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 June 2004
AETERNA ZENTARIS INC.
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(Formerly named AEterna Laboratories Inc.)
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-
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DOCUMENTS INDEX
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DOCUMENTS DESCRIPTION
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1. Press release of June 3, 2004: AETERNA ZENTARIS TO PRESENT AT THREE
UPCOMING CONFERENCES: ASCO, BIO 2004 AND NEEDHAM BIOTECHNOLOGY CONFERENCE
2. Press release of June 7, 2004: AETERNA ZENTARIS REPORTS
ENCOURAGING RESULTS FROM PHASE I TRIAL OF PERIFOSINE IN
COMBINATION WITH RADIOTHERAPY AT THE 2004 AMERICAN SOCIETY OF
CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING
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AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd. AETERNA ZENTARIS Quebec
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881 Frankfurt
PRESS RELEASE
For immediate release
AETERNA ZENTARIS TO PRESENT AT THREE UPCOMING CONFERENCES:
ASCO, BIO 2004 AND NEEDHAM BIOTECHNOLOGY CONFERENCE
QUEBEC CITY, CANADA, JUNE 3, 2004 - AEterna Zentaris Inc. (TSX: AEZ; Nasdaq:
AEZS) announced today presentations at three upcoming conferences - ASCO, BIO
2004 and Needham Biotechnology Conference - in June 2004.
The first presentation will be at the American Society of Clinical Oncology
Annual Meeting at the Ernest Memorial Convention Center in New Orleans, LA, on
June 7, between 8:00 am and 12:00 noon CT. Marcel Verheij, M.D., of the
Netherlands Cancer Institute, will present poster #N3-3064 "PHASE I STUDY OF
COMBINED TREATMENT WITH THE ORAL ALKYL-LYSOPHOSPHOLIPID (ALP) PERIFOSINE AND
RADIATION IN PATIENTS WITH ADVANCED SOLID TUMORS."
Also on June 7, Gilles Gagnon, President and Chief Executive Officer of AEterna
Zentaris, will provide a corporate update at BIO 2004 at 12:00 noon PT, at the
Moscone Convention Center in San Francisco, CA.
Finally, on June 17, at 8:30 a.m. ET, Dr. Jurgen Engel, Executive Vice
President, Global R&D and COO at AEterna Zentaris, will provide a corporate
update at the Third Annual Biotechnology Conference of Needham & Co., at the
Palace Hotel in New York City, NY. A live webcast of the presentation will be
available on the Company's website at WWW.AETERNAZENTARIS.COM in the Investors
section. A replay of the webcast will be available for a period of 90 days at
the same address.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a biopharmaceutical company focused in oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to marketed
products, includes perifosine, an orally-active AKT inhibitor in several Phase
II trials for multiple cancers, and cetrorelix, an LHRH antagonist already
marketed for IN VITRO fertilization under the brand name Cetrotide(R), and also
in advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH).
AEterna Zentaris owns 100% of Zentaris GmbH in Germany. It also owns 62% of
Atrium Biotechnologies Inc., which develops, distributes and markets active
ingredients, specialty fine chemicals, cosmetic and nutritional products for the
cosmetics, chemical, pharmaceutical and nutritional industries.
News releases and additional information about AEterna Zentaris are available on
its new Web site WWW.AETERNAZENTARIS.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:
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
PAUL.BURROUGHS@AETERNAZENTARIS.COM JACQUES.RAYMOND@AETERNAZENTARIS.COM
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Matthias Seeber
Kim Golodetz +49 69 42602 3425
(212) 838-3777 matthias.seeber@zentaris.de
kgolodetz@lhai.com
AEterna Zentaris Inc. 1405 du Parc-Technologique Blvd. AEterna Zentaris Quebec
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881 Frankfurt
PRESS RELEASE
For immediate release
AETERNA ZENTARIS REPORTS ENCOURAGING RESULTS FROM PHASE I TRIAL
OF PERIFOSINE IN COMBINATION WITH RADIOTHERAPY AT THE 2004
AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING
Data demonstrated acceptable safety/tolerability and preliminary evidence of
antitumor activity, including multiple complete and partial responses, at all
dosage levels.
NEW ORLEANS, JUNE 7, 2004 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ: AEZS)
announced today encouraging final results from recently completed Phase I trial
evaluating perifosine, the Company's novel, first-in-class, oral AKT inhibitor,
in combination with radiotherapy in patients with unresectable locally advanced
tumors, in a poster session at the 2004 ASCO Annual Meeting, which takes place
in New Orleans, LA. Marcel Verheij, M.D., of the Netherlands Cancer Institute,
presented poster #N3-3064 entitled "Phase I Study of Combined Treatment with the
Oral Alkyl-Lysophospholipid (ALP) Perifosine and Radiation in Patients with
Advanced Solid Tumors."
