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 April 2004
AETERNA LABORATORIES INC.
---------------------------------------------------
(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
----- -----
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
----- -----
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 of March 29, 2004: AETERNA ADOPTS SHAREHOLDER RIGHTS PLAN
2. Press release of March 31, 2004: AETERNA SUBSIDIARY ZENTARIS REPORTS
POSITIVE PRECLINICAL RESULTS FROM NOVEL PYRAZOLE COMPOUND
3. Press release of April 2, 2004: AETERNA SUBSIDIARY ZENTARIS SIGNS NEW
AGREEMENT WITH ARDANA BIOSCIENCE FOR LHRH ANTAGONIST TEVERELIX
[LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA ADOPTS SHAREHOLDER RIGHTS PLAN
QUEBEC CITY, QUEBEC, MARCH 29, 2004 - AEterna Laboratories Inc. (TSX: AEL;
Nasdaq: AELA) announced today that its Board of Directors has adopted a
shareholder rights plan (the "Rights Plan"), which takes effect immediately. The
objectives of the Rights Plan are to provide adequate time for the Corporation's
Board of Directors and shareholders to assess an unsolicited takeover bid for
the Corporation, to provide the Board of Directors with sufficient time to
explore and develop alternatives for maximizing shareholder value if a takeover
bid is made, and to provide shareholders with an equal opportunity to
participate in a takeover bid.
"This Rights Plan is similar to those adopted by other companies and approved by
their shareholders. Furthermore, AEterna's management and directors believe that
the Rights Plan preserves the fair treatment of all shareholders, is consistent
with Canadian corporate practices and addresses institutional investor
guidelines. AEterna is not adopting this Rights Plan in response to any specific
proposal to acquire control of the Corporation, nor is it aware of any such
intention," said Gilles Gagnon, President and Chief Executive Officer of
AEterna.
While the Rights Plan takes effect immediately, it is subject to regulatory
approval and to ratification by AEterna's shareholders at its annual general
meeting on May 26, 2004. The Rights Plan will be in effect for three (3) years,
with one renewal option, subject to shareholder approval. The rights issued to
the shareholders under the Rights Plan will be exercisable only when a person or
entity, including any related party(ies), acquires or announces its intention to
acquire more than twenty (20) percent of the outstanding subordinate voting
shares of AEterna (as such shares may be redesignated or reclassified) without
complying with the "permitted bid" provisions of the Rights Plan or without
approval of AEterna's Board of Directors. Should such an acquisition occur, each
right would, upon exercise, entitle a holder, other than the person pursuing the
acquisition together with its related party(ies), to purchase subordinate voting
shares of AEterna at a fifty (50) percent discount to the market price of
AEterna's shares at the time.
Under the Rights Plan, a permitted bid is one made to all shareholders that is
open for acceptance for not less than sixty (60) days. If at the end of such
sixty (60)-day period more than fifty (50) percent of the outstanding
subordinate voting shares of AEterna, other than those owned by the person or
entity pursuing the acquisition together with its related party(ies), have been
tendered, the person or entity pursuing the acquisition may take up and pay for
the shares but must extend the bid for a further ten (10) days to allow other
shareholders to tender. Under the permitted bid mechanism, shareholders will
have more time to consider the bid and any other options that may be available
before deciding whether
or not to tender their shares to the bid. The Board of Directors will also have
time to consider and pursue alternatives and to make recommendations to
shareholders.
ABOUT AETERNA LABORATORIES
AEterna Laboratories Inc. along with its wholly-owned subsidiary Zentaris GmbH,
is a biopharmaceutical company with an extensive product portfolio, including
two marketed products and 14 other product candidates under development in
oncology, endocrinology and infectious diseases. Cetrorelix (Cetrotide(R)) is
sold in the U.S., Europe and several other countries to the IN VITRO
fertilization market, and is in Phase II clinical trials for endometriosis,
uterus myoma and enlarged prostate (BPH). Miltefosine (Impavido(R)) is sold for
black fever and has successfully completed a Phase III trial in parasitic skin
disease. Neovastat(R) is in a Phase III trial for non-small cell lung cancer.
