July 12, 2011
Aeterna Zentaris Granted Patent for Perifosine by European Patent Office
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.
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.
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.