A total of 21 radiotherapy-naive patients, of whom 17 had advanced non-small
cell lung cancer (1 Stage IIIA, 15 Stage IIIB, 1 Stage IV) and 14 had become
refractory to prior chemotherapy, received oral perifosine doses ranging from 50
mg to 200 mg/day concurrently with standard doses of radiotherapy. The trial
data demonstrated the following: (i) acceptable safety and tolerability, with
150 mg/day established as the dose recommended for use in subsequent clinical
trials; (ii) dose limiting toxicity (nausea/vomiting) at 200 mg/day; (iii) no
bone marrow toxicity; and (iv) preliminary evidence of antitumor activity at all
dosage levels, including complete or partial responses (complete disappearance
and decreased tumor size, respectively), or stable disease, with a median
follow-up for responders of 8 months (see Phase I trial data summary table at
the end of the press release).
Importantly, in the cohort of 10 patients who were treated with 150 mg/day
established as the dose recommended for use in subsequent clinical trials, there
were 3 complete responses (2 non-small cell lung cancer (NSCLC) and 1 esophageal
cancer), 3 partial responses (2 NSCLC and 1 prostate cancer), and 4 patients
with stable disease. In addition, a patient with bladder cancer who received 50
mg/day perifosine had an unexpected finding, namely a long-lasting complete
response.
These Phase I results support the ongoing clinical development of perifosine and
will form the basis for subsequent placebo-controlled trials evaluating
perifosine in combination with radiotherapy as a potential treatment for
multiple types of cancer. Based on perifosine's pharmacokinetic profile (plasma
concentration fluctuations), in future trials, perifosine will be administered 1
week prior to radiotherapy. AEterna Zentaris plans to initiate Phase II trials
on perifosine in combination with radiotherapy through the ongoing collaboration
with the Netherlands Cancer Institute of Amsterdam.
The ongoing clinical development of perifosine in North America includes nine
open-label, single agent Phase II trials in six cancer types that are being
conducted through collaboration with Keryx Biopharmaceuticals Inc. (NASDAQ:
KERX) and the United States National Cancer Institute (NCI). AEterna Zentaris
holds ex-North America rights to perifosine through Zentaris GmbH, which
originally discovered and developed perifosine.
To date, five Phase I trials have been conducted on perifosine, including the
trial highlighted at ASCO. In the four preceding trials, use of perifosine as a
single agent in a total of 94 patients provided initial, encouraging evidence of
antitumor activity. Namely, investigators observed two partial responses (>50%
reduction) in patients with sarcoma and sixteen stable disease in patients with
breast, prostate, pancreatic and other forms of cancer.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a biopharmaceutical company focused in oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to marketed
products, includes perifosine, an orally-active AKT inhibitor in several Phase
II trials for multiple cancers, and cetrorelix, an LHRH antagonist already
marketed for IN VITRO fertilization under the brand name Cetrotide(R), and also
in advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH).
AEterna Zentaris owns 100% of Zentaris GmbH in Germany. It also owns 62% of
Atrium Biotechnologies Inc., which develops, distributes and markets active
ingredients, specialty fine chemicals, cosmetic and nutritional products for the
cosmetics, chemical, pharmaceutical and nutritional industries.
News releases and additional information about AEterna Zentaris are available on
its new Web site WWW.AETERNAZENTARIS.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:
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
PAUL.BURROUGHS@AETERNAZENTARIS.COM JACQUES.RAYMOND@AETERNAZENTARIS.COM
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Matthias Seeber
Kim Golodetz +49 69 42602 3425
(212) 838-3777 MATTHIAS.SEEBER@ZENTARIS.DE
KGOLODETZ@LHAI.COM
SEE ATTACHED DOCUMENT
AETERNA ZENTARIS INC.
PHASE I TRIAL DATA SUMMARY, POSTER #N3-3064
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PERIFOSINE DOSE NUMBER OF PATIENTS (N) RESPONSE TUMOR TYPE
50 mg/day 3 SD (N=2)
CR (N=1) Bladder
100 mg/day 3 SD (N=2)
PR (N=1) NSCLC
150 mg /day 10 SD (N=4)
PR (N=3) 1 Prostate; 2 NSCLC
CR (N=3) 2 NSCLC; 1 Esophageal
200 mg/day 5 SD (N=4)
CR (N=1) NSCLC
SD=stable disease; PR=partial response; CR=complete response
SIGNATURE
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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 ZENTARIS INC.
DATE: JULY 20, 2004 By: /S/MARIO PARADIS
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Mario Paradis
Senior Director, Finance and Corporate Secretary