AEterna Zentaris Announces Outcome of Management's Strategic Review
QUEBEC CITY, QC, Oct. 2 - AEterna Zentaris, 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 endometriosis, and 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.
AEterna Zentaris has established its cytotoxic conjugate, AEZS-108,Â 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,Â 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 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.
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.