Perifosine, the first orally-active AKT inhibitor, is in Phase II trials for
multiple cancers. Several other clinical programs are underway with various
potential development candidates, supported by a worldwide network of scientific
and marketing partnerships. Furthermore, AEterna benefits from a discovery
platform of 100,000 molecules, which is generating promising new compounds.
AEterna also owns 62% of its subsidiary Atrium Biotechnologies Inc. which
develops and markets active ingredients and speciality fine chemicals in the
health and personal care industry for the cosmetics, chemical, pharmaceutical
and nutritional industries. Its international business network and portfolio of
over 1,000 products sold to over 2,000 institutional customers and to over
36,000 physicians and other health care professionals, have generated
significant growth in sales and earnings since the Company was founded in
January 2000. In 2003, Atrium sales exceeded $120 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.
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.
-30-
CONTACTS:
AETERNA LABORATORIES U.S. INVESTOR RELATIONS
MEDIA RELATIONS Lippert/Heilshorn & Associates
Paul Burroughs Kim Golodetz
(418) 652-8525 ext. 406 (212) 838-3777
paul.burroughs@aeterna.com kgolodetz@lahai.com
INVESTOR RELATIONS Bruce Voss
Jacques Raymond (310) 691-7100
(418) 652-8525 ext. 360 bvoss@lhai.com
Cell. : (514) 703-5654
jacques.raymond@aeterna.com
[LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA SUBSIDIARY ZENTARIS REPORTS POSITIVE PRECLINICAL
RESULTS FROM NOVEL PYRAZOLE COMPOUNd
Results indicate ZEN-014 as a new candidate
for the development of a potent anticancer drug
ORLANDO, FLORIDA (UNITED STATES), MARCH 31, 2004 - AEterna Laboratories Inc.
(TSX: AEL; Nasdaq: AELA) and its subsidiary Zentaris GmbH report that positive
preclinical results of their novel tubulin-inhibitor ZEN-014 were presented
earlier today at the American Association for Cancer Research (AACR) meeting in
Orlando, Florida.
ZEN-014 is a novel pyrazole derivative that was discovered by Zentaris. It
represents a new class of small molecule tubulin binders with antiangiogenic
properties which are assumed to be novel highly potent anticancer drugs with
blockbuster potential.
ZEN-014 inhibits tubulin polymerization with an IC(50) of 1.3 uM. The treatment
with non-toxic concentrations (10 nM) of ZEN-014 inhibits endothelial cell
sprouting and vessel formation. Cancer cells (KB/HeLa) were arrested completely
in the G2M phase of mitosis at nanomolar concentrations (IC(50): 34 nM) and
subsequently underwent apoptosis. Several apoptotic parameters as cell membrane
alterations, increase of caspase 3 and 7 activity, DNA fragmentation and
inactivation of the Bcl-2 protein are detectable in U937 cancer cells after
treatment with nanomolar concentrations of ZEN-014.
The compound shows an excellent antitumor activity profile in a broad panel of
tumor cell lines (average IC(50) of 40 nM) including paclitaxel and vincristine
resistant cells. ZEN-014 exhibits promising IN VIVO activity in a renal cell
carcinoma model at a dose of 50 mg/kg after oral application.
"These excellent results again show the capability of our own drug discovery
unit which is the core for the continuous supply of new development candidates
and essential for the growth of our Company", said Prof. Dr. Jurgen Engel,
Executive Vice President, Global R&D and Chief Operating Officer at AEterna,
Chairman and Managing Director of Zentaris GmbH.
Based on these excellent IN VITRO and IN VIVO activities, ZEN-014 is a promising
new candidate for further preclinical development. ZEN-014 combines
antiproliferative activity at nanomolar concentrations with strong inhibition of
angiogenesis.
