QUEBEC CITY, May 6 /PRNewswire-FirstCall/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS, TSX: AEZ), ("the Company") a late-stage drug
development company specialized in oncology and endocrinology,
today announced that it has received from the U.S. Food and Drug
Administration (FDA), orphan-drug designation for AEZS-108, its
doxorubicin targeted conjugate compound, for the treatment of
ovarian cancer. AEZS-108 is currently in a Phase 2 trial in
advanced ovarian and advanced endometrial cancer in Europe.
Juergen Engel, Ph. D., President
and CEO of Aeterna Zentaris stated, "We are very pleased with
AEZS-108 gaining orphan-drug designation for ovarian cancer from
the FDA as it would provide it with extra market exclusivity
protection. We look forward to reporting the final results from our
ongoing European Phase 2 study in ovarian and endometrial cancer,
later this year."
About Orphan-Drug Designation
Orphan-drug designation is granted by the FDA Office of Orphan
Products Development to novel drugs or biologics that treat a rare
disease or condition affecting fewer than 200,000 patients in the
U.S. The designation provides the drug developer with a seven-year
period of U.S. marketing exclusivity if the drug is the first of
its type approved for the specified indication or if it
demonstrates superior safety, efficacy, or a major contribution to
patient care versus another drug of its type previously granted the
designation for the same indication. It also provides tax credits
for clinical research costs, the ability to apply for annual grant
funding, clinical research trial design assistance and waiver of
Prescription Drug User Fee Act (PDUFA) filing fees.
About Ovarian Cancer
Ovarian cancer is one of the most common gynaecologic
malignancies and the fifth most frequent cause of cancer death in
women, with most of the cases occurring in women between 50 and 75
years of age. Overall, ovarian cancer accounts for 4% of all cancer
diagnoses in women and 5% of all cancer deaths. Approximately
26,000 new cases and 17,000 deaths from this disease are estimated
in the European community every year (Source: Gynaecologic Oncology
2004; 92:819-26). The National Cancer Institute estimates that in
2009, in the United States alone,
there were 21,550 news cases of ovarian cancer and 14,600 related
deaths.
About AEZS-108
AEZS-108 represents a new targeting concept in oncology using a
cytotoxic peptide conjugate which is a hybrid molecule composed of
a synthetic peptide carrier and a well-known cytotoxic agent,
doxorubicin. The design of this product allows for the specific
binding and selective uptake of the cytotoxic conjugate by
LHRH-receptor-positive tumors. The binding of AEZS-108 to cancerous
cells that express these receptors results in its accumulation and
preferential uptake in the malignant tissue.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company
specialized in oncology and endocrine therapy. News releases and
additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties, which 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 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
the 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
except if we are required by a governmental authority or applicable
law.
SOURCE AETERNA ZENTARIS INC.