Full Press Release Details
Management s Discussion and
of Financial Condition and
Results of Operations
Highlights
announced the publication in the renowned American scientific journal, Proceedings of the National Academy of Sciences, of new data
supporting the use of our ghrelin receptor antagonist compound, AEZS-123, for
the treatment of alcohol dependence that involves ghrelin.
On August 3, 2009, our
partner, Keryx Biopharmaceuticals, Inc.
( Keryx ), disclosed that it had reached an agreement with the U.S. Food and
Drug Administration ( FDA ) regarding a Special Protocol Assessment on the
design of a double-blind, placebo-controlled Phase 3 trial with perifosine, in
relapsed or relapsed/refractory multiple myeloma patients previously treated
with bortezomib (VELCADE ).
On August 17, 2009, we
from two Phase 3 studies with cetrorelix in benign prostatic hyperplasia ( BPH ).
Results from the efficacy study Z-033 showed it did not achieve its primary endpoint. Results from the safety study Z-041
were positive and exhibited a similar level of efficacy as the previously
disclosed Phase 2 studies.
On September 16, 2009, our
partner, Keryx, announced that it had
received Orphan Drug designation from the FDA for perifosine for the treatment
of multiple myeloma.
On September 21, 2009, we
disclosed results from a Phase 1 study
with AEZS-112 in patients with advanced solid tumors or lymphoma. Results showed prolonged courses of stable disease, excellent
tolerability and potential for long-term use as a combination treatment for
September 30 2009, we disclosed results for the Thorough QT Z-043 ( TQT ) study
which is part of the cetrorelix pamoate clinical development in BPH. The study
met its primary endpoint of showing that cetrorelix does not increase heart
rate-corrected QT interval (QTc; QTcF: Fridericia corrected) at either time of
observed maximal concentration of cetrorelix (Cetromax),
or at the time of minimum level of serum testosterone (Testmin).
Subsequent to Quarter-End
October 19, 2009, we announced that we initiated activities intended to
complete a Phase 3 clinical trial with macimorelin (AEZS-130) as a first
approved oral diagnostic test for Growth Hormone Deficiency.
October 23, 2009, we completed a US$5.5 million registered direct offering with
US institutional investors. Pursuant to this offering, we issued 4,583,335
units, with each unit consisting of one common share and a warrant to purchase
0.40 of a common share, at a price of $1.20 per unit.
November 2, 2009, we disclosed positive preliminary results for the Phase 2 study
with AEZS-108, a LHRH-receptor targeted cytotoxic conjugate, in patients with platinum-resistant and
taxane-pretreated ovarian cancer. This open-label, multi-center and multi-national Phase 2
study AGO-GYN-5 is being conducted by the German AGO Study Group
(Arbeitsgemeinschaft Gyn kologische Onkologie / Gynaecological Oncology Working
Group; www.ago-ovar.de), in cooperation with clinical sites in Europe.
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 and nine-month periods ended September
30, 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 and nine-month periods ended on September 30, 2009 and 2008. Our consolidated financial
statements, reported in United States dollars ( US dollars ), except where
otherwise noted, 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 ).
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 FDA, 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 required 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 its securities are registered with the United States
Securities and Exchange Commission and is therefore required to file or furnish
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