ABOUT AETERNA LABORATORIES
AEterna Laboratories Inc. along with its wholly-owned subsidiary Zentaris GmbH,
is a biopharmaceutical company with an extensive product portfolio, including
two marketed products and several other product candidates under development in
oncology, endocrinology and infectious diseases. Cetrotide(R) (Cetrorelix) is
sold in the U.S., Europe and several other countries to the IN VITRO
fertilization market, and is in Phase II clinical trials for endometriosis,
uterus myoma and enlarged prostate (BPH). Impavido(R) (Miltefosine) is sold for
black fever and has successfully completed a Phase III trial in parasitic skin
disease. Neovastat(R) is in a Phase III trial for non-small cell lung cancer.
Perifosine, the first orally-active AKT inhibitor, is in Phase II trials for
multiple cancers. Several other clinical programs are underway with various
potential development candidates, supported by a worldwide network of scientific
and marketing partnerships. Furthermore, AEterna benefits from a discovery
platform of 100,000 molecules, which is generating promising new compounds.
In addition, AEterna owns 62% of Atrium Biotechnologies Inc., which develops and
markets active ingredients and specialty chemicals in the health and personal
care industry for the cosmetics, pharmaceutical, chemical and nutritional
sectors. In 2003, Atrium sales exceeded $120 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.
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.
CONTACTS:
AETERNA LABORATORIES
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
(418) 573-8982 cell. (514) 703-5654 cell.
paul.burroughs@aeterna.com jacques.raymond@aeterna.com
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Zentaris GmbH
Kim Golodetz Dr. Mathias Pietras
(212) 838-3777 phone: + 49 69 42 602 3423
kgolodetz@lhai.com fax: + 49 69 42 602 3444
Bruce Voss mathias.pietras@zentaris.de
(310) 691-7100 www.zentaris.com
bvoss@lhai.com
[LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA SUBSIDIARY ZENTARIS SIGNS NEW AGREEMENT WITH
ARDANA BIOSCIENCE FOR LHRH ANTAGONIST TEVERELIx
QUEBEC CITY, QUEBEC, APRIL 2, 2004 - AEterna Laboratories Inc. (TSX: AEL ;
NASDAQ: AELA) announced that its wholly owned subsidiary Zentaris GmbH and
Ardana Bioscience, a specialty pharmaceutical company, from Edinburgh, Scotland,
have signed a new agreement for the LHRH antagonist Teverelix. Ardana acquired
full global rights and is assigned the intellectual property relating to
Teverelix and the underlying microcrystalline suspension technology. In return,
Zentaris receives a substantial payment at signature, fixed annual guaranteed
payments until 2006, as well as potential future income on sales of Teverelix.
As part of the agreement, Zentaris will provide certain development services
and supply clinical samples to Ardana. Teverelix Phase I clinical trial
evaluating a sustained release formulation for use in prostate cancer is nearing
conclusion.
"We are delighted with the restructuring of the existing Teverelix collaboration
in place with our Scottish partner", says Professor Dr. Juergen Engel, Chairman
and Managing Director of Zentaris GmbH and Chief Operating Officer of AEterna.
"It emphasises the commitment of Ardana towards a successful development of
Teverelix. At the same time it allows for Zentaris to generate double-digit
million Euro risk-free income in the short and mid-term, while also potentially
profiting from a successful commercialisation of the product."
Dr Maureen Lindsay, Ardana Chief Operating Officer said, "We are delighted to
have secured all global rights to Teverelix, such that we can reap the full
benefits of its development and commercialization. Our strategy is to focus on
drugs prescribed by specialist clinicians, a market we can service effectively
with our planned specialist sales force. Teverelix fits neatly into this
strategy and is central to our burgeoning research and development portfolio,
which is on track to provide products that address five different indications in
Phase III clinical trials by the end of 2005."
