in this indication. The status further allows a
company to apply for clinical research funding, tax credits on clinical research
and development expenses, potential waiver of fees associated with the filing of
marketing application, and assistance from the FDA Office of Orphan Products
Development in guiding the drug through the regulatory approval process.
NEOVASTAT'S FAVORABLE SAFETY PROFILE CONFIRMED
Dr. Hariton also presented the conclusions of the third meeting of the Data
Safety Monitoring Board, an independent body of oncologists, responsible for
evaluating patient safety and ensuring the integrity of this international
Phase III trial in renal cell carcinoma. The Board stated that the safety
profile of the study drug is acceptable to allow the trial to continue without
adjustment. The same conclusions were conveyed by the Board during the two first
meetings held in November 2001 and April 2002.
ABOUT NEOVASTAT RCC PHASE III TRIAL
AEterna's current international Phase III trial in renal cell carcinoma aims to
increase survival time in patients who have failed to respond to standard
immunotherapy treatment. It is currently being conducted in nine countries on
the American and European continents. The lead investigators for this study are
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, Montreal, in Canada, Dr. Ronald Bukowski, Director of Experimental
Therapeutics Program at the Cleveland Clinic Cancer Center in the United States,
and Dr. Bernard Escudier, Head of Immunotherapy and Innovative Therapy Unit at
the Institut Gustave Roussy in Villejuif, France, in Europe.
Recruitment of all 302 patients for the trial has been completed and results are
expected in the first quarter of 2003. The outcome of a prior Phase I/II
clinical trial in renal cell carcinoma had demonstrated a statistically
significant (p< 0.01) two-fold increase in median survival time for patients who
were administered an optimal dose of Neovastat. A peer-review on the results of
this Phase I/II trial was published in the August issue of ANNALS OF ONCOLOGY.
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.
ABOUT AETERNA AND NEOVASTAT
AEterna is a Canadian biopharmaceutical company and a frontrunner in the
development of an angiogenesis inhibitor, primarily in oncology.
Neovastat, antiangiogenic components extracted from marine cartilage, is
currently undergoing two Phase III clinical trials for the treatment of lung and
kidney cancer and one Phase II trial for the treatment of multiple myeloma, a
form of blood cancer. These trials are currently being held in more than
120 clinical institutions in Canada, the United States and several European
countries.
Atrium Biotechnologies Inc., a 61.8% owned subsidiary of AEterna Laboratories,
develops and markets nutritional supplements, as well as active ingredients and
fine chemicals intended for the cosmetics, nutritional, fine chemicals and
pharmaceutical industries. The Company markets over 500 products in 20 countries
to industry leaders such as Estee Lauder, L'Oreal, Clarins, Chanel, Aventis,
SanofiSynthelabo and Nestle.
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:
Paul Burroughs Jacques Raymond
Tel.: (418) 652-8525 ext. 406 Tel.: (418) 652-8525 ext. 360
Fax: (418) 577-7700 Fax: (418) 577-7700
E-mail: paul.burroughs@aeterna.com E-mail: jacques.raymond@aeterna.com
USA
The Investor Relations Group
Lisa Lindberg
Tel.: (212) 825-3210
Fax: (212) 825-3229
E-mail: TheProTeam@aol.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 LABORATORIES INC.
Date: October 29, 2002 By: /s/Claude Vadboncoeur
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary