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 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-
EXHIBIT INDEX
DOCUMENT DESCRIPTION PAGE
1. Press Release of December 17, 2003: AEterna updates Neovatat's
clinical development plan
[LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA UPDATES NEOVATAT'S CLINICAL DEVELOPMENT PLAN
ALL AMOUNTS ARE IN CANADIAN DOLLARS
QUEBEC CITY, QUEBEC, DECEMBER 17, 2003 -- Gilles Gagnon, President and Chief
Executive Officer at AEterna Laboratories Inc. (TSX: AEL; Nasdaq: AELA) today
presented the Company's updated plan on the clinical development of Neovastat.
This plan includes the continuation of the Phase III trial in non-small cell
lung cancer sponsored by the U.S. National Cancer Institute (NCI) with which
AEterna has just renewed the agreement for a period of two years. Also, for
strategic considerations, AEterna ceases all activities related to renal cell
carcinoma, resulting in a workforce reduction. These decisions are based upon
management's evaluation of the recommendations of an international committee of
six oncology experts, combined with an extensive analysis of the development
plan for AEterna's 12-product portfolio, the competitive environment, as well as
the time and investments that would be required to conduct an additional Phase
III study in kidney cancer. These actions are part of the Company's strategy
aimed at reaching profitability for AEterna.
"This strategic decision will allow us to focus Neovastat efforts in lung cancer
only, even though, as reported by our committee of experts, our product has
shown potential for a sub-group of patients in our Phase III kidney cancer
trial," stated Mr. Gagnon.
Indeed, that trial did show an excellent safety profile and a more than 100%
increase in median survival time for a specific sub-group of healthier patients
(ECOG = 0) with a single metastatic site and clear-cell histology. Despite this
fact, another Phase III trial in kidney cancer would be required either with
patients having the same profile taking Neovastat in monotherapy or with another
group using Neovastat as first-line treatment in combination with standard
therapy. "Since this additional study would require major investments over a
four-year period, a time-frame that would not allow us to meet our main
investment criteria, we have decided not to pursue our activities in kidney
cancer. However, the ongoing Phase III trial in lung cancer with Neovastat does
meet our evaluation and clinical development criteria for an angiogenesis
inhibitor and justifies pursuing this trial," explained Gilles Gagnon. To this
effect, the Company announced the renewal of its agreement with the NCI for this
double-blind, placebo-controlled trial in which Neovastat is administered as
first-line treatment in combination with chemotherapy and radiotherapy. So far,
approximately 300 patients out of the 760 needed for this trial have been
enrolled.
While pursuing the lung cancer trial, the Company is also looking into other
business opportunities to enhance Neovastat's full commercial potential.
These strategic decisions call for a new organizational structure which will
allow optimal use of our different expertise and synergies between all AEterna
subsidiaries. This translates into the elimination of 63 jobs representing 20%
of the workforce at AEterna and its subsidiaries, which now stands at 240
employees in Canada, the United States, Germany and France.
These job-cuts will be made at all levels including four vice presidents: Vice
President, Legal Affairs and Corporate Secretary; Vice President Planning and
External Affairs; Vice President, Technical Operations; and Vice President
Clinical Affairs. Clinical activities will be assumed by the team supervised by
Prof. Dr. Jurgen Engel, PhD, current Executive Vice President, Global R&D and
Chief Operating Officer at AEterna. These measures will take effect as of today.
"I would like to thank all the employees and collaborators affected by these
measures for their hard work, devotion and loyalty during these past few years,"
stated Mr. Gagnon.
"Measures announced today, combined with our other corporate activities, are
part of our goals to be cash flow positive in 2004 and to tend towards
profitability, while maintaining R&D investments at a level of over $30 million
during 2004. I am convinced that these measures, along with our solid financial
position which includes $75 million in cash at September 30, 2003, will greatly
contribute in pursuing AEterna's growth strategy based on maximizing the value
of our 12-product portfolio and on acquisitions," concluded Mr. Gagnon.
ABOUT AETERNA LABORATORIES
AEterna Laboratories is a biopharmaceutical company with an extensive portfolio
of marketed and development-stage products in oncology, endocrinology and
infectious diseases. In oncology, Neovastat(R) is in a Phase III trial for
non-small cell lung cancer. In endocrinology, Cetrotide(R) is sold in the U.S.
and Europe to the IN VITRO fertilization market, and is in Phase II clinical
trials for endometriosis, uterus myoma and enlarged prostate (BPH). A further
seven clinical programs are underway with various compounds.
AEterna owns 100% of the biopharmaceutical company, Zentaris GmbH, based in
Frankfurt, Germany. Zentaris generated more than $30 million in revenues and was
cash flow positive in 2002.
In addition, AEterna owns 62% of Atrium Biotechnologies Inc. which develops and
markets active ingredients and speciality fine chemicals for the cosmetics,
chemical, pharmaceutical and nutritional industries. It sells approximately 800
products to over 2,000 customers including Estee Lauder, L'Oreal, Clarins,
Chanel, Aventis, SanofiSynthelabo and Nestle. In 2002, sales exceeded $100
million.
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. To find out more about the
current Phase III trial in non-small cell lung cancer, call 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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Contacts:
AETERNA LABORATORIES
MEDIA RELATIONS 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: DECEMBER 19, 2003 By: /s/ Claude Vadboncoeur
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Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary