Aeterna Zentaris Granted Special Protocol Assessment by the FDA for Phase 3 Registration Trial in Endometrial Cancer with AEZS

 Aeterna Zentaris Granted Special Protocol Assessment by the FDA for Phase 3
            Registration Trial in Endometrial Cancer with AEZS-108

PR Newswire

QUÉBEC CITY, Dec. 28, 2012

QUÉBEC CITY, Dec. 28, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS)
(TSX:AEZ) (the "Company") today announced that it has reached an agreement
with the U.S. Food and Drug Administration ("FDA") on a Special Protocol
Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial
cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement
states that the proposed trial protocol design, clinical endpoints and planned
analyses are acceptable to the FDA to support a regulatory submission.

"We are pleased with the agreement with the FDA which provides us with a
clearly defined development and regulatory pathway for AEZS-108 in endometrial
cancer", stated Juergen Engel, PhD, President and CEO at Aeterna Zentaris.
"AEZS-108's innovative targeted approach could offer a new treatment option
for women with endometrial cancer and provide the Company with a significant
market opportunity."

Study Design

This will be an open-label, randomized, multicenter Phase 3 trial conducted in
North America and Europe, comparing AEZS-108 with doxorubicin as second line
therapy for locally-advanced, recurrent or metastatic endometrial cancer. The
trial will involve approximately 500 patients and the primary efficacy
endpoint is improvement in median Overall Survival.

About Special Protocol Assessments ("SPA")

The SPA process is a procedure by which the FDA provides official evaluation
and written guidance on the design and size of proposed protocols that are
intended to form the basis for a Biologics License Application ("BLA") or New
Drug Application ("NDA"). Final marketing approval depends on the results of
efficacy, the adverse event profile and an evaluation of the benefit/risk of
treatment demonstrated in the Phase 3 trial.

About AEZS-108

AEZS-108 represents a new targeting concept in oncology using a hybrid
molecule composed of a synthetic peptide carrier and a well-known chemotherapy
agent, doxorubicin. AEZS-108 is the first intravenous drug in advanced
clinical development that directs the chemotherapy agent specifically to
Luteinizing Hormone Releasing Hormone ("LHRH")-receptor expressing tumors,
resulting in more targeted treatment with less damage to healthy tissue. The
product has successfully completed Phase 2 studies for the treatment of
ovarian and endometrial cancer and the Company is currently planning a Phase 3
trial in endometrial cancer under a Special Protocol Assessment. AEZS-108 is
also in Phase 2 trials in prostate, breast and bladder cancer. AEZS-108 has
been granted orphan drug designation by the FDA and orphan medicinal product
designation from the European Medicines Agency for the treatment of ovarian
cancer. Aeterna Zentaris owns the worldwide rights to AEZS-108.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy and develops when
abnormal cells amass to form a tumor in the lining of the uterus. It largely
affects women over the age of 50 with a higher prevalence in Caucasians and a
higher mortality rate among African Americans. Approximately one in 30 women
is diagnosed with endometrial cancer every year. According to the American
Cancer Society, 47,130 new cases of endometrial are expected to be diagnosed
in the United States in 2012, and Data Monitor expects 35,600 new cases in 
EU-G5 in 2013, with about 20% recurrent disease.

About Aeterna Zentaris

Aeterna Zentaris is an oncology and endocrinology drug development company
currently investigating treatments for various unmet medical needs. The
Company's pipeline encompasses compounds at all stages of development, from
drug discovery through to marketed products. For more information please visit
www.aezsinc.com

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the
safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks and uncertainties
that could cause the Company's actual results to differ materially from those
in the forward-looking statements. Such risks and uncertainties include, among
others, the availability of funds and resources to pursue R&D projects, the
successful and timely completion of clinical studies, the risk that safety and
efficacy data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the
ability of the Company to take advantage of business opportunities in the
pharmaceutical industry, uncertainties related to the regulatory process and
general changes in economic conditions. Investors should consult the Company's
quarterly and annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties relating to
forward-looking statements. Investors are cautioned not to rely on these
forward-looking statements. The Company does not undertake to update these
forward-looking statements. We disclaim any obligation to update any such
factors or to publicly announce the result of 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.

SOURCE AETERNA ZENTARIS INC.

Contact:

Investor Relations
Ginette Beaudet Vallières
Investor Relations Coordinator
(418) 652-8525 ext. 265
gvallieres@aezsinc.com

Media Relations
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
 
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