Full Press Release Details
Management s Discussion and Analysis of Financial Condition and Results
July 14, 2010: Perifosine receives orphan-drug
designation by the United States Food and Drug Administration ( FDA ) for the
treatment of neuroblastoma, a cancer of the nervous system affecting mostly
children and infants.
August 5, 2010: Announcement that a clinical investigator had been awarded a grant from
the National Institutes of Health ( NIH ) for a Phase 1/2 study in
advanced refractory prostate cancer with AEZS-108.
July 14, 2010: Presentation at the Seventh
International Congress of Neuroendocrinology in Rouen, France, of an abstract on Solorel, an oral synthetic ghrelin
receptor agonist, as a diagnostic test for Adult Growth Hormone Deficiency ( AGHD ).
Subsequent to Quarter-End
October 5, 2010: Presentation at the Fifth
International Congress of the Growth Hormone Research Society and
the Insulin-like Growth Factors Society in New York City, of interim Phase 3 data on Solorel demonstrating
the potential to provide a simple, well tolerated and safe oral diagnostic test
Discussion and Analysis ( MD&A ) provides a review of the results of
operations, financial condition and cash flows of Aeterna Zentaris Inc. for the
three-month and nine-month periods ended September 30, 2010. In this MD&A, the Company , we , us , our
and the Group mean Aeterna Zentaris Inc. and its subsidiaries. This
discussion should be read in conjunction with the information contained in the
Company s unaudited interim consolidated financial statements and related notes
thereto as at September 30, 2010 and for the three-month and nine-month
periods ended September 30, 2010 and 2009. Those unaudited interim consolidated financial statements 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 ).
All amounts in this MD&A are presented in US dollars, except for
share, option and warrant data, per share and per warrant data and as otherwise
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 , foresee , 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 European
Medicines Agency ( EMA ), 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 information that 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 securities, 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 provide continuous disclosure information such as interim and annual
financial statements, MD&As, proxy circulars, annual reports 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 upon 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
Zentaris Inc. (Nasdaq: AEZS and TSX:
AEZ) is a late-stage oncology drug development company currently
investigating potential treatments for various cancers including colorectal,
ovarian, endometrial cancer, as well as multiple myeloma. Our innovative
approach of personalized medicine means tailoring treatments to a patient s
specific condition and unmet medical needs. The Company s deep pipeline is
drawn from our proprietary discovery unit providing constant and long-term
access to state-of-the-art therapeutic options.
The highest priorities for
the Company are perifosine, for which a Phase 3 program is ongoing in
multiple myeloma and in refractory advanced colorectal cancer, combined with a
Phase 2 program in a number of
different cancers, as well
as AEZS-108, for which a Phase 2 program is ongoing in advanced
endometrial and advanced ovarian cancer.
Additionally, we are
advancing AEZS-112, an oral anticancer agent which involves three mechanisms of
action (tubulin, topoisomerase II and angiogenesis inhibition) in Phase 1, as
well as several preclinical programs with novel targeted potential development
We are also advancing
Solorel, a ghrelin agonist, which is in Phase 3 trial as a growth hormone
stimulation test for the diagnosis of AGHD.
We are currently at a stage
in which some of our products and product candidates are being further
developed or marketed jointly with strategic partners.
Developments for the Three Months Ended September 30, 2010
Status of our drug pipeline
as at November 9, 2010
| Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | Commercial | |||||
| 120,000 compound library | AEZS-120 Prostate cancer vaccine (oncology) AEZS-129, 131 and 132 Erk & PI3K inhibitors (oncology) AEZS-127 ErPC (oncology) AEZS-123 Ghrelin receptor antagonist (endocrinology) AEZS-115 Non-peptide LHRH antagonists (endocrinology and/or oncology) | AEZS-112 (oncology) AEZS-130 Therapeutic in cancer cachexia and other indications (endocrinology) | Perifosine Multiple cancers AEZS-108 Ovarian cancer Endometrial cancer | Perifosine Multiple myeloma Refractory advanced colorectal cancer Solorel Diagnostic in adult growth hormone deficiency (endocrinology) | Cetrotide ( in vitro fertilization) | |||||
| Partners | ||||||||||
| Perifosine: Keryx North America Handok Korea | Perifosine: Keryx North America Handok Korea | Cetrotide : Merck Serono (World except Japan) Nippon Kayaku / Shionogi Japan |
Perifosine is a novel, oral
anticancer treatment that inhibits Akt activation in the phosphoinositide
3-kinase ( PI3K ) pathway. Perifosine, in combination with chemotherapeutic
agents, is currently in Phase 3 studies for the treatment of multiple
myeloma, colorectal cancer and in Phase 2 studies for the treatment of other