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 April 2005
AETERNA ZENTARIS INC.
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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-__________
DOCUMENTS INDEX
Documents Description
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1. Press release dated April 19, 2005 - AEterna Zentaris Announces
Phase I Positive Results for its Oral Growth Hormone Secretagogue
Compound EP-1572.
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[AETERNA ZENTARIS LOGO]
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS ANNOUNCES PHASE I POSITIVE RESULTS FOR ITS
ORAL GROWTH HORMONE SECRETAGOGUE COMPOUND EP-1572
POTENTIAL APPLICATIONS FOR GROWTH DISORDERS IN CHILDREN AND CACHEXIA (MUSCLE
WASTING) ASSOCIATED WITH CHRONIC DISEASE
QUEBEC CITY, CANADA, APRIL 19, 2005 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today announced positive results in a Phase I study of its oral Growth
Hormone Secretagogue (GHS), EP-1572. Conducted by Ardana plc (LSE: ARA), AEterna
Zentaris' development and marketing partner for EP-1572, the study provides
clear evidence that this compound is able to induce a significant rise in growth
hormone levels. Potential applications include treatment for growth retardation
in children and cachexia associated with chronic disease such as AIDS and
cancer. EP-1572, the only orally-administered specific GHS in development,
presents a major competitive advantage in terms of ease and convenience of
delivery over current treatments which are only available through injections.
The open, randomised, placebo-controlled dose-escalation Phase I study involved
a total of 36 healthy male volunteers, divided into three groups of 12
volunteers. Nine subjects in each group received a single oral dose of EP-1572 -
0.005 mg/kg in the first group, 0.05 mg/kg in the second group and 0.5 mg/kg in
the third group - with the other three subjects in each group receiving a
placebo. All subjects had been initially checked for their ability to release
growth hormone by the intravenous administration of another hormone, growth
hormone releasing hormone (GHRH).
The data demonstrated that between 1-2 hours after drug administration there was
a statistically significant increase in the levels of growth hormone in the
blood without any effect on other hormones with the mean GH value being 79.12
ng/ml at the highest dose of EP-1572 (p = 0.009), compared to 52.62 ng/ml with
GHRH and 3.58 ng/ml for placebo. In all cases, EP-1572 was well tolerated and no
adverse events were reported.
Additional studies are ongoing to accelerate development of EP-1572 for growth
hormone disease and the more significant marketing opportunity of cachexia
associated with chronic disease. In 2004 the global growth hormone market was
estimated to be worth US$2.3 billion. (SOURCE: WOOD MACKENZIE'S PRODUCT VIEW
DECEMBER 2004).
[AETERNA ZENTARIS LOGO]
ABOUT GROWTH HORMONE SECRETAGOGUES (GHS) AND EP-1572
Growth Hormone Secretagogues (GHS) represent a new class of pharmacological
agents which directly stimulate growth hormone (GH) secretion from the pituitary
gland. EP-1572 is the only peptidomimetic GHS compound in its class to be orally
administered; other treatments are available through daily injections. EP-1572
has potential applications for the treatment of growth hormone disorders (GHD)
such as growth retardation in children and cachexia in AIDS patients. There are
currently no GHS's on the market.
ABOUT EP-1572 STRATEGIC ALLIANCE WITH ARDANA PLC
In 2002, AEterna Zentaris granted Ardana an exclusive worldwide license to
develop and market the growth hormone secretagogue EP-1572. Ardana is funding
the activities necessary to obtain regulatory and marketing approvals.
Furthermore, the agreement provides milestone payments, as well as royalties on
future worldwide net sales of EP-1572 among other elements to AEterna Zentaris.
ABOUT ARDANA
Ardana plc (LSE: ARA) is an emerging pharmaceutical company focused on the
discovery, development and marketing of innovative products to improve human
reproductive health, a US$23.8 billion market.
Since its foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology in-licensing and
out-licensing to maintain a robust pipeline.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is an oncology and endocrine therapy focused
biopharmaceutical company with proven expertise in drug discovery, development
and commercialization. The Company's broad 20 product pipeline leverages five
different therapeutic approaches, including LHRH antagonists and signal
transduction inhibitors. The lead LHRH antagonist compound, cetrorelix, is
currently marketed for IN VITRO fertilization under the brand name Cetrotide(R).
Cetrorelix is also in late-stage clinical development for endometriosis and
benign prostate hyperplasia (BPH). The lead signal transduction inhibitor
compound, perifosine, is an orally-active AKT inhibitor that is in several Phase
II trials for multiple cancers.
AEterna Zentaris owns 50.7% of Atrium Biotechnologies Inc. (ATB.sv), a leading
developer, manufacturer and marketer of value-added products for the cosmetics,
pharmaceutical, chemical and nutritional industries.
News releases and additional information about AEterna Zentaris are available on
its Web site www.aeternazentaris.com.
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[AETERNA ZENTARIS LOGO]
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:
MEDIA RELATIONS
Paul Burroughs
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
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INVESTOR RELATIONS
Ginette Vallieres
(418) 652-8525 ext. 265
ginette.vallieres@aeternazentaris.com
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EUROPE
Matthias Seeber
+49-6942602-3425
matthias.seeber@zentaris.com
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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 ZENTARIS INC.
Date: April 19, 2005 By: /s/Mario Paradis
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Mario Paradis
Senior Finance Director and Corporate
Secretary