Mr. Gilles Gagnon, President and Chief Executive Officer of AEterna Laboratories
Inc. added, "Ardana continues to be an important partner beyond Teverelix, also
holding the worldwide rights to our Growth Hormone Secretagogue (GHS), another
project from our promising pipeline. This significant transaction is a key step
in the building of our strategic portfolio."
ABOUT ARDANA BIOSCIENCE
Ardana Bioscience is a specialty pharmaceutical company focused on reproductive
health. It aims to become a leading source of clinical and commercial innovation
in the $20 billion human reproductive health market, which is growing at 9% per
annum. In addition to the androgen replacement therapy which will be launched in
the UK in 2004, Ardana has a rich development portfolio including Chronodyne(R)
(terbutaline) for endometriosis-related infertility (being developed in
collaboration with Columbia Laboratories (NASDAQ: CBRX) and LHRH analogs
Teverelix and 'Leuprorelin' for a wide variety of reproductive indications.
Ardana's therapeutic interests encompass androgen replacement, infertility,
sexual dysfunction and obstetrics.
Since its inception, Ardana has raised (pound)34.5 million in three funding
rounds. Ardana investors include Merlin Biosciences Limited, MVM Limited (MVM),
Techno Venture Management (TVM), ABN-AMRO Participates, 3i Group plc, ISIS
Equity Partners plc, Scottish Widows Investment Partnership Ltd, Mitsubishi
Corporation and Green Highlander, LLC. The company was created in July 2000 to
commercialise research by the Medical Research Council (MRC)'s Human
Reproductive Sciences Unit (HRSU) in Edinburgh, Scotland, which has been at the
forefront of this area of research for the last 30 years. The MRC employs nearly
100 staff at the Unit, which currently receives total annual funding of
(pound)3.8 million.
For more information on Ardana, consult www.ardana.co.uk
ABOUT AETERNA LABORATORIES
AEterna Laboratories Inc. along with its wholly-owned subsidiary Zentaris GmbH,
is a biopharmaceutical company with an extensive product portfolio, including
two marketed products and 14 other product candidates under development in
oncology, endocrinology and infectious diseases. Cetrorelix (Cetrotide(R)) is
sold in the U.S., Europe and several other countries to the IN VITRO
fertilization market, and is in Phase II clinical trials for endometriosis,
uterus myoma and enlarged prostate (BPH). Miltefosine (Impavido(R)) is sold for
black fever and has successfully completed a Phase III trial in parasitic skin
disease. Neovastat(R) is in a Phase III trial for non-small cell lung cancer.
Perifosine, the first orally-active AKT inhibitor, is in Phase II trials for
multiple cancers. Several other clinical programs are underway with various
potential development candidates, supported by a worldwide network of scientific
and marketing partnerships. Furthermore, AEterna benefits from a discovery
platform of 100,000 molecules, which is generating promising new compounds.
AEterna also owns 62% of its subsidiary Atrium Biotechnologies Inc. which
develops and markets active ingredients and speciality fine chemicals in the
health and personal care industry for the cosmetics, chemical, pharmaceutical
and nutritional industries. Its international business network and portfolio of
over 1,000 products sold to over 2,000 institutional customers and to over
36,000 physicians and other health care professionals, have generated
significant growth in sales and earnings since the Company was founded in
January 2000. In 2003, Atrium sales exceeded $120 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.
---------------
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.
-30-
CONTACTS:
AETERNA LABORATORIES
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
(418) 573-8982 cell. (514) 703-5654 cell.
paul.burroughs@aeterna.com jacques.raymond@aeterna.com
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Zentaris GmbH
Kim Golodetz Dr. Mathias Pietras
(212) 838-3777 phone: + 49 69 42 602 3423
kgolodetz@lhai.com fax: + 49 69 42 602 3444
Bruce Voss mathias.pietras@zentaris.de
(310) 691-7100 www.zentaris.com
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: April 2, 2004 By: /s/ MARIO PARADIS
-------------------- ----------------------------------
Mario Paradis
Senior Director, Finance and
Corporate Secretary