Full Press Release Details
Management s Discussion and
of Financial Condition and
Results of Operations
Introduction
The following Management s Discussion and Analysis ( MD&A ) provides a
review of the results of operations, financial condition and cash flows of
terna Zentaris Inc. for the three-month period ended March 31, 2009. In this MD&A, the Company , we , us ,
and our mean terna Zentaris Inc. and its subsidiaries. This
discussion should be read in conjunction with the information contained in the
Company s interim consolidated financial statements and related notes for the
three-month periods ended on March 31, 2009 and 2008. Our consolidated financial statements, reported in United States
dollars ( US dollars ) have been prepared in accordance with Canadian Generally
Accepted Accounting Principles ( Canadian GAAP ) for interim financial
information, which differ in certain respects from United States Generally
Accepted Accounting Principles ( US GAAP ).
All amounts presented in this MD&A are in US dollars, except where
About Forward-Looking Statements
This document contains forward-looking
statements, which reflect our current expectations regarding future events.
Forward-looking statements may include words such as anticipate, believe,
could, expect, goal, guidance, intend, may, objective, outlook, plan, seek,
should, strive, target and will.
Forward-looking statements involve risks and
uncertainties, many of which are discussed in this MD&A. Results or performance
may differ significantly from expectations. For example, the results of current
clinical trials cannot be foreseen, nor can changes in policy or actions taken
by such regulatory authorities as the US Food and Drug Administration, the
Therapeutic Products Directorate of Health Canada or any other organization
responsible for enforcing regulations in the pharmaceutical industry.
Given these uncertainties and risk factors,
readers are cautioned not to place undue reliance on any forward-looking statements.
We disclaim any obligation to update any such factors or to publicly announce
any revisions to any of the forward-looking statements contained herein to
reflect future results, events or developments, unless requested to do so by a
governmental authority or by applicable law.
About Material Information
This MD&A includes the information we
believe to be material to investors after considering all circumstances,
including potential market sensitivity. We consider information and disclosures
to be material if they result in, or would reasonably be expected to result in,
a significant change in the market price or value of our shares, or where it is
quite likely that a reasonable investor would consider the information and
disclosures to be important in making an investment decision.
Company is a reporting issuer under the securities legislation of all of the
provinces of Canada and is registered in the United States and is, therefore,
required to file continuous disclosure documents such as interim and annual
financial statements, an MD&A, a Proxy Circular, an Annual Report on Form 20-F,
material change reports and press releases with the appropriate securities
regulatory authorities. Copies of these documents may be obtained free of
charge on request from the office of the Secretary of the Company or on the
Internet at the following addresses: www.aezsinc.com, www.sedar.com and
Company Overview
(TSX: AEZ, NASDAQ: AEZS) is a global biopharmaceutical company focused on
endocrine therapy and oncology.
Our pipeline encompasses compounds at all stages of development, from drug discovery through marketed products. The two highest priorities in drug development are our Phase 3 program in benign prostatic hyperplasia ( BPH ) with our lead endocrinology compound, cetrorelix, and our Phase 2 program in advanced endometrial and ovarian cancers with our lead oncology compound, AEZS-108.
Key Developments for the
Three Months Ended March 31, 2009
Status of our drug pipeline
as at March 31, 2009
| Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | Commercial | |||||
| 120,000 compound library | AEZS-115 (endometriosis & urology) AEZS-120 (oncology vaccine) AEZS-126 (Erk & PI3K Inhibitors - oncology) AEZS-127 (oncology) Ghrelin receptor ligands (endocrinology) | AEZS-112 (oncology) AEZS-130 (endocrinology) | AEZS-108 (endometrial and ovarian cancers) Cetrorelix (endometriosis) (BPH in Japan) Ozarelix (BPH, prostate cancer) Perifosine (multiple cancers) | Cetrorelix (BPH) | Cetrotide ( in vitro fertilization) | |||||
| Partners | ||||||||||
| Cetrorelix: Shionogi in Japan Ozarelix : Spectrum in North America and India, Nippon Kayaku in Japan (oncology) Ozarelix (BPH): Handok in Korea, Indonesia, Malaysia, the Philippines and Singapore Perifosine: Keryx in North America | Cetrorelix (BPH): Sanofi-aventis in U.S.A. Handok in Korea | Cetrotide : Merck Serono (World ex-Japan) Nippon Kayaku / Shionogi (Japan) |
During the three months ended March 31,
2009, we continued to advance the Phase 3 program of cetrorelix in BPH.
The North American trial (Z033) completed
patient recruitment in April 2008 (667 patients randomized). We expect the
results from the double-blind portion of the study to be available during the
third quarter of 2009.
The European trial (Z036) also has all of its
patients enrolled since September 2008 (420 patients randomized). We
expect the results from the double-blind portion of the study to be available
during the fourth quarter of 2009.
Similarly, the safety trial (Z041) is also
fully enrolled (528 patients randomized), and we expect the results to be
available during the fourth quarter of 2009.
During the first quarter of 2009, we initiated
the screening of patients within our QTc safety trial (Z043) with the objective
of disclosing the results by the fourth quarter of 2009. We also held a data
safety monitoring board for Z036, which recommended the continuity of our
ongoing trials without any changes. Our focus is now on the execution of our
studies (Z033, Z036, Z041 and Z043) and on preparing for the analysis of forthcoming
2 trials with AEZS-108 are ongoing, as scheduled. For both indications,
advanced endometrial and ovarian cancers, we continue to progress into the
second stage of development according to the Simon design protocol. Data indicate
one complete response and several partial tumor responses, in addition to
stabilization of disease in a number of other patients, which we find very
encouraging to pursue further development.
We are pursuing a Phase
1 trial with 41 patients enrolled in the study. An abstract has been presented
in April 2009 at the American Association for Cancer Research Annual
Meeting ( AACR ). While we are continuing the Phase 1 trial, we plan to
further develop this compound.
During the quarter, we finalized the European
non-small cell lung cancer study with perifosine studied as a radiosensitizer.
Data are expected in the second quarter of 2009. Our partner, Keryx
Biopharmaceuticals, Inc. ( Keryx ), presented posters and gave a
presentation on perifosine at the AACR annual meeting in Denver in April 2009.
Further development is expected from Keryx during 2009.
Corporate Developments
Cetrorelix Development, Commercialization and
On March 4, 2009, we entered into a development, commercialization