AEterna Zentaris Announces Outcome of Management's Strategic Review
October 02 2007 - 10:52AM
PR Newswire (US)
QUEBEC CITY, QC, Oct. 2 /PRNewswire-FirstCall/ -- 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 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. "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 http://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 http://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. DATASOURCE: AETERNA
ZENTARIS INC. CONTACT: Jenene Thomas, Senior Director, Investor
Relations & Corporate Communications, (908) 938-1475, ; Paul
Burroughs, Media Relations, (418) 652-8525 ext. 406,
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