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, 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
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
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
- The Company prioritized the advancement of preclinical and very
early-stage development programs based on risk-adjusted maximum market
- The Company established a clear global partnering strategy moving
- 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
- 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.
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.
|SOURCE AETERNA ZENTARIS INC.|
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