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 September 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
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(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 September 24, 2003: AEterna reports
phase III trial results in Renal Cell Carcinoma with
Neovastat(R)
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[AETERNA LABORATORIES, INC. LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA LABORATORIES REPORTS PHASE III TRIAL RESULTS
IN RENAL CELL CARCINOMA WITH NEOVASTAT
QUEBEC CITY, CANADA, SEPTEMBER 24, 2003 - AEterna Laboratories Inc. (TSX: AEL;
Nasdaq: AELA) today reported results of a Phase III trial in renal cell
carcinoma, a form of kidney cancer, evaluating Neovastat, the Company's
antiangiogenic compound. Results showed that the study, involving 305 patients
refractory to immunotherapy, did not meet its primary endpoint of improving
overall median survival time. However, significant survival advantage was
observed in a subgroup of healthier patients with clear cell histology and only
a single metastatic site. This 38 patient subgroup showed a median survival time
of 26.3 months for those treated with Neovastat compared to 12.6 months for
patients receiving a placebo (p=0.0236).
Gilles Gagnon, AEterna's President and Chief Executive Officer, stated, "While
this trial in refractory renal cell carcinoma did not reach its primary
endpoint, the results observed for the subgroup of patients with a single
metastatic site suggest Neovastat may be useful in treating specific forms of
kidney cancer. Furthermore, this trial generates very useful data for our
current Phase III trial in non-small cell lung cancer. The significant increase
in median survival time for the renal cell carcinoma subgroup which was at an
earlier disease stage compared to the overall cohort, seems to suggest that
treatment with Neovastat in earlier stage cancer could be more efficacious." The
Phase III trial in non-small cell lung cancer is enrolling newly diagnosed
patients for front line treatment with Neovastat. "This Phase III renal cell
carcinoma trial showed that Neovastat had an excellent safety profile,"
emphasized Dr. Pierre Champagne, Medical Director and Vice President,
Clinical Affairs at AEterna.
Furthermore, patients in the non-small cell lung cancer trial are administered
Neovastat in combination with chemotherapy and radiotherapy. Based on prior
antiangiogenesis trials in cancer, the approach of front line therapy with best
standard treatment is regarded as the strategy most likely to show clinical
benefit.
"Our current Phase III trial in non-small cell lung cancer is part of our
clinical program geared towards developing promising compounds from our
extensive pipeline that encompasses 12 products, with two already marketed,"
continued Mr. Gagnon. "We presently have a solid balance sheet and our corporate
objective is to accelerate the implementation of our growth strategy."
RENAL CELL CARCINOMA PHASE III TRIAL INFORMATION
This randomized, double-blind, placebo-controlled study was conducted in
approximately 50 hospitals and clinical centers throughout Canada, the United
States and Europe. It was designed to evaluate the efficacy of AEterna's
antiangiogenic treatment, Neovastat, in prolonging survival of patients with
progressive metastatic renal cell carcinoma, refractory to immunotherapy.
Patient recruitment opened in May 2000 and was completed in December 2001. The
trial involved 305 patients who had failed to respond to immunotherapy. From
this number, 153 patients were administered Neovastat, while 152 patients were
given a placebo. Overall median survival time for the Neovastat group was 12.4
months compared to 12.3 months for the placebo group. Analysis of a pre-planned
stratification showed that healthier patients (ECOG performance=0, metastatic
site=1) with clear cell histology showed statistically significant clinical
benefit, 26.3 months for Neovastat (n=20) versus 12.6 months for the placebo
group (n=18) (p=0.0236).
Renal cell carcinoma represents approximately 85% of all cases of kidney cancer
in the U.S. and accounts for about 32,000 new cases in North America and about
38,000 new cases in Europe, with a five-year mortality rate of approximately
90%.
The principal investigators for this trial were Dr. Peter Venner, Director of
Medical Oncology at the Cross Center Institute in Edmonton, Alberta for the
Canadian portion, Dr. Ronald Bukowski, Director of the Experimental Therapeutics
Program of the Cleveland Clinic Cancer Center, in Cleveland, Ohio for the U.S.
portion and Dr. Bernard Escudier, Head of Immunotherapy and Innovative Therapy
Unit, Institut Gustave Roussy, Villejuif, France for the European portion of the
trial.
"We would like to acknowledge the dedicated efforts of all our investigators
and thank the 305 patients who took part in this study which was conducted
according to the industry's highest standards," concluded Gilles Gagnon.
CONFERENCE CALL INFORMATION
Management will be hosting an investment community conference call beginning at
9:45 a.m. Eastern Time today, Wednesday, September 24, to discuss this
announcement and to answer questions.
To participate in the live call by telephone, please dial 514-807-8791,
416-640-4127 from Canada or 1-800-814-4890 from outside Canada. A telephone
replay will be available from 12:00 noon eastern on September 24 until 11:59
p.m. Eastern on September 26, by dialing 416-640-1917 and entering passcode
21018858#. Individuals interested in listening to the conference call via the
Internet may do so by visiting WWW.AETERNA.COM. A replay will be available on
the Company's Web site for 30 days.
PRESS MEETING INFORMATION
Management will be holding a press meeting to discuss the Renal Cell Carcinoma
Phase III trial results at 11:00 a.m. Eastern Time today, Wednesday, September
24 in the Fortin-Leduc room at the Loew's - Le Concorde Hotel, 1225 Cours du
General Montcalm in Quebec City.
ABOUT AETERNA LABORATORIES
AEterna Laboratories is a biopharmaceutical company with an extensive portfolio
of marketed and development-stage biopharmaceutical products focused in oncology
and endocrinology. Its lead oncology compound Neovastat(R), a proprietary
angiogenesis inhibitor with multiple mechanisms of action, is currently in a
Phase III clinical trial for non-small cell lung cancer. A Phase III trial in
renal cell carcinoma with Neovastat was recently completed. Neovastat was
granted Orphan Drug Status for renal cell carcinoma, by the FDA. Cetrotide(R),
its lead compound in endocrinology, is sold in the U.S. and Europe to the IN
VITRO fertilization market, and is in clinical testing for endometriosis, uterus
myoma and enlarged prostate (BPH). A further seven clinical programs are
underway with various compounds. In addition, AEterna owns 62% of Atrium
Biotechnologies, a profitable and growing developer, distributor and marketer of
active ingredients, fine chemicals, cosmetic and nutritional products with sales
exceeding $100 million in 2002.
AEterna and its entities have 300 employees in Canada and Europe, and its 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. To find out more about the current Phase III
trial in non-small cell lung cancer, call 1-888-349-3232.
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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MEDIA RELATIONS CANADA INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
paul.burroughs@aeterna.com jacques.raymond@aeterna.com
U.S. INVESTOR RELATIONS
Lippert / Heilshorn & Associates
Kim Golodetz
(212) 838-3777
KGOLODETZ@LHAI.COM
Bruce Voss
(310) 691-7100
bvoss@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 LABORATORIES INC.
Date: July 29, 2003 By: /s/ Claude Vadboncoeur
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary