QUEBEC CITY, July 12, 2011 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced
that the European Patent Office ("EPO") has granted a patent for
the use of alkyl phosphocholines, more specifically perifosine
(octadecyl 1,1-dimethylpiperidino-4-yl phosphate), in the
preparation of a medicament for the treatment of benign and
malignant tumours, prior to and/or during the treatment with
approved anti-tumour anti-metabolites such as 5FU ("fluorouracil")
and capecitabine. Filed on July 29,
2003, the patent (EP #1 545 553) titled, "Use of Alkyl
Phosphocholines in Combination with Anti-Tumour Medicaments",
will be effective as of July 13,
2011, following its announcement in the European Patent
Bulletin, and will expire on July 28,
2023.
Juergen Engel, Ph.D., Aeterna
Zentaris President and Chief Executive Officer, commented, "The
patent protects the use of perifosine in combination with
capecitabine, not only in metastatic colorectal cancer, but also in
other cancer indications such as gastric and breast cancer where
capecitabine is also approved. The patent comes also at a time when
we are looking forward to the completion of the pivotal Phase 3
trials with perifosine in colorectal cancer and multiple
myeloma."
The above-mentioned invention has been filed as a counterpart
application in several countries, including the U.S. and
Canada. The examination procedure
of the counterpart applications is still pending or already
completed in certain countries. For example, granted patents
already exist in Australia,
China, Hong Kong, Mexico, New
Zealand, Taiwan and
Ukraine.
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits
Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The
product works by interfering with membranes of cancer cells thereby
inhibiting Akt signaling which then affects cell death, growth,
differentiation and survival. Perifosine, in combination with
chemotherapeutic agents, is currently being studied for the
treatment of multiple myeloma, colorectal cancer and other cancers,
and is the most advanced anticancer agent of its class. Perifosine,
as monotherapy, is being explored in other indications. The US Food
& Drug Administration ("FDA") has granted perifosine
orphan-drug designation in multiple myeloma and neuroblastoma, and
Fast Track designations in both multiple myeloma and refractory
advanced colorectal cancer. Additionally, an agreement was reached
with the FDA to conduct the Phase 3 trials in both of these
indications under a Special Protocol Assessment. Perifosine has
also been granted orphan medicinal product designation from the
European Medicines Agency ("EMA") in multiple myeloma. Furthermore,
perifosine has received positive Scientific Advice from the EMA for
both the multiple myeloma and advanced colorectal cancer programs,
with ongoing Phase 3 trials for these indications expected to be
sufficient for registration in Europe. Perifosine rights have been licensed
to Keryx Biopharmaceuticals for North
America, Yakult Honsha for Japan and to Handok for Korea.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development
company currently investigating potential treatments for various
cancers including colorectal, multiple myeloma, endometrial,
ovarian, prostate and bladder cancer. The Company's innovative
approach of "personalized medicine" means tailoring treatments to a
patient's specific condition and to unmet medical needs. Aeterna
Zentaris' deep pipeline is drawn from its proprietary discovery
unit providing the Company with constant and long-term access to
state-of-the-art therapeutic options. 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 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.