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Management s Discussion and Analysis of Financial Condition and Results of Operations Highlights Perifosine

Key Takeaway: Management s Discussion and Analysis of Financial Condition and Results of Operations Highlights Perifosine June 1, 2009: Positive Phase 2 data on perifosine in advanced metastatic colon cancer and in advanced renal cell carcinoma were presented at the American Society of C

Full Press Release Details

Management s Discussion and
Analysis of Financial Condition and Results of Operations

Highlights

Perifosine

June 1, 2009: Positive Phase 2 data on perifosine in advanced
metastatic colon cancer and in advanced renal cell carcinoma were presented at
the American Society of Clinical Oncology s ( ASCO ) annual meeting. The data
demonstrated perifosine s anti-cancer activity and efficacy both as a single
agent and in combination therapy. Data were generated by our North American
partner, Keryx Biopharmaceuticals ( Keryx ).
August 3, 2009: An agreement was reached with the United States
Food and Drug Administration ( FDA ) regarding a Special Protocol Assessment ( SPA )
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 ). The Phase 3 trial is to be conducted by Keryx.
September 16, 2009: Perifosine was granted Orphan Drug designation
from the FDA for the treatment of multiple myeloma.
Perifosine was granted Fast Track designation by the FDA for the treatment of
relapsed/refractory multiple myeloma.
Updated positive Phase 2 efficacy and safety data, as well as new survival data
for perifosine in combination with bortezomib (Velcade ) (+/- dexamethasone) in patients with
relapsed/refractory multiple myeloma, were presented at the American Society of
Hematology s ( ASH ) annual meeting. Results showed that the overall response
rate was 41% and median overall survival was reported at 25 months for all
evaluable patients. The combination therapy maintained an acceptable safety
profile and no unexpected adverse events were reported. Data were presented by
December 16, 2009: The
Phase 3 registration clinical trial with perifosine in relapsed/refractory
multiple myeloma was initiated by Keryx.
May 31, 2009: Presentation at the ASCO s Annual Meeting of results
supporting the evaluation of AEZS-108 in prostate cancer.
Disclosure of positive preliminary results for the Phase 2 study with AEZS-108
in patients with platinum-resistant and taxane-pretreated ovarian cancer.
Disclosure of positive efficacy data from a Phase 2 study with AEZS-108 in
patients with advanced or recurrent endometrial cancer.
September 21, 2009: Disclosure of 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 cancer.

AEZS-130

June 11, 2009: Poster presentation on AEZS-130 (SolorelTM) at the annual meeting of the Endocrine Society,
reporting the first clinical data
relating to the use of AEZS-130 (SolorelTM) as a simple diagnostic test for adult growth hormone
August 17, 2009: Disclosure of results from two Phase 3 studies with cetrorelix in benign prostatic hyperplasia ( BPH ). The efficacy study
Z-033 (mainly conducted in North America) 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.
Disclosure of Phase 3 results for our European efficacy trial Z-036 in BPH with
cetrorelix. The study did not reach its primary endpoint.
Corporate Developments
June 23, 2009: Completion of a registered direct offering of
US$10.0 million to certain U.S. institutional investors.
Completion of a US$5.5 million registered direct offering with U.S.
institutional investors.
Appointment of Pierre Lapalme to our Board of Directors.
Development, Commercialization and License Agreement
March 4, 2009: Announcement of a development, commercialization and
licensing agreement with sanofi-aventis U.S. LLC ( sanofi ) for the
development, registration and marketing of cetrorelix in BPH for the U.S.
market. The agreement provided us with a $30.0 million gross upfront
Announcement of the termination of our agreement with sanofi for the
development, commercialization and licensing of cetrorelix in BPH for the U.S.
market, subsequent to negative Phase 3 results.
Subsequent to Year-End
January 22, 2010: Notification from NASDAQ
indicating that we were not in compliance with the minimum closing bid price
January 25, 2010: Updated results of a
Phase 2 study of perifosine in the treatment of advanced metastatic colon
cancer showing a statistically significant benefit in survival, were reported
January 27, 2010: Our partner, Spectrum
Pharmaceuticals, Inc. ( Spectrum ) announced the discontinuation of its
development program for ozarelix in BPH.
January 29, 2010: A publication in the February 2010
issue of the Journal of Clinical Cancer Research
reported positive Phase 2 results for perifosine as a single agent for the
treatment of advanced Waldenstrom s macroglobulinemia.
February 3, 2010: The FDA granted a SPA
for the Phase 3 trial of perifosine in combination with capecitabine (Xeloda ) in refractory metastatic colorectal cancer. The
trial is to be conducted by Keryx.
March 1, 2010: Disclosure that the
Committee for Orphan Medicinal Products of the European Medicines Agency issued
a positive opinion for orphan medicinal product designation for perifosine for
the treatment of multiple myeloma.
March 12, 2010: We filed a Canadian
short-form base shelf prospectus, as well as a registration statement on Form F-3
with the United States Securities and Exchange Commission ( SEC ), which were
declared effective by both the Canadian authorities and the SEC, and which
would permit us to issue up to $60.0 million of freely tradeable common
shares and warrants to purchase common shares.

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 year ended December 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 consolidated financial statements and related notes as at and for the
years ended December 31, 2009, 2008 and 2007. 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
Last updated: Mar 25, 2010