All amounts are in US dollars
QUÉBEC CITY, April 10, 2013 /PRNewswire/ - Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the signing
of a co-development and profit sharing agreement with Ergomed Clinical
Research Ltd. ("Ergomed") for AEZS-108 in endometrial cancer. Ergomed
was selected as the contract clinical development organization to
conduct the multicenter, multinational, randomized Phase 3 trial with
AEZS-108 in endometrial cancer.
Under the terms of the agreement, Ergomed will assume 30% (up to $10
million) of the clinical and regulatory costs for the Phase 3 trial
with AEZS-108 in endometrial cancer, which are estimated at
approximately $30 million over the course of the study. Ergomed will
receive its return on investment based on an agreed single digit
percentage of any net income received by Aeterna Zentaris for AEZS-108
in this indication, up to a specified maximum amount.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We
look forward to working with Ergomed which has a proven track record of
delivering cost effective and efficient drug development services
worldwide. This agreement is part of our non-dilutive strategy aimed at
minimizing R&D costs while maximizing drug development efficiency. Our
goal for AEZS-108 with this collaboration, is to provide a much needed
new treatment option to women with late-stage endometrial cancer."
Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are delighted to
co-invest with Aeterna Zentaris in the development of AEZS-108 which
has shown promising results in Phase 2 trials to date. This agreement
is the fifth co-development deal we have signed to date, and
demonstrates again the attractive alternative it offers to
sophisticated drug developers, as they look to maximise investment
returns. Ergomed is now established as one of the leading companies
worldwide offering and completing deals under this innovative model."
This will be an open-label, randomized, multicenter Phase 3 trial
conducted in North America, Europe, Israel and other countries under a
Special Protocol Assessment, 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
For more information on this trial, go to www.clinicaltrials.gov NCT 01767155.
About AEZS-108 (doxorubicin peptide conjugate)
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 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 triple-negative breast cancer,
prostate cancer 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, an
estimated 49,560 new cases of endometrial cancer in the U.S., and
35,600 in Europe, are expected during 2013, with about 20% of recurring
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, visit www.aezsinc.com.
Ergomed offers clinical development services for the biotechnology and
pharmaceutical industry specializing in therapeutics for oncology,
neurology and immunology. Ergomed also engages in shared risk ventures
through co-development agreements. With its global infrastructure in
Western and Eastern Europe, the Middle East and North America, Ergomed
offers cost effective and efficient drug development. For further
information, visit www.ergomed-cro.com.
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.