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 October 2007
AETERNA ZENTARIS 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
------ ------
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 October 2, 2007: AEterna Zentaris Announces
Outcome of Management's Strategic Review
[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 OUTCOME OF MANAGEMENT'S STRATEGIC REVIEW
QUEBEC CITY, CANADA, OCTOBER 2, 2007 - AEterna Zentaris Inc. (TSX: AEZ; Nasdaq:
AEZS), a global biopharmaceutical company focused on endocrine therapy and
oncology, will announce today at 11:00 a.m. Eastern Time, during a live
webcast presentation and conference call hosted by President and Chief Executive
Officer, David J. Mazzo, Ph.D., the outcome of management's review of the
Company's pipeline and business operations along with key elements of the new
strategic plan implemented to achieve short-term and long-term success.
David J. Mazzo, President and Chief Executive Officer of AEterna Zentaris
stated, "Over the past four months, our Executive Team has been tasked with
completing a thorough review of our extensive pipeline and business operations
with the goal of creating a strategy optimized for success. As a result of this
extensive exercise, we established a harmonized global vision and elucidated our
strategic imperatives. Based on a rigorous assessment of the value of our
assets, our abilities and resources, the probability of success and return on
investment potential of each of our product candidates and our objective to
maximize shareholder value, we additionally established a set of priorities and
plans to achieve our vision."
During the live webcast, the company will discuss in detail the following
fundamentals of their strategic plan .
/ / AEterna Zentaris is now a multinational company with a clear vision to
eventually become a fully integrated biopharmaceutical company (without
commercial manufacturing). The necessary resources have been identified
and allocated to achieve business success.
/ / AEterna Zentaris has prioritized its pipeline, developed a partnering
strategy and determined the value of its most immediate assets:
Cetrorelix
Cetrorelix, currently in a Phase 3 program for benign
prostatic hyperplasia (BPH), is clearly the Company's highest
priority, being the asset with the largest combination of
probability of success, proximity to launch and potential
medical and commercial value. The Company has decided to seek
a commercialization partner for cetrorelix, which, in this
indication, has potential for base case peak annual sales of
over $500 million in the United States market alone. After
defining
[AETERNA ZENTARIS LOGO]
the critical path to registration, the Company expects to
launch cetrorelix in the BPH indication in 2011.
Furthermore, after optimization of formulation and trial
design, the company plans to move into Phase 2b in the
endometriosis indication and will announce timelines relative
to this program in the near future. As was announced in May
2007, the rights to cetrorelix in the endometriosis indication
were regained from Solvay. The decision to proceed with
development was made based on:
a) the proven safety and efficacy of Cetrotide(R)
b) the overall database from preclinical and clinical
studies in endometriosis
c) the large unmet medical needs and commercial
opportunity in the area of endometriosis.
Additionally, as with the BPH indication, AEterna Zentaris
will eventually seek a commercialization partner as cetrorelix
has the potential for base case peak annual sales of
approximately $200 million in the U.S. market alone in the
endometriosis indication.
AEZS-108
AEterna Zentaris has established its cytotoxic conjugate,
AEZS-108, as its highest earlier-stage priority, and will
therefore initiate a Phase 2 trial with this compound in a
both endometrial and ovarian cancers before year end. The
Company feels AEZS-108 has large market opportunities that
could compare to those for doxorubicin.
/ / The Company provided clarity regarding its partnered development
programs. The Company will minimize internal spend on partnered
programs while continuing to respect its contractual obligations to
support its partners for the development of ozarelix, perifosine,
AEZS-127 and AEZS-130. AEterna Zentaris will employ a "piggy back"
registration strategy to bring these products to market in the
territories where is retains rights as commercial opportunity size
dictates.
/ / The Company prioritized the advancement of preclinical and very
early-stage development programs based on risk-adjusted maximum market
potential.
/ / The Company established a clear global partnering strategy moving
forward:
- All commercially viable projects will be ideally developed
internally through proof-of-concept in man;
- Asia (especially Japan) remains a market of interest
for AEZS.
/ / The Company also identified non-core assets and will actively seek to
monetize/divest these assets as a potential source of non-dilutive
funding.
/ / The Company provided updated guidance for the 2007 total expected burn
in a range of $25-$27 million. Additionally, in an effort to ensure
financial flexibility, the Company recently filed a shelf prospectus.
2
[AETERNA ZENTARIS LOGO]
"It has been our guiding principle to communicate the complete picture of
AEterna Zentaris as it is and as it is planned to be with updated timelines,
priorities, key issues and expectations. After a rigorous review of the
projects, risks, plans and commercial opportunities, we are more bullish than
ever about the unrealized intrinsic value of AEZS and our ability to unlock it
to the benefit of patients and shareholders," concluded Dr. Mazzo.
CONFERENCE CALL AND WEBCAST
Participants may access the live webcast via the Company's website at
www.aeternazentaris.com in the "Investors" section, or by telephone using the
-----------------------
following numbers: 416-644-3414, 514-807-8791 or 800-733-7571.
A replay of the webcast will also be available on the Company's website for a
period of 30 days.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is 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.
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
Jenene Thomas
Senior Director, Investor Relations & Corporate Communications
(908) 938-1475
jenene.thomas@aeternazentaris.com
---------------------------------
Paul Burroughs
Media Relations
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
----------------------------------
3
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: October 3, 2007 By: /s/ Mario Paradis
--------------------------------
Mario Paradis
Senior Vice President,
Administrative and Legal Affairs
and Corporate Secretary