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 July 2003
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
1. Press release dated July 29, 2003: AEterna reports positive Phase III
trial results with Impavido(R) (miltefosine)
[AETERNA LABORATORIES LOGO]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA REPORTS POSITIVE PHASE III TRIAL RESULTS
WITH IMPAVIDO(R) (MILTEFOSINE)
QUEBEC CITY, CANADA / FRANKFURT/MAIN, GERMANY JULY 29, 2003. - AEterna
Laboratories Inc. (NASDAQ: AELA, TSX: AEL) reported today that results of a
Phase III trial evaluating its drug Impavido(R) (miltefosine) for the treatment
of cutaneous Leishmaniasis, a severe skin disease, showed that patients taking
Impavido(R) had a 220% better cure rate compared with those in the placebo
group. The average cure rate after treatment with Impavido(R) was 70%. This
favourable data enables AEterna's subsidiary, Zentaris, which develops the drug,
to immediately apply for a marketing authorization in South American countries
where the cutaneous form of the disease is predominant.
"Impavido(R) is a breakthrough drug for the treatment of Leishmaniasis," said
Prof. Jurgen Engel, Managing Director of Zentaris GmbH, Executive Vice President
R&D and Chief Operating Officer at AEterna. "It has recently been approved in
India as the first effective oral treatment for the life-threatening visceral
form of Leishmaniasis. An even larger number of patients worldwide suffer from
the cutaneous form of Leishmaniasis which can become a chronic, severely
disfiguring condition. These patients are currently treated with toxic drugs
that require hospitalization and intravenous administration which is often the
source of new infections, like HIV. For that reason an effective orally
administered drug is eagerly awaited."
Gilles Gagnon, President and Chief Executive Officer at AEterna added, "These
results are another example of the depth and potential of our 12 product
pipeline. Within the last three years, this pipeline has yielded three
successful Phase III trials with Cetrotide(R) and Impavido(R), products which
are already generating significant revenues."
ABOUT THE PHASE III TRIAL
Impavido(R) was tested in a randomized, double-blind, placebo-controlled study
in Colombia and Guatemala, involving 133 patients suffering from cutaneous
Leishmaniasis. Of these patients, 89 were treated with Impavido(R), at a dosage
of 150 mg/day for four weeks, while 44 received placebo. Cure from the disease
was assessed six months after the end of treatment; all skin lesions had to be
healed at that time and no new skin lesions were allowed to appear. Importantly,
patients with newly diagnosed cutaneous Leishmaniasis responded to treatment
equally well as patients who were not cured by prior therapy. The new treatment
was well tolerated; side effects of Impavido(R) were limited to short episodes
of vomiting or diarrhea, similar to earlier findings in patients with visceral
Leishmaniasis.
ABOUT LEISHMANIASIS
Leishmaniasis is a tropical disease caused by the Leishmania parasite. According
to the World Health Organization (WHO), more than 12 million people are affected
worldwide, with an infection rate of 2 million new cases per year. Impavido(R)
has recently been approved in India for the treatment of the visceral form of
this disease.
ABOUT AETERNA LABORATORIES INC.
AEterna Laboratories has an extensive portfolio of marketed and
development-stage biopharmaceutical products focused in oncology and
endocrinology. Its lead oncology compound is Neovastat(R), a proprietary
angiogenesis inhibitor with multiple mechanisms of action in a Phase III
clinical trial for renal cell carcinoma (data available by year-end 2003) and
in a Phase III trial for non-small cell lung cancer. 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 $Cdn 100 million in 2002.
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. To find out more about the current 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.
-30-
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) 577-7671 Fax: (418) 577-7671
E-mail: paul.burroughs@aeterna.com E-mail: jacques.raymond@aeterna.com
USA GERMANY
INVESTOR RELATIONS SALES & MARKETING
Lippert/Heilshorn & Associates Dr.Mathias Pietras
Kim Sutton Golodetz Tel.: +49 69 426023423
Tel: (212) 838-3777 Fax: +49 69 426023444
E-mail: kgolodetz@lhai.com E-mail: mathias.pietras@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: July 29, 2003 By: /s/Claude Vadboncoeur
-------------------- ---------------------------------
Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary