Full Press Release Details
Management s Discussion and Analysis of Financial Condition and Results
January 25, 2010: Updated results of a
Phase 2 study related to the use of perifosine in the treatment of advanced metastatic colon
cancer showing a statistically significant benefit in survival.
January 29, 2010: Publication in the February 2010 issue of
the Journal of Clinical Cancer Research of
positive Phase 2 results for perifosine as a single agent for the treatment of
advanced Waldenstrom s macroglobulinemia.
February 3, 2010: Special Protocol Assessment ( SPA ) granted by
the United States Food and Drug Administration ( FDA ) for the Phase 3 trial of
perifosine in combination with capecitabine (Xeloda ) in refractory advanced colorectal cancer. The trial
is to be conducted and sponsored by our partner, Keryx Biopharmaceuticals, Inc.
March 1, 2010: Disclosure that the Committee for Orphan Medicinal
Products of the European Medicines Agency ( EMA ) had issued a positive opinion
for orphan medicinal product designation for perifosine for the treatment of
Subsequent to Quarter-End
April 5, 2010: Perifosine receives FDA Fast Track Designation for the Phase 3 X-PECT (Xeloda + Perifosine
Evaluation in Colorectal cancer Treatment) registration trial.
April 8, 2010: Initiation
of a Phase 3 registration trial with perifosine in refractory advanced
colorectal cancer by Keryx.
April 15, 2010: Positive
Scientific Advice from the European Medicines Agency for the Phase 3 program
with perifosine in multiple myeloma.
April 20, 2010: Presentations
of preclinical data on Erk inhibitor, AEZS-131, and Erk/PI3K dual inhibitor,
AEZS-132, as well as preclinical data from a study sponsored by the National
Institutes of Health with perifosine in oncology at the American Association
for Cancer Research Annual Meeting in Washington, D.C.
April 20, 2010: Completion
of a US$15.0 million registered direct offering with certain institutional
April 23, 2010: Regained
compliance with Nasdaq s minimum bid price listing requirement.
May 6, 2010: Received orphan-drug designation from the FDA for
AEZS-108, our doxorubicin targeted conjugate compound, for the treatment of
May 12, 2010: Received approval from the FDA for our
Investigational New Drug ( IND ) application for AEZS-108, in luteinizing
hormone-releasing hormone ( LHRH ) receptor positive urothelial (bladder)
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, 2010. 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 March 31, 2010 and 2009. 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 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
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. The Company 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 late-stage drug development company specialized
in oncology and endocrine therapy.
Our pipeline encompasses
compounds at all stages of development, from drug discovery through marketed
products. The highest priorities in oncology are our Phase 3 program with
perifosine in multiple myeloma and colorectal cancer, combined with our Phase 2
program in multiple cancers, as well as our Phase 2 program with AEZS-108 in
advanced endometrial and advanced ovarian cancer combined with potential
developments in other cancer indications. In endocrinology, AEZS-130 (SolorelTM), which is being studied as
a growth hormone stimulation test for the diagnosis of growth hormone deficiency ( GHD ) in adults, is
our lead Phase 3 program.
Key Developments for the
Three Months Ended March 31, 2010