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 May 2007
AETERNA ZENTARIS INC.
----------------------------------------
1405, Parc-Technologique Boulevard
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 May 23, 2007: AEterna Zentaris' Partner, Spectrum,
Discloses Detailed Phase 2 Data for Ozarelix in BPH at Annual AUA Meeting
--------------------------------------------------------------------------------
AETERNA ZENTARIS
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' PARTNER, SPECTRUM, DISCLOSES DETAILED PHASE 2 DATA FOR
OZARELIX, IN BPH AT ANNUAL AUA MEETING
OZARELIX IMPROVED LUTS SYMPTOMS AND URINE FLOW OVER 28-WEEK PERIOD
ALL AMOUNTS ARE IN U.S. DOLLARS
QUEBEC CITY, CANADA, MAY 23, 2007 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS), a global biopharmaceutical company focused on endocrine therapy and
oncology, today announced that its partner Spectrum Pharmaceuticals (NASDAQ:
SPPI) presented an abstract outlining detailed Phase 2 results for AEterna
Zentaris' fourth-generation luteinizing hormone-releasing hormone (LHRH/GnRH)
antagonist, ozarelix, in benign prostatic hyperplasia (BPH). Results indicate
that ozarelix was well tolerated and demonstrated statistically significant as
well as clinically meaningful efficacy in the treatment of lower urinary tract
symptoms (LUTS) secondary to BPH. Results also showed no statistically
significant impact on quality of life or erectile function. The abstract was
presented yesterday afternoon at the American Urological Association (AUA)
Annual Meeting being held this week at the Anaheim Convention Center in Anaheim,
California.
"We are encouraged by these data with ozarelix and look forward to seeing
further results from the fully-enrolled Phase 2b trial," said David J. Mazzo,
Ph.D., President and CEO of AEterna Zentaris. "With cetrorelix in an ongoing
Phase 3 program and ozarelix completing a Phase 2b trial this year, we are
fortunate to be leading the LHRH antagonist class with two very promising
compounds for the treatment of BPH."
DETAILS
The abstract #93629 (Poster #1552) titled, "THE EFFICACY AND SAFETY OF OZARELIX,
A NOVEL GnRH ANTAGONIST IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) DUE TO
BENIGN PROSTATIC HYPERPLASIA (BPH)" reviewed results of a randomized,
double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 trial in
BPH.
Ozarelix was given intramuscularly (IM) to men with moderate to severe LUTS due
to BPH, to assess the compound's efficacy and safety. Eligible patients were
treated with placebo for
AETERNA ZENTARIS
4 weeks to establish baseline International Prostate Symptom Score (IPSS) and
uroflow values. Afterwards, 144 patients meeting the inclusion criteria were
randomly allocated to one of five treatment groups with the following dosage
regimens:
- Placebo;
- Ozarelix 5 mg on Day 1 + 5 mg on Day 15;
- Ozarelix 10 mg on Day 1 +10 mg on Day 15;
- Ozarelix 15 mg on Day 1 + 15 mg on Day 15; or
- Ozarelix 20 mg on Day 1 only.
Patients were followed for 28 weeks. The primary efficacy endpoint was change in
IPSS at week 12 compared to baseline. Secondary efficacy endpoints included
changes in IPSS, Quality of Life (QoL), patients with GREATER THAN OR EQUAL TO
30% and GREATER THAN OR EQUAL TO 40% improvement in IPSS, uroflow values
(Q SUB(max)), postvoid residual (PVR) urine volume and prostate volume. Safety
analysis included changes in sexual function (IIEF-5), treatment of emergent
adverse events (AEs), lab values (including testosterone (T), PSA) and vital
signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, (Q SUB(max)) 9.7 mL/sec.
and prostate size (cm (TO THE POWER OF 3)) 41.6 at baseline.
RESULTS
The effects developed rapidly, with noticeable activity at four weeks from
starting treatment, were maximal at 12-16 weeks, and persisted for the 6 month
observation period. At week 12, all ozarelix-treated groups showed improvement
with the greatest improvement in the 15 mg + 15 mg group. Change from baseline
in IPSS was 8.6 (p LESS THAN 0.001); change from baseline in urine flow was 4.7
(p=0.002); T levels declined transiently and returned to baseline in most
patients by 4 weeks and all patients by 6 weeks following dosing. Based on IIEF,
there was no effect seen on erectile function.
Serious adverse events were reported in 4 patients on ozarelix (myocardial
infarction, pneumonitis, hypotension, renal colic), but were not considered
treatment related. No systemic allergic reactions were seen and the injections
were well tolerated.
CONCLUSIONS
- Ozarelix was well tolerated;
- Statistically significant and clinically meaningful efficacy in the
treatment of LUTS secondary to BPH;
- No statistically significant impact on quality of life or erectile
function; and
- Intramuscular 15 mg + 15 mg was the most effective regimen in this study.
ABOUT OZARELIX AND PARTNERSHIPS
Ozarelix is a fourth generation luteinizing hormone-releasing hormone (LHRH)
antagonist administered as a depot formulation for the treatment of benign and
malign hormone-dependent diseases. It is currently in Phase 2b clinical trials
for both BPH and prostate cancer.
In August 2004, AEterna Zentaris granted Spectrum Pharmaceuticals an exclusive
license to develop and market ozarelix for all potential indications in North
America and India, while
2
AETERNA ZENTARIS
AEterna Zentaris retains exclusive rights to the rest of the world. Spectrum
will also receive 50% of any upfront and milestone payments, royalties and/or
profits from sales of the product in Japan.
Furthermore, AEterna Zentaris recently granted Japanese rights for all potential
oncology indications to Nippon Kayaku, a key player in the Japanese oncology
market.
ABOUT BENIGN PROSTATIC HYPERPLASIA
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the
prostate frequently occurring in men over the age of 50. The enlargement can
result in the gradual squeezing of the urethra, resulting in increased frequency
or difficulty in urinating. Enlargement of the prostate is controlled by
testosterone. According to the National Institutes of Health, BPH affects more
than 50% of men over the age of 60 and as many as 90% of men over the age of 70.
Treatment options for BPH include surgery and medications to reduce the amount
of tissue and increase the flow of urine. Current treatment options are
inconvenient, leading to ineffective compliance and are only effective in
roughly half of the patients treated. According to Decision Resource, in 2004,
the total prevalence cases of BPH in the major pharmaceutical markets was
estimated at 56 million men and is expected to increase to 65 million cases by
2014. The BPH market is a significant market, with current annual sales of more
than $2.6 billion.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine
therapy and oncology with proven expertise in drug discovery, development and
commercialization. News releases and additional information are available at
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.
Statements that are not historical facts, including statements preceded by,
followed by, or that include the words "believes", "anticipates", "intends",
"plans", "expects", "estimates", "will," "may", "should", "approximately", and
the negative or other variations of those terms or comparable terminology, are
forward-looking statements. Such statements reflect management's current views,
intentions, strategies and plans and are based on certain assumptions.
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 ability of AEterna Zentaris to implement its business strategies,
the availability of funds and resources to pursue R&D projects, the successful
and timely completion of clinical studies, the ability of AEterna Zentaris 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.
3
AETERNA ZENTARIS
-30-
CONTACTS:
Jenene Thomas
Senior Director, Investor Relations & Corporate Communications
(418) 655-6420
jenene.thomas@aeternazentaris.com
Paul Burroughs
Media Relations
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
4
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: May 24, 2007 By: /s/Mario Paradis
--------------------------------------------
Mario Paradis
Vice President, Finance & Administration and
Corporate Secretary